Assyro AI

Orange Book product · Brand (NDA)

OPZELURA

RUXOLITINIB PHOSPHATE

Brand (NDA)NDA 215309RX INCYTE CORP
View RUXOLITINIB PHOSPHATE familyOpen on FDA Orange Book

At a glance

Sep 21, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

39

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 21, 2021

    4 yr 10 mo ago

  2. Exclusivity ends · I-896

    New indication exclusivity (3 years)

    Jul 18, 2025

    11 mo ago

  3. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Jan 18, 2026

    5 mo ago

  4. Today

  5. Patent 10639310 expires

    Listed method-of-use patent (U-3229) expiration.

    Dec 12, 2026

    in 6 mo

  6. Patent 9079912 expires

    Listed method-of-use patent (U-3404) expiration.

    Dec 12, 2026

    in 6 mo

  7. Patent 9079912 expires

    Listed method-of-use patent (U-3229) expiration.

    Dec 12, 2026

    in 6 mo

  8. Patent 9974790 expires

    Listed method-of-use patent (U-3404) expiration.

    Dec 12, 2026

    in 6 mo

  9. Patent 9974790 expires

    Listed method-of-use patent (U-3229) expiration.

    Dec 12, 2026

    in 6 mo

  10. Patent 10639310*PED expires

    Listed listed patent expiration.

    Jun 12, 2027

    in 1 yr

  11. Patent 9079912*PED expires

    Listed listed patent expiration.

    Jun 12, 2027

    in 1 yr

  12. Patent 9974790*PED expires

    Listed listed patent expiration.

    Jun 12, 2027

    in 1 yr

  13. Patent 7598257 expires

    Listed drug substance patent expiration.

    Dec 24, 2027

    in 1 yr 6 mo

  14. Patent 8415362 expires

    Listed drug substance patent expiration.

    Dec 24, 2027

    in 1 yr 6 mo

  15. Patent 10610530 expires

    Listed method-of-use patent (U-3404) expiration.

    Jun 12, 2028

    in 2 yr

  16. Patent 10610530 expires

    Listed method-of-use patent (U-3229) expiration.

    Jun 12, 2028

    in 2 yr

  17. Patent 8722693 expires

    Listed drug substance patent expiration.

    Jun 12, 2028

    in 2 yr

  18. Patent 8822481 expires

    Listed method-of-use patent (U-3404) expiration.

    Jun 12, 2028

    in 2 yr

  19. Patent 8822481 expires

    Listed method-of-use patent (U-3229) expiration.

    Jun 12, 2028

    in 2 yr

  20. Patent 7598257*PED expires

    Listed listed patent expiration.

    Jun 24, 2028

    in 2 yr 1 mo

  21. Patent 8415362*PED expires

    Listed listed patent expiration.

    Jun 24, 2028

    in 2 yr 1 mo

  22. Exclusivity ends · NPP

    New patient population exclusivity (3 years)

    Sep 18, 2028

    in 2 yr 3 mo

  23. Patent 10610530*PED expires

    Listed listed patent expiration.

    Dec 12, 2028

    in 2 yr 6 mo

  24. Patent 8722693*PED expires

    Listed listed patent expiration.

    Dec 12, 2028

    in 2 yr 6 mo

  25. Patent 8822481*PED expires

    Listed listed patent expiration.

    Dec 12, 2028

    in 2 yr 6 mo

  26. Patent 10758543 expires

    Listed drug product patent expiration.

    May 20, 2031

    in 5 yr

  27. Patent 10869870 expires

    Listed method-of-use patent (U-3404) expiration.

    May 20, 2031

    in 5 yr

  28. Patent 10869870 expires

    Listed method-of-use patent (U-3229) expiration.

    May 20, 2031

    in 5 yr

  29. Patent 11219624 expires

    Listed drug product patent expiration.

    May 20, 2031

    in 5 yr

  30. Patent 11571425 expires

    Listed drug product patent expiration.

    May 20, 2031

    in 5 yr

  31. Patent 11590136 expires

    Listed method-of-use patent (U-3229) expiration.

    May 20, 2031

    in 5 yr

  32. Patent 11590136 expires

    Listed method-of-use patent (U-3404) expiration.

    May 20, 2031

    in 5 yr

  33. Patent 12226419 expires

    Listed drug product patent expiration.

    May 20, 2031

    in 5 yr

  34. Patent 12544381 expires

    Listed drug product patent expiration.

