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Last Updated: February 26, 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 Mylan Labs Ltd, Aurobindo Pharma, Aurobindo Pharma Ltd, Cipla, Laurus, Lupin Ltd, Teva Pharms Usa, Zydus Pharms, and Viiv Hlthcare, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Seven 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 a Trial⤷  Try a Trial60MG; 30MGTABLET; ORAL
⤷  Try a Trial⤷  Try a TrialEQ 300MG BASE; 150MG; 300MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial600MG; 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 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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cipla ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 091144-001 Mar 28, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare TRIZIVIR abacavir sulfate; lamivudine; zidovudine TABLET;ORAL 021205-001 Nov 14, 2000 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE abacavir sulfate; lamivudine; zidovudine TABLET;ORAL 202912-001 Dec 5, 2013 RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Labs Ltd ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET, FOR SUSPENSION;ORAL 204311-001 Dec 22, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare EPZICOM abacavir sulfate; lamivudine TABLET;ORAL 021652-001 Aug 2, 2004 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 204990-001 Mar 28, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 206151-001 Mar 28, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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

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Serving leading biopharmaceutical companies globally:

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