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Also known as: 74381-53-6, Leuprorelin acetate;h-pyr-his-trp-ser-tyr-d-leu-leu-arg-pro-nhet.ch3co2h, Lupron (tn), Mfcd00072080, Fensolvi (tn), Eligard (tn)
Molecular Formula
C61H88N16O14
Molecular Weight
1269.4  g/mol
InChI Key
RGLRXNKKBLIBQS-UHFFFAOYSA-N

Leuprolide Acetate
1 2D Structure

Leuprolide Acetate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
acetic acid;N-[1-[[1-[[1-[[1-[[1-[[1-[[5-(diaminomethylideneamino)-1-[2-(ethylcarbamoyl)pyrrolidin-1-yl]-1-oxopentan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-3-(4-hydroxyphenyl)-1-oxopropan-2-yl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino]-3-(1H-imidazol-5-yl)-1-oxopropan-2-yl]-5-oxopyrrolidine-2-carboxamide
2.1.2 InChI
InChI=1S/C59H84N16O12.C2H4O2/c1-6-63-57(86)48-14-10-22-75(48)58(87)41(13-9-21-64-59(60)61)68-51(80)42(23-32(2)3)69-52(81)43(24-33(4)5)70-53(82)44(25-34-15-17-37(77)18-16-34)71-56(85)47(30-76)74-54(83)45(26-35-28-65-39-12-8-7-11-38(35)39)72-55(84)46(27-36-29-62-31-66-36)73-50(79)40-19-20-49(78)67-40;1-2(3)4/h7-8,11-12,15-18,28-29,31-33,40-48,65,76-77H,6,9-10,13-14,19-27,30H2,1-5H3,(H,62,66)(H,63,86)(H,67,78)(H,68,80)(H,69,81)(H,70,82)(H,71,85)(H,72,84)(H,73,79)(H,74,83)(H4,60,61,64);1H3,(H,3,4)
2.1.3 InChI Key
RGLRXNKKBLIBQS-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCNC(=O)C1CCCN1C(=O)C(CCCN=C(N)N)NC(=O)C(CC(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC2=CC=C(C=C2)O)NC(=O)C(CO)NC(=O)C(CC3=CNC4=CC=CC=C43)NC(=O)C(CC5=CN=CN5)NC(=O)C6CCC(=O)N6.CC(=O)O
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. 74381-53-6

2. Leuprorelin Acetate;h-pyr-his-trp-ser-tyr-d-leu-leu-arg-pro-nhet.ch3co2h

3. Lupron (tn)

4. Mfcd00072080

5. Fensolvi (tn)

6. Eligard (tn)

7. Lutrate (tn)

8. Leuprolide Acetate (usp)

9. Leuprorelin Acetate (jp17)

10. Schembl1651429

11. 5-oxopro-his-trp-ser-tyr-d-leu-leu-arg-pronhc2h5 Dihydrate

12. Amy12301

13. Nsc746847

14. Nsc-746847

15. Sy225936

16. Ft-0627807

17. D00989

18. Leuprorelin Acetate; Lupron; Leuprolide Acetate

2.3 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 1269.4 g/mol
Molecular Formula C61H88N16O14
Hydrogen Bond Donor Count16
Hydrogen Bond Acceptor Count16
Rotatable Bond Count32
Exact Mass1268.66659154 g/mol
Monoisotopic Mass1268.66659154 g/mol
Topological Polar Surface Area469 Ų
Heavy Atom Count91
Formal Charge0
Complexity2420
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count9
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameLeuprolide acetate
Drug LabelLeuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-s...
Active IngredientLeuprolide acetate
Dosage FormInjectable
RouteInjection
Strength1mg/0.2ml
Market StatusPrescription
CompanyTeva Pharms Usa; Sandoz; Sun Pharma Global

2 of 2  
Drug NameLeuprolide acetate
Drug LabelLeuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-s...
Active IngredientLeuprolide acetate
Dosage FormInjectable
RouteInjection
Strength1mg/0.2ml
Market StatusPrescription
CompanyTeva Pharms Usa; Sandoz; Sun Pharma Global

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Bachem Ag

Switzerland
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Virtual BoothBachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

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DMF Number : 13822

Submission : 1998-11-06

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Genzyme Corp

France
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Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Submission : 1999-10-08

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Aspen Oss Bv

Netherlands
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Virtual BoothAspen API. More than just an API.

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Submission : 2014-11-06

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Virtual BoothTAPI offers customized CDMO Solutions for API development and manufacturing services.

