Assyro AI

Orange Book product · Brand (NDA)

ZORYVE

ROFLUMILAST

Brand (NDA)NDA 217242RX ARCUTIS
View ROFLUMILAST familyOpen on FDA Orange Book

At a glance

Dec 15, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

26

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 15, 2023

    2 yr 7 mo ago

  2. Today

  3. Exclusivity ends · NP

    New product exclusivity (3 years)

    Dec 15, 2026

    in 6 mo

  4. Exclusivity ends · I-969

    New indication exclusivity (3 years)

    May 22, 2028

    in 1 yr 11 mo

  5. Patent 10940142 expires

    Listed drug product patent expiration.

    Jun 07, 2037

    in 11 yr 2 mo

  6. Patent 11793796 expires

    Listed drug product patent expiration.

    Jun 07, 2037

    in 11 yr 2 mo

  7. Patent 11819496 expires

    Listed method-of-use patent (U-4203) expiration.

    Jun 07, 2037

    in 11 yr 2 mo

  8. Patent 11819496 expires

    Listed method-of-use patent (U-3773) expiration.

    Jun 07, 2037

    in 11 yr 2 mo

  9. Patent 11992480 expires

    Listed method-of-use patent (U-4203) expiration.

    Jun 07, 2037

    in 11 yr 2 mo

  10. Patent 11992480 expires

    Listed method-of-use patent (U-3773) expiration.

    Jun 07, 2037

    in 11 yr 2 mo

  11. Patent 12005051 expires

    Listed method-of-use patent (U-4203) expiration.

    Jun 07, 2037

    in 11 yr 2 mo

  12. Patent 12005051 expires

    Listed method-of-use patent (U-3773) expiration.

    Jun 07, 2037

    in 11 yr 2 mo

  13. Patent 12005052 expires

    Listed drug product patent expiration.

    Jun 07, 2037

    in 11 yr 2 mo

  14. Patent 12011437 expires

    Listed drug product patent expiration.

    Jun 07, 2037

    in 11 yr 2 mo

  15. Patent 12016848 expires

    Listed drug product patent expiration.

    Jun 07, 2037

    in 11 yr 2 mo

  16. Patent 12042487 expires

    Listed drug product patent expiration.

    Jun 07, 2037

    in 11 yr 2 mo

  17. Patent 12220409 expires

    Listed drug product patent expiration.

    Jun 07, 2037

    in 11 yr 2 mo

  18. Patent 12257242 expires

    Listed drug product patent expiration.

    Jun 07, 2037

    in 11 yr 2 mo

  19. Patent 12310956 expires

    Listed method-of-use patent (U-3773) expiration.

    Jun 07, 2037

    in 11 yr 2 mo

  20. Patent 12310956 expires

    Listed method-of-use patent (U-4203) expiration.

    Jun 07, 2037

    in 11 yr 2 mo

  21. Patent 12336983 expires

    Listed drug product patent expiration.

    Jun 07, 2037

    in 11 yr 2 mo

  22. Patent 12390453 expires

    Listed drug product patent expiration.

    Jun 07, 2037

    in 11 yr 2 mo

  23. Patent 9884050 expires

    Listed drug product patent expiration.

    Jun 07, 2037

    in 11 yr 2 mo

  24. Patent 9907788 expires

    Listed method-of-use patent (U-4203) expiration.

    Jun 07, 2037

    in 11 yr 2 mo

  25. Patent 9907788 expires

    Listed method-of-use patent (U-3773) expiration.

    Jun 07, 2037

    in 11 yr 2 mo

  26. Patent 11129818 expires

    Listed method-of-use patent (U-4203) expiration.

    Aug 25, 2037

    in 11 yr 4 mo

  27. Patent 11129818 expires

    Listed method-of-use patent (U-3773) expiration.

    Aug 25, 2037

    in 11 yr 4 mo

  28. Patent 11707454 expires

    Listed method-of-use patent (U-3773) expiration.

    Dec 03, 2041

    in 15 yr 8 mo

  29. Patent 12329751 expires

    Listed method-of-use patent (U-3773) expiration.

    Dec 03, 2041

    in 15 yr 8 mo

  30. Patent 12453721 expires

    Listed drug product patent expiration.

    Aug 19, 2042

    in 16 yr 5 mo

Pharmaceutical detail

Active ingredient

ROFLUMILAST

Strength

0.3%

Dosage form

FOAM

Route

TOPICAL

TE code

Not listed

Application

NDA 217242

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 (2)

  • NPNew product exclusivity (3 years)

    Dec 15, 2026

    in 6 mo

  • I-969New indication exclusivity (3 years)

    May 22, 2028

    in 1 yr 11 mo

Listed patents (26)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10940142Jun 07, 2037in 11 yr 2 mo
Product
11793796Jun 07, 2037in 11 yr 2 mo
Product
11819496Jun 07, 2037in 11 yr 2 mo
U-4203
11819496Jun 07, 2037in 11 yr 2 mo
U-3773
11992480Jun 07, 2037in 11 yr 2 mo
U-4203
11992480Jun 07, 2037in 11 yr 2 mo
U-3773
12005051Jun 07, 2037in 11 yr 2 mo
U-4203
12005051Jun 07, 2037in 11 yr 2 mo
U-3773
12005052Jun 07, 2037in 11 yr 2 mo
Product
12011437Jun 07, 2037in 11 yr 2 mo
Product
12016848Jun 07, 2037in 11 yr 2 mo
Product
12042487Jun 07, 2037in 11 yr 2 mo
Product
12220409Jun 07, 2037in 11 yr 2 mo
Product
12257242Jun 07, 2037in 11 yr 2 mo
Product
12310956Jun 07, 2037in 11 yr 2 mo
U-3773
12310956Jun 07, 2037in 11 yr 2 mo
U-4203
12336983Jun 07, 2037in 11 yr 2 mo
Product
12390453Jun 07, 2037in 11 yr 2 mo
Product
9884050Jun 07, 2037in 11 yr 2 mo
Product
9907788Jun 07, 2037in 11 yr 2 mo
U-4203
9907788Jun 07, 2037in 11 yr 2 mo
U-3773
11129818Aug 25, 2037in 11 yr 4 mo
U-4203
11129818Aug 25, 2037in 11 yr 4 mo
U-3773
11707454Dec 03, 2041in 15 yr 8 mo
U-3773
12329751Dec 03, 2041in 15 yr 8 mo
U-3773
12453721Aug 19, 2042in 16 yr 5 mo
Product
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