trametinib dimethyl sulfoxide · Novartis · NDA 204114, 217513
Mekinist
Earliest generic entry, as listed · earliest of 3 marketed strengths
15 Apr 2031
Other strengths are listed to 28 Feb 2034.
Blocked by patent: US 8703781, US 8952018.
Listed patents · 21 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10869869 | — | 28 Feb 2034 |
| US 10869869 | use U-3184 | 30 Aug 2033 |
| US 8580304 | — | 28 Jul 2032 |
| US 9155706 | — | 28 Jul 2032 |
| US 9271941 | — | 28 Jul 2032 |
| US 9399021 | — | 28 Jul 2032 |
| US 8580304 | product | 28 Jan 2032 |
| US 9155706 | product | 28 Jan 2032 |
| US 9271941 | product | 28 Jan 2032 |
| US 9399021 | product | 28 Jan 2032 |
| US 8703781 | — | 15 Apr 2031 |
| US 8952018 | — | 15 Apr 2031 |
| US 8703781 | substance, product, use U-2037 | 15 Oct 2030 |
| US 8703781 | substance, product, use U-2305 | 15 Oct 2030 |
| US 8703781 | substance, product, use U-1712 | 15 Oct 2030 |
| US 8703781 | substance, product, use U-2020 | 15 Oct 2030 |
| US 8703781 | substance, product, use U-2302 | 15 Oct 2030 |
| US 8703781 | substance, product, use U-3564 | 15 Oct 2030 |
| US 8952018 | use U-2020 | 15 Oct 2030 |
| US 7378423 | — | 29 Nov 2027 |
| US 7378423 | substance, product | 29 May 2027 |
Exclusivities · 2 unexpired
| PED | pediatric (6 months added) | 16 Sep 2030 |
| ODE-428 | orphan drug (7 years) | 16 Mar 2030 |
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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 204114 · 001 · RLD | tablet, oral | EQ 0.5MG | 28 Feb 2034 |
| 204114 · 002 · RLD · discontinued | tablet, oral | EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 28 Feb 2034 |
| 204114 · 003 · RLD | tablet, oral | EQ 2MG | 28 Feb 2034 |
| 217513 · 001 · RLD | solution, oral | EQ 0.05MG BASE/ML | 15 Apr 2031 |
Expired or delisted (3)
- PED · 16 Sep 2026
- NP · 16 Mar 2026
- I-908 · 16 Mar 2026