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Norethisterone Acetate
US Exclusivities

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SPI Pharma has been solving formulation challenges using superior functional materials.

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Norethisterone Acetate

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FAMAR CDMO- From early development to commercial manufacturing.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Norethisterone Acetate

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

22 API Suppliers, 12 USDMF, 4 CEP/COS, 2 JDMF, 3 EU WC, 6 NDC API, 11 Listed Suppliers, $ API Reference Price

22 API Suppliers
12 USDMF
4 CEP/COS
2 JDMF
3 EU WC
6 NDC API
11 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

25 Drugs in Development

25 Drugs in Development

FINISHED DOSAGE FORMULATIONS

172 FDF Dossiers, 119 FDA Orange Book, 39 Europe, 7 Canada, 7 Listed Dossiers

172 FDF Dossiers
119 FDA Orange Book
39 Europe
7 Canada
7 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.02MG;1MG, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG, CAPSULE;ORAL - 0.02MG;1MG, TABLET, CHEWABLE, TABLET;ORAL - 0.01MG,0.01MG,N/A;1MG,N/A,N/A, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.14MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.25MG/24HR, TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG;0.5MG, TABLET;ORAL - 0.0025MG;0.5MG, TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.01MG,0.01MG;1MG,N/A

TABLET;ORAL-28 - 0.02MG;1MG
TABLET;ORAL-21 - 0.03MG;1.5MG
TABLET;ORAL-21 - 0.03MG;1.5MG
TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG
INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG
CAPSULE;ORAL - 0.02MG;1MG
TABLET, CHEWABLE, TABLET;ORAL - 0.01MG,0.01MG,N/A;1MG,N/A,N/A
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.14MG/24HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.25MG/24HR
TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 1MG;0.5MG
TABLET;ORAL - 0.0025MG;0.5MG
TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.01MG,0.01MG;1MG,N/A

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 5 SPI Pharma, 4 DKSH, 7 Faran Shimi Pharmaceutical, 6 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 4 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 19 BASF, 2 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 11 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 38 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 Nanjing Bold Chemical, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 23 Roquette, 13 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 12 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

80 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 31 Disintegrants & Superdisintegrants, 30 Direct Compression, 28 Controlled & Modified Release, 27 Granulation, 25 Solubilizers, 22 Thickeners and Stabilizers, 20 Lubricants & Glidants, 17 Taste Masking, 16 Film Formers & Plasticizers, 14 Parenteral, 14 Co-Processed Excipients, 10 Emulsifying Agents, 9 Topical, 8 API Stability Enhancers, 7 Chewable & Orodispersible Aids, 6 Rheology Modifiers, 5 Coloring Agents, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 4 Vegetarian Capsules

80 Fillers, Diluents & Binders
56 Coating Systems & Additives
31 Disintegrants & Superdisintegrants
30 Direct Compression
28 Controlled & Modified Release
27 Granulation
25 Solubilizers
22 Thickeners and Stabilizers
20 Lubricants & Glidants
17 Taste Masking
16 Film Formers & Plasticizers
14 Parenteral
14 Co-Processed Excipients
10 Emulsifying Agents
9 Topical
8 API Stability Enhancers
7 Chewable & Orodispersible Aids
6 Rheology Modifiers
5 Coloring Agents
5 Empty Capsules
5 Surfactant & Foaming Agents
4 Vegetarian Capsules

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 47 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
47 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 40 Finished Drug Prices, 9 Annual Reports

2 US Medicaid Prescriptions
40 Finished Drug Prices
9 Annual Reports

MARKET PLACE

7 APIs

7 APIs

PATENTS & EXCLUSIVITIES

9 US Patents, 5 US Exclusivities

9 US Patents
5 US Exclusivities

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 3 Others

2 EDQM
1 USP
3 Others

$ API Ref.Price (USD/KG) : 3,462 Xls

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01 4ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

02 1ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

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01 12024-05-26

02 12025-08-05

03 12025-12-18

04 12026-01-27

05 12027-07-22

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01 1I-898

02 1M-289

03 1NCE

04 2NP

Coral Drugs Norethisterone Acetate

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SUMITOMO PHARMA

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ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

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M-289

Exclusivity Expiration Date

2026-01-27

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214846

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1

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01

SUMITOMO PHARMA

ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

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Japan

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ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

Exclusivity Code : M-289

Exclusivity Expiration Date : 2026-01-27

Application Number : 214846

Product Number : 1

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ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

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Exclusivity Expiration Date

2024-05-26

Application Number

214846

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1

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SUMITOMO PHARMA

ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

The Generic Rx Session

Not Confirmed

SUMITOMO PHARMA

Japan

The Generic Rx Session

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ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

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Exclusivity Expiration Date : 2024-05-26

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SUMITOMO PHARMA

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2025-12-18

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SUMITOMO PHARMA

ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

The Generic Rx Session

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SUMITOMO PHARMA

Japan

The Generic Rx Session

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ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

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Exclusivity Expiration Date : 2025-12-18

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ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

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2027-07-22

Application Number

218718

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1

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MILLICENT PR

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

The Generic Rx Session

Not Confirmed

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The Generic Rx Session

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ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Exclusivity Code : NP

Exclusivity Expiration Date : 2027-07-22

Application Number : 218718

Product Number : 1

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SUMITOMO PHARMA

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ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

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Exclusivity Code

I-898

Exclusivity Expiration Date

2025-08-05

Application Number

214846

Product Number

1

Exclusivity Details

05

SUMITOMO PHARMA

ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

The Generic Rx Session

Not Confirmed

SUMITOMO PHARMA

Japan

The Generic Rx Session

Not Confirmed

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ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

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Exclusivity Expiration Date : 2025-08-05

Application Number : 214846

Product Number : 1

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