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Last Updated: November 2, 2024

ABACAVIR SULFATE; LAMIVUDINE - Generic Drug Details


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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

SponsorPhase
ViiV HealthcarePhase 4
Gilead SciencesPhase 3
GlaxoSmithKlinePhase 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 Up60MG; 30MGTABLET; ORAL
⤷  Sign Up⤷  Sign UpEQ 300MG BASE; 150MG; 300MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up600MG; 300MGTABLET; 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 ClassHepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of ActionCytochrome 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

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare EPZICOM abacavir sulfate; lamivudine TABLET;ORAL 021652-001 Aug 2, 2004 DISCN Yes No ⤷  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
Zydus Pharms ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 208990-001 Nov 15, 2018 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 206151-001 Mar 28, 2017 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Laurus ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 216332-001 Jul 25, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
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
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

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Expired US Patents for ABACAVIR SULFATE; LAMIVUDINE

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
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

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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.

 
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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