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PYRIMETHAMINE

ANDA

PYRIMETHAMINE | A207127 | SANALUZ LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: DARAPRIM(TE code: AB)

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2020-P-1369 · 4 docket documents Hyman, Phelps & McNamara, P.C. filed this citizen petition on behalf of interests seeking to expand generic competition for Pyrimethamine Tablets, 25 mg. The petitioner requests that the FDA designate ANDA 207127 held by Cerovene, Inc. as a new reference standard in the Orange Book because the curre	505(q)	2020-05-11	Withdrawn	Hyman, Phelps & McNamara, P.C.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$137.01

per ea

Lowest NADAC/Unit

$137.01

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
43598067201PYRIMETHAMINE 25 MG TABLET	$137.01	EA	Generic	—	2026-05-20
43598067230PYRIMETHAMINE 25 MG TABLET	$137.01	EA	Generic	—	2026-05-20

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$8687.25

Highest Price

$29249.02

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
43598-0672-01PYRIMETHAMINE 25MG TAB	$29249.02	FSS	Golden State Medical Supply, Inc.	06/14/2028
43598-0672-30PYRIMETHAMINE 25MG TAB	$8687.25	FSS	Golden State Medical Supply, Inc.	06/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain5 active DMFs

5 active API suppliers hold Drug Master Files for this ingredient.

FUKUZYU PHARMACEUTICAL CO LTDPYRIMETHAMINE

DMF 99981992

IPCA LABORATORIES LTDPYRIMETHAMINE USP

DMF 228802009

ALVOGEN INCPYRIMETHAMINE

DMF 337592019

INTERQUIM SA DE CVPYRIMETHAMINE

DMF 351212020

APITORIA PHARMA PRIVATE LTDPYRIMETHAMINE USP

DMF 360982021

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 18, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 25MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 28, 2020

No patent or exclusivity listings for this strength.