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Synopsis

Synopsis

Chemistry

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Also known as: Nn9535, Ozempic, Rybelsus, 910463-68-2, Nn 9535, Nnc 0113-0217
Molecular Formula
C187H291N45O59
Molecular Weight
4114  g/mol
InChI Key
DLSWIYLPEUIQAV-CCUURXOWSA-N

Semaglutide
1 2D Structure

Semaglutide

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
18-[[(1R)-4-[2-[2-[2-[2-[2-[2-[[(5S)-5-[[(2S)-2-[[(2S)-2-[[(2S)-5-amino-2-[[2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-2-[[(2S,3R)-2-[[2-[[(2S)-2-[[2-[[(2S)-2-amino-3-(1H-imidazol-5-yl)propanoyl]amino]-2-methylpropanoyl]amino]-4-carboxybutanoyl]amino]acetyl]amino]-3-hydroxybutanoyl]amino]-3-phenylpropanoyl]amino]-3-hydroxybutanoyl]amino]-3-hydroxypropanoyl]amino]-3-carboxypropanoyl]amino]-3-methylbutanoyl]amino]-3-hydroxypropanoyl]amino]-3-hydroxypropanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-4-methylpentanoyl]amino]-4-carboxybutanoyl]amino]acetyl]amino]-5-oxopentanoyl]amino]propanoyl]amino]propanoyl]amino]-6-[[(2S)-1-[[(2S)-1-[[(2S,3S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-5-carbamimidamido-1-[[2-[[(2S)-5-carbamimidamido-1-(carboxymethylamino)-1-oxopentan-2-yl]amino]-2-oxoethyl]amino]-1-oxopentan-2-yl]amino]-3-methyl-1-oxobutan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino]-1-oxopropan-2-yl]amino]-3-methyl-1-oxopentan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-4-carboxy-1-oxobutan-2-yl]amino]-6-oxohexyl]amino]-2-oxoethoxy]ethoxy]ethylamino]-2-oxoethoxy]ethoxy]ethylamino]-1-carboxy-4-oxobutyl]amino]-18-oxooctadecanoic acid
2.1.2 InChI
InChI=1S/C187H291N45O59/c1-18-105(10)154(180(282)208-108(13)159(261)216-133(86-114-89-200-119-50-40-39-49-117(114)119)170(272)218-129(82-102(4)5)171(273)228-152(103(6)7)178(280)215-121(53-44-72-199-186(192)193)162(264)201-91-141(242)209-120(52-43-71-198-185(190)191)161(263)204-94-151(257)258)230-172(274)131(83-111-45-33-31-34-46-111)219-167(269)126(64-69-149(253)254)214-166(268)122(51-41-42-70-195-144(245)98-290-79-78-289-76-74-197-145(246)99-291-80-77-288-75-73-196-139(240)66-61-127(183(285)286)211-140(241)54-37-29-27-25-23-21-19-20-22-24-26-28-30-38-55-146(247)248)212-158(260)107(12)206-157(259)106(11)207-165(267)125(60-65-138(189)239)210-142(243)92-202-163(265)123(62-67-147(249)250)213-168(270)128(81-101(2)3)217-169(271)130(85-113-56-58-116(238)59-57-113)220-175(277)135(95-233)223-177(279)137(97-235)224-179(281)153(104(8)9)229-174(276)134(88-150(255)256)221-176(278)136(96-234)225-182(284)156(110(15)237)231-173(275)132(84-112-47-35-32-36-48-112)222-181(283)155(109(14)236)227-143(244)93-203-164(266)124(63-68-148(251)252)226-184(287)187(16,17)232-160(262)118(188)87-115-90-194-100-205-115/h31-36,39-40,45-50,56-59,89-90,100-110,118,120-137,152-156,200,233-238H,18-30,37-38,41-44,51-55,60-88,91-99,188H2,1-17H3,(H2,189,239)(H,194,205)(H,195,245)(H,196,240)(H,197,246)(H,201,264)(H,202,265)(H,203,266)(H,204,263)(H,206,259)(H,207,267)(H,208,282)(H,209,242)(H,210,243)(H,211,241)(H,212,260)(H,213,270)(H,214,268)(H,215,280)(H,216,261)(H,217,271)(H,218,272)(H,219,269)(H,220,277)(H,221,278)(H,222,283)(H,223,279)(H,224,281)(H,225,284)(H,226,287)(H,227,244)(H,228,273)(H,229,276)(H,230,274)(H,231,275)(H,232,262)(H,247,248)(H,249,250)(H,251,252)(H,253,254)(H,255,256)(H,257,258)(H,285,286)(H4,190,191,198)(H4,192,193,199)/t105-,106-,107-,108-,109+,110+,118-,120-,121-,122-,123-,124-,125-,126-,127+,128-,129-,130-,131-,132-,133-,134-,135-,136-,137-,152-,153-,154-,155-,156-/m0/s1
2.1.3 InChI Key
DLSWIYLPEUIQAV-CCUURXOWSA-N
2.1.4 Canonical SMILES
CCC(C)C(C(=O)NC(C)C(=O)NC(CC1=CNC2=CC=CC=C21)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)O)NC(=O)C(CC3=CC=CC=C3)NC(=O)C(CCC(=O)O)NC(=O)C(CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CCC(C(=O)O)NC(=O)CCCCCCCCCCCCCCCCC(=O)O)NC(=O)C(C)NC(=O)C(C)NC(=O)C(CCC(=O)N)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CC4=CC=C(C=C4)O)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(C(C)C)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CC5=CC=CC=C5)NC(=O)C(C(C)O)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)(C)NC(=O)C(CC6=CN=CN6)N
2.1.5 Isomeric SMILES
CC[C@H](C)[C@@H](C(=O)N[C@@H](C)C(=O)N[C@@H](CC1=CNC2=CC=CC=C21)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCNC(=N)N)C(=O)NCC(=O)N[C@@H](CCCNC(=N)N)C(=O)NCC(=O)O)NC(=O)[C@H](CC3=CC=CC=C3)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CC[C@H](C(=O)O)NC(=O)CCCCCCCCCCCCCCCCC(=O)O)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)N)NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC4=CC=C(C=C4)O)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CC5=CC=CC=C5)NC(=O)[C@H]([C@@H](C)O)NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)C(C)(C)NC(=O)[C@H](CC6=CN=CN6)N
2.2 Synonyms
2.2.1 MeSH Synonyms

