momelotinib dihydrochloride · Glaxosmithkline · NDA 216873
Ojjaara
Earliest generic entry, as listed · earliest of 3 marketed strengths
2 Dec 2040
Blocked by patent: US 11963962. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11963962 | use U-3928 · sets the listed date | 2 Dec 2040 |
| US 12576089 | use U-4441 | 21 Aug 2039 |
| US 9809559 | use U-1201 | 11 Jun 2035 |
| US RE48285 | drug substance, drug product, use U-1201 | 11 Jun 2035 |
| US 8486941 | drug substance, drug product, use U-1201 | 3 Jan 2035 |
Exclusivities · 2 unexpired
| ODE-441 | orphan drug (7 years) | 15 Sep 2030 |
| NCE | new chemical entity (5 years) | 15 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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216873 · 001 · RLD | tablet, oral | EQ 100MG BASE | 2 Dec 2040 |
| 216873 · 002 · RLD | tablet, oral | EQ 150MG BASE | 2 Dec 2040 |
| 216873 · 003 · RLD | tablet, oral | EQ 200MG BASE | 2 Dec 2040 |