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Abacavir sulfate - Generic Drug Details
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What are the generic drug sources for abacavir sulfate and what is the scope of freedom to operate?
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.
Summary for abacavir sulfate
US Patents: | 2 |
Tradenames: | 7 |
Applicants: | 10 |
NDAs: | 20 |
Drug Master File Entries: | 12 |
Suppliers / Packagers: | 13 |
Bulk Api Vendors: | 125 |
Clinical Trials: | 11 |
Patent Applications: | 6,076 |
Formulation / Manufacturing: | see details |
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 |
National Cancer Institute (NCI) | N/A |
ViiV Healthcare | N/A |
Generic filers with tentative approvals for ABACAVIR SULFATE
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 60MG | TABLET; ORAL |
Start Trial | Start Trial | 60MG; 30MG | TABLET; ORAL |
Start Trial | Start Trial | 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 | Nucleoside Reverse Transcriptase Inhibitors |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Viiv Hlthcare | ZIAGEN | abacavir sulfate | TABLET;ORAL | 020977-001 | Dec 17, 1998 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
Aurobindo Pharma Ltd | ABACAVIR SULFATE AND LAMIVUDINE | abacavir sulfate; lamivudine | TABLET;ORAL | 206151-001 | Mar 28, 2017 | AB | RX | 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 | |||
>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 | 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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