1. Ozempic

2. Rybelsus

2.2.2 Depositor-Supplied Synonyms

1. Nn9535

2. Ozempic

3. Rybelsus

4. 910463-68-2

5. Nn 9535

6. Nnc 0113-0217

7. Nn-9535

8. Unii-53axn4nnhx

9. Semaglutide [usan:inn]

10. Wegovy

11. 53axn4nnhx

12. Rybelsus (oral Semaglutide)

13. Gtpl9724

14. Ozempic (injectable Semaglutide)

15. Chebi:167574

16. Ex-a2424

17. Ac-32580

18. Nnc-0113-0217

19. Rybelsus;ozempic;nn9535;og217sc;nnc 0113-0217

2.3 Create Date
2012-03-21
3 Chemical and Physical Properties
Molecular Weight 4114 g/mol
Molecular Formula C187H291N45O59
XLogP3-5.8
Hydrogen Bond Donor Count57
Hydrogen Bond Acceptor Count63
Rotatable Bond Count151
Exact Mass4112.1187318 g/mol
Monoisotopic Mass4111.1153770 g/mol
Topological Polar Surface Area1650 Ų
Heavy Atom Count291
Formal Charge0
Complexity9590
Isotope Atom Count0
Defined Atom Stereocenter Count30
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:

- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications;

- in addition to other medicinal products for the treatment of diabetes.

For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4. 4, 4. 5 and 5. 1.


Treatment of obesity


Treatment of type II diabetes mellitus


Rybelsus is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise

- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications

- in combination with other medicinal products for the treatment of diabetes.

For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4. 4, 4. 5 and 5. 1.


Treatment of type II diabetes mellitus


Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of

- 30 kg/m (obesity), or

- 27 kg/m to < 30 kg/m (overweight) in the presence of at least one weight-related comorbidity e. g. dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.


5 Pharmacology and Biochemistry
5.1 FDA Pharmacological Classification
5.1.1 Pharmacological Classes
Glucagon-Like Peptide 1 [CS]; Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]; GLP-1 Receptor Agonist [EPC]
5.2 ATC Code

A10BJ06


A10BJ06


A10BJ06


A - Alimentary tract and metabolism

A10 - Drugs used in diabetes

A10B - Blood glucose lowering drugs, excl. insulins

A10BJ - Glucagon-like peptide-1 (glp-1) analogues

A10BJ06 - Semaglutide


API SUPPLIERS

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Bachem AG

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Supriya Lifescience

India

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Chunghwa Chemical Synthesis & Biot...

