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Last Updated: January 19, 2022

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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 seven 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 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 twelve 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

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

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Generic filers with tentative approvals for ABACAVIR SULFATE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free60MGTABLET; ORAL
⤷  Try it Free⤷  Try it Free60MG; 30MGTABLET; ORAL
⤷  Try it Free⤷  Try it Free60MGTABLET; 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 NDA Submissiondate
ZIAGEN SOLUTION;ORAL abacavir sulfate 020978 2012-12-27
ZIAGEN TABLET;ORAL abacavir sulfate 020977 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
Aurobindo Pharma Ltd ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 090159-001 Nov 15, 2018 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Apotex Inc ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 201570-001 Dec 17, 2012 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Hetero Labs Ltd Iii ABACAVIR SULFATE abacavir sulfate SOLUTION;ORAL 201107-001 Sep 26, 2016 AA RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998 ⤷  Try it Free ⤷  Try it Free
Viiv Hlthcare ZIAGEN abacavir sulfate TABLET;ORAL 020977-001 Dec 17, 1998 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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