Assyro AI

Orange Book product · Brand (NDA)

BRAFTOVI

ENCORAFENIB

Brand (NDA)NDA 210496RX ARRAY BIOPHARMA INC
View ENCORAFENIB familyOpen on FDA Orange Book

At a glance

Jun 27, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

37

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 27, 2018

    8 yr 1 mo ago

  2. Today

  3. Exclusivity ends · I-928

    New indication exclusivity (3 years)

    Oct 11, 2026

    in 4 mo

  4. Exclusivity ends · I-957

    New indication exclusivity (3 years)

    Dec 20, 2027

    in 1 yr 6 mo

  5. Patent 8946250 expires

    Listed drug substance patent expiration.

    Jul 23, 2029

    in 3 yr 2 mo

  6. Patent 8541575 expires

    Listed drug substance patent expiration.

    Feb 26, 2030

    in 3 yr 9 mo

  7. Patent 8541575 expires

    Listed drug substance patent expiration.

    Feb 26, 2030

    in 3 yr 9 mo

  8. Patent 8541575 expires

    Listed drug substance patent expiration.

    Feb 26, 2030

    in 3 yr 9 mo

  9. Patent 8541575 expires

    Listed drug substance patent expiration.

    Feb 26, 2030

    in 3 yr 9 mo

  10. Patent 8541575 expires

    Listed drug substance patent expiration.

    Feb 26, 2030

    in 3 yr 9 mo

  11. Patent 8541575 expires

    Listed drug substance patent expiration.

    Feb 26, 2030

    in 3 yr 9 mo

  12. Patent RE49556 expires

    Listed drug substance patent expiration.

    Feb 27, 2030

    in 3 yr 9 mo

  13. Patent 10005761 expires

    Listed method-of-use patent (U-2335) expiration.

    Aug 27, 2030

    in 4 yr 3 mo

  14. Patent 10005761 expires

    Listed method-of-use patent (U-4440) expiration.

    Aug 27, 2030

    in 4 yr 3 mo

  15. Patent 10005761 expires

    Listed method-of-use patent (U-2802) expiration.

    Aug 27, 2030

    in 4 yr 3 mo

  16. Patent 10005761 expires

    Listed method-of-use patent (U-2803) expiration.

    Aug 27, 2030

    in 4 yr 3 mo

  17. Patent 10005761 expires

    Listed method-of-use patent (U-3738) expiration.

    Aug 27, 2030

    in 4 yr 3 mo

  18. Patent 10005761 expires

    Listed method-of-use patent (U-4051) expiration.

    Aug 27, 2030

    in 4 yr 3 mo

  19. Patent 9593099 expires

    Listed drug substance patent expiration.

    Aug 27, 2030

    in 4 yr 3 mo

  20. Patent 9593100 expires

    Listed drug product patent expiration.

    Aug 27, 2030

    in 4 yr 3 mo

  21. Patent 9850229 expires

    Listed method-of-use patent (U-2337) expiration.

    Aug 27, 2030

    in 4 yr 3 mo

  22. Patent 9850230 expires

    Listed method-of-use patent (U-2334) expiration.

    Aug 27, 2030

    in 4 yr 3 mo

  23. Patent 9850230 expires

    Listed method-of-use patent (U-4440) expiration.

    Aug 27, 2030

    in 4 yr 3 mo

  24. Patent 9850230 expires

    Listed method-of-use patent (U-2802) expiration.

    Aug 27, 2030

    in 4 yr 3 mo

  25. Patent 9850230 expires

    Listed method-of-use patent (U-2803) expiration.

    Aug 27, 2030

    in 4 yr 3 mo

  26. Patent 9850230 expires

    Listed method-of-use patent (U-3738) expiration.

    Aug 27, 2030

    in 4 yr 3 mo

  27. Patent 9850230 expires

    Listed method-of-use patent (U-4051) expiration.

    Aug 27, 2030

    in 4 yr 3 mo

  28. Exclusivity ends · ODE-445

    Orphan-drug exclusivity (7 years)

    Oct 11, 2030

    in 4 yr 5 mo

  29. Patent 9314464 expires

    Listed method-of-use patent (U-2336) expiration.

    Jul 04, 2031

    in 5 yr 1 mo

  30. Patent 9314464 expires

    Listed method-of-use patent (U-4440) expiration.

    Jul 04, 2031

    in 5 yr 1 mo

  31. Patent 9314464 expires

    Listed method-of-use patent (U-2802) expiration.

    Jul 04, 2031

    in 5 yr 1 mo

  32. Patent 9314464 expires

    Listed method-of-use patent (U-2803) expiration.

