Stavudine - Generic Drug Details

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

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

See all stavudine clinical trials

Generic filers with tentative approvals for STAVUDINE

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

Anti-HIV Agents

Antimetabolites

Reverse Transcriptase Inhibitors

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
Aurobindo Pharma	STAVUDINE	stavudine	CAPSULE;ORAL	077672-004	Dec 29, 2008		DISCN	No	No
Bristol	ZERIT	stavudine	FOR SOLUTION;ORAL	020413-001	Sep 6, 1996		DISCN	Yes	No
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-002	Dec 31, 2002		DISCN	No	No					Y
Aurobindo Pharma	STAVUDINE	stavudine	FOR SOLUTION;ORAL	077774-001	Dec 29, 2008		DISCN	No	No

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
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-004	Dec 31, 2002
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-001	Jun 24, 1994
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-004	Jun 24, 1994
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-003	Jun 24, 1994

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

International Patents for stavudine

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

Supplementary Protection Certificates for stavudine

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