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Last Updated: August 15, 2020

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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 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.

Recent Clinical Trials for ABACAVIR SULFATE

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

SponsorPhase
ViiV HealthcareN/A
Cynthia L Gay, MDN/A
National Cancer Institute (NCI)N/A

See all ABACAVIR SULFATE clinical trials

Generic filers with tentative approvals for ABACAVIR SULFATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial60MGTABLET; ORAL
  Start Trial  Start Trial60MG; 30MGTABLET; ORAL
  Start Trial  Start 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 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
Zydus Pharms ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 208990-001 Nov 15, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 090159-001 Nov 15, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE abacavir sulfate; lamivudine; zidovudine TABLET;ORAL 202912-001 Dec 5, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Hetero Labs Ltd Iii ABACAVIR SULFATE abacavir sulfate SOLUTION;ORAL 201107-001 Sep 26, 2016 AA RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 204990-001 Mar 28, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 077844-001 Dec 17, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Cipla ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 091144-001 Mar 28, 2017 AB RX No No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998   Start Trial   Start Trial
Viiv Hlthcare ZIAGEN abacavir sulfate TABLET;ORAL 020977-001 Dec 17, 1998   Start Trial   Start Trial
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998   Start Trial   Start Trial
Viiv Hlthcare ZIAGEN abacavir sulfate TABLET;ORAL 020977-001 Dec 17, 1998   Start Trial   Start Trial
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998   Start Trial   Start Trial
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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