Question 1

Is there a generic for Tazemetostat hydrobromide?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Tazemetostat hydrobromide. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Tazemetostat hydrobromide?

Accepted Answer

TAZVERIK (NDA 211723, EPIZYME INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Tazemetostat hydrobromide?

Accepted Answer

The Orange Book lists 27 patents against Tazemetostat hydrobromide products, with the earliest listed expiry in 2031. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Tazemetostat hydrobromide have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Tazemetostat hydrobromide. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Tazemetostat hydrobromide are approved?

Accepted Answer

Tazemetostat hydrobromide is approved in the following dosage form: tablet.

Patent	Expires	In	Type
10155002	Sep 12, 2031	in 5 yr 4 mo	U-2736
9549931	Sep 12, 2031	in 5 yr 4 mo	U-2736
9855275	Sep 12, 2031	in 5 yr 4 mo	U-2736
10420775	Sep 12, 2031	in 5 yr 4 mo	U-2736
11052093	Sep 12, 2031	in 5 yr 4 mo	SubstanceProductU-2736
8765732	Sep 12, 2031	in 5 yr 4 mo	U-2852
9334527	Sep 12, 2031	in 5 yr 4 mo	U-2852
9333217	Sep 12, 2031	in 5 yr 4 mo	U-2852
8691507	Sep 12, 2031	in 5 yr 4 mo	U-2852
9175331	Sep 12, 2031	in 5 yr 4 mo	U-2852
8895245	Sep 12, 2031	in 5 yr 4 mo	U-2852
9949999	Sep 12, 2031	in 5 yr 4 mo	U-2851
12161645	Sep 12, 2031	in 5 yr 4 mo	U-2853
12168016	Sep 12, 2031	in 5 yr 4 mo	U-2736
9090562	Sep 12, 2031	in 5 yr 4 mo	SubstanceProduct
12168015	Sep 12, 2031	in 5 yr 4 mo	SubstanceProduct
10245269	Apr 11, 2033	in 6 yr 11 mo	U-2737
9394283	Apr 11, 2033	in 6 yr 11 mo	SubstanceProductU-2852
11491163	Apr 11, 2033	in 6 yr 11 mo	U-2852
10821113	Apr 11, 2033	in 6 yr 11 mo	SubstanceProduct
8410088	Jan 23, 2034	in 7 yr 9 mo	SubstanceProduct
12162865	Jun 12, 2034	in 8 yr 1 mo	U-2736
9688665	Aug 22, 2034	in 8 yr 4 mo	U-2736
9889138	Oct 16, 2035	in 9 yr 6 mo	U-2736
10369155	Oct 16, 2035	in 9 yr 6 mo	U-2736
10786511	Dec 19, 2035	in 9 yr 8 mo	Product
12168014	May 03, 2038	in 12 yr 1 mo	U-2736

Tazemetostat hydrobromide

Brand (NDA) products · tablet

Marketing exclusivity (2)

Listed patents (27)

Tazemetostat hydrobromide — frequently asked questions

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