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Last Updated: August 4, 2020

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PRIMAQUINE Drug Profile

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US ANDA Litigation and Generic Entry Outlook for Primaquine

A generic version of PRIMAQUINE was approved as primaquine phosphate by ALVOGEN INC on February 3rd, 2014.

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Drug patent expirations by year for PRIMAQUINE
Drug Prices for PRIMAQUINE

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Recent Clinical Trials for PRIMAQUINE

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SponsorPhase
University of MelbournePhase 3
National Centre for Parasitology, Entomology and Malaria Control, CambodiaPhase 3
Addis Ababa UniversityPhase 3

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Pharmacology for PRIMAQUINE
Drug ClassAntimalarial

US Patents and Regulatory Information for PRIMAQUINE

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
Alvogen Inc PRIMAQUINE PHOSPHATE primaquine phosphate TABLET;ORAL 203924-001 Feb 3, 2014 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
>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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Serving leading biopharmaceutical companies globally:

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AstraZeneca
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Harvard Business School
Express Scripts

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