Is Epizyme, Inc. FDA approved?

Epizyme, Inc. holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Epizyme, Inc. make?

1 product is listed under Epizyme, Inc. in the openFDA NDC Directory, most often as tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Epizyme, Inc.

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

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Registered sites: 0
Active NDC listings: 1
Live patents: 27
Exclusivities: 1
Countries: 0

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10155002	TAZVERIKtazemetostat hydrobromide	use	Sept 2031
10420775	TAZVERIKtazemetostat hydrobromide	use	Sept 2031
11052093	TAZVERIKtazemetostat hydrobromide	substance, product	Sept 2031
12161645	TAZVERIKtazemetostat hydrobromide	use	Sept 2031
12168015	TAZVERIKtazemetostat hydrobromide	substance, product	Sept 2031
12168016	TAZVERIKtazemetostat hydrobromide	use	Sept 2031
8691507	TAZVERIKtazemetostat hydrobromide	use	Sept 2031
8765732	TAZVERIKtazemetostat hydrobromide	use	Sept 2031
8895245	TAZVERIKtazemetostat hydrobromide	use	Sept 2031
9090562	TAZVERIKtazemetostat hydrobromide	substance, product	Sept 2031
9175331	TAZVERIKtazemetostat hydrobromide	use	Sept 2031
9333217	TAZVERIKtazemetostat hydrobromide	use	Sept 2031
9334527	TAZVERIKtazemetostat hydrobromide	use	Sept 2031
9549931	TAZVERIKtazemetostat hydrobromide	use	Sept 2031
9855275	TAZVERIKtazemetostat hydrobromide	use	Sept 2031
9949999	TAZVERIKtazemetostat hydrobromide	use	Sept 2031
10245269	TAZVERIKtazemetostat hydrobromide	use	Apr 2033
10821113	TAZVERIKtazemetostat hydrobromide	substance, product	Apr 2033
11491163	TAZVERIKtazemetostat hydrobromide	use	Apr 2033
9394283	TAZVERIKtazemetostat hydrobromide	substance, product	Apr 2033
8410088	TAZVERIKtazemetostat hydrobromide	substance, product	Jan 2034
12162865	TAZVERIKtazemetostat hydrobromide	use	Jun 2034
9688665	TAZVERIKtazemetostat hydrobromide	use	Aug 2034
10369155	TAZVERIKtazemetostat hydrobromide	use	Oct 2035
9889138	TAZVERIKtazemetostat hydrobromide	use	Oct 2035
10786511	TAZVERIKtazemetostat hydrobromide	product	Dec 2035
12168014	TAZVERIKtazemetostat hydrobromide	use	May 2038

Product	Exclusivity	Until
TAZVERIKTAZEMETOSTAT HYDROBROMIDE	ODE-314 Orphan drug	Jun 2027

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
TAZVERIK	tazemetostat	tablet, film coated, oral	72607-100NDA

Enquiry

Common questions

Is Epizyme, Inc. FDA approved?: Epizyme, Inc. holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Epizyme, Inc. make?: 1 product is listed under Epizyme, Inc. in the openFDA NDC Directory, most often as tablet, film coated. 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.