Stavudine Patent Expiration
Stavudine is used for managing HIV-1 infection. It was first introduced by Bristol Myers Squibb Co
Stavudine Patents
Given below is the list of patents protecting Stavudine, 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 |
|---|---|---|---|---|
| Zerit Xr |
US7135465 (Pediatric) | Sustained release beadlets containing stavudine |
Aug 18, 2023
(Expired) | Bristol Myers Squibb |
| Zerit Xr | US7135465 | Sustained release beadlets containing stavudine |
Feb 18, 2023
(Expired) | Bristol Myers Squibb |
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 Stavudine's patents.
Latest Legal Activities on Stavudine's Patents
Given below is the list recent legal activities going on the following patents of Stavudine.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 03 May, 2018 | US7135465 |
| Post Issue Communication - Certificate of Correction | 21 Aug, 2007 | US7135465 |
| Recordation of Patent Grant Mailed Critical | 14 Nov, 2006 | US7135465 |
| Patent Issue Date Used in PTA Calculation Critical | 14 Nov, 2006 | US7135465 |
| Issue Notification Mailed Critical | 25 Oct, 2006 | US7135465 |
| Application Is Considered Ready for Issue Critical | 18 Oct, 2006 | US7135465 |
| Dispatch to FDC | 18 Oct, 2006 | US7135465 |
| Issue Fee Payment Received Critical | 13 Oct, 2006 | US7135465 |
| Issue Fee Payment Verified Critical | 13 Oct, 2006 | US7135465 |
| Mail Notice of Allowance Critical | 18 Jul, 2006 | US7135465 |
Stavudine's Family Patents
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Stavudine Generic API Manufacturers
Several generic applications have been filed for Stavudine. The first generic version for Stavudine was by Norvium Bioscience Llc and was approved on Dec 29, 2008. And the latest generic version is by Cipla Ltd and was approved on Mar 20, 2009.
Given below is the list of companies who have filed for Stavudine generic, along with the locations of their manufacturing plants worldwide.
1. AUROBINDO PHARMA
Aurobindo Pharma Ltd has filed for 5 different strengths of generic version for Stavudine. 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 |
|---|---|---|---|---|---|
| 30MG | capsule | Discontinued | ORAL | N/A | Dec 29, 2008 |
| 40MG | capsule | Discontinued | ORAL | N/A | Dec 29, 2008 |
| 15MG | capsule | Discontinued | ORAL | N/A | Dec 29, 2008 |
| 20MG | capsule | Discontinued | ORAL | N/A | Dec 29, 2008 |
| 1MG/ML | for solution | Discontinued | ORAL | N/A | Dec 29, 2008 |
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 |
| |||||||||
| United States |
| |||||||||
2. CIPLA LTD
Cipla Ltd has filed for 1 generic for Stavudine. Given below are the details of the strengths of this generic introduced by Cipla Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1MG/ML | for solution | Discontinued | ORAL | N/A | Mar 20, 2009 |
Manufacturing Plant Locations New
Cipla Ltd'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 Cipla Ltd as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| India |
| |||
3. HETERO LABS LTD III
Hetero Labs Ltd Unit Iii has filed for 4 different strengths of generic version for Stavudine. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd Iii.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 15MG | capsule | Discontinued | ORAL | N/A | Dec 29, 2008 |
| 20MG | capsule | Discontinued | ORAL | N/A | Dec 29, 2008 |
| 30MG | capsule | Discontinued | ORAL | N/A | Dec 29, 2008 |
| 40MG | capsule | Discontinued | ORAL | N/A | Dec 29, 2008 |
4. NORVIUM BIOSCIENCE
Norvium Bioscience Llc has filed for 4 different strengths of generic version for Stavudine. 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 |
|---|---|---|---|---|---|
| 40MG | capsule | Discontinued | ORAL | N/A | Jan 5, 2009 |
| 15MG | capsule | Discontinued | ORAL | N/A | Dec 29, 2008 |
| 20MG | capsule | Discontinued | ORAL | N/A | Dec 29, 2008 |
| 30MG | capsule | Discontinued | ORAL | N/A | Jan 5, 2009 |