FDA Orange Book · active-ingredient family
Roflumilast
Roflumilast is approved as 3 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ZORYVE · NDA 215985
3
Brand (NDA)
11
Generics (ANDA)
20
Listed patents
5
Exclusivity periods
Brand (NDA) products · cream, foam, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZORYVERLD×3 | ARCUTIS | NDA 215985 | — | Jul 09, 2024 | |
| ZORYVERLD | ARCUTIS | NDA 217242 | — | Dec 15, 2023 | |
| DALIRESPRLD×2 | ASTRAZENECA | NDA 022522 | AB | Jan 23, 2018 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ROFLUMILAST×2 | AUROBINDO PHARMA LTD | ANDA 213298 | AB | Jan 31, 2025 | |
| ROFLUMILAST×2 | TORRENT | ANDA 208272 | — | Oct 18, 2024 | |
| ROFLUMILAST×2 | SENORES PHARMS | ANDA 208236 | AB | Oct 19, 2023 | |
| ROFLUMILAST×2 | STRIDES PHARMA | ANDA 208247 | AB | Jun 20, 2023 | |
| ROFLUMILAST×2 | ALKEM LABS LTD | ANDA 212490 | AB | Apr 18, 2023 | |
| ROFLUMILAST×2 | HETERO LABS LTD III | ANDA 208213 | AB | Apr 18, 2023 | |
| ROFLUMILAST×2 | MICRO LABS | ANDA 208180 | AB | Apr 18, 2023 | |
| ROFLUMILAST×2 | ZYDUS PHARMS | ANDA 208303 | AB | Apr 18, 2023 | |
| ROFLUMILAST×2 | MSN | ANDA 208256 | AB | Sep 07, 2022 | |
| ROFLUMILAST | PRINSTON INC | ANDA 208299 | AB | May 10, 2022 | |
| ROFLUMILAST | PHARMOBEDIENT | ANDA 208257 | — | Jul 13, 2018 |
Marketing exclusivity (5)
- NSNew strength exclusivity (3 years)
Jul 09, 2027
in 1 yr 1 mo
- NPPNew patient population exclusivity (3 years)
Oct 05, 2026
in 4 mo
- NSNew strength exclusivity (3 years)
Oct 04, 2028
in 2 yr 4 mo
- I-969New indication exclusivity (3 years)
May 22, 2028
in 1 yr 11 mo
- NPNew product exclusivity (3 years)
Dec 15, 2026
in 6 mo
Listed patents (20)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12005051 | Jun 07, 2037 | in 11 yr 2 mo | U-3970 |
| 11992480 | Jun 07, 2037 | in 11 yr 2 mo | U-3970 |
| 11819496 | Jun 07, 2037 | in 11 yr 2 mo | U-3970 |
| 12310956 | Jun 07, 2037 | in 11 yr 2 mo | U-3970 |
| 9907788 | Jun 07, 2037 | in 11 yr 2 mo | U-3970 |
| 12042487 | Jun 07, 2037 | in 11 yr 2 mo | Product |
| 12016848 | Jun 07, 2037 | in 11 yr 2 mo | Product |
| 12336983 | Jun 07, 2037 | in 11 yr 2 mo | Product |
| 12011437 | Jun 07, 2037 | in 11 yr 2 mo | Product |
| 10940142 | Jun 07, 2037 | in 11 yr 2 mo | Product |
| 12005052 | 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 |
| 9884050 | Jun 07, 2037 | in 11 yr 2 mo | Product |
| 11793796 | Jun 07, 2037 | in 11 yr 2 mo | Product |
| 12390453 | Jun 07, 2037 | in 11 yr 2 mo | Product |
| 11129818 | Aug 25, 2037 | in 11 yr 4 mo | U-3970 |
| 12329751 | Dec 03, 2041 | in 15 yr 8 mo | U-3773 |
| 11707454 | Dec 03, 2041 | in 15 yr 8 mo | U-3773 |
| 12453721 | Aug 19, 2042 | in 16 yr 5 mo | Product |
Roflumilast — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
