roflumilast · Arcutis · NDA 215985, 217242
Zoryve
Earliest generic entry, as listed · earliest of 4 marketed strengths
25 Aug 2037
Other strengths are listed to 19 Aug 2042.
Blocked by patent: US 11129818. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 22 unexpired
51 Orange Book listing rows for 22 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12453721 | drug product | 19 Aug 2042 |
| US 11707454 | use U-3773 | 3 Dec 2041 |
| US 12329751 | use U-3773 | 3 Dec 2041 |
| US 11129818 | use U-3408, U-3712, U-3773, U-3970, U-4203, U-4301, U-4578 | 25 Aug 2037 |
| US 11129818 listing row | use U-3408 · sets the listed date | 25 Aug 2037 |
| US 11129818 listing row | use U-3712 · sets the listed date | 25 Aug 2037 |
| US 11129818 listing row | use U-3773 · sets the listed date | 25 Aug 2037 |
| US 11129818 listing row | use U-3970 · sets the listed date | 25 Aug 2037 |
| US 11129818 listing row | use U-4203 · sets the listed date | 25 Aug 2037 |
| US 11129818 listing row | use U-4301 · sets the listed date | 25 Aug 2037 |
| US 11129818 listing row | use U-4578 · sets the listed date | 25 Aug 2037 |
| US 10940142 | drug product | 7 Jun 2037 |
| US 11793796 | drug product | 7 Jun 2037 |
| US 11819496 | use U-3748, U-3773, U-3970, U-4203, U-4301, U-4578 | 7 Jun 2037 |
| US 11819496 listing row | use U-3748 | 7 Jun 2037 |
| US 11819496 listing row | use U-3773 | 7 Jun 2037 |
| US 11819496 listing row | use U-3970 | 7 Jun 2037 |
| US 11819496 listing row | use U-4203 | 7 Jun 2037 |
| US 11819496 listing row | use U-4301 | 7 Jun 2037 |
| US 11819496 listing row | use U-4578 | 7 Jun 2037 |
| US 11992480 | use U-3773, U-3970, U-4203, U-4301, U-4578 | 7 Jun 2037 |
| US 11992480 listing row | use U-3773 | 7 Jun 2037 |
| US 11992480 listing row | use U-3970 | 7 Jun 2037 |
| US 11992480 listing row | use U-4203 | 7 Jun 2037 |
| US 11992480 listing row | use U-4301 | 7 Jun 2037 |
| US 11992480 listing row | use U-4578 | 7 Jun 2037 |
| US 12005051 | use U-3773, U-3970, U-4203, U-4301, U-4578 | 7 Jun 2037 |
| US 12005051 listing row | use U-3773 | 7 Jun 2037 |
| US 12005051 listing row | use U-3970 | 7 Jun 2037 |
| US 12005051 listing row | use U-4203 | 7 Jun 2037 |
| US 12005051 listing row | use U-4301 | 7 Jun 2037 |
| US 12005051 listing row | use U-4578 | 7 Jun 2037 |
| US 12005052 | drug product | 7 Jun 2037 |
| US 12011437 | drug product | 7 Jun 2037 |
| US 12016848 | drug product | 7 Jun 2037 |
| US 12042487 | drug product | 7 Jun 2037 |
| US 12220409 | drug product | 7 Jun 2037 |
| US 12257242 | drug product | 7 Jun 2037 |
| US 12310956 | use U-3773, U-3970, U-4203, U-4301, U-4578 | 7 Jun 2037 |
| US 12310956 listing row | use U-3773 | 7 Jun 2037 |
| US 12310956 listing row | use U-3970 | 7 Jun 2037 |
| US 12310956 listing row | use U-4203 | 7 Jun 2037 |
| US 12310956 listing row | use U-4301 | 7 Jun 2037 |
| US 12310956 listing row | use U-4578 | 7 Jun 2037 |
| US 12336983 | drug product | 7 Jun 2037 |
| US 12390453 | drug product | 7 Jun 2037 |
| US 12685727 | use U-4301 | 7 Jun 2037 |
| US 12697329 | drug product | 7 Jun 2037 |
| US 9884050 | drug product | 7 Jun 2037 |
| US 9907788 | use U-3408, U-3712, U-3773, U-3970, U-4203, U-4301, U-4578 | 7 Jun 2037 |
| US 9907788 listing row | use U-3408 | 7 Jun 2037 |
| US 9907788 listing row | use U-3712 | 7 Jun 2037 |
| US 9907788 listing row | use U-3773 | 7 Jun 2037 |
| US 9907788 listing row | use U-3970 | 7 Jun 2037 |
| US 9907788 listing row | use U-4203 | 7 Jun 2037 |
| US 9907788 listing row | use U-4301 | 7 Jun 2037 |
| US 9907788 listing row | use U-4578 | 7 Jun 2037 |
Exclusivities · 4 unexpired
| NPP | new patient population | 29 Jun 2029 |
| NS | new strength | 4 Oct 2028 |
| I-969 | new indication (3 years) | 22 May 2028 |
| NS | new strength | 9 Jul 2027 |
| NP | new product | 15 Dec 2026 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- Exclusivity expires within 90 days NP · 217242-001Exclusivity expires 15 Dec 2026Detected 24 Oct 2026
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215985 · 001 · RLD | cream, topical | 0.3% | 25 Aug 2037 |
| 215985 · 002 · RLD | cream, topical | 0.15% | 25 Aug 2037 |
| 215985 · 003 · RLD | cream, topical | 0.05% | 25 Aug 2037 |
| 217242 · 001 · RLD | foam, topical | 0.3% | 19 Aug 2042 |
Expired or delisted (1)
- NPP · 5 Oct 2026