Assyro AI

Orange Book product · Brand (NDA)

TAZVERIK

TAZEMETOSTAT HYDROBROMIDE

Brand (NDA)NDA 211723DISCN EPIZYME INC
View TAZEMETOSTAT HYDROBROMIDE familyOpen on FDA Orange Book

At a glance

Jan 23, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

46

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 23, 2020

    6 yr 6 mo ago

  2. Today

  3. Exclusivity ends · ODE-299

    Orphan-drug exclusivity (7 years)

    Jan 23, 2027

    in 7 mo

  4. Exclusivity ends · ODE-314

    Orphan-drug exclusivity (7 years)

    Jun 18, 2027

    in 1 yr

  5. Patent 10155002 expires

    Listed method-of-use patent (U-2736) expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  6. Patent 10420775 expires

    Listed method-of-use patent (U-2736) expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  7. Patent 10420775 expires

    Listed method-of-use patent (U-2852) expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  8. Patent 10420775 expires

    Listed method-of-use patent (U-2853) expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  9. Patent 11052093 expires

    Listed drug substance patent expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  10. Patent 11052093 expires

    Listed drug substance patent expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  11. Patent 11052093 expires

    Listed drug substance patent expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  12. Patent 12161645 expires

    Listed method-of-use patent (U-2853) expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  13. Patent 12168015 expires

    Listed drug substance patent expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  14. Patent 12168016 expires

    Listed method-of-use patent (U-2736) expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  15. Patent 12168016 expires

    Listed method-of-use patent (U-2853) expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  16. Patent 8691507 expires

    Listed method-of-use patent (U-2852) expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  17. Patent 8765732 expires

    Listed method-of-use patent (U-2852) expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  18. Patent 8765732 expires

    Listed method-of-use patent (U-2853) expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  19. Patent 8895245 expires

    Listed method-of-use patent (U-2852) expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  20. Patent 9090562 expires

    Listed drug substance patent expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  21. Patent 9175331 expires

    Listed method-of-use patent (U-2852) expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  22. Patent 9333217 expires

    Listed method-of-use patent (U-2852) expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  23. Patent 9334527 expires

    Listed method-of-use patent (U-2852) expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  24. Patent 9549931 expires

    Listed method-of-use patent (U-2736) expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  25. Patent 9549931 expires

    Listed method-of-use patent (U-2853) expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  26. Patent 9549931 expires

    Listed method-of-use patent (U-2852) expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  27. Patent 9855275 expires

    Listed method-of-use patent (U-2736) expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  28. Patent 9949999 expires

    Listed method-of-use patent (U-2851) expiration.

    Sep 12, 2031

    in 5 yr 4 mo

  29. Patent 10245269 expires

    Listed method-of-use patent (U-2737) expiration.

    Apr 11, 2033

    in 6 yr 11 mo

  30. Patent 10245269 expires

    Listed method-of-use patent (U-2851) expiration.

    Apr 11, 2033

    in 6 yr 11 mo

  31. Patent 10245269 expires

    Listed method-of-use patent (U-2854) expiration.

    Apr 11, 2033

    in 6 yr 11 mo

  32. Patent 10821113 expires

    Listed drug substance patent expiration.

    Apr 11, 2033

    in 6 yr 11 mo

  33. Patent 11491163 expires

    Listed method-of-use patent (U-2852) expiration.

    Apr 11, 2033

    in 6 yr 11 mo

  34. Patent 11491163 expires

    Listed method-of-use patent (U-2853) expiration.

    Apr 11, 2033

    in 6 yr 11 mo

  35. Patent 11491163 expires

    Listed method-of-use patent (U-2736) expiration.

    Apr 11, 2033

    in 6 yr 11 mo

  36. Patent 9394283 expires

    Listed drug substance patent expiration.

    Apr 11, 2033

    in 6 yr 11 mo

  37. Patent 9394283 expires

    Listed drug substance patent expiration.

    Apr 11, 2033

    in 6 yr 11 mo

  38. Patent 8410088 expires

    Listed drug substance patent expiration.

    Jan 23, 2034

    in 7 yr 9 mo

  39. Patent 12162865 expires

    Listed method-of-use patent (U-2736) expiration.

    Jun 12, 2034

    in 8 yr 1 mo

  40. Patent 9688665 expires

    Listed method-of-use patent (U-2736) expiration.

    Aug 22, 2034

    in 8 yr 4 mo

  41. Patent 10369155 expires

    Listed method-of-use patent (U-2736) expiration.

    Oct 16, 2035

    in 9 yr 6 mo

  42. Patent 10369155 expires

    Listed method-of-use patent (U-2853) expiration.

    Oct 16, 2035

    in 9 yr 6 mo

  43. Patent 10369155 expires

    Listed method-of-use patent (U-2852) expiration.

