Testosterone Patent Expiration
Testosterone was first introduced by Alza Corp
Testosterone Patents
Given below is the list of patents protecting Testosterone, 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 |
|---|---|---|---|---|
| Androgel | US6503894 | Pharmaceutical composition and method for treating hypogonadism |
Aug 30, 2020
(Expired) | Besins Hlthcare |
| Androgel |
US6503894 (Pediatric) | Pharmaceutical composition and method for treating hypogonadism |
Mar 01, 2021
(Expired) | Besins Hlthcare |
| Androgel |
US6503894 (Pediatric) | Pharmaceutical composition and method for treating hypogonadism |
Mar 02, 2021
(Expired) | Besins Hlthcare |
| Androgel | US8446138 | Stability compensation circuit and DC-DC converter including the same | Oct 12, 2026 | Besins Hlthcare |
| Androgel | US8466136 | Testosterone gel and method of use | Oct 12, 2026 | Besins Hlthcare |
| Androgel | US8466137 | Testosterone gel and method of use | Oct 12, 2026 | Besins Hlthcare |
| Androgel | US8466138 | Testosterone gel and method of use | Oct 12, 2026 | Besins Hlthcare |
| Androgel | US8486925 | Testosterone gel and method of use | Oct 12, 2026 | Besins Hlthcare |
| Androgel | US8729057 | Testosterone gel and method of use | Oct 12, 2026 | Besins Hlthcare |
| Androgel | US8741881 | Testosterone gel and method of use | Oct 12, 2026 | Besins Hlthcare |
| Androgel | US8754070 | Testosterone gel and method of use | Oct 12, 2026 | Besins Hlthcare |
| Androgel | US8759329 | Testosterone gel and method of use | Oct 12, 2026 | Besins Hlthcare |
| Androgel | US9125816 | Pharmaceutical composition and method for treating hypogonadism |
Aug 30, 2020
(Expired) | Besins Hlthcare |
| Androgel |
US9125816 (Pediatric) | Pharmaceutical composition and method for treating hypogonadism |
Mar 02, 2021
(Expired) | Besins Hlthcare |
| Androgel | US9132089 | Pharmaceutical composition and method for treating hypogonadism |
Aug 30, 2020
(Expired) | Besins Hlthcare |
| Androgel |
US9132089 (Pediatric) | Pharmaceutical composition and method for treating hypogonadism |
Mar 02, 2021
(Expired) | Besins Hlthcare |
| Axiron | US6299900 | Dermal penetration enhancers and drug delivery systems involving same |
Feb 19, 2017
(Expired) | Eli Lilly And Co |
| Axiron | US6818226 | Dermal penetration enhancers and drug delivery systems involving same |
Feb 19, 2017
(Expired) | Eli Lilly And Co |
| Axiron | US6923983 | Transdermal delivery of hormones |
Feb 19, 2017
(Expired) | Eli Lilly And Co |
| Axiron | US8071075 | Dermal penetration enhancers and drug delivery systems involving the same |
Feb 19, 2017
(Expired) | Eli Lilly And Co |
| Axiron | US8419307 | Spreading implement | Feb 26, 2027 | Eli Lilly And Co |
| Axiron | US8435944 | Method and composition for transdermal drug delivery | Sep 27, 2027 | Eli Lilly And Co |
| Axiron | US8784878 | Transdermal delivery rate control using amorphous pharmaceutical compositions |
Jul 13, 2023
(Expired) | Eli Lilly And Co |
| Axiron | US8807861 | Spreading implement | Feb 26, 2027 | Eli Lilly And Co |
| Axiron | US8993520 | Method and composition for transdermal drug delivery | Jun 02, 2026 | Eli Lilly And Co |
| Axiron | US9180194 | Method and composition for transdermal drug delivery | Jun 02, 2026 | Eli Lilly And Co |
| Axiron | US9289586 | Spreading implement | Feb 26, 2027 | Eli Lilly And Co |
| Fortesta | US6319913 | Penetration enhancing and irritation reducing systems |
Nov 09, 2018
(Expired) | Endo Operations |
| Fortesta | US6579865 | Penetration enhancing and irritation reducing systems |
Nov 09, 2018
(Expired) | Endo Operations |
| Natesto | US11090312 | Methods of treating hypogonadism with transnasal testerosterone bio-adhesive gel formulations in male with allergic rhinitis, and methods for preventing an allergic rhinitis event | Mar 17, 2034 | Acerus |
| Natesto | US8574622 | Controlled release delivery system for nasal applications |
Feb 04, 2024
(Expired) | Acerus |
| Natesto | US8784869 | Controlled release delivery system for nasal applications and methods of treatment |
Feb 04, 2024
(Expired) | Acerus |
| Natesto | US8784882 | Controlled release delivery system for nasal applications and method of treatment |
Feb 04, 2024
(Expired) | Acerus |
| Natesto | US8877230 | Controlled release delivery system for nasal applications |
Feb 04, 2024
(Expired) | Acerus |
| Striant | US6248358 | Bioadhesive progressive hydration tablets and methods of making and using the same |
Aug 23, 2019
(Expired) | Auxilium Pharms Llc |
| Testim | US7320968 | Pharmaceutical composition | Jan 18, 2025 | Endo Operations |
