Orange Book product · Brand (NDA)
ZORYVE
ROFLUMILAST
At a glance
Jul 09, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
16
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 09, 2024
2 yr ago
Today
Exclusivity ends · NS
New strength exclusivity (3 years)
Jul 09, 2027
in 1 yr 1 mo
Patent 10940142 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 11793796 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 11819496 expires
Listed method-of-use patent (U-3970) expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 11992480 expires
Listed method-of-use patent (U-3970) expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 12005051 expires
Listed method-of-use patent (U-3970) expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 12005052 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 12011437 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 12016848 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 12042487 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 12220409 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 12257242 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 12310956 expires
Listed method-of-use patent (U-3970) expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 12336983 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 9884050 expires
Listed drug product patent expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 9907788 expires
Listed method-of-use patent (U-3970) expiration.
Jun 07, 2037
in 11 yr 2 mo
Patent 11129818 expires
Listed method-of-use patent (U-3970) expiration.
Aug 25, 2037
in 11 yr 4 mo
Pharmaceutical detail
Active ingredient
ROFLUMILAST
Strength
0.15%
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 215985
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2023ZORYVEBrand (NDA)
NDA 217242 · ARCUTIS
- 2018DALIRESPBrand (NDA)
NDA 022522 · ASTRAZENECA
- 2025ROFLUMILASTGeneric (ANDA)
ANDA 213298 · AUROBINDO PHARMA LTD
- 2024ROFLUMILASTGeneric (ANDA)
ANDA 208272 · TORRENT
- 2023ROFLUMILASTGeneric (ANDA)
ANDA 208236 · SENORES PHARMS
- 2023ROFLUMILASTGeneric (ANDA)
ANDA 208247 · STRIDES PHARMA
- 2023ROFLUMILASTGeneric (ANDA)
ANDA 212490 · ALKEM LABS LTD
- 2023ROFLUMILASTGeneric (ANDA)
ANDA 208213 · HETERO LABS LTD III
- 2023ROFLUMILASTGeneric (ANDA)
ANDA 208180 · MICRO LABS
- 2023ROFLUMILASTGeneric (ANDA)
ANDA 208303 · ZYDUS PHARMS
- 2022ROFLUMILASTGeneric (ANDA)
ANDA 208256 · MSN
- 2022ROFLUMILASTGeneric (ANDA)
ANDA 208299 · PRINSTON INC
Marketing exclusivity (1)
- NSNew strength exclusivity (3 years)
Jul 09, 2027
in 1 yr 1 mo
Listed patents (16)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10940142 | Jun 07, 2037 | in 11 yr 2 mo | Product |
| 11793796 | Jun 07, 2037 | in 11 yr 2 mo | Product |
| 11819496 | Jun 07, 2037 | in 11 yr 2 mo | U-3970 |
| 11992480 | Jun 07, 2037 | in 11 yr 2 mo | U-3970 |
| 12005051 | Jun 07, 2037 | in 11 yr 2 mo | U-3970 |
| 12005052 | Jun 07, 2037 | in 11 yr 2 mo | Product |
| 12011437 | Jun 07, 2037 | in 11 yr 2 mo | Product |
| 12016848 | Jun 07, 2037 | in 11 yr 2 mo | Product |
| 12042487 | Jun 07, 2037 | in 11 yr 2 mo | Product |
| 12220409 | Jun 07, 2037 | in 11 yr 2 mo | Product |
| 12257242 | Jun 07, 2037 | in 11 yr 2 mo | Product |
| 12310956 | Jun 07, 2037 | in 11 yr 2 mo | U-3970 |
| 12336983 | Jun 07, 2037 | in 11 yr 2 mo | Product |
| 9884050 | Jun 07, 2037 | in 11 yr 2 mo | Product |
| 9907788 | Jun 07, 2037 | in 11 yr 2 mo | U-3970 |
| 11129818 | Aug 25, 2037 | in 11 yr 4 mo | U-3970 |