    May 20, 2031

    in 5 yr

  35. Patent 12564593 expires

    Listed drug product patent expiration.

    May 20, 2031

    in 5 yr

  36. Patent 10758543*PED expires

    Listed listed patent expiration.

    Nov 20, 2031

    in 5 yr 6 mo

  37. Patent 10869870*PED expires

    Listed listed patent expiration.

    Nov 20, 2031

    in 5 yr 6 mo

  38. Patent 11219624*PED expires

    Listed listed patent expiration.

    Nov 20, 2031

    in 5 yr 6 mo

  39. Patent 11590138 expires

    Listed method-of-use patent (U-3551) expiration.

    Jun 10, 2040

    in 14 yr 2 mo

  40. Patent 12233067 expires

    Listed method-of-use patent (U-4151) expiration.

    Jul 28, 2040

    in 14 yr 4 mo

  41. Patent 11510923 expires

    Listed method-of-use patent (U-3505) expiration.

    Sep 04, 2040

    in 14 yr 5 mo

  42. Patent 11590137 expires

    Listed method-of-use patent (U-3505) expiration.

    Sep 04, 2040

    in 14 yr 5 mo

  43. Patent 12589096 expires

    Listed method-of-use patent (U-3505) expiration.

    Sep 04, 2040

    in 14 yr 5 mo

  44. Patent 11602536 expires

    Listed method-of-use patent (U-3550) expiration.

    May 05, 2041

    in 15 yr 1 mo

Pharmaceutical detail

Active ingredient

RUXOLITINIB PHOSPHATE

Strength

EQ 1.5% BASE

Dosage form

CREAM

Route

TOPICAL

TE code

Not listed

Application

NDA 215309

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 (3)

  • I-896New indication exclusivity (3 years)

    Jul 18, 2025

    11 mo ago

  • PEDPediatric exclusivity (adds 6 months)

    Jan 18, 2026

    5 mo ago

  • NPPNew patient population exclusivity (3 years)

    Sep 18, 2028

    in 2 yr 3 mo

Listed patents (39)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10639310Dec 12, 2026in 6 mo
U-3229
9079912Dec 12, 2026in 6 mo
U-3404
9079912Dec 12, 2026in 6 mo
U-3229
9974790Dec 12, 2026in 6 mo
U-3404
9974790Dec 12, 2026in 6 mo
U-3229
10639310*PEDJun 12, 2027in 1 yr
9079912*PEDJun 12, 2027in 1 yr
9974790*PEDJun 12, 2027in 1 yr
7598257Dec 24, 2027in 1 yr 6 mo
SubstanceProduct
8415362Dec 24, 2027in 1 yr 6 mo
SubstanceProduct
10610530Jun 12, 2028in 2 yr
U-3404
10610530Jun 12, 2028in 2 yr
U-3229
8722693Jun 12, 2028in 2 yr
SubstanceProduct
8822481Jun 12, 2028in 2 yr
U-3404
8822481Jun 12, 2028in 2 yr
U-3229
7598257*PEDJun 24, 2028in 2 yr 1 mo
8415362*PEDJun 24, 2028in 2 yr 1 mo
10610530*PEDDec 12, 2028in 2 yr 6 mo
8722693*PEDDec 12, 2028in 2 yr 6 mo
8822481*PEDDec 12, 2028in 2 yr 6 mo
10758543May 20, 2031in 5 yr
Product
10869870May 20, 2031in 5 yr
U-3404
10869870May 20, 2031in 5 yr
U-3229
11219624May 20, 2031in 5 yr
ProductU-3229
11571425May 20, 2031in 5 yr
Product
11590136May 20, 2031in 5 yr
U-3229
11590136May 20, 2031in 5 yr
U-3404
12226419May 20, 2031in 5 yr
Product
12544381May 20, 2031in 5 yr
Product
12564593May 20, 2031in 5 yr
Product
10758543*PEDNov 20, 2031in 5 yr 6 mo
10869870*PEDNov 20, 2031in 5 yr 6 mo
11219624*PEDNov 20, 2031in 5 yr 6 mo
11590138Jun 10, 2040in 14 yr 2 mo
U-3551
12233067Jul 28, 2040in 14 yr 4 mo
U-4151
11510923Sep 04, 2040in 14 yr 5 mo
U-3505
11590137Sep 04, 2040in 14 yr 5 mo
U-3505
12589096Sep 04, 2040in 14 yr 5 mo
U-3505
11602536May 05, 2041in 15 yr 1 mo
U-3550
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