Taiwan

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ChemWerth Inc

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Transo-Pharm USA LLC

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LGM Pharma

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Transo-Pharm Handels GmbH

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Inabata France S.A.S

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Rochem International Inc

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USDMF

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Bachem Ag

Switzerland
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GDUFA

DMF Review : Complete

Rev. Date : 2024-04-30

Pay. Date : 2023-03-02

DMF Number : 37594

Submission : 2023-03-16

Status : Active

Type : II

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Ambiopharm Inc

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DMF Review : Complete

Rev. Date : 2021-09-21

Pay. Date : 2021-06-10

DMF Number : 36015

Submission : 2021-08-06

Status : Active

Type : II

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Switzerland

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Polypeptide Sa

Switzerland
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DMF Review : Complete

Rev. Date : 2023-08-31

Pay. Date : 2023-03-27

DMF Number : 38177

Submission : 2023-08-02

Status : Active

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Switzerland

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Polypeptide Sa

Switzerland
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DMF Number : 36101

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DMF Number : 36009

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Rev. Date : 2021-12-20

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DMF Number : 36273

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Semaglutide

Registrant Name : Otran Pharm Korea Co., Ltd.

Registration Date : 2024-02-05

Registration Number : 20240205-210-J-1604

Manufacturer Name : Sinopep-Allsino Biopharmaceu...

Manufacturer Address : No. 28, Linpu Road, Economic & Technological Development Zone, Lianyungang, Jiangsu P...

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Semaglutide

Registrant Name : Sampoong Finechem Co., Ltd.

Registration Date : 2024-07-03

Registration Number : 20240205-210-J-1604(1)

Manufacturer Name : Sinopep-Allsino Biopharmaceu...

Manufacturer Address : No. 28, Linpu Road, Economic & Technological Development Zone, Lianyungang, Jiangsu P...

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Semaglutide

Registrant Name : Iksoo Pharmaceutical Co., Ltd.

Registration Date : 2024-09-13

Registration Number : 69-18-ND

Manufacturer Name : Zhejiang Peptites Biotech Co...

Manufacturer Address : No.8, Hengyizhi Road, Sanjie Town, Shengzhou City, Shaoxing City, Zhejiang Province, ...

