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Last Updated: October 2, 2023

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. Four 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:	4
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	524
Patent Applications:	6,546
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

Drug Prices for ZIDOVUDINE

See drug prices for ZIDOVUDINE

Recent Clinical Trials for ZIDOVUDINE

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

Sponsor	Phase
Michelle Abou-Jaoude	Phase 1
Inflammasome Therapeutics	Phase 1
Johns Hopkins University	Phase 1/Phase 2

See all ZIDOVUDINE clinical trials

Generic filers with tentative approvals for ZIDOVUDINE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	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

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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
Aurobindo	ZIDOVUDINE	zidovudine	TABLET;ORAL	077267-001	Sep 19, 2005	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Labs Ltd	ZIDOVUDINE	zidovudine	TABLET;ORAL	200732-001	Feb 23, 2011		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ranbaxy Labs Ltd	ZIDOVUDINE	zidovudine	TABLET;ORAL	077327-001	Sep 19, 2005		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-002	Oct 4, 1996		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma Ltd	ZIDOVUDINE	zidovudine	CAPSULE;ORAL	078128-001	Mar 27, 2006	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-001	Dec 19, 1995		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Viiv Hlthcare	RETROVIR	zidovudine	SOLUTION;ORAL	019910-001	Sep 28, 1989	AA	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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 ZIDOVUDINE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	RETROVIR	zidovudine	INJECTABLE;INJECTION	019951-001	Feb 2, 1990	⤷ Try a Trial	⤷ Try a Trial
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-002	Oct 4, 1996	⤷ Try a Trial	⤷ Try a Trial
Viiv Hlthcare	RETROVIR	zidovudine	CAPSULE;ORAL	019655-001	Mar 19, 1987	⤷ Try a Trial	⤷ Try a Trial
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-002	Oct 4, 1996	⤷ Try a Trial	⤷ Try a Trial
Viiv Hlthcare	RETROVIR	zidovudine	CAPSULE;ORAL	019655-001	Mar 19, 1987	⤷ Try a Trial	⤷ Try a Trial
Viiv Hlthcare	RETROVIR	zidovudine	INJECTABLE;INJECTION	019951-001	Feb 2, 1990	⤷ Try a Trial	⤷ Try a Trial
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-001	Dec 19, 1995	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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