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Last Updated: May 20, 2022

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 patent protection?

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.

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 Health (HSPH)Phase 2
Harvard School of Public HealthPhase 2

See all abacavir sulfate; lamivudine; zidovudine clinical trials

Generic filers with tentative approvals for ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 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 Strength NDA ANDAs Submitted Submissiondate
TRIZIVIR Tablets abacavir sulfate; lamivudine; zidovudine 300 mg/150 mg/ 300 mg 021205 1 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
Viiv Hlthcare TRIZIVIR abacavir sulfate; lamivudine; zidovudine TABLET;ORAL 021205-001 Nov 14, 2000 AB RX Yes Yes 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
>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:

Boehringer Ingelheim
Merck
Dow
Mallinckrodt
Colorcon
Baxter

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.