Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

McKesson
Dow
AstraZeneca
Medtronic
McKinsey
Colorcon

Last Updated: November 26, 2022

Stavudine - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


What are the generic drug sources for stavudine and what is the scope of freedom to operate?

Stavudine is the generic ingredient in three branded drugs marketed by Bristol Myers Squibb, Aurobindo Pharma, Hetero Labs Ltd Iii, Mylan, Mylan Labs Ltd, Bristol, and Cipla Ltd, 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. One supplier is listed for this compound. There are ten tentative approvals for this compound.

Summary for stavudine
International Patents:28
US Patents:1
Tradenames:3
Applicants:7
NDAs:9
Drug Master File Entries: 14
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 113
Clinical Trials: 173
Patent Applications: 7,379
Formulation / Manufacturing:see details
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
Christian Medical College, Vellore, IndiaPhase 4
Tufts UniversityPhase 4
Radboud UniversityPhase 2/Phase 3

See all stavudine clinical trials

Generic filers with tentative approvals for STAVUDINE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing40MG; 150MG; 200MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing40MG; 150MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing40MG; 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
Mylan Labs Ltd STAVUDINE stavudine CAPSULE;ORAL 078775-001 Jan 5, 2009 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma STAVUDINE stavudine CAPSULE;ORAL 077672-004 Dec 29, 2008 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bristol ZERIT stavudine FOR SOLUTION;ORAL 020413-001 Sep 6, 1996 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-002 Dec 31, 2002 DISCN No No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Aurobindo Pharma STAVUDINE stavudine FOR SOLUTION;ORAL 077774-001 Dec 29, 2008 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-004 Dec 31, 2002 See Plans and Pricing See Plans and Pricing
Bristol ZERIT stavudine CAPSULE;ORAL 020412-001 Jun 24, 1994 See Plans and Pricing See Plans and Pricing
Bristol ZERIT stavudine CAPSULE;ORAL 020412-004 Jun 24, 1994 See Plans and Pricing See Plans and Pricing
Bristol ZERIT stavudine CAPSULE;ORAL 020412-003 Jun 24, 1994 See Plans and Pricing See Plans and Pricing
>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

International Patents for stavudine

Country Patent Number Title Estimated Expiration
Lithuania 5045 PROLONGUOTO IŠSISKYRIMO GRANULĖS, TURINČIOS STAVUDINO (SUSTAINED RELEASE BEADLETS CONTAINING STAVUDINE) See Plans and Pricing
China 1187052 See Plans and Pricing
Russian Federation 2239435 ГРАНУЛЫ ПРОЛОНГИРОВАННОГО ВЫСВОБОЖДЕНИЯ, СОДЕРЖАЩИЕ СТАВУДИН (STAVUDINE-CONTAINING SUSTAINED-RELEASE GRANULE) See Plans and Pricing
Australia 4959101 See Plans and Pricing
Poland 366089 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for stavudine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0273277 SPC/GB96/049 United Kingdom See Plans and Pricing 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
0273277 C960024 Netherlands See Plans and Pricing PRODUCT NAME: STAVUDINE; REGISTRATION NO/DATE: EU/1/96/009/001 - EU/1/96/009/009 19960508
0383472 96C0040 Belgium See Plans and Pricing PRODUCT NAME: STAVUDINE; NAT. REGISTRATION NO/DATE: EU/1/96/009/001-009 19960509; FIRST REGISTRATION:
0273277 96C0039 Belgium See Plans and Pricing PRODUCT NAME: STAVUDINE; REGISTRATION NO/DATE: EU/1/96/009/001 19960508
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Johnson and Johnson
Colorcon
AstraZeneca
Merck
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.