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API Reference Price

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CHEMEXCEL INTERNATIONAL (ASIA) LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"BDR PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.25","actualQuantity":"250","unit":"GMS","unitRateFc":"315","totalValueFC":"79653.4","currency":"USD","unitRateINR":"26633.3","date":"29-Jul-2024","totalValueINR":"6658312.5","totalValueInUsd":"79653.4","indian_port":"Bombay Air","hs_no":"29371900","bill_no":"4753952","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"ROOM 910, 225 XIN JINQIAO ROADPUDONG SHANGHAI 201206CHINA CN","customerAddress":"407\/408,SHARDA CHAMBERS,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722191400,"product":"SEMAGLUTIDE, CAS NO. 910463-68-2, BATCH NO. 240501KF","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"HANGZHOU ZHONGMEIHUADONG PHARMACEUT","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"100","unit":"GMS","unitRateFc":"320","totalValueFC":"32367.1","currency":"USD","unitRateINR":"27056","date":"29-Jul-2024","totalValueINR":"2705600","totalValueInUsd":"32367.1","indian_port":"Delhi Air","hs_no":"29379090","bill_no":"4768317","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"ICAL JIANGDONG CO., LTD.NO. 7278 MEILIN AVENUE, DAJIANGDONGINDUSTRIALCLUSTER ZONE HANGZHOU CHINA","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722277800,"product":"SEMAGLUTIDE","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"SINOPEP ALLSINO BIOPHARMACEUTICAL ","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CIPLA","customerCountry":"INDIA","quantity":"0.57","actualQuantity":"570","unit":"GMS","unitRateFc":"600","totalValueFC":"345923.3","currency":"USD","unitRateINR":"50730","date":"30-Jul-2024","totalValueINR":"28916100","totalValueInUsd":"345923.3","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"4780024","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.28 LINPU ROAD LIANYUNGANGINDUSTRIAL AREA ECO AND TECHDEVELOPMENT ZO1NE, 222000 CHINA","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723141800,"product":"SEMAGLUTIDE INTERMEDIATE(SE02)","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,,","city":"AHMEDABAD,GUJARAT","supplier":"ZHEJIANG Z-STAR PHARMA CO., LTD.","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"100","unit":"GMS","unitRateFc":"53","totalValueFC":"5345.6","currency":"USD","unitRateINR":"4483.8","date":"09-Aug-2024","totalValueINR":"448380","totalValueInUsd":"5345.6","indian_port":"Bombay Air","hs_no":"29371900","bill_no":"4976302","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"ROOM1507,EAST NO.1 BLDG.,TENGDA CENTRAL NO.1800 DONGHAI ROAD,BAIYUN STREET, JIAOJIANG DISTRICT,TAIZHOU CI China","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723401000,"product":"SEMAGLUTIDE INTERMEDIATE","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,,","city":"AHMEDABAD,GUJARAT","supplier":"HUADONG MICROBIOLOGY CO.,LTD.","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.20","actualQuantity":"200","unit":"GMS","unitRateFc":"34","totalValueFC":"6858.5","currency":"USD","unitRateINR":"2876.4","date":"12-Aug-2024","totalValueINR":"575280","totalValueInUsd":"6858.5","indian_port":"Bombay Air","hs_no":"29371900","bill_no":"5017548","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"ROOM 2303,BUILDING 1,KAIXUAN ROAD 399,CHANGNING DISTRICT, SHANGHAI,CHI China","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723573800,"product":"TBUO-STE-GLU(AEEA-AEEA-OH)-OTBU (SEMAGLUTIDE SIDE CHAIN) CAS: 1118767-16-0 (1 BOTTLE) (LAB CHEMICALS)","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"CHEMTOUR BIOTECH SUZHOU ","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"18000","totalValueFC":"1815.5","currency":"USD","unitRateINR":"1522800","date":"14-Aug-2024","totalValueINR":"152280","totalValueInUsd":"1815.5","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"5046915","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"41-1402, CECEP, NO.18 DONGCHANGROAD SUZHOU INDUSTRIAL PARK,JIANGSU PROVINCE CHINA","customerAddress":"ALEMBIC ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724956200,"product":"SEMAGLUTIDE ( QTY 0.200 KGS) FOR R&D USEAGE ONLY , BY CHEMICAL SYTHESIS","address":"505 SAFAL PRELUDE, SATELLITE","city":"AHMEDABAD GUJARAT","supplier":"SUZHOU LIXIN PHARMACEUTICAL CO ., LTD","supplierCountry":"CHINA","foreign_port":"SUZHOU","customer":"FTF PHARMA PRIVATE ","customerCountry":"INDIA","quantity":"0.20","actualQuantity":"0.2","unit":"KGS","unitRateFc":"175000","totalValueFC":"35405.4","currency":"USD","unitRateINR":"14848750","date":"30-Aug-2024","totalValueINR":"2969750","totalValueInUsd":"35405.4","indian_port":"Ahmedabad Air","hs_no":"29332990","bill_no":"5337415","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SUZHOU","supplierAddress":"NO 21 TANGXI ROAD SUZHOU NEW DISTRICT 25151 PR CHINASDNF CHINA","customerAddress":"505 SAFAL PRELUDE, SATELLITE"}]
27-Feb-2021
30-Aug-2024
KGS
overview
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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FDF Dossiers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Semaglutide

Brand Name :

Dosage Form : Subcutaneous Pen

Dosage Strength : 0.25MG/0.5ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Supriya

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Semaglutide

Brand Name :

Dosage Form : Subcutaneous Pen

Dosage Strength : 0.5MG/0.5ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Supriya

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Semaglutide

Brand Name :

Dosage Form : Subcutaneous Pen

Dosage Strength : 1MG/0.5ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Supriya

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Semaglutide

Brand Name :

Dosage Form : Subcutaneous Pen

Dosage Strength : 1.7MG/0.75ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Supriya

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Semaglutide

Brand Name :

Dosage Form : Subcutaneous Pen

Dosage Strength : 2.4MG/0.75ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Supriya

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Semaglutide

Brand Name :

Dosage Form : Tablet

Dosage Strength : 14MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Supriya

07

Pharmathen SA

Greece
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Flag Greece
Digital Content Digital Content

Regulatory Info : USA

Registration Country : Greece

Semaglutide

Brand Name :

Dosage Form : Tablet

Dosage Strength : 3MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Pharmathen

