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Last Updated: January 19, 2022

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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 Aurobindo Pharma Ltd, Cipla, Lupin Ltd, Teva Pharms Usa, Zydus Pharms, and Viiv Hlthcare, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for abacavir sulfate; lamivudine. Nine suppliers are listed for this compound. There are five tentative approvals for this compound.

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
⤷  Try it Free⤷  Try it Free60MG; 30MGTABLET; ORAL
⤷  Try it Free⤷  Try it FreeEQ 300MG BASE; 150MG; 300MGTABLET; ORAL
⤷  Try it Free⤷  Try it Free600MG; 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.

Paragraph IV (Patent) Challenges for ABACAVIR SULFATE; LAMIVUDINE
Tradename Dosage Ingredient NDA Submissiondate
EPZICOM TABLET;ORAL abacavir sulfate; lamivudine 021652 2007-09-27

US Patents and Regulatory Information for abacavir sulfate; lamivudine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 204990-001 Mar 28, 2017 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Aurobindo Pharma Ltd ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 206151-001 Mar 28, 2017 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Zydus Pharms ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 208990-001 Nov 15, 2018 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Teva Pharms Usa ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 079246-001 Sep 29, 2016 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Lupin Ltd ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE abacavir sulfate; lamivudine; zidovudine TABLET;ORAL 202912-001 Dec 5, 2013 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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

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 ⤷  Try it Free ⤷  Try it Free
Viiv Hlthcare EPZICOM abacavir sulfate; lamivudine TABLET;ORAL 021652-001 Aug 2, 2004 ⤷  Try it Free ⤷  Try it Free
Viiv Hlthcare EPZICOM abacavir sulfate; lamivudine TABLET;ORAL 021652-001 Aug 2, 2004 ⤷  Try it Free ⤷  Try it Free
Viiv Hlthcare EPZICOM abacavir sulfate; lamivudine TABLET;ORAL 021652-001 Aug 2, 2004 ⤷  Try it Free ⤷  Try it Free
Viiv Hlthcare EPZICOM abacavir sulfate; lamivudine TABLET;ORAL 021652-001 Aug 2, 2004 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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