| Testim | US7608605 | Pharmaceutical composition |
Apr 21, 2023
(Expired) | Endo Operations |
| Testim | US7608606 | Pharmaceutical composition |
Apr 21, 2023
(Expired) | Endo Operations |
| Testim | US7608607 | Pharmaceutical composition |
Apr 21, 2023
(Expired) | Endo Operations |
| Testim | US7608608 | Pharmaceutical composition |
Apr 21, 2023
(Expired) | Endo Operations |
| Testim | US7608609 | Pharmaceutical composition |
Apr 21, 2023
(Expired) | Endo Operations |
| Testim | US7608610 | Pharmaceutical composition |
Apr 21, 2023
(Expired) | Endo Operations |
| Testim | US7935690 | Pharmaceutical composition |
Apr 21, 2023
(Expired) | Endo Operations |
| Testim | US8063029 | Pharmaceutical composition |
Apr 21, 2023
(Expired) | Endo Operations |
| Testim | US8178518 | Pharmaceutical composition |
Apr 21, 2023
(Expired) | Endo Operations |
| Testoderm | US5840327 | Transdermal drug delivery device having enhanced adhesion |
Aug 15, 2016
(Expired) | Alza |
| Testoderm Tts | US6348210 | Methods for transdermal drug administration |
Nov 10, 2019
(Expired) | Alza |
| Vogelxo | US8785426 | Testosterone gel compositions and related methods | Feb 11, 2034 | Upsher Smith Labs |
| Vogelxo | US9295675 | Testosterone gel compositions and related methods | Feb 11, 2034 | Upsher Smith Labs |
| Vogelxo | US9622340 | Flexible circuit board and method for manufacturing same | Feb 11, 2034 | Upsher Smith Labs |
| Vogelxo | US9662340 | Testosterone gel compositions and related methods | Feb 11, 2034 | Upsher Smith Labs |
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 Testosterone's patents.
Latest Legal Activities on Testosterone's Patents
Given below is the list recent legal activities going on the following patents of Testosterone.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Expire Patent | 17 Jun, 2024 | US8178518(Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Jun, 2024 | US9662340 |
| Maintenance Fee Reminder Mailed | 01 Jan, 2024 | US8178518(Litigated) |
| Expire Patent | 25 Dec, 2023 | US8063029(Litigated) |
| Maintenance Fee Reminder Mailed | 10 Jul, 2023 | US8063029(Litigated) |
| Expire Patent | 05 Jun, 2023 | US7935690(Litigated) |
| Maintenance Fee Reminder Mailed | 19 Dec, 2022 | US7935690(Litigated) |
| Expire Patent | 29 Nov, 2021 | US7608606(Litigated) |
| Expire Patent | 29 Nov, 2021 | US7608605(Litigated) |
| Expire Patent | 29 Nov, 2021 | US7608607(Litigated) |
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Testosterone Generics
Several generic applications have been filed for Testosterone. The first generic version for Testosterone was by Endo Operations Ltd 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 Feb 9, 2024.
Given below is the list of companies who have filed for Testosterone generic.
1. ENCUBE
Encube Ethicals Private Ltd has filed for 4 different strengths of generic version for Testosterone. Given below are the details of the strengths of this generic introduced by Encube.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1.62% (20.25MG/1.25GM ACTUATION) | gel, metered | Prescription | TRANSDERMAL | AB | Apr 10, 2019 |
| 30MG/1.5ML ACTUATION | solution, metered | Prescription | TRANSDERMAL | AT | Jan 11, 2021 |
| 50MG/5GM PACKET | gel | Prescription | TRANSDERMAL | AB1 | Nov 9, 2021 |
| 12.5MG/1.25GM ACTUATION | gel, metered | Prescription | TRANSDERMAL | AB1 | Feb 9, 2024 |
2. DR REDDYS
Dr Reddys Laboratories Ltd has filed for 1 generic for Testosterone. Given below are the details of the strengths of this generic introduced by Dr Reddys.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 100MG/ML | injectable | Discontinued | INJECTION | N/A | Jul 7, 1983 |
3. ACTAVIS LABS UT INC
Actavis Laboratories Ut Inc has filed for 8 different strengths of generic version for Testosterone. Given below are the details of the strengths of this generic introduced by Actavis Labs Ut Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25MG/2.5GM PACKET | gel | Prescription | TRANSDERMAL | AB1 | Jan 27, 2006 |
| 50MG/5GM PACKET | gel | Prescription | TRANSDERMAL | AB2 | Sep 18, 2017 |
| 12.5MG/1.25GM ACTUATION
(reference standard) | gel, metered | Prescription | TRANSDERMAL | AB1 | Mar 9, 2015 |
| 10MG/0.5GM ACTUATION
(reference standard) | gel, metered | Prescription | TRANSDERMAL | N/A | Aug 5, 2015 |
| 30MG/1.5ML ACTUATION | solution, metered | Prescription | TRANSDERMAL | AT | Aug 7, 2017 |
| 1.62% (20.25MG/1.25GM ACTUATION) | gel, metered | Prescription | TRANSDERMAL | AB | Apr 10, 2019 |
