cobimetinib fumarate · Genentech Inc · NDA 206192
Cotellic
Earliest generic entry, as listed
30 Dec 2036
Blocked by patent: US 10590102, US 11254649.
Listed patents · 11 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10590102 | — | 30 Dec 2036 |
| US 11254649 | — | 30 Dec 2036 |
| US 10478400 | — | 29 Dec 2036 |
| US 10590102 | substance, product, use U-1776 | 30 Jun 2036 |
| US 11254649 | substance, product, use U-1776 | 30 Jun 2036 |
| US 10478400 | substance, product, use U-1776 | 29 Jun 2036 |
| US 11087354 | — | 22 Dec 2034 |
| US 11087354 | use U-1776 | 22 Jun 2034 |
| US 7803839 | — | 10 May 2030 |
| US 7803839 | substance, product | 10 Nov 2029 |
| US 8362002 | — | 5 Apr 2027 |
Exclusivities · 1 unexpired
| ODE-416 | orphan drug (7 years) | 28 Oct 2029 |
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 |
|---|---|---|---|
| 206192 · 001 · RLD | tablet, oral | EQ 20MG BASE | 30 Dec 2036 |
Expired or delisted (4)
- US 11597699 · use U-3554 · 5 Oct 2026
- US 8362002 · use U-1776 · 5 Oct 2026
- PED · 28 Jan 2026
- M-278 · 28 Jul 2025