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Last Updated: June 27, 2022

ABACAVIR SULFATE - Generic Drug Details


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What are the generic sources for abacavir sulfate and what is the scope of patent protection?

Abacavir sulfate is the generic ingredient in eight branded drugs marketed by Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Viiv Hlthcare, Apotex Inc, Cipla, Mylan Pharms Inc, Strides Pharma, Lupin Ltd, Teva Pharms Usa, and Zydus Pharms, and is included in twenty-one NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for abacavir sulfate. Thirteen suppliers are listed for this compound. There are eleven tentative approvals for this compound.

Summary for ABACAVIR SULFATE
Recent Clinical Trials for ABACAVIR SULFATE

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

SponsorPhase
Cynthia L Gay, MDN/A
ViiV HealthcareN/A
University of North Carolina, Chapel HillN/A

See all ABACAVIR SULFATE clinical trials

Generic filers with tentative approvals for ABACAVIR SULFATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing60MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing60MG; 30MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing60MGTABLET; 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
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZIAGEN Oral Solution abacavir sulfate 20 mg/mL 020978 1 2012-12-27
ZIAGEN Tablets abacavir sulfate 300 mg 020977 1 2009-01-28

US Patents and Regulatory Information for ABACAVIR SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hetero Labs Ltd Iii ABACAVIR SULFATE abacavir sulfate SOLUTION;ORAL 201107-001 Sep 26, 2016 AA RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Viiv Hlthcare TRIUMEQ PD abacavir sulfate; dolutegravir sodium; lamivudine TABLET, FOR SUSPENSION;ORAL 215413-001 Mar 30, 2022 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Aurobindo Pharma Ltd ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 077844-001 Dec 17, 2012 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998 See Plans and Pricing See Plans and Pricing
Viiv Hlthcare ZIAGEN abacavir sulfate TABLET;ORAL 020977-001 Dec 17, 1998 See Plans and Pricing See Plans and Pricing
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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