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Information, Expiry, & Status of FDA Orange Book Exclusivities covering Estradiol

Client Email

Product

Estradiol
Estradiol Acetate
Estradiol Valerate
Estradiol Benzoate
CAS 50-28-2
Estradiol Enanthate
Estradiol Cypionate
2-Methoxyestradiol
Ethinyl Estradiol
Polyestradiol Phosphate
U.S. EXCLUSIVITIES

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Estradiol

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

30 API Suppliers, 11 USDMF, 9 CEP/COS, 2 JDMF, 2 EU WC, 10 KDMF, 33 NDC API, 4 VMF, 17 Listed Suppliers, $ API Reference Price

30 API Suppliers
11 USDMF
9 CEP/COS
2 JDMF
2 EU WC
10 KDMF
33 NDC API
4 VMF
17 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

39 Drugs in Development

39 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

INTERMEDIATES

1 API Suppliers

1 API Suppliers

FINISHED DOSAGE FORMULATIONS

534 FDF Dossiers, 223 FDA Orange Book, 222 Europe, 29 Canada, 23 Australia, 27 South Africa, 10 Listed Dossiers

534 FDF Dossiers
223 FDA Orange Book
222 Europe
29 Canada
23 Australia
27 South Africa
10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FILM, EXTENDED RELEASE;TRANSDERMAL - 0.025MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.0375MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.06MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.075MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.1MG/24HR, INSERT, EXTENDED RELEASE;VAGINAL - 0.0075MG/24HR, SYSTEM;TRANSDERMAL - 0.025MG/24HR, SYSTEM;TRANSDERMAL - 0.0375MG/24HR, SYSTEM;TRANSDERMAL - 0.05MG/24HR, SYSTEM;TRANSDERMAL - 0.075MG/24HR, SYSTEM;TRANSDERMAL - 0.1MG/24HR, 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TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG;0.5MG, TABLET;VAGINAL - 10MCG, TABLET;VAGINAL - 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 0.5MG;100MG, CAPSULE;ORAL - 1MG;100MG, GEL, METERED;TRANSDERMAL - 0.06% (1.25GM/ACTIVATION), FILM, EXTENDED RELEASE;TRANSDERMAL - 0.045MG/24HR;0.015MG/24HR, TABLET;ORAL - 0.25MG;0.5MG, TABLET;ORAL - 0.5MG;1MG, GEL, METERED;TRANSDERMAL - 0.06% (0.87GM/ACTIVATION), SPRAY;TRANSDERMAL - 1.53MG/SPRAY, GEL;TRANSDERMAL - 0.1% (0.25GM/PACKET), GEL;TRANSDERMAL - 0.1% (0.5GM/PACKET), GEL;TRANSDERMAL - 0.1% (0.75GM/PACKET), GEL;TRANSDERMAL - 0.1% (1.25GM/PACKET), GEL;TRANSDERMAL - 0.1% (1GM/PACKET), CREAM;VAGINAL - 0.01%

FILM, EXTENDED RELEASE;TRANSDERMAL - 0.025MG/24HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.0375MG/24HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.06MG/24HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.075MG/24HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.1MG/24HR
INSERT, EXTENDED RELEASE;VAGINAL - 0.0075MG/24HR
SYSTEM;TRANSDERMAL - 0.025MG/24HR
SYSTEM;TRANSDERMAL - 0.0375MG/24HR
SYSTEM;TRANSDERMAL - 0.05MG/24HR
SYSTEM;TRANSDERMAL - 0.075MG/24HR
SYSTEM;TRANSDERMAL - 0.1MG/24HR
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;VAGINAL - 10MCG
TABLET;VAGINAL - 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - 0.5MG;100MG
CAPSULE;ORAL - 1MG;100MG
GEL, METERED;TRANSDERMAL - 0.06% (1.25GM/ACTIVATION)
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.045MG/24HR;0.015MG/24HR
TABLET;ORAL - 0.25MG;0.5MG
TABLET;ORAL - 0.5MG;1MG
GEL, METERED;TRANSDERMAL - 0.06% (0.87GM/ACTIVATION)
SPRAY;TRANSDERMAL - 1.53MG/SPRAY
GEL;TRANSDERMAL - 0.1% (0.25GM/PACKET)
GEL;TRANSDERMAL - 0.1% (0.5GM/PACKET)
GEL;TRANSDERMAL - 0.1% (0.75GM/PACKET)
GEL;TRANSDERMAL - 0.1% (1.25GM/PACKET)
GEL;TRANSDERMAL - 0.1% (1GM/PACKET)
CREAM;VAGINAL - 0.01%