08

Pharmathen SA

Greece
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Flag Greece
Digital Content Digital Content

Regulatory Info : USA

Registration Country : Greece

Semaglutide

Brand Name :

Dosage Form : Tablet

Dosage Strength : 7MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Pharmathen

09

Pharmathen SA

Greece
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Flag Greece
Digital Content Digital Content

Regulatory Info : USA

Registration Country : Greece

Semaglutide

Brand Name :

Dosage Form : Tablet

Dosage Strength : 14MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Pharmathen

10

Pharmathen SA

Greece
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Flag Greece
Digital Content Digital Content

Regulatory Info : USA

Registration Country : Greece

Semaglutide

Brand Name :

Dosage Form : Injection For Subcutaneous Use

Dosage Strength : 2MG/1.5ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Pharmathen
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FDA Orange Book

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01

NOVO

Denmark
Luxepack
Not Confirmed
arrow

NOVO

Denmark
arrow
Luxepack
Not Confirmed

SEMAGLUTIDE

Brand Name : OZEMPIC

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : 2MG/1.5ML (1.34MG/ML)

Approval Date : 2017-12-05

Application Number : 209637

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank

02

NOVO

Denmark
Luxepack
Not Confirmed
arrow

NOVO

Denmark
arrow
Luxepack
Not Confirmed

SEMAGLUTIDE

Brand Name : OZEMPIC

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : 4MG/3ML (1.34MG/ML)

Approval Date : 2019-04-09

Application Number : 209637

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank

03

NOVO

Denmark
Luxepack
Not Confirmed
arrow

NOVO

Denmark
arrow
Luxepack
Not Confirmed

SEMAGLUTIDE

Brand Name : OZEMPIC

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : 8MG/3ML (2.68MG/ML)

Approval Date : 2022-03-28

Application Number : 209637

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank

04

NOVO

Denmark
Luxepack
Not Confirmed
arrow

NOVO

Denmark
arrow
Luxepack
Not Confirmed

SEMAGLUTIDE

Brand Name : OZEMPIC

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : 2MG/3ML (0.68MG/ML)

Approval Date : 2022-10-06

Application Number : 209637

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank

05

NOVO

Denmark
Luxepack
Not Confirmed
arrow

NOVO

Denmark
arrow
Luxepack
Not Confirmed

SEMAGLUTIDE

Brand Name : RYBELSUS

Dosage Form : TABLET;ORAL

Dosage Strength : 3MG

Approval Date : 2019-09-20

Application Number : 213051

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank

06

NOVO

Denmark
Luxepack
Not Confirmed
arrow

NOVO

Denmark
arrow
Luxepack
Not Confirmed

SEMAGLUTIDE

Brand Name : RYBELSUS

Dosage Form : TABLET;ORAL

Dosage Strength : 7MG

Approval Date : 2019-09-20

Application Number : 213051

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank

07

NOVO

Denmark
Luxepack
Not Confirmed
arrow

NOVO

Denmark
arrow
Luxepack
Not Confirmed

SEMAGLUTIDE

Brand Name : RYBELSUS

Dosage Form : TABLET;ORAL

Dosage Strength : 14MG

Approval Date : 2019-09-20

Application Number : 213051

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank

08

Luxepack
Not Confirmed
arrow
arrow
Luxepack
Not Confirmed

SEMAGLUTIDE

Brand Name : RYBELSUS

Dosage Form : TABLET;ORAL

Dosage Strength : 3MG

Approval Date :

Application Number : 213182

RX/OTC/DISCN :

RLD :

TE Code :

blank

09

NOVO

Denmark
Luxepack
Not Confirmed
arrow

NOVO

Denmark
arrow
Luxepack
Not Confirmed

SEMAGLUTIDE

Brand Name : WEGOVY

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : 1MG/0.5ML (1MG/0.5ML)

Approval Date : 2021-06-04

Application Number : 215256

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank

10

NOVO

Denmark
Luxepack
Not Confirmed
arrow

NOVO

Denmark
arrow
Luxepack
Not Confirmed

SEMAGLUTIDE

Brand Name : WEGOVY

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : 1.7MG/0.75ML (1.7MG/0.75ML)

Approval Date : 2021-06-04

Application Number : 215256

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank
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Europe

