Estradiol Patent Expiration

Estradiol was first introduced by Novartis Pharmaceuticals Corp in its drug Estraderm on Sep 10, 1986. Other drugs containing Estradiol are Imvexxy, Estrogel, Vivelle, Vagifem, Estradiol, Alora, Menostar, Elestrin, Minivelle, Vivelle-Dot, Estring, Evamist, Climara, Fempatch, Divigel, Esclim. 39 different companies have introduced drugs containing Estradiol.

Estradiol Patents

Given below is the list of patents protecting Estradiol, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in	Drug Patent Number	Drug Patent Title	Drug Patent Expiry	Drug Owner
Imvexxy	US11266661	Vaginal inserted estradiol pharmaceutical compositions and methods	Feb 02, 2034	Mayne Pharma
Imvexxy	US10258630	Vaginal inserted estradiol pharmaceutical compositions and methods	Nov 21, 2032	Mayne Pharma
Imvexxy	US10398708	Vaginal inserted estradiol pharmaceutical compositions and methods	Nov 21, 2032	Mayne Pharma
Imvexxy	US10471072	Vaginal inserted estradiol pharmaceutical compositions and methods	Nov 21, 2032	Mayne Pharma
Imvexxy	US10537581	Vaginal inserted estradiol pharmaceutical compositions and methods	Nov 21, 2032	Mayne Pharma
Imvexxy	US10568891	Vaginal inserted estradiol pharmaceutical compositions and methods	Nov 21, 2032	Mayne Pharma
Imvexxy	US10668082	Vaginal inserted estradiol pharmaceutical compositions and methods	Nov 21, 2032	Mayne Pharma
Imvexxy	US10806697	Vaginal inserted estradiol pharmaceutical compositions and methods	Nov 21, 2032	Mayne Pharma
Imvexxy	US10835487	Vaginal inserted estradiol pharmaceutical compositions and methods	Nov 21, 2032	Mayne Pharma
Imvexxy	US10888516	Soluble estradiol capsule for vaginal insertion	Nov 21, 2032	Mayne Pharma
Imvexxy	US11065197	Soluble estradiol capsule for vaginal insertion	Nov 21, 2032	Mayne Pharma
Imvexxy	US11116717	Soluble estradiol capsule for vaginal insertion	Nov 21, 2032	Mayne Pharma
Imvexxy	US11123283	Soluble estradiol capsule for vaginal insertion	Nov 21, 2032	Mayne Pharma
Imvexxy	US11241445	Vaginal inserted estradiol pharmaceutical compositions and methods	Nov 21, 2032	Mayne Pharma
Imvexxy	US11246875	Vaginal inserted estradiol pharmaceutical compositions and methods	Nov 21, 2032	Mayne Pharma
Imvexxy	US11304959	Vaginal inserted estradiol pharmaceutical compositions and methods	Nov 21, 2032	Mayne Pharma
Imvexxy	US11351182	Vaginal inserted estradiol pharmaceutical compositions and methods	Nov 21, 2032	Mayne Pharma
Imvexxy	US11497709	Vaginal inserted estradiol pharmaceutical compositions and methods	Nov 21, 2032	Mayne Pharma
Imvexxy	US9180091	Soluble estradiol capsule for vaginal insertion	Nov 21, 2032	Mayne Pharma
Imvexxy	US9289382	Vaginal inserted estradiol pharmaceutical compositions and methods	Nov 21, 2032	Mayne Pharma
Minivelle	US8231906	Transdermal estrogen device and delivery	Jul 04, 2030	Noven
Minivelle	US9724310	Transdermal estrogen device and delivery	Jul 10, 2028	Noven
Minivelle	US9730900	Transdermal estrogen device and delivery	Jul 10, 2028	Noven
Minivelle	US9833419	Transdermal estrogen device and delivery	Jul 10, 2028	Noven
Vagifem	US7018992	Hormone composition	Sep 17, 2022 (Expired)	Novo Nordisk Inc
Elestrin	US7198801	Formulations for transdermal or transmucosal application	Jun 25, 2022 (Expired)	Viatris
Evamist	US6978945	Dispensing device	Nov 30, 2021 (Expired)	Padagis Us
Elestrin	US7470433	Formulations for transdermal or transmucosal application	Aug 03, 2021 (Expired)	Viatris
Minivelle	US6841716	Patch	Apr 27, 2020 (Expired)	Noven
Menostar	US5891868	Methods for treating postmenopausal women using ultra-low doses of estrogen	Nov 21, 2017 (Expired)	Bayer Hlthcare
Menostar	US6692763	Methods for treating postmenopausal women using ultra-low doses of estrogen	Nov 21, 2017 (Expired)	Bayer Hlthcare
Vagifem	US5860946	Instrument for inserting a suppository	Jul 01, 2017 (Expired)	Novo Nordisk Inc
Evamist	US6299900	Dermal penetration enhancers and drug delivery systems involving same	Feb 19, 2017 (Expired)	Padagis Us
Evamist	US6818226	Dermal penetration enhancers and drug delivery systems involving same	Feb 19, 2017 (Expired)	Padagis Us
Evamist	US6923983	Transdermal delivery of hormones	Feb 19, 2017 (Expired)	Padagis Us
Minivelle	US5646286	Palladium catalyzed vinylic substitution reactions with 2-substituted-pyridines	Aug 12, 2014 (Expired)	Noven
Minivelle	US5656286	Solubility parameter based drug delivery system and method for altering drug saturation concentration	Aug 12, 2014 (Expired)	Noven
Vivelle-dot	US5656286	Solubility parameter based drug delivery system and method for altering drug saturation concentration	Aug 12, 2014 (Expired)	Sandoz
Minivelle	US6024976	Solubility parameter based drug delivery system and method for altering drug saturation concentration	Jan 07, 2014 (Expired)	Noven
Vivelle-dot	US6024976	Solubility parameter based drug delivery system and method for altering drug saturation concentration	Jan 07, 2014 (Expired)	Sandoz
Vivelle-dot	US5474783	Solubility parameter based drug delivery system and method for altering drug saturation concentration	Dec 12, 2012 (Expired)	Sandoz
Vivelle-dot	US5958446	Solubility parameter based drug delivery system and method for altering drug saturation concentration	Dec 12, 2012 (Expired)	Sandoz

