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Harvard Business School

Last Updated: April 12, 2021

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Which patents cover Abacavir Sulfate, and what generic alternatives are available?

Abacavir Sulfate is a drug marketed by Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Apotex Inc, Cipla, Mylan Pharms Inc, Strides Pharma, Lupin Ltd, Teva Pharms Usa, and Zydus Pharms. and is included in fifteen NDAs.

The generic ingredient in ABACAVIR SULFATE is abacavir sulfate; lamivudine; zidovudine. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine; zidovudine profile page.

Drug patent expirations by year for ABACAVIR SULFATE
Recent Clinical Trials for ABACAVIR SULFATE

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

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

See all ABACAVIR SULFATE clinical trials

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 abacavir sulfate SOLUTION;ORAL 077950-001 Mar 14, 2018 AA RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc ABACAVIR SULFATE abacavir sulfate TABLET;ORAL 091294-001 Jun 18, 2012 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
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson

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.