    Jul 04, 2031

    in 5 yr 1 mo

  33. Patent 9314464 expires

    Listed method-of-use patent (U-3738) expiration.

    Jul 04, 2031

    in 5 yr 1 mo

  34. Patent 9314464 expires

    Listed method-of-use patent (U-4051) expiration.

    Jul 04, 2031

    in 5 yr 1 mo

  35. Patent 10258622 expires

    Listed method-of-use patent (U-4439) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  36. Patent 10258622 expires

    Listed method-of-use patent (U-2802) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  37. Patent 10258622 expires

    Listed method-of-use patent (U-4051) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  38. Patent 9387208 expires

    Listed drug product patent expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  39. Patent 9763941 expires

    Listed method-of-use patent (U-2335) expiration.

    Nov 21, 2032

    in 6 yr 6 mo

  40. Patent 9474754 expires

    Listed method-of-use patent (U-4440) expiration.

    Aug 05, 2033

    in 7 yr 3 mo

  41. Patent 9474754 expires

    Listed method-of-use patent (U-2802) expiration.

    Aug 05, 2033

    in 7 yr 3 mo

  42. Patent 9474754 expires

    Listed method-of-use patent (U-4051) expiration.

    Aug 05, 2033

    in 7 yr 3 mo

Pharmaceutical detail

Active ingredient

ENCORAFENIB

Strength

75MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 210496

Product number

002

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 (3)

  • I-928New indication exclusivity (3 years)

    Oct 11, 2026

    in 4 mo

  • I-957New indication exclusivity (3 years)

    Dec 20, 2027

    in 1 yr 6 mo

  • ODE-445Orphan-drug exclusivity (7 years)

    Oct 11, 2030

    in 4 yr 5 mo

Listed patents (37)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8946250Jul 23, 2029in 3 yr 2 mo
SubstanceProduct
8541575Feb 26, 2030in 3 yr 9 mo
SubstanceProductU-2335
8541575Feb 26, 2030in 3 yr 9 mo
SubstanceProductU-4440
8541575Feb 26, 2030in 3 yr 9 mo
SubstanceProductU-2803
8541575Feb 26, 2030in 3 yr 9 mo
SubstanceProductU-2802
8541575Feb 26, 2030in 3 yr 9 mo
SubstanceProductU-3738
8541575Feb 26, 2030in 3 yr 9 mo
SubstanceProductU-4051
RE49556Feb 27, 2030in 3 yr 9 mo
SubstanceProduct
10005761Aug 27, 2030in 4 yr 3 mo
U-2335
10005761Aug 27, 2030in 4 yr 3 mo
U-4440
10005761Aug 27, 2030in 4 yr 3 mo
U-2802
10005761Aug 27, 2030in 4 yr 3 mo
U-2803
10005761Aug 27, 2030in 4 yr 3 mo
U-3738
10005761Aug 27, 2030in 4 yr 3 mo
U-4051
9593099Aug 27, 2030in 4 yr 3 mo
Substance
9593100Aug 27, 2030in 4 yr 3 mo
Product
9850229Aug 27, 2030in 4 yr 3 mo
U-2337
9850230Aug 27, 2030in 4 yr 3 mo
U-2334
9850230Aug 27, 2030in 4 yr 3 mo
U-4440
9850230Aug 27, 2030in 4 yr 3 mo
U-2802
9850230Aug 27, 2030in 4 yr 3 mo
U-2803
9850230Aug 27, 2030in 4 yr 3 mo
U-3738
9850230Aug 27, 2030in 4 yr 3 mo
U-4051
9314464Jul 04, 2031in 5 yr 1 mo
U-2336
9314464Jul 04, 2031in 5 yr 1 mo
U-4440
9314464Jul 04, 2031in 5 yr 1 mo
U-2802
9314464Jul 04, 2031in 5 yr 1 mo
U-2803
9314464Jul 04, 2031in 5 yr 1 mo
U-3738
9314464Jul 04, 2031in 5 yr 1 mo
U-4051
10258622Nov 21, 2032in 6 yr 6 mo
U-4439
10258622Nov 21, 2032in 6 yr 6 mo
U-2802
10258622Nov 21, 2032in 6 yr 6 mo
U-4051
9387208Nov 21, 2032in 6 yr 6 mo
Product
9763941Nov 21, 2032in 6 yr 6 mo
U-2335
9474754Aug 05, 2033in 7 yr 3 mo
U-4440
9474754Aug 05, 2033in 7 yr 3 mo
U-2802
9474754Aug 05, 2033in 7 yr 3 mo
U-4051
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