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Stavudine Patent Expiration

Stavudine is used for managing HIV-1 infection. It was first introduced by Bristol Myers Squibb Co in its drug Zerit on Jun 24, 1994. Another drug containing Stavudine is Zerit Xr. 7 different companies have introduced drugs containing Stavudine.


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 Sustained release beadlets containing stavudine Feb 18, 2023

(Expired)

 Bristol Myers Squibb
Zerit Xr US7135465

(Pediatric)

 Sustained release beadlets containing stavudine Aug 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.

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

Event Date Patent/Publication
Patent litigations
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 14 Nov, 2006 US7135465
Patent Issue Date Used in PTA Calculation 14 Nov, 2006 US7135465
Issue Notification Mailed 25 Oct, 2006 US7135465
Application Is Considered Ready for Issue 18 Oct, 2006 US7135465
Dispatch to FDC 18 Oct, 2006 US7135465
Issue Fee Payment Received 13 Oct, 2006 US7135465
Issue Fee Payment Verified 13 Oct, 2006 US7135465
Mail Notice of Allowance 18 Jul, 2006 US7135465



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Stavudine Generics

Several generic applications have been filed for Stavudine. The first generic version for Stavudine was by Mylan Pharmaceuticals Inc 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.


1. MYLAN

Mylan Pharmaceuticals Inc has filed for 4 different strengths of generic version for Stavudine. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
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
30MG capsule Discontinued ORAL N/A Dec 29, 2008


2. MYLAN LABS LTD

Mylan Laboratories Ltd has filed for 2 different strengths of generic version for Stavudine. Given below are the details of the strengths of this generic introduced by Mylan Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
30MG capsule Discontinued ORAL N/A Jan 5, 2009
40MG capsule Discontinued ORAL N/A Jan 5, 2009


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. 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


5. 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