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Orange Book product · Brand (NDA)

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RIPRETINIB

Brand (NDA)NDA 213973RX DECIPHERA PHARMS
View RIPRETINIB familyOpen on FDA Orange Book

At a glance

May 15, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

41

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 15, 2020

    6 yr 2 mo ago

  2. Today

  3. Exclusivity ends · ODE-298

    Orphan-drug exclusivity (7 years)

    May 15, 2027

    in 11 mo

  4. Patent 8188113 expires

    Listed drug substance patent expiration.

    Jul 27, 2030

    in 4 yr 2 mo

  5. Patent RE48731 expires

    Listed method-of-use patent (U-3219) expiration.

    Jun 07, 2032

    in 6 yr 1 mo

  6. Patent 8461179 expires

    Listed drug substance patent expiration.

    May 15, 2034

    in 8 yr

  7. Patent 10966966 expires

    Listed method-of-use patent (U-3153) expiration.

    Aug 12, 2040

    in 14 yr 4 mo

  8. Patent 11266635 expires

    Listed method-of-use patent (U-3330) expiration.

    Aug 12, 2040

    in 14 yr 4 mo

  9. Patent 11344536 expires

    Listed method-of-use patent (U-3381) expiration.

    Aug 12, 2040

    in 14 yr 4 mo

  10. Patent 11426390 expires

    Listed method-of-use patent (U-3416) expiration.

    Aug 12, 2040

    in 14 yr 4 mo

  11. Patent 11433056 expires

    Listed method-of-use patent (U-3423) expiration.

    Aug 12, 2040

    in 14 yr 4 mo

  12. Patent 11529336 expires

    Listed method-of-use patent (U-3382) expiration.

    Aug 12, 2040

    in 14 yr 4 mo

  13. Patent 11534432 expires

    Listed method-of-use patent (U-3442) expiration.

    Aug 12, 2040

    in 14 yr 4 mo

  14. Patent 11576904 expires

    Listed method-of-use patent (U-3537) expiration.

    Aug 12, 2040

    in 14 yr 4 mo

  15. Patent 11813251 expires

    Listed method-of-use patent (U-3750) expiration.

    Aug 12, 2040

    in 14 yr 4 mo

  16. Patent 12023325 expires

    Listed method-of-use patent (U-3960) expiration.

    Aug 12, 2040

    in 14 yr 4 mo

  17. Patent 12023326 expires

    Listed method-of-use patent (U-3959) expiration.

    Aug 12, 2040

    in 14 yr 4 mo

  18. Patent 12023327 expires

    Listed method-of-use patent (U-3958) expiration.

    Aug 12, 2040

    in 14 yr 4 mo

  19. Patent 12059410 expires

    Listed method-of-use patent (U-3153) expiration.

    Aug 12, 2040

    in 14 yr 4 mo

  20. Patent 12059411 expires

    Listed method-of-use patent (U-3971) expiration.

    Aug 12, 2040

    in 14 yr 4 mo

  21. Patent 12295944 expires

    Listed method-of-use patent (U-4183) expiration.

    Aug 12, 2040

    in 14 yr 4 mo

  22. Patent 12318373 expires

    Listed method-of-use patent (U-4191) expiration.

    Aug 12, 2040

    in 14 yr 4 mo

  23. Patent 11185535 expires

    Listed drug product patent expiration.

    Dec 30, 2040

    in 14 yr 9 mo

  24. Patent 11395818 expires

    Listed drug product patent expiration.

    Dec 30, 2040

    in 14 yr 9 mo

  25. Patent 11576903 expires

    Listed drug product patent expiration.

    Dec 30, 2040

    in 14 yr 9 mo

  26. Patent 11612591 expires

    Listed drug product patent expiration.

    Dec 30, 2040

    in 14 yr 9 mo

  27. Patent 11793795 expires

    Listed drug product patent expiration.

    Dec 30, 2040

    in 14 yr 9 mo

  28. Patent 11801237 expires

    Listed drug product patent expiration.

    Dec 30, 2040

    in 14 yr 9 mo

  29. Patent 11844788 expires

    Listed drug product patent expiration.

    Dec 30, 2040

    in 14 yr 9 mo

  30. Patent 11850240 expires

    Listed drug product patent expiration.

    Dec 30, 2040

    in 14 yr 9 mo

  31. Patent 11850241 expires

    Listed drug product patent expiration.

    Dec 30, 2040

    in 14 yr 9 mo

  32. Patent 11896585 expires

    Listed drug product patent expiration.

    Dec 30, 2040

    in 14 yr 9 mo

  33. Patent 11903933 expires

    Listed drug product patent expiration.

    Dec 30, 2040

    in 14 yr 9 mo

  34. Patent 11911370 expires

    Listed drug product patent expiration.

