DrugPatentWatch Database Preview
Stavudine - Generic Drug Details
» See Plans and Pricing
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-myers Squibb, 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 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 111 |
Clinical Trials: | 153 |
Patent Applications: | 7,150 |
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
Sponsor | Phase |
---|---|
Christian Medical College, Vellore, India | Phase 4 |
Tufts University | Phase 4 |
Chulalongkorn University | Phase 2/Phase 3 |
Generic filers with tentative approvals for STAVUDINE
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 40MG; 150MG; 200MG | TABLET; ORAL |
Start Trial | Start Trial | 40MG; 150MG | TABLET; ORAL |
Start Trial | Start Trial | 40MG; 150MG; 200MG | TABLET; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for stavudine
Drug Class | Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor |
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
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 | STAVUDINE | stavudine | CAPSULE;ORAL | 079069-001 | Dec 29, 2008 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Aurobindo Pharma | STAVUDINE | stavudine | CAPSULE;ORAL | 077672-004 | Dec 29, 2008 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Mylan | STAVUDINE | stavudine | CAPSULE;ORAL | 079069-004 | Dec 29, 2008 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Bristol Myers Squibb | ZERIT XR | stavudine | CAPSULE, EXTENDED RELEASE;ORAL | 021453-002 | Dec 31, 2002 | DISCN | No | No | Start Trial | Start Trial | Y | Start Trial | |||
Hetero Labs Ltd Iii | STAVUDINE | stavudine | CAPSULE;ORAL | 078957-002 | Dec 29, 2008 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Hetero Labs Ltd Iii | STAVUDINE | stavudine | CAPSULE;ORAL | 078957-003 | 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 | ||||
>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 XR | stavudine | CAPSULE, EXTENDED RELEASE;ORAL | 021453-004 | Dec 31, 2002 | 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 | 020412-001 | 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 | stavudine | FOR SOLUTION;ORAL | 020413-001 | Sep 6, 1996 | Start Trial | Start Trial |
Bristol-myers Squibb | ZERIT | stavudine | CAPSULE;ORAL | 020412-004 | Jun 24, 1994 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for stavudine
Country | Patent Number | Estimated Expiration |
---|---|---|
Israel | 151475 | Start Trial |
China | 1187052 | Start Trial |
Lithuania | 2002099 | Start Trial |
World Intellectual Property Organization (WIPO) | 0174329 | Start Trial |
Australia | 4959101 | Start Trial |
European Patent Office | 1267879 | Start Trial |
South Africa | 200207760 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for stavudine
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 |
0273277 | 96C0039 | Belgium | Start Trial | PRODUCT NAME: STAVUDINE; REGISTRATION NO/DATE: EU/1/96/009/001 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 |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:






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.