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Submission : 2000-12-11

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API Reference Price

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SOLA BRIDGE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1661797800,"product":"CUSTOM PEPTIDE (LEUPROLIDE ACETATE)","address":"VILLAGE NAG KALAN,MAJITHA ROAD,MAJ ITHA","city":"AMRITSAR,PUNJAB","supplier":"QUANZHOU FORTUNE TRADE ","supplierCountry":"CHINA","foreign_port":"NA","customer":"KWALITY PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.03","actualQuantity":"30","unit":"GMS","unitRateFc":"120","totalValueFC":"3642.2","currency":"USD","unitRateINR":"9660","date":"30-Aug-2022","totalValueINR":"289800","totalValueInUsd":"3642.2","indian_port":"DELHI AIR","hs_no":"29339990","bill_no":"2227955","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"VILLAGE NAG KALAN,MAJITHA ROAD,MAJ ITHA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706121000,"product":"LEUPROLIDE ACETATE","address":"DNA HOUSE, B3, GODREJ INTERIO,RAIP","city":"HARIDWAR,UTTARAKHAND","supplier":"NANJING HABO MEDICAL TECHNOLOGY CO LTD","supplierCountry":"CHINA","foreign_port":"HONG KONG","customer":"BIOZENTA LIFESCIENCE PRIVATE ","customerCountry":"INDIA","quantity":"0.17","actualQuantity":"169.5","unit":"GMS","unitRateFc":"88","totalValueFC":"15093.4","currency":"USD","unitRateINR":"7400.8","date":"25-Jan-2024","totalValueINR":"1254435.6","totalValueInUsd":"15093.4","indian_port":"Delhi Air","hs_no":"29371900","bill_no":"9816990","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HONG KONG","supplierAddress":"NO 9 WEIDI ROAD XIANLIN UNIVERSITYQIXIA DISTRICT NANJING JIANGSU CHINA Nanjing, , CHINA CHINA","customerAddress":"DNA HOUSE, B3, GODREJ INTERIO,RAIP"}]
16-Jan-2021
30-Oct-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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DRUG PRODUCT COMPOSITIONS

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DOSAGE - POWDER;INTRAMUSCULAR - 11.25MG

USFDA APPLICATION NUMBER - 20263

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DOSAGE - POWDER;INTRAMUSCULAR - 15MG

USFDA APPLICATION NUMBER - 20263

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DOSAGE - POWDER;INTRAMUSCULAR - 3.75MG,7.5MG ...DOSAGE - POWDER;INTRAMUSCULAR - 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20263

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DOSAGE - POWDER;INTRAMUSCULAR - 30MG

USFDA APPLICATION NUMBER - 20263

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DOSAGE - POWDER;INTRAMUSCULAR - 45MG

USFDA APPLICATION NUMBER - 20263

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DOSAGE - POWDER;INTRAMUSCULAR - 7.5MG

USFDA APPLICATION NUMBER - 20263

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DOSAGE - POWDER;INTRAMUSCULAR - 7.5MG,7.5MG *...DOSAGE - POWDER;INTRAMUSCULAR - 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20263

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DOSAGE - INJECTABLE, TABLET;INTRAMUSCULAR, OR...DOSAGE - INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG

USFDA APPLICATION NUMBER - 203696

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DOSAGE - INJECTABLE, TABLET;INTRAMUSCULAR, OR...DOSAGE - INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG

USFDA APPLICATION NUMBER - 203696

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Global Sales Information

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Finished Drug Prices

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01

Brand Name : LUPRON DEPOT

U.S.A
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Antibody Engineering
Not Confirmed

Leuprolide Acetate

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 7.5MG

Price Per Pack :

Published in :

Country : USA

RX/OTC/DISCN : RX

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02

Brand Name : Enanton Depot Dual

Finland
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Antibody Engineering
Not Confirmed

Leuprolide Acetate

Dosage Form : Powder and liquid to the injecti...

Dosage Strength : 11.25 mg

Price Per Pack (Euro) : 320.20

Published in :

Country : Norway

RX/OTC/DISCN :

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03

Brand Name : Lucrin Depot PDS

U.S.A
arrow
Antibody Engineering
Not Confirmed

Leuprolide Acetate

Dosage Form : Dry Sub

Dosage Strength : 3.75mg

Price Per Pack (Euro) : 123.67

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

Abbvie Company Banner

04

Brand Name : Lucrin Depot PDS

U.S.A
arrow
Antibody Engineering
Not Confirmed

Leuprolide Acetate

Dosage Form : Dry Sub

Dosage Strength : 11.25mg

Price Per Pack (Euro) : 360.01

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

Abbvie Company Banner

05

Brand Name : Lucrin Depot PDS

U.S.A
arrow
Antibody Engineering
Not Confirmed

Leuprolide Acetate

Dosage Form : Dry Sub

Dosage Strength : 30mg

Price Per Pack (Euro) : 930.57

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

Abbvie Company Banner

06

Brand Name : LUPRON DEPOT

U.S.A
arrow
Antibody Engineering
Not Confirmed

Leuprolide Acetate

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 11.25MG

Price Per Pack :

