Estradiol Patent Expiration
Estradiol was first introduced by Novartis Pharmaceuticals Corp
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 |
|---|---|---|---|---|
| Elestrin | US7198801 | Formulations for transdermal or transmucosal application |
Jun 25, 2022
(Expired) | Mylan Speciality Lp |
| Elestrin | US7470433 | Formulations for transdermal or transmucosal application |
Aug 03, 2021
(Expired) | Mylan Speciality Lp |
| 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 |
| Evamist | US6978945 | Dispensing device |
Nov 30, 2021
(Expired) | Padagis Us |
| Imvexxy | US10258630 | Vaginal inserted estradiol pharmaceutical compositions and methods | Dec 20, 2033 | Mayne Pharma |
| Imvexxy | US10398708 | Vaginal inserted estradiol pharmaceutical compositions and methods | Dec 20, 2033 | Mayne Pharma |
| Imvexxy | US10471072 | Vaginal inserted estradiol pharmaceutical compositions and methods | Jun 18, 2033 | 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 | Jun 18, 2033 | Mayne Pharma |
| Imvexxy | US10668082 | Vaginal inserted estradiol pharmaceutical compositions and methods | Jun 18, 2033 | 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 | Jun 18, 2033 | Mayne Pharma |
| Imvexxy | US11065197 | Soluble estradiol capsule for vaginal insertion | Jun 18, 2033 | Mayne Pharma |
| Imvexxy | US11116717 | Soluble estradiol capsule for vaginal insertion | Jun 18, 2033 | Mayne Pharma |
| Imvexxy | US11123283 | Soluble estradiol capsule for vaginal insertion | Jun 18, 2033 | 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 | US11266661 | Vaginal inserted estradiol pharmaceutical compositions and methods | Feb 02, 2034 | 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 | Dec 20, 2033 | Mayne Pharma |
| Imvexxy | US9289382 | Vaginal inserted estradiol pharmaceutical compositions and methods | Nov 21, 2032 | Mayne Pharma |
| 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 |
| 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 |
| Minivelle | US6024976 | Solubility parameter based drug delivery system and method for altering drug saturation concentration |
Jan 07, 2014
(Expired) | Noven |
| Minivelle | US6841716 | Patch |
Apr 27, 2020
(Expired) | Noven |
| 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 | US5860946 | Instrument for inserting a suppository |
Jul 01, 2017
(Expired) | Novo Nordisk Inc |
| Vagifem | US7018992 | Hormone composition |
Sep 17, 2022
(Expired) | Novo Nordisk Inc |
| Vivelle-dot | US5474783 | Solubility parameter based drug delivery system and method for altering drug saturation concentration |
Dec 12, 2012
(Expired) | Sandoz |
| Vivelle-dot | US5656286 | Solubility parameter based drug delivery system and method for altering drug saturation concentration |
Aug 12, 2014
(Expired) | Sandoz |
| Vivelle-dot | US5958446 | Solubility parameter based drug delivery system and method for altering drug saturation concentration |
Dec 12, 2012
(Expired) | Sandoz |
| Vivelle-dot | US6024976 | Solubility parameter based drug delivery system and method for altering drug saturation concentration |
Jan 07, 2014
(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.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Patent Issue Date Used in PTA Calculation | 28 Mar, 2006 | US7018992 |
| Recordation of Patent Grant Mailed | 28 Mar, 2006 | US7018992 |
| Issue Notification Mailed | 08 Mar, 2006 | US7018992 |
| Receipt into Pubs | 23 Feb, 2006 | US7018992 |
| Dispatch to FDC | 22 Feb, 2006 | US7018992 |
| Application Is Considered Ready for Issue | 22 Feb, 2006 | US7018992 |
| Receipt into Pubs | 20 Jan, 2006 | US7018992 |
| Printer Rush- No mailing | 27 Sep, 2005 | US7018992 |
| Pubs Case Remand to TC | 06 Sep, 2005 | US7018992 |
| Workflow - File Sent to Contractor | 03 Jun, 2005 | US7018992 |
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Estradiol Generics
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 Solaris Pharma Corp and was approved on Apr 22, 2024.
Given below is the list of companies who have filed for Estradiol generic.
