PYRIMETHAMINE - Generic Drug Details

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What are the generic sources for pyrimethamine and what is the scope of freedom to operate?

Pyrimethamine is the generic ingredient in three branded drugs marketed by Tilde Sciences, Alvogen, Aurobindo Pharma Ltd, Sanaluz, Teva Pharms, and Roche, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for pyrimethamine. Eight suppliers are listed for this compound.

Sponsor	Phase
Kamuzu University of Health Sciences	Phase 4
Malaria Consortium	Phase 3
Washington University School of Medicine	Early Phase 1

Sponsor

Phase

Kamuzu University of Health Sciences

Phase 4

Malaria Consortium

Phase 3

Washington University School of Medicine

Early Phase 1

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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
Roche	FANSIDAR	pyrimethamine; sulfadoxine	TABLET;ORAL	018557-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alvogen	PYRIMETHAMINE	pyrimethamine	TABLET;ORAL	211271-001	Jul 27, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	PYRIMETHAMINE	pyrimethamine	TABLET;ORAL	216983-001	Oct 25, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sanaluz	PYRIMETHAMINE	pyrimethamine	TABLET;ORAL	207127-001	Feb 28, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Tilde Sciences	DARAPRIM	pyrimethamine	TABLET;ORAL	008578-001	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

US Patents:	0
Tradenames:	3
Applicants:	6
NDAs:	6
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	222
Patent Applications:	6,762
Drug Prices:	Drug price trends for PYRIMETHAMINE
What excipients (inactive ingredients) are in PYRIMETHAMINE?	PYRIMETHAMINE excipients list
DailyMed Link:	PYRIMETHAMINE at DailyMed

Drug Class	Dihydrofolate Reductase Inhibitor Antimalarial
Mechanism of Action	Dihydrofolate Reductase Inhibitors