ABACAVIR SULFATE Drug Patent Profile
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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, Mylan Labs Ltd, Aurobindo Pharma, Chartwell Rx, Laurus, Teva Pharms Usa, Zydus Pharms, and Lupin Ltd. and is included in seventeen NDAs.
The generic ingredient in ABACAVIR SULFATE is abacavir sulfate; lamivudine; zidovudine. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the abacavir sulfate; lamivudine; zidovudine profile page.
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Summary for ABACAVIR SULFATE
US Patents: | 0 |
Applicants: | 13 |
NDAs: | 17 |
Finished Product Suppliers / Packagers: | 12 |
Raw Ingredient (Bulk) Api Vendors: | 89 |
Clinical Trials: | 65 |
Patent Applications: | 2,847 |
Formulation / Manufacturing: | see details |
DailyMed Link: | ABACAVIR SULFATE at DailyMed |
![ABACAVIR SULFATE drug patent expirations Drug patent expirations by year for ABACAVIR SULFATE](/p/graph/s/t/ABACAVIR_SULFATE-patent-expirations.png)
Recent Clinical Trials for ABACAVIR SULFATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of North Carolina, Chapel Hill | N/A |
National Cancer Institute (NCI) | N/A |
Cynthia L Gay, MD | N/A |
Pharmacology for ABACAVIR SULFATE
Anatomical Therapeutic Chemical (ATC) Classes for ABACAVIR SULFATE
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aurobindo Pharma Ltd | ABACAVIR SULFATE | abacavir sulfate | SOLUTION;ORAL | 077950-001 | Mar 14, 2018 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Mylan Pharms Inc | ABACAVIR SULFATE | abacavir sulfate | TABLET;ORAL | 091294-001 | Jun 18, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Aurobindo Pharma Ltd | ABACAVIR SULFATE | abacavir sulfate | TABLET;ORAL | 077844-001 | Dec 17, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |