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
Sponsor | Phase |
---|---|
Cynthia L Gay, MD | N/A |
ViiV Healthcare | N/A |
University of North Carolina, Chapel Hill | N/A |
Generic filers with tentative approvals for ABACAVIR SULFATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 60MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 60MG; 30MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 60MG | TABLET; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for ABACAVIR SULFATE
Drug Class | Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor |
Mechanism of Action | Cytochrome P450 1A1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Viiv Hlthcare | TRIUMEQ PD | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET, FOR SUSPENSION;ORAL | 215413-001 | Mar 30, 2022 | RX | Yes | Yes | ⤷ 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 | |||
Cipla | ABACAVIR SULFATE AND LAMIVUDINE | abacavir sulfate; lamivudine | TABLET;ORAL | 091144-001 | Mar 28, 2017 | AB | RX | No | Yes | ⤷ 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 |
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 | 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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