A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Estradiol's patents.

Latest Legal Activities on Estradiol's Patents

Given below is the list recent legal activities going on the following patents of Estradiol.

Activity	Date	Patent Number

Patent Issue Date Used in PTA Calculation Critical	28 Mar, 2006	US7018992
Recordation of Patent Grant Mailed Critical	28 Mar, 2006	US7018992
Issue Notification Mailed Critical	08 Mar, 2006	US7018992
Receipt into Pubs	23 Feb, 2006	US7018992
Dispatch to FDC	22 Feb, 2006	US7018992
Application Is Considered Ready for Issue Critical	22 Feb, 2006	US7018992
Receipt into Pubs	20 Jan, 2006	US7018992
Printer Rush- No mailing	27 Sep, 2005	US7018992
Pubs Case Remand to TC Critical	06 Sep, 2005	US7018992
Workflow - File Sent to Contractor	03 Jun, 2005	US7018992

Estradiol's Family Patents

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Estradiol Generic API Manufacturers

Several generic applications have been filed for Estradiol. The first generic version for Estradiol was by Bristol Myers Squibb Co Pharmaceutical Research Institute and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Encube Ethicals Private Ltd and was approved on Mar 5, 2025.

Given below is the list of companies who have filed for Estradiol generic, along with the locations of their manufacturing plants worldwide.

1. ALLERGAN

Allergan Sales Llc has filed for 1 generic for Estradiol. This 0.01% version comes by the name ESTRACE. Given below are the details of the strengths of this generic introduced by Allergan.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
0.01% (reference standard)	cream	Prescription	VAGINAL	AB	Jan 31, 1984

Strength

Dosage Form

Availability

Application Pathway

TE code

Launch Date

0.01%

cream

Prescription

VAGINAL

Jan 31, 1984

Manufacturing Plant Locations
^New

Allergan's manufacturing plants are situated in 4 countries - United States, Costa Rica, France, Ireland. Given below are the details of these plant locations as well as the firm names of Allergan as present at those locations.

