Is Agios Pharmaceuticals, Inc. FDA approved?

Agios Pharmaceuticals, Inc. holds no registered establishment of its own; 7 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Agios Pharmaceuticals, Inc. make?

7 products are listed under Agios Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as tablet, film coated; kit. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Agios Pharmaceuticals, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 7
Live patents: 33
Exclusivities: 2
Countries: 0

Catalogue

Drug listings by form and route

7 active NDC listings: 7 human prescription drug. By marketing category: NDA 7.

Dosage form	NDCs
tablet, film coated	5
kit	2

Route	NDCs
oral	5

Labeller name on the listing	NDCs
agios pharmaceuticals, inc.	7

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10632114	AQVESME, PYRUKYNDmitapivat sulfate	use	May 2032
9682080	AQVESME, PYRUKYNDmitapivat sulfate	use	May 2032
9980961	PYRUKYNDmitapivat sulfate	use	May 2032
9193701	AQVESME, PYRUKYNDmitapivat sulfate	use	Oct 2032
11793806	PYRUKYNDmitapivat sulfate	use	Apr 2033
RE49582	AQVESME, PYRUKYNDmitapivat sulfate	substance, product	Apr 2035
11234976	PYRUKYNDmitapivat sulfate	use	Oct 2038
11254652	AQVESME, PYRUKYNDmitapivat sulfate	substance, product	Nov 2038
11878049	AQVESME, PYRUKYNDmitapivat sulfate	use	Jul 2041

Product	Exclusivity	Until
AQVESMEMITAPIVAT SULFATE	ODE-522 Orphan drug	Dec 2032
PYRUKYNDMITAPIVAT SULFATE	ODE-392 Orphan drug	Feb 2029

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
AQVESME	mitapivat	tablet, film coated, oral	71334-235NDA
PYRUKYND	mitapivat	tablet, film coated, oral	71334-205NDA
PYRUKYND	mitapivat	tablet, film coated, oral	71334-210NDA
PYRUKYND	mitapivat	tablet, film coated, oral	71334-215NDA
PYRUKYND	mitapivat	tablet, film coated, oral	71334-220NDA
PYRUKYND	mitapivat	kit	71334-225NDA
PYRUKYND	mitapivat	kit	71334-230NDA

Enquiry

Common questions

Is Agios Pharmaceuticals, Inc. FDA approved?: Agios Pharmaceuticals, Inc. holds no registered establishment of its own; 7 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Agios Pharmaceuticals, Inc. make?: 7 products are listed under Agios Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as tablet, film coated; kit. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.