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01

Luxepack
Not Confirmed
arrow
arrow
Luxepack
Not Confirmed

Semaglutide

Brand Name : Ozempic DualDose

Dosage Form : Inj L?s

Dosage Strength : 2mg/1.5ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

02

Luxepack
Not Confirmed
arrow
arrow
Luxepack
Not Confirmed

Semaglutide

Brand Name : Ozempic FixDose

Dosage Form : Inj L?s

Dosage Strength : 4mg/3ml(1mg/dose)

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

03

Luxepack
Not Confirmed
arrow
arrow
Luxepack
Not Confirmed

Semaglutide

Brand Name : Rybelsus

Dosage Form : Tabl

Dosage Strength : 14mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

04

Luxepack
Not Confirmed
arrow
arrow
Luxepack
Not Confirmed

Semaglutide

Brand Name : Rybelsus

Dosage Form : Tabl

Dosage Strength : 14mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

05

Luxepack
Not Confirmed
arrow
arrow
Luxepack
Not Confirmed

Semaglutide

Brand Name : Rybelsus

Dosage Form : Tablet

Dosage Strength : 7mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

06

Luxepack
Not Confirmed
arrow
arrow
Luxepack
Not Confirmed

Semaglutide

Brand Name : Rybelsus

Dosage Form : Tablet

Dosage Strength : 7mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

07

Luxepack
Not Confirmed
arrow
arrow
Luxepack
Not Confirmed

Semaglutide

Brand Name : Wegovy

Dosage Form : Multi Fixdose Inj L?s

Dosage Strength : 0.25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

08

Luxepack
Not Confirmed
arrow
arrow
Luxepack
Not Confirmed

Semaglutide

Brand Name : Wegovy

Dosage Form : Multi Fixdose Inj Solution

Dosage Strength : 0.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

09

Luxepack
Not Confirmed
arrow
arrow
Luxepack
Not Confirmed

Semaglutide

Brand Name : Wegovy

Dosage Form : Multi Fixdose Inj Solution

Dosage Strength : 1.7mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

10

Luxepack
Not Confirmed
arrow
arrow
Luxepack
Not Confirmed

Semaglutide

Brand Name : Wegovy

Dosage Form : Multi Fixdose Inj Solution

Dosage Strength : 1mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank
click full view
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Canada

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01

Luxepack
Not Confirmed
arrow
arrow
Luxepack
Not Confirmed

SEMAGLUTIDE

Brand Name : RYBELSUS

Dosage Form : TABLET

Dosage Strength : 3MG

Packaging : 30

Approval Date :

Application Number : 2497581

Regulatory Info : Prescription

Registration Country : Canada

blank

02

Luxepack
Not Confirmed
arrow
arrow
Luxepack
Not Confirmed

SEMAGLUTIDE

Brand Name : RYBELSUS

Dosage Form : TABLET

Dosage Strength : 7MG

Packaging : 30

Approval Date :

Application Number : 2497603

Regulatory Info : Prescription

Registration Country : Canada

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03

Luxepack
Not Confirmed
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SEMAGLUTIDE

Brand Name : RYBELSUS

Dosage Form : TABLET

Dosage Strength : 14MG

Packaging : 30

Approval Date :

Application Number : 2497611

Regulatory Info : Prescription

Registration Country : Canada

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04

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

SEMAGLUTIDE

Brand Name : OZEMPIC

Dosage Form : SOLUTION

Dosage Strength : 1MG/ACT

Packaging : 2 X2MG/PEN

Approval Date :

Application Number : 2471469

Regulatory Info : Prescription

Registration Country : Canada

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05

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

SEMAGLUTIDE

Brand Name : OZEMPIC

Dosage Form : SOLUTION

Dosage Strength : 1.34MG/ML

Packaging : 1X 2MG/PEN

Approval Date :

Application Number : 2471477

Regulatory Info : Prescription

Registration Country : Canada

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06

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

SEMAGLUTIDE

Brand Name : WEGOVY

Dosage Form : SOLUTION

Dosage Strength : 1MG/1.5ML

Packaging :

Approval Date :

Application Number : 2528509

Regulatory Info : Prescription

Registration Country : Canada

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07

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

SEMAGLUTIDE

Brand Name : WEGOVY

Dosage Form : SOLUTION

Dosage Strength : 2MG/1.5ML

Packaging :

Approval Date :

Application Number : 2528517

Regulatory Info : Prescription

Registration Country : Canada

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08

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

SEMAGLUTIDE

Brand Name : WEGOVY

Dosage Form : SOLUTION

Dosage Strength : 4MG/3ML

Packaging :

