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

Listed patents · 46 unexpired

PatentClaimsExpires
US 12168014use U-28523 May 2038
US 12168014use U-27363 May 2038
US 12168014use U-28533 May 2038
US 10786511product19 Dec 2035
US 10369155use U-285216 Oct 2035
US 10369155use U-285316 Oct 2035
US 10369155use U-273616 Oct 2035
US 9889138use U-285216 Oct 2035
US 9889138use U-285316 Oct 2035
US 9889138use U-273616 Oct 2035
US 9688665use U-273622 Aug 2034
US 12162865use U-273612 Jun 2034
US 8410088substance, product23 Jan 2034
US 10245269use U-285411 Apr 2033
US 10245269use U-273711 Apr 2033
US 10245269use U-285111 Apr 2033
US 10821113substance, product11 Apr 2033
US 11491163use U-273611 Apr 2033
US 11491163use U-285211 Apr 2033
US 11491163use U-285311 Apr 2033
US 9394283substance, product, use U-285211 Apr 2033
US 9394283substance, product, use U-285311 Apr 2033
US 10155002use U-273612 Sep 2031
US 10420775use U-273612 Sep 2031
US 10420775use U-285212 Sep 2031
US 10420775use U-285312 Sep 2031
US 11052093substance, product, use U-273612 Sep 2031
US 11052093substance, product, use U-285212 Sep 2031
US 11052093substance, product, use U-285312 Sep 2031
US 12161645use U-285312 Sep 2031
US 12168015substance, product12 Sep 2031
US 12168016use U-273612 Sep 2031
US 12168016use U-285312 Sep 2031
US 8691507use U-285212 Sep 2031
US 8765732use U-285312 Sep 2031
US 8765732use U-285212 Sep 2031
US 8895245use U-285212 Sep 2031
US 9090562substance, product12 Sep 2031
US 9175331use U-285212 Sep 2031
US 9333217use U-285212 Sep 2031
US 9334527use U-285212 Sep 2031
US 9549931use U-285212 Sep 2031
US 9549931use U-273612 Sep 2031
US 9549931use 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

  • 25 Oct 2026Exclusivity expires within 90 days ODE-299 · 211723-001

Products covered · 1

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