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Last Updated: January 18, 2020

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Abacavir sulfate; lamivudine; zidovudine - Generic Drug Details

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What are the generic drug sources for abacavir sulfate; lamivudine; zidovudine and what is the scope of freedom to operate?

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.

There are twelve drug master file entries for abacavir sulfate; lamivudine; zidovudine. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for abacavir sulfate; lamivudine; zidovudine

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

SponsorPhase
Gilead SciencesPhase 3
Harvard School of Public HealthPhase 2
Makerere UniversityPhase 3

See all abacavir sulfate; lamivudine; zidovudine clinical trials

Recent Litigation for abacavir sulfate; lamivudine; zidovudine

Identify potential future generic entrants

District Court Litigation
Case NameDate
ViiV Healthcare UK Ltd. v. Lupin Ltd.2011-06-29
Glaxo Group Ltd. v. Lupin Ltd.2008-08-29

See all abacavir sulfate; lamivudine; zidovudine litigation

PTAB Litigation
PetitionerDate
Teva Pharmaceuticals USA, Inc.2015-01-08
Apotex Corp.2014-06-02

See all abacavir sulfate; lamivudine; zidovudine litigation

Generic filers with tentative approvals for ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 300MG BASE; 150MG; 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; ZIDOVUDINE
Tradename Dosage Ingredient NDA Submissiondate
TRIZIVIR TABLET;ORAL abacavir sulfate; lamivudine; zidovudine 021205 2011-03-22

US Patents and Regulatory Information for abacavir sulfate; lamivudine; zidovudine

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, LAMIVUDINE AND ZIDOVUDINE abacavir sulfate; lamivudine; zidovudine TABLET;ORAL 202912-001 Dec 5, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Viiv Hlthcare TRIZIVIR abacavir sulfate; lamivudine; zidovudine TABLET;ORAL 021205-001 Nov 14, 2000 AB RX Yes Yes   Start Trial   Start Trial   Start 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 abacavir sulfate; lamivudine; zidovudine

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Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
Dow
Johnson and Johnson
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Boehringer Ingelheim

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