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, Norvium Bioscience, Bristol, and Cipla Ltd, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

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

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

Sponsor	Phase
Christian Medical College, Vellore, India	Phase 4
Tufts University	Phase 4
Chulalongkorn University	Phase 2/Phase 3

See all stavudine clinical trials

Generic filers with tentative approvals for STAVUDINE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	40MG; 150MG; 200MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	40MG; 150MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	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.

Medical Subject Heading (MeSH) Categories for stavudine

Anti-HIV Agents
Antimetabolites
Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for stavudine

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for stavudine

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hetero Labs Ltd Iii	STAVUDINE	stavudine	CAPSULE;ORAL	078957-002	Dec 29, 2008		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd Iii	STAVUDINE	stavudine	CAPSULE;ORAL	078957-001	Dec 29, 2008		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	STAVUDINE	stavudine	CAPSULE;ORAL	077672-004	Dec 29, 2008		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

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for stavudine

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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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