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Last Updated: April 24, 2024

Abacavir sulfate - Generic Drug Details


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

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, Mylan Labs Ltd, Aurobindo Pharma, Chartwell Rx, Laurus, Teva Pharms Usa, Zydus Pharms, and Lupin Ltd, and is included in twenty-three 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
⤷  Try a Trial⤷  Try a Trial60MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial60MG; 30MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial60MGTABLET; 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
Zydus Pharms ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 208990-001 Nov 15, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare TRIUMEQ PD abacavir sulfate; dolutegravir sodium; lamivudine TABLET, FOR SUSPENSION;ORAL 215413-001 Mar 30, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hetero Labs Ltd Iii ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 091560-001 Sep 13, 2013 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare TRIUMEQ PD abacavir sulfate; dolutegravir sodium; lamivudine TABLET, FOR SUSPENSION;ORAL 215413-001 Mar 30, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 090159-001 Nov 15, 2018 AB RX 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare ZIAGEN abacavir sulfate TABLET;ORAL 020977-001 Dec 17, 1998 ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998 ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998 ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998 ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare ZIAGEN abacavir sulfate TABLET;ORAL 020977-001 Dec 17, 1998 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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