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Last Updated: August 12, 2020

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Primaquine phosphate - Generic Drug Details

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What are the generic sources for primaquine phosphate and what is the scope of patent protection?

Primaquine phosphate is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Alvogen Inc, 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 four drug master file entries for primaquine phosphate. Five suppliers are listed for this compound.

Recent Clinical Trials for primaquine phosphate

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

SponsorPhase
University of Mississippi, OxfordPhase 1
Fundação de Medicina Tropical Dr. Heitor Vieira DouradoPhase 2
Conselho Nacional de Desenvolvimento Científico e TecnológicoPhase 2

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
Sanofi Aventis Us PRIMAQUINE primaquine phosphate TABLET;ORAL 008316-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Novast Labs PRIMAQUINE PHOSPHATE primaquine phosphate TABLET;ORAL 206043-001 Jun 23, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Bayshore Pharms Llc PRIMAQUINE PHOSPHATE primaquine phosphate TABLET;ORAL 204476-001 Feb 25, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Alvogen Inc PRIMAQUINE PHOSPHATE primaquine phosphate TABLET;ORAL 203924-001 Feb 3, 2014 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

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