ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE - Generic Drug Details

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What are the generic sources for abacavir sulfate; lamivudine; zidovudine and what is the scope of patent protection?

Abacavir sulfate; lamivudine; zidovudine is the generic ingredient in two branded drugs marketed by Lupin Ltd and Viiv Hlthcare, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	6
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE
DailyMed Link:	ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE at DailyMed

Recent Clinical Trials for ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

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

Sponsor	Phase
Gilead Sciences	Phase 3
Harvard School of Public Health (HSPH)	Phase 2
Harvard School of Public Health	Phase 2

See all ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE clinical trials

Generic filers with tentative approvals for ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	EQ 300MG BASE; 150MG; 300MG	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 ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Cytochrome P450 1A1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

Paragraph IV (Patent) Challenges for ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRIZIVIR	Tablets	abacavir sulfate; lamivudine; zidovudine	300 mg/150 mg/ 300 mg	021205	1	2011-03-22

US Patents and Regulatory Information for ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

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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
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Ltd	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	202912-001	Dec 5, 2013		RX	No	Yes	⤷ 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 ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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