Vardenafil Hydrochloride Patent Expiration
Vardenafil Hydrochloride is Used for treating erectile dysfunction. It was first introduced by Bayer Healthcare Pharmaceuticals Inc
Vardenafil Hydrochloride Patents
Given below is the list of patents protecting Vardenafil Hydrochloride, 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 |
|---|---|---|---|---|
| Staxyn | US8613950 | Pharmaceutical forms with improved pharmacokinetic properties | Dec 23, 2028 | Bayer Hlthcare |
| Levitra | US8273876 | Medicaments containing vardenafil hydrochloride trihydrate | Jul 23, 2027 | Bayer Hlthcare |
| Levitra | US8841446 | Medicaments containing vardenafil hydrochloride trihydrate |
Jul 03, 2023
(Expired) | Bayer Hlthcare |
| Levitra | US6362178 | 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors |
Oct 31, 2018
(Expired) | Bayer Hlthcare |
| Levitra | US7696206 | 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors |
Oct 31, 2018
(Expired) | Bayer Hlthcare |
| Staxyn | US6362178 | 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors |
Oct 31, 2018
(Expired) | Bayer Hlthcare |
| Staxyn | US7696206 | 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors |
Oct 31, 2018
(Expired) | Bayer Hlthcare |
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 Vardenafil Hydrochloride's patents.
Latest Legal Activities on Vardenafil Hydrochloride's Patents
Given below is the list recent legal activities going on the following patents of Vardenafil Hydrochloride.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Jun, 2021 | US8613950(Litigated) |
| Mail O.P. Petition Decision | 16 Jan, 2015 | US8613950(Litigated) |
| Mail-Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 13 Jan, 2015 | US8613950(Litigated) |
| O.P. Petition Decision | 12 Jan, 2015 | US8613950(Litigated) |
| Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 12 Jan, 2015 | US8613950(Litigated) |
| Adjustment of PTA Calculation by PTO | 07 Jan, 2015 | US8613950(Litigated) |
| Petition Entered | 21 Feb, 2014 | US8613950(Litigated) |
| Recordation of Patent Grant Mailed Critical | 24 Dec, 2013 | US8613950(Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 24 Dec, 2013 | US8613950(Litigated) |
| Email Notification Critical | 05 Dec, 2013 | US8613950(Litigated) |
Vardenafil Hydrochloride's Family Patents
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Vardenafil Hydrochloride Generic API Manufacturers
Several generic applications have been filed for Vardenafil Hydrochloride. The first generic version for Vardenafil Hydrochloride was by Teva Pharmaceuticals Usa and was approved on May 3, 2012. And the latest generic version is by Alembic Pharmaceuticals Ltd and was approved on Aug 4, 2020.
Given below is the list of companies who have filed for Vardenafil Hydrochloride generic, along with the locations of their manufacturing plants worldwide.
1. ALEMBIC
Alembic Pharmaceuticals Ltd has filed for 5 different strengths of generic version for Vardenafil Hydrochloride. Given below are the details of the strengths of this generic introduced by Alembic.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG
(reference standard) | tablet, orally disintegrating | Prescription | ORAL | AB | Nov 16, 2018 |
| EQ 2.5MG BASE | tablet | Prescription | ORAL | AB | Aug 4, 2020 |
| EQ 5MG BASE | tablet | Prescription | ORAL | AB | Aug 4, 2020 |
| EQ 10MG BASE | tablet | Prescription | ORAL | AB | Aug 4, 2020 |
| EQ 20MG BASE | tablet | Prescription | ORAL | AB | Aug 4, 2020 |
Manufacturing Plant Locations New
Alembic'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 Alembic as present at those locations.
| Country | City | Firm Name | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
| |||||||||||||||
2. CROSSMEDIKA SA
Crossmedika Sa has filed for 4 different strengths of generic version for Vardenafil Hydrochloride. Given below are the details of the strengths of this generic introduced by Crossmedika Sa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 5MG BASE | tablet | Prescription | ORAL | AB | Oct 31, 2018 |
| EQ 2.5MG BASE | tablet | Prescription | ORAL | AB | Oct 31, 2018 |
| EQ 20MG BASE | tablet | Prescription | ORAL | AB | Oct 31, 2018 |
| EQ 10MG BASE | tablet | Prescription | ORAL | AB | Oct 31, 2018 |
3. MACLEODS PHARMS LTD
Macleods Pharmaceuticals Ltd has filed for 5 different strengths of generic version for Vardenafil Hydrochloride. Given below are the details of the strengths of this generic introduced by Macleods Pharms Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2.5MG BASE | tablet | Prescription | ORAL | AB | Oct 22, 2019 |
| EQ 20MG BASE | tablet | Prescription | ORAL | AB | Oct 22, 2019 |
| EQ 10MG BASE | tablet | Prescription | ORAL | AB | Oct 22, 2019 |
| EQ 5MG BASE | tablet | Prescription | ORAL | AB | Oct 22, 2019 |
| 10MG | tablet, orally disintegrating | Prescription | ORAL | AB | Mar 10, 2020 |
4. STEVENS J
Jerome Stevens Pharmaceuticals Inc has filed for 3 different strengths of generic version for Vardenafil Hydrochloride. Given below are the details of the strengths of this generic introduced by Stevens J.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 20MG BASE | tablet | Discontinued | ORAL | N/A | Oct 31, 2018 |
| EQ 10MG BASE | tablet | Discontinued | ORAL | N/A | Oct 31, 2018 |
| EQ 5MG BASE | tablet | Discontinued | ORAL | N/A | Oct 31, 2018 |
5. TEVA PHARMS
Teva Pharmaceuticals Usa has filed for 4 different strengths of generic version for Vardenafil Hydrochloride. Given below are the details of the strengths of this generic introduced by Teva Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 10MG BASE | tablet | Prescription | ORAL | AB | May 3, 2012 |
| EQ 20MG BASE | tablet | Prescription | ORAL | AB | May 3, 2012 |
| EQ 2.5MG BASE | tablet | Prescription | ORAL | AB | May 3, 2012 |
| EQ 5MG BASE | tablet | Prescription | ORAL | AB | May 3, 2012 |
6. WATSON LABS TEVA
Watson Laboratories Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 1 generic for Vardenafil Hydrochloride. Given below are the details of the strengths of this generic introduced by Watson Labs Teva.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | tablet, orally disintegrating | Prescription | ORAL | AB | Apr 22, 2015 |
7. ZYDUS PHARMS
Zydus Pharmaceuticals Usa Inc has filed for 4 different strengths of generic version for Vardenafil Hydrochloride. 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 |
|---|---|---|---|---|---|
| EQ 2.5MG BASE | tablet | Prescription | ORAL | AB | Oct 31, 2018 |
| EQ 5MG BASE | tablet | Prescription | ORAL | AB | Oct 31, 2018 |
| EQ 10MG BASE | tablet | Prescription | ORAL | AB | Oct 31, 2018 |
| EQ 20MG BASE
(reference standard) | tablet | Prescription | ORAL | AB | Oct 31, 2018 |