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Last Updated: October 4, 2024

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, Norvium Bioscience, 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
US Patents:2
Tradenames:8
Applicants:14
NDAs:23
Drug Master File Entries: 10
Finished Product Suppliers / Packagers: 13
Raw Ingredient (Bulk) Api Vendors: 89
Clinical Trials: 65
Patent Applications: 4,461
What excipients (inactive ingredients) are in ABACAVIR SULFATE?ABACAVIR SULFATE excipients list
DailyMed Link:ABACAVIR SULFATE at DailyMed
Recent Clinical Trials for ABACAVIR SULFATE

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

SponsorPhase
University of North Carolina, Chapel HillN/A
National Cancer Institute (NCI)N/A
Cynthia L Gay, MDN/A

See all ABACAVIR SULFATE clinical trials

Generic filers with tentative approvals for ABACAVIR SULFATE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up60MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up60MG; 30MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up60MGTABLET; 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
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998 AA RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Laurus ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 216332-001 Jul 25, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hetero Labs Ltd Iii ABACAVIR SULFATE abacavir sulfate SOLUTION;ORAL 201107-001 Sep 26, 2016 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 079246-001 Sep 29, 2016 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Strides Pharma ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 091050-001 Oct 28, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare TRIUMEQ abacavir sulfate; dolutegravir sodium; lamivudine TABLET;ORAL 205551-001 Aug 22, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998 ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998 ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998 ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998 ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare ZIAGEN abacavir sulfate TABLET;ORAL 020977-001 Dec 17, 1998 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.