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 8 SPI Pharma, 2 Seqens, 10 DKSH, 2 Jai Radhe Sales, 2 Nippon Fine Chemical, 6 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 9 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 8 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 33 BASF, 1 BioSpectra, 1 Clariant, 14 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 2 Finar, 13 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 16 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 20 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 12 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

92 Fillers, Diluents & Binders, 60 Coating Systems & Additives, 46 Direct Compression, 35 Controlled & Modified Release, 34 Solubilizers, 34 Disintegrants & Superdisintegrants, 32 Thickeners and Stabilizers, 31 Granulation, 31 Topical, 24 Parenteral, 24 Film Formers & Plasticizers, 22 Lubricants & Glidants, 21 Co-Processed Excipients, 17 Taste Masking, 15 Emulsifying Agents, 9 API Stability Enhancers, 9 Empty Capsules, 8 Chewable & Orodispersible Aids, 7 Surfactant & Foaming Agents, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules

92 Fillers, Diluents & Binders
60 Coating Systems & Additives
46 Direct Compression
35 Controlled & Modified Release
34 Solubilizers
34 Disintegrants & Superdisintegrants
32 Thickeners and Stabilizers
31 Granulation
31 Topical
24 Parenteral
24 Film Formers & Plasticizers
22 Lubricants & Glidants
21 Co-Processed Excipients
17 Taste Masking
15 Emulsifying Agents
9 API Stability Enhancers
9 Empty Capsules
8 Chewable & Orodispersible Aids
7 Surfactant & Foaming Agents
5 Coloring Agents
5 Rheology Modifiers
4 Vegetarian Capsules

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 40 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
40 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 126 Finished Drug Prices, 7 Annual Reports

1 US Medicaid Prescriptions
126 Finished Drug Prices
7 Annual Reports

MARKET PLACE

10 APIs, 3 FDF Dossiers

10 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

131 US Patents, 6 US Exclusivities

131 US Patents
6 US Exclusivities

REF. STANDARDS & IMPURITIES

4 EDQM, 3 USP, 4 Others

4 EDQM
3 USP
4 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 3,513 Xls

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filter Company Name Reset all filters

6 All

01 1GE HEALTHCARE

02 1SOLARIS PHARMA CORP

03 4SUMITOMO PHARMA

filter Product Reset all filters

6 All

01 1ESTRADIOL

02 4ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

03 1FLUOROESTRADIOL F-18

filter Exclusivity Expiration Date Reset all filters

6 All

01 12024-05-26

02 12024-10-23

03 12025-05-20

04 12025-08-05

05 12025-12-18

06 12026-01-27

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6 All

01 1CGT

02 1I-898

03 1M-289

04 2NCE

05 1NP

Symbiotec Estradiol

US Patents
US Exclusivities

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SUMITOMO PHARMA

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ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

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Exclusivity Code

NCE

Exclusivity Expiration Date

2025-12-18

Application Number

214846

Product Number

1

Exclusivity Details

01

SUMITOMO PHARMA

ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

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ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

Exclusivity Code : NCE

Exclusivity Expiration Date : 2025-12-18

Application Number : 214846

Product Number : 1

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SOLARIS PHARMA CORP

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ESTRADIOL

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Exclusivity Code

CGT

Exclusivity Expiration Date

2024-10-23

Application Number

216160

Product Number

1

Exclusivity Details

02

SOLARIS PHARMA CORP

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U.S.A

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Exclusivity Code : CGT

Exclusivity Expiration Date : 2024-10-23

Application Number : 216160

Product Number : 1

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GE HEALTHCARE

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FLUOROESTRADIOL F-18

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Exclusivity Code

NCE

Exclusivity Expiration Date

2025-05-20

Application Number

212155

Product Number

1

Exclusivity Details

03

GE HEALTHCARE

FLUOROESTRADIOL F-18

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GE HEALTHCARE

United Kingdom

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FLUOROESTRADIOL F-18

Exclusivity Code : NCE

Exclusivity Expiration Date : 2025-05-20

Application Number : 212155

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

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Exclusivity Code : I-898

Exclusivity Expiration Date : 2025-08-05

Application Number : 214846

Product Number : 1

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ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

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Exclusivity Code

M-289

Exclusivity Expiration Date

2026-01-27

Application Number

214846

Product Number

1

Exclusivity Details

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SUMITOMO PHARMA

ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

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Exclusivity Code : M-289

Exclusivity Expiration Date : 2026-01-27

Application Number : 214846

Product Number : 1

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SUMITOMO PHARMA

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ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX

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Exclusivity Code

NP

Exclusivity Expiration Date

2024-05-26

Application Number

214846

Product Number

1

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Exclusivity Code : NP

Exclusivity Expiration Date : 2024-05-26

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Product Number : 1

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