    Oct 16, 2035

    in 9 yr 6 mo

  44. Patent 9889138 expires

    Listed method-of-use patent (U-2736) expiration.

    Oct 16, 2035

    in 9 yr 6 mo

  45. Patent 9889138 expires

    Listed method-of-use patent (U-2852) expiration.

    Oct 16, 2035

    in 9 yr 6 mo

  46. Patent 9889138 expires

    Listed method-of-use patent (U-2853) expiration.

    Oct 16, 2035

    in 9 yr 6 mo

  47. Patent 10786511 expires

    Listed drug product patent expiration.

    Dec 19, 2035

    in 9 yr 8 mo

  48. Patent 12168014 expires

    Listed method-of-use patent (U-2736) expiration.

    May 03, 2038

    in 12 yr 1 mo

  49. Patent 12168014 expires

    Listed method-of-use patent (U-2853) expiration.

    May 03, 2038

    in 12 yr 1 mo

  50. Patent 12168014 expires

    Listed method-of-use patent (U-2852) expiration.

    May 03, 2038

    in 12 yr 1 mo

Pharmaceutical detail

Active ingredient

TAZEMETOSTAT HYDROBROMIDE

Strength

EQ 200MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 211723

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (2)

  • ODE-299Orphan-drug exclusivity (7 years)

    Jan 23, 2027

    in 7 mo

  • ODE-314Orphan-drug exclusivity (7 years)

    Jun 18, 2027

    in 1 yr

Listed patents (46)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10155002Sep 12, 2031in 5 yr 4 mo
U-2736
10420775Sep 12, 2031in 5 yr 4 mo
U-2736
10420775Sep 12, 2031in 5 yr 4 mo
U-2852
10420775Sep 12, 2031in 5 yr 4 mo
U-2853
11052093Sep 12, 2031in 5 yr 4 mo
SubstanceProductU-2736
11052093Sep 12, 2031in 5 yr 4 mo
SubstanceProductU-2852
11052093Sep 12, 2031in 5 yr 4 mo
SubstanceProductU-2853
12161645Sep 12, 2031in 5 yr 4 mo
U-2853
12168015Sep 12, 2031in 5 yr 4 mo
SubstanceProduct
12168016Sep 12, 2031in 5 yr 4 mo
U-2736
12168016Sep 12, 2031in 5 yr 4 mo
U-2853
8691507Sep 12, 2031in 5 yr 4 mo
U-2852
8765732Sep 12, 2031in 5 yr 4 mo
U-2852
8765732Sep 12, 2031in 5 yr 4 mo
U-2853
8895245Sep 12, 2031in 5 yr 4 mo
U-2852
9090562Sep 12, 2031in 5 yr 4 mo
SubstanceProduct
9175331Sep 12, 2031in 5 yr 4 mo
U-2852
9333217Sep 12, 2031in 5 yr 4 mo
U-2852
9334527Sep 12, 2031in 5 yr 4 mo
U-2852
9549931Sep 12, 2031in 5 yr 4 mo
U-2736
9549931Sep 12, 2031in 5 yr 4 mo
U-2853
9549931Sep 12, 2031in 5 yr 4 mo
U-2852
9855275Sep 12, 2031in 5 yr 4 mo
U-2736
9949999Sep 12, 2031in 5 yr 4 mo
U-2851
10245269Apr 11, 2033in 6 yr 11 mo
U-2737
10245269Apr 11, 2033in 6 yr 11 mo
U-2851
10245269Apr 11, 2033in 6 yr 11 mo
U-2854
10821113Apr 11, 2033in 6 yr 11 mo
SubstanceProduct
11491163Apr 11, 2033in 6 yr 11 mo
U-2852
11491163Apr 11, 2033in 6 yr 11 mo
U-2853
11491163Apr 11, 2033in 6 yr 11 mo
U-2736
9394283Apr 11, 2033in 6 yr 11 mo
SubstanceProductU-2852
9394283Apr 11, 2033in 6 yr 11 mo
SubstanceProductU-2853
8410088Jan 23, 2034in 7 yr 9 mo
SubstanceProduct
12162865Jun 12, 2034in 8 yr 1 mo
U-2736
9688665Aug 22, 2034in 8 yr 4 mo
U-2736
10369155Oct 16, 2035in 9 yr 6 mo
U-2736
10369155Oct 16, 2035in 9 yr 6 mo
U-2853
10369155Oct 16, 2035in 9 yr 6 mo
U-2852
9889138Oct 16, 2035in 9 yr 6 mo
U-2736
9889138Oct 16, 2035in 9 yr 6 mo
U-2852
9889138Oct 16, 2035in 9 yr 6 mo
U-2853
10786511Dec 19, 2035in 9 yr 8 mo
Product
12168014May 03, 2038in 12 yr 1 mo
U-2736
12168014May 03, 2038in 12 yr 1 mo
U-2853
12168014May 03, 2038in 12 yr 1 mo
U-2852
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo