Abacavir sulfate; lamivudine - Generic Drug Details

✉ Email this page to a colleague

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

Abacavir sulfate; lamivudine is the generic ingredient in four branded drugs marketed by Norvium Bioscience, Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Laurus, Teva Pharms Usa, Zydus Pharms, Viiv Hlthcare, and Lupin Ltd, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for abacavir sulfate; lamivudine

US Patents:	0
Tradenames:	4
Applicants:	10
NDAs:	11
Finished Product Suppliers / Packagers:	6
Clinical Trials:	8
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for abacavir sulfate; lamivudine
DailyMed Link:	abacavir sulfate; lamivudine at DailyMed

Recent Clinical Trials for abacavir sulfate; lamivudine

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

Sponsor	Phase
ViiV Healthcare	Phase 4
Gilead Sciences	Phase 3
GlaxoSmithKline	Phase 4

See all abacavir sulfate; lamivudine clinical trials

Generic filers with tentative approvals for ABACAVIR SULFATE; LAMIVUDINE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	60MG; 30MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	EQ 300MG BASE; 150MG; 300MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	600MG; 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

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

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

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

Paragraph IV (Patent) Challenges for ABACAVIR SULFATE; LAMIVUDINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPZICOM	Tablets	abacavir sulfate; lamivudine	600 mg/300 mg	021652	1	2007-09-27

US Patents and Regulatory Information for abacavir sulfate; lamivudine

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa	ABACAVIR SULFATE AND LAMIVUDINE	abacavir sulfate; lamivudine	TABLET;ORAL	079246-001	Sep 29, 2016		DISCN	No	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
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	ABACAVIR SULFATE AND LAMIVUDINE	abacavir sulfate; lamivudine	TABLET;ORAL	090159-001	Nov 15, 2018	AB	RX	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 abacavir sulfate; lamivudine

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.