Country

City

Firm Name

United States

Cincinnati	Allergan Sales LLC
Waco	Allergan Sales, LLC
Irvine	Allergan Sales, LLC
Campbell	Allergan Sales, LLC dba Bioscience Laboratories
Madison	ALLERGAN SALES, LLC
Goleta	Allergan

Costa Rica

Heredia

ALLERGAN

France

Pringy

Allergan Industrie SAS

Ireland

Westport

Allergan Pharmaceuticals Ireland

2. AMNEAL

Amneal Pharmaceuticals Llc has filed for 10 different strengths of generic version for Estradiol. Given below are the details of the strengths of this generic introduced by Amneal.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
0.075MG/24HR	film, extended release	Prescription	TRANSDERMAL	AB3	Sep 28, 2020
0.1MG/24HR	film, extended release	Prescription	TRANSDERMAL	AB3	Sep 28, 2020
0.025MG/24HR	film, extended release	Prescription	TRANSDERMAL	AB3	Sep 28, 2020
0.05MG/24HR	film, extended release	Prescription	TRANSDERMAL	AB3	Sep 28, 2020
0.0375MG/24HR	film, extended release	Prescription	TRANSDERMAL	AB3	Sep 28, 2020
0.1% (1.25GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Jul 12, 2024
0.1% (1GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Jul 12, 2024
0.1% (0.75GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Jul 12, 2024
0.1% (0.5GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Jul 12, 2024
0.1% (0.25GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Jul 12, 2024

Manufacturing Plant Locations
^New

Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.

Country

City

Firm Name

United States

Brookhaven	Amneal Pharmaceuticals of New York, LLC
Piscataway	Amneal Pharmaceuticals, LLC
East Hanover	Amneal Pharmaceuticals LLC
Paterson	Amneal Pharmaceuticals, Llc
Hauppauge	Amneal Pharmaceuticals of New York, LLC
Branchburg	Amneal Pharmaceuticals, LLC
Glasgow	Amneal Pharmaceuticals LLC
Bridgewater	Amneal Complex Products Research LLC

India

Tal Bavla, Ahmedabad	Amneal Pharmaceuticals Pvt. Ltd.
Hyderabad	Amneal Oncology Private Limited
Matoda	Amneal Pharmaceuticals Private Ltd.
Ahmedabad	Amneal Pharmaceuticals Private Ltd.

3. AMNEAL PHARMS

Amneal Pharmaceuticals has filed for 1 generic for Estradiol. Given below are the details of the strengths of this generic introduced by Amneal Pharms.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
10MCG	tablet	Prescription	VAGINAL	AB	May 29, 2015

4. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 1 generic for Estradiol. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
10MCG	tablet	Prescription	VAGINAL	AB	Aug 2, 2024

Manufacturing Plant Locations
^New

Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.

Country

City

Firm Name

India

Bachupally	Aurobindo Pharma Limited
Polepally, Mahaboob Nagar	Aurobindo Pharma Limited
Sangareddy	Aurobindo Pharma Limited
Medchal	Aurobindo Pharma Ltd

United States

East Windsor

Aurobindo Pharma USA Inc

5. BARR LABS INC

Barr Laboratories Inc has filed for 3 different strengths of generic version for Estradiol. Given below are the details of the strengths of this generic introduced by Barr Labs Inc.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
1MG	tablet	Prescription	ORAL	AB	Oct 22, 1997
2MG (reference standard)	tablet	Prescription	ORAL	AB	Oct 22, 1997
0.5MG	tablet	Prescription	ORAL	AB	Oct 22, 1997

Strength

Dosage Form

Availability

Application Pathway

TE code

Launch Date

1MG

tablet

Prescription

ORAL

Oct 22, 1997

2MG

tablet

Prescription

ORAL

Oct 22, 1997

0.5MG

tablet

Prescription

ORAL

Oct 22, 1997

6. BRISTOL MYERS SQUIBB

Bristol Myers Squibb Co has filed for 3 different strengths of generic version for Estradiol. All of these versions come by the name ESTRACE. Given below are the details of the strengths of this generic introduced by Bristol Myers Squibb.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
1MG	tablet	Discontinued	ORAL	N/A	Approved Prior to Jan 1, 1982
2MG	tablet	Discontinued	ORAL	N/A	Approved Prior to Jan 1, 1982
0.5MG	tablet	Discontinued	ORAL	N/A	Jun 30, 1993

Manufacturing Plant Locations
^New

Bristol Myers Squibb's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Bristol Myers Squibb as present at those locations.

Country

City

Firm Name

United States

Catano	Bristol Myers Squibb Pr
Plainsboro	Bristol Myers Squibb Company
Princeton	Bristol Myers Squibb
Mayaguez	Bristol Myers Squibb Caribbean Company

7. CHEMO RESEARCH SL

Chemo Research Sl has filed for 3 different strengths of generic version for Estradiol. Given below are the details of the strengths of this generic introduced by Chemo Research Sl.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
0.1% (0.25GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Aug 10, 2022
0.1% (1GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Aug 10, 2022
0.1% (0.5GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Aug 10, 2022

8. DR REDDYS LABS SA

Dr Reddys Laboratories Sa has filed for 3 different strengths of generic version for Estradiol. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Sa.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
2MG	tablet	Discontinued	ORAL	N/A	Mar 14, 1996
1MG	tablet	Discontinued	ORAL	N/A	Mar 14, 1996
0.5MG	tablet	Discontinued	ORAL	N/A	Mar 14, 1996

9. DURAMED PHARMS BARR

Duramed Pharmaceuticals Inc Sub Barr Laboratories Inc has filed for 4 different strengths of generic version for Estradiol. All of these versions come by the name GYNODIOL. Given below are the details of the strengths of this generic introduced by Duramed Pharms Barr.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
0.5MG	tablet	Discontinued	ORAL	N/A	Dec 29, 1997
1MG	tablet	Discontinued	ORAL	N/A	Dec 29, 1997
2MG	tablet	Discontinued	ORAL	N/A	Dec 29, 1997
1.5MG	tablet	Discontinued	ORAL	N/A	Dec 29, 1997

10. ENCUBE

Encube Ethicals Private Ltd has filed for 6 different strengths of generic version for Estradiol. Given below are the details of the strengths of this generic introduced by Encube.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
0.01%	cream	Prescription	VAGINAL	AB	Mar 5, 2018
0.1% (0.25GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Mar 5, 2025
0.1% (1.25GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Mar 5, 2025
0.1% (1GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Mar 5, 2025
0.1% (0.75GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Mar 5, 2025
0.1% (0.5GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Mar 5, 2025

Manufacturing Plant Locations
^New

Encube's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Encube as present at those locations.

Country

City

Firm Name

India

Andheri East, Mumbai	Encube Ethicals Private Ltd
Ponda	Encube Ethicals Pvt. Ltd.

11. EPIC PHARMA LLC

Epic Pharma Llc has filed for 3 different strengths of generic version for Estradiol. Given below are the details of the strengths of this generic introduced by Epic Pharma Llc.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
1MG	tablet	Prescription	ORAL	AB	Dec 29, 1998
0.5MG	tablet	Prescription	ORAL	AB	Dec 29, 1998
2MG	tablet	Prescription	ORAL	AB	Dec 29, 1998

12. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 1 generic for Estradiol. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Ltd.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
10MCG	tablet	Prescription	VAGINAL	AB	Sep 14, 2018

13. LANNETT CO INC

Lannett Co Inc has filed for 3 different strengths of generic version for Estradiol. Given below are the details of the strengths of this generic introduced by Lannett Co Inc.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
0.5MG	tablet	Discontinued	ORAL	N/A	Jan 30, 1998
2MG	tablet	Discontinued	ORAL	N/A	Jan 30, 1998
1MG	tablet	Discontinued	ORAL	N/A	Jan 30, 1998

14. MYLAN

Mylan Pharmaceuticals Inc has filed for 1 generic for Estradiol. Given below are the details of the strengths of this generic introduced by Mylan.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
0.01%	cream	Prescription	VAGINAL	AB	Dec 29, 2017

Manufacturing Plant Locations
^New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country

City

Firm Name

United States

Rockford	Mylan Institutional, Inc.
Morgantown	MYLAN CONSUMER HEALTHCARE Inc.
Saint Albans	Mylan Technologies, Inc.
Greensboro	Mylan Pharmaceuticals Inc
San Carlos	Mylan Pharmaceuticals Inc.
Morgantown	Mylan Specialty, L.P.
Santa Barbara	Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.

