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Orange Book product · Brand (NDA)

RETEVMO

SELPERCATINIB

Brand (NDA)NDA 213246RX ELI LILLY AND CO
View SELPERCATINIB familyOpen on FDA Orange Book

At a glance

May 08, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

27

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 08, 2020

    6 yr 2 mo ago

  2. Today

  3. Exclusivity ends · ODE-301

    Orphan-drug exclusivity (7 years)

    May 08, 2027

    in 11 mo

  4. Exclusivity ends · ODE-302

    Orphan-drug exclusivity (7 years)

    May 08, 2027

    in 11 mo

  5. Exclusivity ends · ODE-303

    Orphan-drug exclusivity (7 years)

    May 08, 2027

    in 11 mo

  6. Exclusivity ends · NPP

    New patient population exclusivity (3 years)

    May 29, 2027

    in 11 mo

  7. Exclusivity ends · M-311

    New use / labeling-change exclusivity (3 years)

    Sep 27, 2027

    in 1 yr 4 mo

  8. Exclusivity ends · M-312

    New use / labeling-change exclusivity (3 years)

    Sep 27, 2027

    in 1 yr 4 mo

  9. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Nov 08, 2027

    in 1 yr 5 mo

  10. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Nov 08, 2027

    in 1 yr 5 mo

  11. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Nov 08, 2027

    in 1 yr 5 mo

  12. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Nov 29, 2027

    in 1 yr 6 mo

  13. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Mar 27, 2028

    in 1 yr 10 mo

  14. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Mar 27, 2028

    in 1 yr 10 mo

  15. Exclusivity ends · ODE-409

    Orphan-drug exclusivity (7 years)

    Sep 21, 2029

    in 3 yr 4 mo

  16. Exclusivity ends · ODE-412

    Orphan-drug exclusivity (7 years)

    Sep 21, 2029

    in 3 yr 4 mo

  17. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Mar 21, 2030

    in 3 yr 10 mo

  18. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Mar 21, 2030

    in 3 yr 10 mo

  19. Exclusivity ends · ODE-484

    Orphan-drug exclusivity (7 years)

    May 29, 2031

    in 5 yr

  20. Exclusivity ends · ODE-485

    Orphan-drug exclusivity (7 years)

    May 29, 2031

    in 5 yr

  21. Exclusivity ends · ODE-487

    Orphan-drug exclusivity (7 years)

    May 29, 2031

    in 5 yr

  22. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Nov 29, 2031

    in 5 yr 6 mo

  23. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Nov 29, 2031

    in 5 yr 6 mo

  24. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Nov 29, 2031

    in 5 yr 6 mo

  25. Patent 10112942 expires

    Listed drug substance patent expiration.

    Oct 10, 2037

    in 11 yr 6 mo

  26. Patent 10137124 expires

    Listed method-of-use patent (U-3450) expiration.

    Oct 10, 2037

    in 11 yr 6 mo

  27. Patent 10137124 expires

    Listed method-of-use patent (U-3949) expiration.

    Oct 10, 2037

    in 11 yr 6 mo

  28. Patent 10137124 expires

    Listed method-of-use patent (U-3950) expiration.

    Oct 10, 2037

    in 11 yr 6 mo

  29. Patent 10137124 expires

    Listed method-of-use patent (U-3951) expiration.

    Oct 10, 2037

    in 11 yr 6 mo

  30. Patent 10172851 expires

    Listed method-of-use patent (U-3450) expiration.

    Oct 10, 2037

    in 11 yr 6 mo

  31. Patent 10172851 expires

    Listed method-of-use patent (U-3949) expiration.

    Oct 10, 2037

    in 11 yr 6 mo

  32. Patent 10172851 expires

    Listed method-of-use patent (U-3950) expiration.

    Oct 10, 2037

    in 11 yr 6 mo

  33. Patent 10172851 expires

    Listed method-of-use patent (U-3951) expiration.

    Oct 10, 2037

    in 11 yr 6 mo

  34. Patent 10112942*PED expires

    Listed listed patent expiration.

    Apr 10, 2038

    in 12 yr

  35. Patent 10137124*PED expires

    Listed listed patent expiration.

    Apr 10, 2038

    in 12 yr

  36. Patent 10172851*PED expires

    Listed listed patent expiration.

    Apr 10, 2038

    in 12 yr

  37. Patent 10584124 expires

    Listed drug substance patent expiration.

    Oct 10, 2038

    in 12 yr 6 mo

  38. Patent 10584124 expires

    Listed drug substance patent expiration.

    Oct 10, 2038

    in 12 yr 6 mo

  39. Patent 10584124 expires

    Listed drug substance patent expiration.

    Oct 10, 2038

    in 12 yr 6 mo

  40. Patent 10584124 expires

    Listed drug substance patent expiration.

    Oct 10, 2038

    in 12 yr 6 mo

  41. Patent 10786489 expires

    Listed drug product patent expiration.

    Oct 10, 2038

    in 12 yr 6 mo

  42. Patent 10786489 expires

    Listed drug product patent expiration.

    Oct 10, 2038

    in 12 yr 6 mo

  43. Patent 10786489 expires

    Listed drug product patent expiration.

    Oct 10, 2038

    in 12 yr 6 mo

  44. Patent 10786489 expires

    Listed drug product patent expiration.

    Oct 10, 2038

    in 12 yr 6 mo

  45. Patent 12138250 expires

    Listed method-of-use patent (U-3949) expiration.