| 1.62% (20.25MG/1.25GM PACKET) | gel | Prescription | TRANSDERMAL | AB2 | Jul 17, 2020 |
| 1.62% (40.5MG/2.5GM PACKET) | gel | Prescription | TRANSDERMAL | AB2 | Jul 17, 2020 |
4. CIPLA
Cipla Ltd has filed for 1 generic for Testosterone. Given below are the details of the strengths of this generic introduced by Cipla.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 30MG/1.5ML ACTUATION | solution, metered | Prescription | TRANSDERMAL | AT | Jan 29, 2018 |
5. AMNEAL
Amneal Pharmaceuticals Llc has filed for 1 generic for Testosterone. Given below are the details of the strengths of this generic introduced by Amneal.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1.62% (20.25MG/1.25GM ACTUATION) | gel, metered | Prescription | TRANSDERMAL | AB | Apr 10, 2019 |
6. WATSON LABS
Watson Laboratories Inc has filed for 2 different strengths of generic version for Testosterone. Given below are the details of the strengths of this generic introduced by Watson Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25MG/ML | injectable | Discontinued | INJECTION | N/A | May 10, 1983 |
| 50MG/ML | injectable | Discontinued | INJECTION | N/A | Aug 23, 1983 |
7. LUPIN LTD
Lupin Ltd has filed for 1 generic for Testosterone. Given below are the details of the strengths of this generic introduced by Lupin Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 30MG/1.5ML ACTUATION | solution, metered | Prescription | TRANSDERMAL | AT | Oct 23, 2017 |
8. LUPIN
Lupin Inc has filed for 1 generic for Testosterone. Given below are the details of the strengths of this generic introduced by Lupin.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1.62% (20.25MG/1.25GM ACTUATION) | gel, metered | Prescription | TRANSDERMAL | AB | Apr 10, 2019 |
9. TWI PHARMS
Twi Pharmaceuticals Inc has filed for 2 different strengths of generic version for Testosterone. Given below are the details of the strengths of this generic introduced by Twi Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1.62% (20.25MG/1.25GM ACTUATION) | gel, metered | Prescription | TRANSDERMAL | AB | Sep 23, 2019 |
| 30MG/1.5ML ACTUATION | solution, metered | Prescription | TRANSDERMAL | AT | Sep 3, 2021 |
10. XIROMED
Xiromed Pharma Espana Sl has filed for 1 generic for Testosterone. Given below are the details of the strengths of this generic introduced by Xiromed.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1.62% (20.25MG/1.25GM ACTUATION) | gel, metered | Prescription | TRANSDERMAL | AB | Apr 16, 2020 |
11. STRIDES PHARMA
Strides Pharma Global Pte Ltd has filed for 2 different strengths of generic version for Testosterone. Given below are the details of the strengths of this generic introduced by Strides Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG/5GM PACKET | gel | Prescription | TRANSDERMAL | AB1 | May 23, 2007 |
| 25MG/2.5GM PACKET | gel | Prescription | TRANSDERMAL | AB1 | May 23, 2007 |
12. ENDO OPERATIONS
Endo Operations Ltd has filed for 1 generic for Testosterone. This 75mg version comes by the name TESTOPEL. Given below are the details of the strengths of this generic introduced by Endo Operations.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 75MG
(reference standard) | pellet | Prescription | IMPLANTATION | N/A | Approved Prior to Jan 1, 1982 |
13. ALEMBIC
Alembic Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Testosterone. Given below are the details of the strengths of this generic introduced by Alembic.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1.62% (20.25MG/1.25GM ACTUATION) | gel, metered | Discontinued | TRANSDERMAL | N/A | Mar 3, 2021 |
| 30MG/1.5ML ACTUATION | solution, metered | Discontinued | TRANSDERMAL | N/A | Jun 14, 2021 |
14. APOTEX
Apotex Inc has filed for 1 generic for Testosterone. Given below are the details of the strengths of this generic introduced by Apotex.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 30MG/1.5ML ACTUATION | solution, metered | Discontinued | TRANSDERMAL | N/A | Nov 25, 2020 |
15. PADAGIS ISRAEL
Padagis Israel Pharmaceuticals Ltd has filed for 4 different strengths of generic version for Testosterone. 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 |
|---|---|---|---|---|---|
| 1.62% (20.25MG/1.25GM ACTUATION) | gel, metered | Prescription | TRANSDERMAL | AB | Aug 4, 2015 |
| 30MG/1.5ML ACTUATION
(reference standard) | solution, metered | Prescription | TRANSDERMAL | AT | Feb 28, 2017 |
| 1.62% (20.25MG/1.25GM PACKET) | gel | Prescription | TRANSDERMAL | AB2 | Jul 12, 2017 |
| 1.62% (40.5MG/2.5GM PACKET)
(reference standard) | gel | Prescription | TRANSDERMAL | AB2 | Jul 12, 2017 |