Approval Date :

Application Number : 2528525

Regulatory Info : Prescription

Registration Country : Canada

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09

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

SEMAGLUTIDE

Brand Name : WEGOVY

Dosage Form : SOLUTION

Dosage Strength : 6.8MG/3ML

Packaging :

Approval Date :

Application Number : 2528533

Regulatory Info : Prescription

Registration Country : Canada

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Luxepack
Not Confirmed
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Not Confirmed

SEMAGLUTIDE

Brand Name : WEGOVY

Dosage Form : SOLUTION

Dosage Strength : 9.6MG/3ML

Packaging :

Approval Date :

Application Number : 2528541

Regulatory Info : Prescription

Registration Country : Canada

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Australia

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01

Discovery on Target
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semaglutide

Brand Name : Ozempic

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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02

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

semaglutide

Brand Name : Ozempic

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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03

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

semaglutide

Brand Name : Ozempic

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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04

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

semaglutide

Brand Name : Ozempic

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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DRUG PRODUCT COMPOSITIONS

Do you need Business Intel? Ask us

DOSAGE - SOLUTION;SUBCUTANEOUS - 2MG/3ML (0.6...DOSAGE - SOLUTION;SUBCUTANEOUS - 2MG/3ML (0.68MG/ML)

USFDA APPLICATION NUMBER - 209637

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DOSAGE - SOLUTION;SUBCUTANEOUS - 2MG/1.5ML (1...DOSAGE - SOLUTION;SUBCUTANEOUS - 2MG/1.5ML (1.34MG/ML)

USFDA APPLICATION NUMBER - 209637

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DOSAGE - SOLUTION;SUBCUTANEOUS - 4MG/3ML (1.3...DOSAGE - SOLUTION;SUBCUTANEOUS - 4MG/3ML (1.34MG/ML)

USFDA APPLICATION NUMBER - 209637

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DOSAGE - SOLUTION;SUBCUTANEOUS - 8MG/3ML (2.6...DOSAGE - SOLUTION;SUBCUTANEOUS - 8MG/3ML (2.68MG/ML)

USFDA APPLICATION NUMBER - 209637

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Patents & EXCLUSIVITIES

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US Patents

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01

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Not Confirmed

NOVO

Denmark
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SEMAGLUTIDE

US Patent Number : 9132239

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 209637

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-02-01

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02

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Luxepack
Not Confirmed

NOVO

Denmark
arrow
Luxepack
Not Confirmed

SEMAGLUTIDE

US Patent Number : 11382957

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 213051

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-12-16

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03

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Luxepack
Not Confirmed

NOVO

Denmark
arrow
Luxepack
Not Confirmed

SEMAGLUTIDE

US Patent Number : 10376652

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 209637

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2026-01-20

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04

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Luxepack
Not Confirmed

NOVO

Denmark
arrow
Luxepack
Not Confirmed

SEMAGLUTIDE

US Patent Number : 11318191

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 215256

Patent Use Code : U-3162

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2041-02-17

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05

arrow
Luxepack
Not Confirmed

NOVO

Denmark
arrow
Luxepack
Not Confirmed

SEMAGLUTIDE

US Patent Number : 11097063

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 209637

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2026-07-17

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06

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Luxepack
Not Confirmed

NOVO

Denmark
arrow
Luxepack
Not Confirmed

SEMAGLUTIDE

US Patent Number : 9457154

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 209637

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-09-29

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07

arrow
Luxepack
Not Confirmed

NOVO

Denmark
arrow
Luxepack
Not Confirmed

SEMAGLUTIDE

US Patent Number : 9616180

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 209637

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2026-01-20

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08

arrow
Luxepack
Not Confirmed

NOVO

Denmark
arrow
Luxepack
Not Confirmed

SEMAGLUTIDE

US Patent Number : 11759503

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 213051

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-03-15

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09

arrow
Luxepack
Not Confirmed

NOVO

Denmark
arrow
Luxepack
Not Confirmed

SEMAGLUTIDE

US Patent Number : 10888605

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 215256

Patent Use Code : U-3162

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-08-24

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10

arrow
Luxepack
Not Confirmed

NOVO

Denmark
arrow
Luxepack
Not Confirmed

SEMAGLUTIDE

US Patent Number : 9278123

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 213051

Patent Use Code : U-2628

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-12-16

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