    Oct 10, 2038

    in 12 yr 6 mo

  46. Patent 12138250 expires

    Listed method-of-use patent (U-3951) expiration.

    Oct 10, 2038

    in 12 yr 6 mo

  47. Patent 12138250 expires

    Listed method-of-use patent (U-3950) expiration.

    Oct 10, 2038

    in 12 yr 6 mo

  48. Patent 12138250 expires

    Listed method-of-use patent (U-3450) expiration.

    Oct 10, 2038

    in 12 yr 6 mo

  49. Patent 10584124*PED expires

    Listed listed patent expiration.

    Apr 10, 2039

    in 13 yr

  50. Patent 10786489*PED expires

    Listed listed patent expiration.

    Apr 10, 2039

    in 13 yr

  51. Patent 12138250*PED expires

    Listed listed patent expiration.

    Apr 10, 2039

    in 13 yr

Pharmaceutical detail

Active ingredient

SELPERCATINIB

Strength

40MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 213246

Product number

001

Marketing status

RX

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 (22)

  • ODE-301Orphan-drug exclusivity (7 years)

    May 08, 2027

    in 11 mo

  • ODE-302Orphan-drug exclusivity (7 years)

    May 08, 2027

    in 11 mo

  • ODE-303Orphan-drug exclusivity (7 years)

    May 08, 2027

    in 11 mo

  • NPPNew patient population exclusivity (3 years)

    May 29, 2027

    in 11 mo

  • M-311New use / labeling-change exclusivity (3 years)

    Sep 27, 2027

    in 1 yr 4 mo

  • M-312New use / labeling-change exclusivity (3 years)

    Sep 27, 2027

    in 1 yr 4 mo

  • PEDPediatric exclusivity (adds 6 months)

    Nov 08, 2027

    in 1 yr 5 mo

  • PEDPediatric exclusivity (adds 6 months)

    Nov 08, 2027

    in 1 yr 5 mo

  • PEDPediatric exclusivity (adds 6 months)

    Nov 08, 2027

    in 1 yr 5 mo

  • PEDPediatric exclusivity (adds 6 months)

    Nov 29, 2027

    in 1 yr 6 mo

  • PEDPediatric exclusivity (adds 6 months)

    Mar 27, 2028

    in 1 yr 10 mo

  • PEDPediatric exclusivity (adds 6 months)

    Mar 27, 2028

    in 1 yr 10 mo

  • ODE-409Orphan-drug exclusivity (7 years)

    Sep 21, 2029

    in 3 yr 4 mo

  • ODE-412Orphan-drug exclusivity (7 years)

    Sep 21, 2029

    in 3 yr 4 mo

  • PEDPediatric exclusivity (adds 6 months)

    Mar 21, 2030

    in 3 yr 10 mo

  • PEDPediatric exclusivity (adds 6 months)

    Mar 21, 2030

    in 3 yr 10 mo

  • ODE-484Orphan-drug exclusivity (7 years)

    May 29, 2031

    in 5 yr

  • ODE-485Orphan-drug exclusivity (7 years)

    May 29, 2031

    in 5 yr

  • ODE-487Orphan-drug exclusivity (7 years)

    May 29, 2031

    in 5 yr

  • PEDPediatric exclusivity (adds 6 months)

    Nov 29, 2031

    in 5 yr 6 mo

  • PEDPediatric exclusivity (adds 6 months)

    Nov 29, 2031

    in 5 yr 6 mo

  • PEDPediatric exclusivity (adds 6 months)

    Nov 29, 2031

    in 5 yr 6 mo

Listed patents (27)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10112942Oct 10, 2037in 11 yr 6 mo
SubstanceProduct
10137124Oct 10, 2037in 11 yr 6 mo
U-3450
10137124Oct 10, 2037in 11 yr 6 mo
U-3949
10137124Oct 10, 2037in 11 yr 6 mo
U-3950
10137124Oct 10, 2037in 11 yr 6 mo
U-3951
10172851Oct 10, 2037in 11 yr 6 mo
U-3450
10172851Oct 10, 2037in 11 yr 6 mo
U-3949
10172851Oct 10, 2037in 11 yr 6 mo
U-3950
10172851Oct 10, 2037in 11 yr 6 mo
U-3951
10112942*PEDApr 10, 2038in 12 yr
10137124*PEDApr 10, 2038in 12 yr
10172851*PEDApr 10, 2038in 12 yr
10584124Oct 10, 2038in 12 yr 6 mo
SubstanceU-3450
10584124Oct 10, 2038in 12 yr 6 mo
SubstanceU-3949
10584124Oct 10, 2038in 12 yr 6 mo
SubstanceU-3950
10584124Oct 10, 2038in 12 yr 6 mo
SubstanceU-3951
10786489Oct 10, 2038in 12 yr 6 mo
ProductU-3450
10786489Oct 10, 2038in 12 yr 6 mo
ProductU-3949
10786489Oct 10, 2038in 12 yr 6 mo
ProductU-3951
10786489Oct 10, 2038in 12 yr 6 mo
ProductU-3950
12138250Oct 10, 2038in 12 yr 6 mo
U-3949
12138250Oct 10, 2038in 12 yr 6 mo
U-3951
12138250Oct 10, 2038in 12 yr 6 mo
U-3950
12138250Oct 10, 2038in 12 yr 6 mo
U-3450
10584124*PEDApr 10, 2039in 13 yr
10786489*PEDApr 10, 2039in 13 yr
12138250*PEDApr 10, 2039in 13 yr
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