    Dec 30, 2040

    in 14 yr 9 mo

  35. Patent 11918564 expires

    Listed drug product patent expiration.

    Dec 30, 2040

    in 14 yr 9 mo

  36. Patent 11969415 expires

    Listed method-of-use patent (U-3219) expiration.

    Dec 30, 2040

    in 14 yr 9 mo

  37. Patent 12023328 expires

    Listed method-of-use patent (U-3957) expiration.

    Dec 30, 2040

    in 14 yr 9 mo

  38. Patent 12064422 expires

    Listed method-of-use patent (U-3219) expiration.

    Dec 30, 2040

    in 14 yr 9 mo

  39. Patent 12213967 expires

    Listed drug product patent expiration.

    Dec 30, 2040

    in 14 yr 9 mo

  40. Patent 12213968 expires

    Listed drug product patent expiration.

    Dec 30, 2040

    in 14 yr 9 mo

  41. Patent 12226406 expires

    Listed drug product patent expiration.

    Dec 30, 2040

    in 14 yr 9 mo

  42. Patent 12318374 expires

    Listed drug product patent expiration.

    Dec 30, 2040

    in 14 yr 9 mo

  43. Patent 11969414 expires

    Listed method-of-use patent (U-3897) expiration.

    Feb 08, 2041

    in 14 yr 10 mo

  44. Patent 11779572 expires

    Listed method-of-use patent (U-3714) expiration.

    Oct 06, 2042

    in 16 yr 6 mo

Pharmaceutical detail

Active ingredient

RIPRETINIB

Strength

50MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 213973

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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 (1)

  • ODE-298Orphan-drug exclusivity (7 years)

    May 15, 2027

    in 11 mo

Listed patents (41)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8188113Jul 27, 2030in 4 yr 2 mo
SubstanceProduct
RE48731Jun 07, 2032in 6 yr 1 mo
U-3219
8461179May 15, 2034in 8 yr
SubstanceProduct
10966966Aug 12, 2040in 14 yr 4 mo
U-3153
11266635Aug 12, 2040in 14 yr 4 mo
U-3330
11344536Aug 12, 2040in 14 yr 4 mo
U-3381
11426390Aug 12, 2040in 14 yr 4 mo
U-3416
11433056Aug 12, 2040in 14 yr 4 mo
U-3423
11529336Aug 12, 2040in 14 yr 4 mo
U-3382
11534432Aug 12, 2040in 14 yr 4 mo
U-3442
11576904Aug 12, 2040in 14 yr 4 mo
U-3537
11813251Aug 12, 2040in 14 yr 4 mo
U-3750
12023325Aug 12, 2040in 14 yr 4 mo
U-3960
12023326Aug 12, 2040in 14 yr 4 mo
U-3959
12023327Aug 12, 2040in 14 yr 4 mo
U-3958
12059410Aug 12, 2040in 14 yr 4 mo
U-3153
12059411Aug 12, 2040in 14 yr 4 mo
U-3971
12295944Aug 12, 2040in 14 yr 4 mo
U-4183
12318373Aug 12, 2040in 14 yr 4 mo
U-4191
11185535Dec 30, 2040in 14 yr 9 mo
Product
11395818Dec 30, 2040in 14 yr 9 mo
Product
11576903Dec 30, 2040in 14 yr 9 mo
Product
11612591Dec 30, 2040in 14 yr 9 mo
Product
11793795Dec 30, 2040in 14 yr 9 mo
Product
11801237Dec 30, 2040in 14 yr 9 mo
ProductU-3219
11844788Dec 30, 2040in 14 yr 9 mo
Product
11850240Dec 30, 2040in 14 yr 9 mo
Product
11850241Dec 30, 2040in 14 yr 9 mo
Product
11896585Dec 30, 2040in 14 yr 9 mo
Product
11903933Dec 30, 2040in 14 yr 9 mo
Product
11911370Dec 30, 2040in 14 yr 9 mo
Product
11918564Dec 30, 2040in 14 yr 9 mo
Product
11969415Dec 30, 2040in 14 yr 9 mo
U-3219
12023328Dec 30, 2040in 14 yr 9 mo
U-3957
12064422Dec 30, 2040in 14 yr 9 mo
U-3219
12213967Dec 30, 2040in 14 yr 9 mo
Product
12213968Dec 30, 2040in 14 yr 9 mo
Product
12226406Dec 30, 2040in 14 yr 9 mo
Product
12318374Dec 30, 2040in 14 yr 9 mo
Product
11969414Feb 08, 2041in 14 yr 10 mo
U-3897
11779572Oct 06, 2042in 16 yr 6 mo
U-3714
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