India

Hosur	Mylan Laboratories Limited
Aurangabad	Mylan Laboratories Limited (FDF-2)
Sinnar	Mylan Laboratories Limited
Bangalore	Mylan Laboratories Limited
Anekal Taluk, Bangalore	Mylan Laboratories Limited
Sarigam	Mylan Laboratories Limited
Pithampur, District Dhar	Mylan Laboratories Limited
Hyderabad	Mylan Laboratories Limited

Canada

Etobicoke

Mylan Pharmaceuticals ULC

Ireland

Inverin

Mylan Teoranta

15. MYLAN TECHNOLOGIES

Mylan Technologies Inc has filed for 6 different strengths of generic version for Estradiol. Given below are the details of the strengths of this generic introduced by Mylan Technologies.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
0.05MG/24HR	film, extended release	Prescription	TRANSDERMAL	AB3	Aug 15, 2018
0.1MG/24HR	film, extended release	Prescription	TRANSDERMAL	AB3	Aug 15, 2018
0.025MG/24HR	film, extended release	Prescription	TRANSDERMAL	AB3	Aug 15, 2018
0.075MG/24HR	film, extended release	Prescription	TRANSDERMAL	AB3	Aug 15, 2018
0.06MG/24HR	film, extended release	Prescription	TRANSDERMAL	AB2	Jul 20, 2006
0.0375MG/24HR	film, extended release	Prescription	TRANSDERMAL	AB3	Aug 15, 2018

Manufacturing Plant Locations
^New

Mylan Technologies's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Mylan Technologies as present at those locations.

Country

City

Firm Name

United States

Saint Albans

Mylan Technologies, Inc.

16. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 3 different strengths of generic version for Estradiol. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
2MG	tablet	Discontinued	ORAL	N/A	Apr 21, 1999
0.5MG	tablet	Discontinued	ORAL	N/A	Apr 21, 1999
1MG	tablet	Discontinued	ORAL	N/A	Apr 21, 1999

17. NOVITIUM PHARMA

Novitium Pharma Llc has filed for 9 different strengths of generic version for Estradiol. Given below are the details of the strengths of this generic introduced by Novitium Pharma.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
0.1% (1.25GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Aug 24, 2023
0.1% (1GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Aug 24, 2023
0.1% (0.75GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Aug 24, 2023
0.1% (0.5GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Aug 24, 2023
0.1% (0.25GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Aug 24, 2023
0.5MG	tablet	Prescription	ORAL	AB	Sep 6, 2023
2MG	tablet	Prescription	ORAL	AB	Sep 6, 2023
1MG	tablet	Prescription	ORAL	AB	Sep 6, 2023
0.06% (1.25GM/ACTIVATION)	gel, metered	Prescription	TRANSDERMAL	AB	Oct 23, 2024

Manufacturing Plant Locations
^New

Novitium Pharma's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Novitium Pharma as present at those locations.

Country

City

Firm Name

United States

East Windsor

Novitium Pharma LLC

18. NOVO NORDISK INC

Novo Nordisk Inc has filed for 3 different strengths of generic version for Estradiol. All of these versions come by the name INNOFEM. Given below are the details of the strengths of this generic introduced by Novo Nordisk Inc.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
1MG	tablet	Discontinued	ORAL	N/A	Nov 19, 1999
2MG	tablet	Discontinued	ORAL	N/A	Nov 19, 1999
0.5MG	tablet	Discontinued	ORAL	N/A	Nov 19, 1999

Manufacturing Plant Locations
^New

Novo Nordisk Inc's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Novo Nordisk Inc as present at those locations.

Country

City

Firm Name

United States

Plainsboro

Novo Nordisk Inc.

19. PADAGIS ISRAEL

Padagis Israel Pharmaceuticals Ltd has filed for 6 different strengths of generic version for Estradiol. Given below are the details of the strengths of this generic introduced by Padagis Israel.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
0.01%	cream	Prescription	VAGINAL	AB	Jan 22, 2018
0.1% (0.5GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Nov 14, 2023
0.1% (0.25GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Nov 14, 2023
0.1% (0.75GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Nov 14, 2023
0.1% (1GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Nov 14, 2023
0.1% (1.25GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Nov 14, 2023

Manufacturing Plant Locations
^New

Padagis Israel's manufacturing plants are situated in 1 country - Israel. Given below are the details of these plant locations as well as the firm names of Padagis Israel as present at those locations.

