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, 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

See all primaquine phosphate clinical trials

Pharmacology for primaquine phosphate

Drug Class	Antimalarial

Medical Subject Heading (MeSH) Categories for primaquine phosphate

Antimalarials

Anatomical Therapeutic Chemical (ATC) Classes for primaquine phosphate

P01BA	Aminoquinolines
P01B	ANTIMALARIALS
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

US Patents and Regulatory Information for primaquine phosphate

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Glossary

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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
>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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