cobimetinib fumarate · Genentech Inc · NDA 206192

Cotellic

Earliest generic entry, as listed

30 Dec 2036

Blocked by patent: US 10590102 (pediatric extension), US 11254649 (pediatric extension).

Listed patents · 6 unexpired

11 Orange Book listing rows for 6 patents, including 6 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

Patent	Claims	Expires	Notes
US 10590102	drug substance, drug product, use U-1776	30 Dec 2036	2 listing rows
US 10590102 listing row	drug substance, drug product, use U-1776	30 Jun 2036	listed 8 Apr 2020
US 10590102 listing row	pediatric extension · sets the listed date	30 Dec 2036
US 11254649	drug substance, drug product, use U-1776	30 Dec 2036	2 listing rows
US 11254649 listing row	drug substance, drug product, use U-1776	30 Jun 2036	listed 21 Mar 2022
US 11254649 listing row	pediatric extension · sets the listed date	30 Dec 2036
US 10478400	drug substance, drug product, use U-1776	29 Dec 2036	2 listing rows
US 10478400 listing row	drug substance, drug product, use U-1776	29 Jun 2036	listed 18 Dec 2019
US 10478400 listing row	pediatric extension	29 Dec 2036
US 11087354	use U-1776	22 Dec 2034	2 listing rows
US 11087354 listing row	use U-1776	22 Jun 2034	listed 8 Sep 2021
US 11087354 listing row	pediatric extension	22 Dec 2034
US 7803839	drug substance, drug product	10 May 2030	2 listing rows
US 7803839 listing row	drug substance, drug product	10 Nov 2029	listed 9 Dec 2015
US 7803839 listing row	pediatric extension	10 May 2030
US 8362002	pediatric extension	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	Approved	Listed expiry
206192 · 001 · RLD	tablet, oral	EQ 20MG BASE	10 Nov 2015	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