Country

City

Firm Name

Israel

Yerucham

Padagis Israel Pharmaceuticals Ltd.

20. PRASCO

Prasco Llc Dba Prasco Laboratories has filed for 1 generic for Estradiol. Given below are the details of the strengths of this generic introduced by Prasco.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
0.01%	cream	Prescription	VAGINAL	AB	Jul 15, 2021

Manufacturing Plant Locations
^New

Prasco's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Prasco as present at those locations.

Country

City

Firm Name

United States

Mason

Prasco LLC

21. QUAGEN

Quagen Pharmaceuticals Llc has filed for 5 different strengths of generic version for Estradiol. Given below are the details of the strengths of this generic introduced by Quagen.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
0.1% (0.25GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Jul 12, 2024
0.1% (0.5GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Jul 12, 2024
0.1% (0.75GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Jul 12, 2024
0.1% (1.25GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Jul 12, 2024
0.1% (1GM/PACKET)	gel	Prescription	TRANSDERMAL	AB	Jul 12, 2024

Manufacturing Plant Locations
^New

Quagen's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Quagen as present at those locations.

Country

City

Firm Name

United States

West Caldwell	Quagen Pharma, LLC
West Caldwell	Quagen Pharmacuticals, LLC

22. SOLARIS PHARMA CORP

Solaris Pharma Corp has filed for 1 generic for Estradiol. Given below are the details of the strengths of this generic introduced by Solaris Pharma Corp.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
0.06% (1.25GM/ACTIVATION)	gel, metered	Prescription	TRANSDERMAL	AB	Apr 22, 2024

Manufacturing Plant Locations
^New

Solaris Pharma Corp's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Solaris Pharma Corp as present at those locations.

Country

City

Firm Name

United States

Bridgewater

Solaris Pharma Corp

23. TEVA PHARMS USA

Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Estradiol. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
10MCG	tablet	Prescription	VAGINAL	AB	Jul 21, 2017
0.01%	cream	Prescription	VAGINAL	AB	Mar 30, 2018

24. USL PHARMA

Usl Pharma Inc has filed for 3 different strengths of generic version for Estradiol. Given below are the details of the strengths of this generic introduced by Usl Pharma.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
1MG	tablet	Discontinued	ORAL	N/A	Apr 17, 2002
2MG	tablet	Discontinued	ORAL	N/A	Apr 17, 2002
0.5MG	tablet	Discontinued	ORAL	N/A	Apr 17, 2002

25. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 7 different strengths of generic version for Estradiol. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength	Dosage Form	Availability	Application Pathway	TE code	Launch Date
0.025MG/24HR	film, extended release	Prescription	TRANSDERMAL	AB2	Mar 29, 2023
0.0375MG/24HR	film, extended release	Prescription	TRANSDERMAL	AB2	Mar 29, 2023
0.05MG/24HR	film, extended release	Prescription	TRANSDERMAL	AB2	Mar 29, 2023
0.075MG/24HR	film, extended release	Prescription	TRANSDERMAL	AB2	Mar 29, 2023
0.1MG/24HR	film, extended release	Prescription	TRANSDERMAL	AB2	Mar 29, 2023
0.06MG/24HR	film, extended release	Prescription	TRANSDERMAL	AB2	Mar 29, 2023
0.014MG/24HR	system	Prescription	TRANSDERMAL	AB	Apr 17, 2023

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Estradiol Generic API Manufacturers

1. ALLERGAN

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2. AMNEAL

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3. AMNEAL PHARMS

4. AUROBINDO PHARMA

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5. BARR LABS INC

6. BRISTOL MYERS SQUIBB

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7. CHEMO RESEARCH SL

8. DR REDDYS LABS SA

9. DURAMED PHARMS BARR

10. ENCUBE

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11. EPIC PHARMA LLC

12. GLENMARK PHARMS LTD

13. LANNETT CO INC

14. MYLAN

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15. MYLAN TECHNOLOGIES

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16. NORVIUM BIOSCIENCE

17. NOVITIUM PHARMA

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18. NOVO NORDISK INC

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19. PADAGIS ISRAEL

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20. PRASCO

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21. QUAGEN

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22. SOLARIS PHARMA CORP

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23. TEVA PHARMS USA

24. USL PHARMA

25. ZYDUS PHARMS

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