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Last Updated: November 24, 2024

STAVUDINE - Generic Drug Details


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Summary for STAVUDINE
US Patents:0
Tradenames:3
Applicants:6
NDAs:9
Drug Master File Entries: 14
Raw Ingredient (Bulk) Api Vendors: 119
Clinical Trials: 173
Patent Applications: 6,712
What excipients (inactive ingredients) are in STAVUDINE?STAVUDINE excipients list
DailyMed Link:STAVUDINE at DailyMed
Recent Clinical Trials for STAVUDINE

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

SponsorPhase
Tufts UniversityPhase 4
Christian Medical College, Vellore, IndiaPhase 4
Willem Daniel Francois VenterPhase 3

See all STAVUDINE clinical trials

Generic filers with tentative approvals for STAVUDINE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up40MG; 150MG; 200MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up40MG; 150MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up40MG; 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
Norvium Bioscience STAVUDINE stavudine CAPSULE;ORAL 079069-001 Dec 29, 2008 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol ZERIT stavudine CAPSULE;ORAL 020412-005 Jun 24, 1994 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hetero Labs Ltd Iii STAVUDINE stavudine CAPSULE;ORAL 078957-004 Dec 29, 2008 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Norvium Bioscience STAVUDINE stavudine CAPSULE;ORAL 078775-001 Jan 5, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Norvium Bioscience STAVUDINE stavudine CAPSULE;ORAL 079069-003 Dec 29, 2008 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-001 Dec 31, 2002 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ZERIT stavudine CAPSULE;ORAL 020412-005 Jun 24, 1994 ⤷  Sign Up ⤷  Sign Up
Bristol ZERIT stavudine CAPSULE;ORAL 020412-004 Jun 24, 1994 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-001 Dec 31, 2002 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-002 Dec 31, 2002 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-003 Dec 31, 2002 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-004 Dec 31, 2002 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for STAVUDINE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Bristol-Myers Squibb Pharma EEIG Zerit stavudine EMEA/H/C/000110
Hard capsulesZerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (over the age of three months) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.Powder for oral solutionZerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (from birth) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.
Withdrawn no no no 1996-05-08
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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