ruxolitinib phosphate · Incyte Corp · NDA 215309
Opzelura
Earliest generic entry, as listed
5 May 2041
Blocked by patent: US 11602536. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 22 unexpired
39 Orange Book listing rows for 22 patents, including 11 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11602536 | use U-3550 · sets the listed date | 5 May 2041 |
| US 11510923 | use U-3505 | 4 Sep 2040 |
| US 11590137 | use U-3505 | 4 Sep 2040 |
| US 12589096 | use U-3505 | 4 Sep 2040 |
| US 12233067 | use U-4151 | 28 Jul 2040 |
| US 11590138 | use U-3551 | 10 Jun 2040 |
| US 10758543 | drug product | 20 Nov 2031 |
| US 10758543 listing row | drug product | 20 May 2031 |
| US 10758543 listing row | pediatric extension | 20 Nov 2031 |
| US 10869870 | use U-3229, U-3404 | 20 Nov 2031 |
| US 10869870 listing row | use U-3229 | 20 May 2031 |
| US 10869870 listing row | use U-3404 | 20 May 2031 |
| US 10869870 listing row | pediatric extension | 20 Nov 2031 |
| US 11219624 | drug product, use U-3229 | 20 Nov 2031 |
| US 11219624 listing row | drug product, use U-3229 | 20 May 2031 |
| US 11219624 listing row | pediatric extension | 20 Nov 2031 |
| US 11571425 | drug product | 20 May 2031 |
| US 11590136 | use U-3229, U-3404 | 20 May 2031 |
| US 11590136 listing row | use U-3229 | 20 May 2031 |
| US 11590136 listing row | use U-3404 | 20 May 2031 |
| US 12226419 | drug product | 20 May 2031 |
| US 12544381 | drug product | 20 May 2031 |
| US 12564593 | drug product | 20 May 2031 |
| US 10610530 | use U-3229, U-3404 | 12 Dec 2028 |
| US 10610530 listing row | use U-3229 | 12 Jun 2028 |
| US 10610530 listing row | use U-3404 | 12 Jun 2028 |
| US 10610530 listing row | pediatric extension | 12 Dec 2028 |
| US 8722693 | drug substance, drug product | 12 Dec 2028 |
| US 8722693 listing row | drug substance, drug product | 12 Jun 2028 |
| US 8722693 listing row | pediatric extension | 12 Dec 2028 |
| US 8822481 | use U-3229, U-3404 | 12 Dec 2028 |
| US 8822481 listing row | use U-3229 | 12 Jun 2028 |
| US 8822481 listing row | use U-3404 | 12 Jun 2028 |
| US 8822481 listing row | pediatric extension | 12 Dec 2028 |
| US 7598257 | drug substance, drug product | 24 Jun 2028 |
| US 7598257 listing row | drug substance, drug product | 24 Dec 2027 |
| US 7598257 listing row | pediatric extension | 24 Jun 2028 |
| US 8415362 | drug substance, drug product | 24 Jun 2028 |
| US 8415362 listing row | drug substance, drug product | 24 Dec 2027 |
| US 8415362 listing row | pediatric extension | 24 Jun 2028 |
| US 10639310 | use U-3229 | 12 Jun 2027 |
| US 10639310 listing row | use U-3229 | 12 Dec 2026 |
| US 10639310 listing row | pediatric extension | 12 Jun 2027 |
| US 9079912 | use U-3229, U-3404 | 12 Jun 2027 |
| US 9079912 listing row | use U-3229 | 12 Dec 2026 |
| US 9079912 listing row | use U-3404 | 12 Dec 2026 |
| US 9079912 listing row | pediatric extension | 12 Jun 2027 |
| US 9974790 | use U-3229, U-3404 | 12 Jun 2027 |
| US 9974790 listing row | use U-3229 | 12 Dec 2026 |
| US 9974790 listing row | use U-3404 | 12 Dec 2026 |
| US 9974790 listing row | pediatric extension | 12 Jun 2027 |
Exclusivities · 1 unexpired
| NPP | new patient population | 18 Sep 2028 |
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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215309 · 001 · RLD | cream, topical | EQ 1.5% BASE | 5 May 2041 |
Expired or delisted (2)
- PED · 18 Jan 2026
- I-896 · 18 Jul 2025