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ZIDOVUDINE - Generic Drug Details

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What are the generic sources for zidovudine and what is the scope of patent protection?

Zidovudine is the generic ingredient in two branded drugs marketed by Viiv Hlthcare, Aurobindo Pharma Ltd, Cipla Ltd, Am Regent, Liaoning Chengda, Aurobindo, Aurobindo Pharma, Cipla, Hec Pharm, Hetero Labs Ltd Iii, Hikma, Mylan Labs Ltd, Mylan Pharms Inc, and Ranbaxy Labs Ltd, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-two drug master file entries for zidovudine. Seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ZIDOVUDINE

US Patents:	0
Tradenames:	2
Applicants:	14
NDAs:	19
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	488
Patent Applications:	7,000
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for ZIDOVUDINE
What excipients (inactive ingredients) are in ZIDOVUDINE?	ZIDOVUDINE excipients list
DailyMed Link:	ZIDOVUDINE at DailyMed

See drug prices for ZIDOVUDINE

Recent Clinical Trials for ZIDOVUDINE

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

Sponsor	Phase
Augusta University	Phase 4
University of Cape Town	Phase 4
Infectious Diseases Institute, Uganda	Phase 3

See all ZIDOVUDINE clinical trials

Generic filers with tentative approvals for ZIDOVUDINE

Applicant	Application No.	Strength	Dosage Form
		100MG	CAPSULE; 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 ZIDOVUDINE

Drug Class	Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for ZIDOVUDINE

Anti-HIV Agents

Antimetabolites

Reverse Transcriptase Inhibitors

US Patents and Regulatory Information for ZIDOVUDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ranbaxy Labs Ltd	ZIDOVUDINE	zidovudine	TABLET;ORAL	077327-001	Sep 19, 2005		DISCN	No	No
Viiv Hlthcare	RETROVIR	zidovudine	SOLUTION;ORAL	019910-001	Sep 28, 1989	AA	RX	Yes	Yes
Aurobindo Pharma	ZIDOVUDINE	zidovudine	TABLET;ORAL	022294-001	Jul 23, 2009		DISCN	No	No
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-002	Oct 4, 1996		DISCN	Yes	No
Mylan Labs Ltd	ZIDOVUDINE	zidovudine	TABLET;ORAL	200732-001	Feb 23, 2011		DISCN	No	No

Expired US Patents for ZIDOVUDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	RETROVIR	zidovudine	INJECTABLE;INJECTION	019951-001	Feb 2, 1990
Viiv Hlthcare	RETROVIR	zidovudine	CAPSULE;ORAL	019655-001	Mar 19, 1987
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-002	Oct 4, 1996
Viiv Hlthcare	RETROVIR	zidovudine	CAPSULE;ORAL	019655-001	Mar 19, 1987
Viiv Hlthcare	RETROVIR	zidovudine	INJECTABLE;INJECTION	019951-001	Feb 2, 1990