ruxolitinib phosphate · Incyte Corp · NDA 202192
Jakafi
Earliest generic entry, as listed · earliest of 5 marketed strengths
22 Mar 2029
Blocked by exclusivity: PED.
Listed patents · 8 unexpired
29 Orange Book listing rows for 8 patents, including 8 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10016429 | use U-3226, U-3230 | 12 Dec 2028 |
| US 10016429 listing row | use U-3226 | 12 Jun 2028 |
| US 10016429 listing row | use U-3230 | 12 Jun 2028 |
| US 10016429 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-1573, U-3226, U-3227, U-3228, U-3230 | 12 Dec 2028 |
| US 8822481 listing row | use U-1573 | 12 Jun 2028 |
| US 8822481 listing row | use U-3226 | 12 Jun 2028 |
| US 8822481 listing row | use U-3227 | 12 Jun 2028 |
| US 8822481 listing row | use U-3228 | 12 Jun 2028 |
| US 8822481 listing row | use U-3230 | 12 Jun 2028 |
| US 8822481 listing row | pediatric extension | 12 Dec 2028 |
| US 8829013 | use U-1201, U-1622, U-3227, U-3228 | 12 Dec 2028 |
| US 8829013 listing row | use U-1201 | 12 Jun 2028 |
| US 8829013 listing row | use U-1622 | 12 Jun 2028 |
| US 8829013 listing row | use U-3227 | 12 Jun 2028 |
| US 8829013 listing row | use U-3228 | 12 Jun 2028 |
| US 8829013 listing row | pediatric extension | 12 Dec 2028 |
| US 7598257 | drug substance, drug product, use U-3227, U-3228 | 24 Jun 2028 |
| US 7598257 listing row | drug substance, drug product, use U-3227 | 24 Dec 2027 |
| US 7598257 listing row | drug substance, drug product, use U-3228 | 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 9079912 | use U-3226, U-3227, U-3228, U-3230 | 12 Jun 2027 |
| US 9079912 listing row | use U-3226 | 12 Dec 2026 |
| US 9079912 listing row | use U-3227 | 12 Dec 2026 |
| US 9079912 listing row | use U-3228 | 12 Dec 2026 |
| US 9079912 listing row | use U-3230 | 12 Dec 2026 |
| US 9079912 listing row | pediatric extension | 12 Jun 2027 |
| US 9814722 | use U-3226, U-3230 | 12 Jun 2027 |
| US 9814722 listing row | use U-3226 | 12 Dec 2026 |
| US 9814722 listing row | use U-3230 | 12 Dec 2026 |
| US 9814722 listing row | pediatric extension | 12 Jun 2027 |
Exclusivities · 2 unexpired
| PED | pediatric (6 months added) | 22 Mar 2029 |
| ODE-373 | orphan drug (7 years) | 22 Sep 2028 |
| PED | pediatric (6 months added) | 24 Nov 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
- 24 Oct 2026Exclusivity expires within 90 days PED · 202192-00524 Nov 2026
- 24 Oct 2026Exclusivity expires within 90 days PED · 202192-00424 Nov 2026
- 24 Oct 2026Exclusivity expires within 90 days PED · 202192-00324 Nov 2026
- 24 Oct 2026Exclusivity expires within 90 days PED · 202192-00224 Nov 2026
- 24 Oct 2026Exclusivity expires within 90 days PED · 202192-00124 Nov 2026
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 202192 · 001 · RLD | tablet, oral | EQ 5MG BASE | 22 Mar 2029 |
| 202192 · 002 · RLD | tablet, oral | EQ 10MG BASE | 22 Mar 2029 |
| 202192 · 003 · RLD | tablet, oral | EQ 15MG BASE | 22 Mar 2029 |
| 202192 · 004 · RLD | tablet, oral | EQ 20MG BASE | 22 Mar 2029 |
| 202192 · 005 · RLD | tablet, oral | EQ 25MG BASE | 22 Mar 2029 |
Expired or delisted (3)
- PED · 19 Jun 2026
- ODE-238 · 24 May 2026
- M-285 · 19 Dec 2025