1. AMNEAL
Amneal 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 Amneal.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.1MG/24HR | film, extended release | Prescription | TRANSDERMAL | AB3 | Sep 28, 2020 |
| 0.025MG/24HR | film, extended release | Prescription | TRANSDERMAL | AB3 | Sep 28, 2020 |
| 0.0375MG/24HR | film, extended release | Prescription | TRANSDERMAL | AB3 | Sep 28, 2020 |
| 0.05MG/24HR | film, extended release | Prescription | TRANSDERMAL | AB3 | Sep 28, 2020 |
| 0.075MG/24HR | film, extended release | Prescription | TRANSDERMAL | AB3 | Sep 28, 2020 |
2. 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 |
|---|---|---|---|---|---|
| 1.5MG | tablet | Discontinued | ORAL | N/A | Dec 29, 1997 |
| 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 |
3. 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 |
4. 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 |
5. 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 |
6. 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) (reference listed drug) | cream | Prescription | VAGINAL | AB | Jan 31, 1984 |
7. 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 |
|---|---|---|---|---|---|
| 2MG | tablet | Discontinued | ORAL | N/A | Nov 19, 1999 |
| 0.5MG | tablet | Discontinued | ORAL | N/A | Nov 19, 1999 |
| 1MG | tablet | Discontinued | ORAL | N/A | Nov 19, 1999 |
8. 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 |
9. 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 |
10. CHEMO RESEARCH SL
Chemo Research Sl has filed for 1 generic 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% | gel | Prescription | TRANSDERMAL | AB | Aug 10, 2022 |
11. 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 |
|---|---|---|---|---|---|
| 0.0375MG/24HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Mar 29, 2023 |
| 0.1MG/24HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Mar 29, 2023 |
| 0.075MG/24HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Mar 29, 2023 |
| 0.05MG/24HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Mar 29, 2023 |
| 0.025MG/24HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Mar 29, 2023 |
| 0.06MG/24HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Mar 29, 2023 |
| 0.014MG/24HR | system | Prescription | TRANSDERMAL | AB | Apr 17, 2023 |
12. 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 |
| 0.5MG | tablet | Discontinued | ORAL | N/A | Mar 14, 1996 |
| 1MG | tablet | Discontinued | ORAL | N/A | Mar 14, 1996 |
13. 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 |
| 0.5MG | tablet | Discontinued | ORAL | N/A | Apr 17, 2002 |
| 2MG | tablet | Discontinued | ORAL | N/A | Apr 17, 2002 |
14. ALVOGEN
Alvogen Inc has filed for 1 generic for Estradiol. Given below are the details of the strengths of this generic introduced by Alvogen.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.01% | cream | Prescription | VAGINAL | AB | Mar 5, 2018 |
15. 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 |
16. NOVITIUM PHARMA
Novitium Pharma Llc has filed for 4 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% | gel | Prescription | TRANSDERMAL | AB | Aug 24, 2023 |
| 0.5MG | tablet | Prescription | ORAL | AB | Sep 6, 2023 |
| 1MG | tablet | Prescription | ORAL | AB | Sep 6, 2023 |
| 2MG | tablet | Prescription | ORAL | AB | Sep 6, 2023 |
17. MYLAN
Mylan Pharmaceuticals Inc has filed for 4 different strengths of generic version 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 |
|---|---|---|---|---|---|
| 1MG | tablet | Discontinued | ORAL | N/A | Apr 21, 1999 |
| 0.5MG | tablet | Discontinued | ORAL | N/A | Apr 21, 1999 |
| 2MG | tablet | Discontinued | ORAL | N/A | Apr 21, 1999 |
| 0.01% | cream | Prescription | VAGINAL | AB | Dec 29, 2017 |
18. 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 |
|---|---|---|---|---|---|
| 2MG
(reference listed drug) | tablet | Discontinued | ORAL | N/A | Approved Prior to Jan 1, 1982 |
| 1MG
(reference listed drug) | tablet | Discontinued | ORAL | N/A | Approved Prior to Jan 1, 1982 |
| 0.5MG | tablet | Discontinued | ORAL | N/A | Jun 30, 1993 |
19. 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 |
|---|---|---|---|---|---|
| 0.1MG/24HR | film, extended release | Prescription | TRANSDERMAL | AB3 | Aug 15, 2018 |
| 0.05MG/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 | AB | Jul 20, 2006 |
| 0.0375MG/24HR | film, extended release | Prescription | TRANSDERMAL | AB3 | Aug 15, 2018 |
20. 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 |
21. 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 |
| 2MG | tablet | Prescription | ORAL | AB | Dec 29, 1998 |
| 0.5MG | tablet | Prescription | ORAL | AB | Dec 29, 1998 |
22. PADAGIS ISRAEL
Padagis Israel Pharmaceuticals Ltd has filed for 2 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% | gel | Prescription | TRANSDERMAL | AB | Nov 14, 2023 |