Published in :

Country : USA

RX/OTC/DISCN : RX

Abbvie Company Banner

07

Brand Name : Procren Depot

U.S.A
arrow
Antibody Engineering
Not Confirmed

Leuprolide Acetate

Dosage Form : Powder and liquid to the injecti...

Dosage Strength : 11.25 mg

Price Per Pack (Euro) : 320.20

Published in :

Country : Norway

RX/OTC/DISCN :

Abbvie Company Banner

08

Brand Name : Procren Depot

U.S.A
arrow
Antibody Engineering
Not Confirmed

Leuprolide Acetate

Dosage Form : Powder and liquid to the injecti...

Dosage Strength : 3.75 mg

Price Per Pack (Euro) : 148.01

Published in :

Country : Norway

RX/OTC/DISCN :

Abbvie Company Banner

09

Brand Name : Procren Depot

U.S.A
arrow
Antibody Engineering
Not Confirmed

Leuprolide Acetate

Dosage Form : Powder and liquid to the injecti...

Dosage Strength : 3.75 mg

Price Per Pack (Euro) : 434.53

Published in :

Country : Norway

RX/OTC/DISCN :

Abbvie Company Banner

10

Brand Name : Procren Depot

U.S.A
arrow
Antibody Engineering
Not Confirmed

Leuprolide Acetate

Dosage Form : Powder and liquid to the injecti...

Dosage Strength : 30 mg

Price Per Pack (Euro) : 635.66

Published in :

Country : Norway

RX/OTC/DISCN :

Abbvie Company Banner
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Market Place

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APIs

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Patents & EXCLUSIVITIES

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US Patents

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01

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DDL Conference
Not Confirmed

LEUPROLIDE ACETATE

US Patent Number : 8921326

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 20263

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-02-05

Abbvie Company Banner

02

arrow
DDL Conference
Not Confirmed

LEUPROLIDE ACETATE

US Patent Number : 9617303

Drug Substance Claim :

Drug Product Claim :

Application Number : 20517

Patent Use Code : U-4001

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-03-22

Abbvie Company Banner

03

arrow
DDL Conference
Not Confirmed

LEUPROLIDE ACETATE

US Patent Number : 9617303

Drug Substance Claim :

Drug Product Claim :

Application Number : 20263

Patent Use Code : U-3611

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-03-22

Abbvie Company Banner

04

arrow
DDL Conference
Not Confirmed

LEUPROLIDE ACETATE

US Patent Number : 8921326

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 20517

Patent Use Code : U-1666

Delist Requested :

Patent Use Description : PALLIATIVE TREATMENT O...

Patent Expiration Date : 2031-02-05

Abbvie Company Banner

05

arrow
DDL Conference
Not Confirmed

TOLMAR

U.S.A
arrow
DDL Conference
Not Confirmed

LEUPROLIDE ACETATE

US Patent Number : 11931559

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 21343

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2041-12-22

blank

06

arrow
DDL Conference
Not Confirmed

TOLMAR

U.S.A
arrow
DDL Conference
Not Confirmed

LEUPROLIDE ACETATE

US Patent Number : 11931559

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 21488

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2041-12-22

blank

07

arrow
DDL Conference
Not Confirmed

TOLMAR

U.S.A
arrow
DDL Conference
Not Confirmed

LEUPROLIDE ACETATE

US Patent Number : 11771841

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 21343

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2041-12-22

blank

08

arrow
DDL Conference
Not Confirmed

TOLMAR

U.S.A
arrow
DDL Conference
Not Confirmed

LEUPROLIDE ACETATE

US Patent Number : 11771841

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 21488

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2041-12-22

blank

09

arrow
DDL Conference
Not Confirmed

TOLMAR

U.S.A
arrow
DDL Conference
Not Confirmed

LEUPROLIDE ACETATE

US Patent Number : 11771841

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 213150

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2041-12-22

blank

10

arrow
DDL Conference
Not Confirmed

TOLMAR

U.S.A
arrow
DDL Conference
Not Confirmed

LEUPROLIDE ACETATE

US Patent Number : 11931559

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 21731

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2041-12-22

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