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Last Updated: January 27, 2023

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

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

Recent Clinical Trials for abacavir sulfate; lamivudine

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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
See Plans and PricingSee Plans and Pricing60MG; 30MGTABLET; ORAL
See Plans and PricingSee Plans and PricingEQ 300MG BASE; 150MG; 300MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing600MG; 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
Teva Pharms Usa ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 079246-001 Sep 29, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma Ltd ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 090159-001 Nov 15, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Laurus ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 216332-001 Jul 25, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lupin Ltd ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE abacavir sulfate; lamivudine; zidovudine TABLET;ORAL 202912-001 Dec 5, 2013 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 208990-001 Nov 15, 2018 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 206151-001 Mar 28, 2017 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cipla ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 091144-001 Mar 28, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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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