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Last Updated: September 24, 2020

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Stavudine - Generic Drug Details

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What are the generic drug sources for stavudine and what is the scope of patent protection?

Stavudine is the generic ingredient in three branded drugs marketed by Bristol Myers Squibb, Aurobindo Pharma, Hetero Labs Ltd Iii, Mylan, Mylan Labs Ltd, Cipla Ltd, and Bristol-myers Squibb, and is included in nine NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Stavudine has twenty-eight patent family members in twenty-five countries.

There are fourteen drug master file entries for stavudine. Three suppliers are listed for this compound. There are ten tentative approvals for this compound.

Summary for stavudine
Recent Clinical Trials for stavudine

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Tufts UniversityPhase 4
Christian Medical College, Vellore, IndiaPhase 4
Chulalongkorn UniversityPhase 2/Phase 3

See all stavudine clinical trials

Generic filers with tentative approvals for STAVUDINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial40MG; 150MG; 200MGTABLET; ORAL
  Start Trial  Start Trial40MG; 150MGTABLET; ORAL
  Start Trial  Start Trial40MG; 150MG; 200MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for stavudine

US Patents and Regulatory Information for stavudine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma STAVUDINE stavudine FOR SOLUTION;ORAL 077774-001 Dec 29, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Cipla Ltd STAVUDINE stavudine FOR SOLUTION;ORAL 078030-001 Mar 20, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Hetero Labs Ltd Iii STAVUDINE stavudine CAPSULE;ORAL 078957-001 Dec 29, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-004 Dec 31, 2002 DISCN No No   Start Trial   Start Trial Y   Start Trial
Bristol-myers Squibb ZERIT stavudine FOR SOLUTION;ORAL 020413-001 Sep 6, 1996 DISCN Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for stavudine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-001 Dec 31, 2002   Start Trial   Start Trial
Bristol Myers Squibb ZERIT stavudine CAPSULE;ORAL 020412-004 Jun 24, 1994   Start Trial   Start Trial
Bristol Myers Squibb ZERIT stavudine CAPSULE;ORAL 020412-005 Jun 24, 1994   Start Trial   Start Trial
Bristol Myers Squibb ZERIT stavudine CAPSULE;ORAL 020412-003 Jun 24, 1994   Start Trial   Start Trial
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-004 Dec 31, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for stavudine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0273277 96C0039 Belgium   Start Trial PRODUCT NAME: STAVUDINE; REGISTRATION NO/DATE: EU/1/96/009/001 19960508
0273277 SPC/GB96/049 United Kingdom   Start Trial PRODUCT NAME: STAVUDINE; REGISTERED: UK EU/1/96/009/001 19960508; UK EU/1/96/009/002 19960508; UK EU/1/96/009/003 19960508; UK EU/1/96/009/004 19960508; UK EU/1/96/009/005 19960508; UK EU/1/96/009/006 19960508; UK EU/1/96/009/007 19960508; UK EU/1/96/009/008 19960508; UK EU/1/96/009/009 19960508
0383472 96C0040 Belgium   Start Trial PRODUCT NAME: STAVUDINE; NAT. REGISTRATION NO/DATE: EU/1/96/009/001-009 19960509; FIRST REGISTRATION:
0273277 C960024 Netherlands   Start Trial PRODUCT NAME: STAVUDINE; REGISTRATION NO/DATE: EU/1/96/009/001 - EU/1/96/009/009 19960508
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
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Baxter
Mallinckrodt
AstraZeneca
Dow

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