ticagrelor · Astrazeneca · NDA 022433

Brilinta

Earliest generic entry, as listed · earliest of 2 marketed strengths

27 Jul 2036

Blocked by patent: US 10300065 (pediatric extension).

FDA has approved 15 generic applications (ANDAs) for Brilinta, though its earliest generic-entry date is 27 Jul 2036 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 · 2 unexpired

5 Orange Book listing rows for 2 patents, including 2 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 10300065	use U-2541, U-2542	27 Jul 2036	3 listing rows
US 10300065 listing row	use U-2541	27 Jan 2036	2 strengths · listed 24 Jun 2019
US 10300065 listing row	use U-2542	27 Jan 2036	2 strengths · listed 24 Jun 2019
US 10300065 listing row	pediatric extension · sets the listed date	27 Jul 2036	2 strengths
US 8425934	drug product	17 Oct 2030	2 listing rows
US 8425934 listing row	drug product	17 Apr 2030	2 strengths · listed 20 May 2013
US 8425934 listing row	pediatric extension	17 Oct 2030	2 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 approved · ANDA 217679, Mankind Pharma · 022433-001Approved 6 Feb 2026Detected 25 Oct 2026Historical import
Generic approved · ANDA 219006, Zhejiang Jingxin · 022433-001Approved 24 Mar 2026Detected 25 Oct 2026Historical import
Generic approved · ANDA 218962, Sciegen Pharms · 022433-001Approved 28 Oct 2025Detected 25 Oct 2026Historical import
Generic approved · ANDA 208596, Msn · 022433-001Approved 28 Oct 2025Detected 25 Oct 2026Historical import
Generic approved · ANDA 208584, Apotex · 022433-001Approved 28 Oct 2025Detected 25 Oct 2026Historical import
Generic approved · ANDA 208576, Alembic · 022433-001Approved 28 Oct 2025Detected 25 Oct 2026Historical import
Generic approved · ANDA 218869, Pharmobedient · 022433-001Approved 20 Aug 2026Detected 25 Oct 2026Historical import
Generic approved · ANDA 208541, Dr Reddys · 022433-001Approved 28 Oct 2025Detected 25 Oct 2026Historical import
Generic approved · ANDA 208539, Micro Labs · 022433-001Approved 27 Apr 2026Detected 25 Oct 2026Historical import
Generic approved · ANDA 208537, Invagen Pharms · 022433-001Approved 28 Oct 2025Detected 25 Oct 2026Historical import
Generic approved · ANDA 208508, Sunshine · 022433-001Approved 28 Oct 2025Detected 25 Oct 2026Historical import
Generic approved · ANDA 210219, Alkem Labs Ltd · 022433-001Approved 28 Oct 2025Detected 25 Oct 2026Historical import
Generic approved · ANDA 212258, Macleods Pharms · 022433-001Approved 28 Oct 2025Detected 25 Oct 2026Historical import
Generic approved · ANDA 216187, Changzhou Pharm · 022433-001Approved 28 Oct 2025Detected 25 Oct 2026Historical import
Generic approved · ANDA 211498, Taro · 022433-001Approved 28 Oct 2025Detected 25 Oct 2026Historical import

Products covered · 2

NDA · product	Form	Strength	Approved	Listed expiry
022433 · 001 · RLD	tablet, oral	90MG	20 Jul 2011	27 Jul 2036
022433 · 002 · RLD	tablet, oral	60MG	3 Sep 2015	27 Jul 2036