PRIMAQUINE PHOSPHATE - Generic Drug Details
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What are the generic sources for primaquine phosphate and what is the scope of freedom to operate?
Primaquine phosphate
is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Alvogen, Bayshore Pharms Llc, and Novast Labs, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.There are three drug master file entries for primaquine phosphate. Six suppliers are listed for this compound.
Summary for PRIMAQUINE PHOSPHATE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 4 |
NDAs: | 4 |
Drug Master File Entries: | 3 |
Finished Product Suppliers / Packagers: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 85 |
Clinical Trials: | 40 |
Patent Applications: | 1,275 |
What excipients (inactive ingredients) are in PRIMAQUINE PHOSPHATE? | PRIMAQUINE PHOSPHATE excipients list |
DailyMed Link: | PRIMAQUINE PHOSPHATE at DailyMed |
Recent Clinical Trials for PRIMAQUINE PHOSPHATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of California, San Francisco | Phase 2/Phase 3 |
Pan American Health Organization | Phase 2/Phase 3 |
Mahidol Oxford Tropical Medicine Research Unit | Phase 4 |
Pharmacology for PRIMAQUINE PHOSPHATE
Drug Class | Antimalarial |
Medical Subject Heading (MeSH) Categories for PRIMAQUINE PHOSPHATE
Anatomical Therapeutic Chemical (ATC) Classes for PRIMAQUINE PHOSPHATE
US Patents and Regulatory Information for PRIMAQUINE PHOSPHATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novast Labs | PRIMAQUINE PHOSPHATE | primaquine phosphate | TABLET;ORAL | 206043-001 | Jun 23, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Alvogen | PRIMAQUINE PHOSPHATE | primaquine phosphate | TABLET;ORAL | 203924-001 | Feb 3, 2014 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Bayshore Pharms Llc | PRIMAQUINE PHOSPHATE | primaquine phosphate | TABLET;ORAL | 204476-001 | Feb 25, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sanofi Aventis Us | PRIMAQUINE | primaquine phosphate | TABLET;ORAL | 008316-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | 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 |
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