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Last Updated: March 19, 2024

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
Recent Clinical Trials for PRIMAQUINE PHOSPHATE

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

SponsorPhase
University of California, San FranciscoPhase 2/Phase 3
Pan American Health OrganizationPhase 2/Phase 3
Mahidol Oxford Tropical Medicine Research UnitPhase 4

See all PRIMAQUINE PHOSPHATE clinical trials

Pharmacology for PRIMAQUINE PHOSPHATE
Drug ClassAntimalarial
Medical Subject Heading (MeSH) Categories 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
Alvogen PRIMAQUINE PHOSPHATE primaquine phosphate TABLET;ORAL 203924-001 Feb 3, 2014 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us PRIMAQUINE primaquine phosphate TABLET;ORAL 008316-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novast Labs PRIMAQUINE PHOSPHATE primaquine phosphate TABLET;ORAL 206043-001 Jun 23, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bayshore Pharms Llc PRIMAQUINE PHOSPHATE primaquine phosphate TABLET;ORAL 204476-001 Feb 25, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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