afatinib dimaleate · Boehringer Ingelheim · NDA 201292

Gilotrif

Earliest generic entry, as listed · earliest of 3 marketed strengths

5 Jan 2031

Blocked by patent: US 10004743 (pediatric extension).

FDA has approved 2 generic applications (ANDAs) for Gilotrif, though its earliest generic-entry date is 5 Jan 2031 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch

Listed patents · 4 unexpired

8 Orange Book listing rows for 4 patents, including 4 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 10004743	drug product	5 Jan 2031	2 listing rows
US 10004743 listing row	drug product	5 Jul 2030	3 strengths · listed 2 Aug 2018
US 10004743 listing row	pediatric extension · sets the listed date	5 Jan 2031	3 strengths
US 8545884	drug product	19 Jun 2030	2 listing rows
US 8545884 listing row	drug product	19 Dec 2029	3 strengths · listed 28 Oct 2013
US 8545884 listing row	pediatric extension	19 Jun 2030	3 strengths
US 8426586	drug substance	10 Apr 2030	2 listing rows
US 8426586 listing row	drug substance	10 Oct 2029	3 strengths · listed 1 Aug 2013
US 8426586 listing row	pediatric extension	10 Apr 2030	3 strengths
US 9539258	use U-1950	9 May 2027	2 listing rows
US 9539258 listing row	use U-1950	9 Nov 2026	3 strengths · listed 2 Feb 2017
US 9539258 listing row	pediatric extension	9 May 2027	3 strengths

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

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

Generic tentatively approved · ANDA 210804, Msn Pharmaceuticals Inc · 201292-001Tentative approval 18 Feb 2026Detected 25 Oct 2026Historical import
First generic approved · ANDA 210750, Hetero Labs Ltd V · 201292-001Approved 14 Jul 2026Detected 25 Oct 2026Historical import
Generic approved · ANDA 210750, Hetero Labs Ltd V · 201292-001Approved 14 Jul 2026Detected 25 Oct 2026Historical import
First generic approved · ANDA 210725, Apotex · 201292-001Approved 14 Jul 2026Detected 25 Oct 2026Historical import
Generic approved · ANDA 210725, Apotex · 201292-001Approved 14 Jul 2026Detected 25 Oct 2026Historical import

Products covered · 3

NDA · product	Form	Strength	Approved	Listed expiry
201292 · 001 · RLD	tablet, oral	EQ 20MG BASE	12 Jul 2013	5 Jan 2031
201292 · 002 · RLD	tablet, oral	EQ 30MG BASE	12 Jul 2013	5 Jan 2031
201292 · 003 · RLD	tablet, oral	EQ 40MG BASE	12 Jul 2013	5 Jan 2031

Expired or delisted (2)

US RE43431 · — · 13 Jul 2026
US RE43431 · substance · 13 Jan 2026