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tazemetostat hydrobromide · Epizyme Inc · NDA 211723

Tazverik

Earliest generic entry, as listed
3 May 2038

No marketed reference-listed strength; date taken from all listed strengths.

Blocked by patent: US 12168014. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 27 unexpired

46 Orange Book listing rows for 27 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 12168014use U-2736, U-2852, U-28533 May 2038
US 12168014 listing rowuse U-2736 · sets the listed date3 May 2038
US 12168014 listing rowuse U-2852 · sets the listed date3 May 2038
US 12168014 listing rowuse U-2853 · sets the listed date3 May 2038
US 10786511drug product19 Dec 2035
US 10369155use U-2736, U-2852, U-285316 Oct 2035
US 10369155 listing rowuse U-273616 Oct 2035
US 10369155 listing rowuse U-285216 Oct 2035
US 10369155 listing rowuse U-285316 Oct 2035
US 9889138use U-2736, U-2852, U-285316 Oct 2035
US 9889138 listing rowuse U-273616 Oct 2035
US 9889138 listing rowuse U-285216 Oct 2035
US 9889138 listing rowuse U-285316 Oct 2035
US 9688665use U-273622 Aug 2034
US 12162865use U-273612 Jun 2034
US 8410088drug substance, drug product23 Jan 2034
US 10245269use U-2737, U-2851, U-285411 Apr 2033
US 10245269 listing rowuse U-273711 Apr 2033
US 10245269 listing rowuse U-285111 Apr 2033
US 10245269 listing rowuse U-285411 Apr 2033
US 10821113drug substance, drug product11 Apr 2033
US 11491163use U-2736, U-2852, U-285311 Apr 2033
US 11491163 listing rowuse U-273611 Apr 2033
US 11491163 listing rowuse U-285211 Apr 2033
US 11491163 listing rowuse U-285311 Apr 2033
US 9394283drug substance, drug product, use U-2852, U-285311 Apr 2033
US 9394283 listing rowdrug substance, drug product, use U-285211 Apr 2033
US 9394283 listing rowdrug substance, drug product, use U-285311 Apr 2033
US 10155002use U-273612 Sep 2031
US 10420775use U-2736, U-2852, U-285312 Sep 2031
US 10420775 listing rowuse U-273612 Sep 2031
US 10420775 listing rowuse U-285212 Sep 2031
US 10420775 listing rowuse U-285312 Sep 2031
US 11052093drug substance, drug product, use U-2736, U-2852, U-285312 Sep 2031
US 11052093 listing rowdrug substance, drug product, use U-273612 Sep 2031
US 11052093 listing rowdrug substance, drug product, use U-285212 Sep 2031
US 11052093 listing rowdrug substance, drug product, use U-285312 Sep 2031
US 12161645use U-285312 Sep 2031
US 12168015drug substance, drug product12 Sep 2031
US 12168016use U-2736, U-285312 Sep 2031
US 12168016 listing rowuse U-273612 Sep 2031
US 12168016 listing rowuse U-285312 Sep 2031
US 8691507use U-285212 Sep 2031
US 8765732use U-2852, U-285312 Sep 2031
US 8765732 listing rowuse U-285212 Sep 2031
US 8765732 listing rowuse U-285312 Sep 2031
US 8895245use U-285212 Sep 2031
US 9090562drug substance, drug product12 Sep 2031
US 9175331use U-285212 Sep 2031
US 9333217use U-285212 Sep 2031
US 9334527use U-285212 Sep 2031
US 9549931use U-2736, U-2852, U-285312 Sep 2031
US 9549931 listing rowuse U-273612 Sep 2031
US 9549931 listing rowuse U-285212 Sep 2031
US 9549931 listing rowuse U-285312 Sep 2031
US 9855275use U-273612 Sep 2031
US 9949999use U-285112 Sep 2031

Exclusivities · 2 unexpired

ODE-314orphan drug (7 years)18 Jun 2027
ODE-299orphan drug (7 years)23 Jan 2027

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

  • Exclusivity expires within 90 days ODE-299 · 211723-001Exclusivity expires 23 Jan 2027Detected 25 Oct 2026

Products covered · 1

NDA · productFormStrengthListed expiry
211723 · 001 · RLD · discontinuedtablet, oralEQ 200MG BASE3 May 2038