macitentan · Actelion · NDA 204410

Opsumit

Earliest generic entry, as listed

18 Oct 2029

Blocked by patent: US 8268847 (pediatric extension).

FDA has approved 5 generic applications (ANDAs) for Opsumit, though its earliest generic-entry date is 18 Oct 2029 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

7 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 8268847	use U-1446	18 Oct 2029	2 listing rows
US 8268847 listing row	use U-1446	18 Apr 2029	listed 6 Nov 2013
US 8268847 listing row	pediatric extension · sets the listed date	18 Oct 2029
US 8367685	drug product, use U-1445	4 Apr 2029	2 listing rows
US 8367685 listing row	drug product, use U-1445	4 Oct 2028	listed 6 Nov 2013
US 8367685 listing row	pediatric extension	4 Apr 2029
US 9265762	drug product, use U-1820	29 Nov 2027	2 listing rows
US 9265762 listing row	drug product, use U-1820	29 May 2027	listed 16 Mar 2016
US 9265762 listing row	pediatric extension	29 Nov 2027
US 10946015	pediatric extension	11 Mar 2027

Exclusivities · 2 unexpired

PED	pediatric (6 months added)	28 Aug 2028
M-187	miscellaneous (3 years)	28 Feb 2028

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 211026, Lepu Pharm · 204410-001Approved 3 Dec 2025Detected 25 Oct 2026Historical import
Generic approved · ANDA 211000, Amneal · 204410-001Approved 8 Jun 2026Detected 25 Oct 2026Historical import
Generic approved · ANDA 211120, Laurus · 204410-001Approved 5 Nov 2025Detected 25 Oct 2026Historical import
Generic approved · ANDA 211187, Teva Pharms Usa Inc · 204410-001Approved 8 Jun 2026Detected 25 Oct 2026Historical import
Generic approved · ANDA 211161, Mylan · 204410-001Approved 3 Dec 2025Detected 25 Oct 2026Historical import

Products covered · 1

NDA · product	Form	Strength	Approved	Listed expiry
204410 · 001 · RLD	tablet, oral	10MG	18 Oct 2013	18 Oct 2029

Expired or delisted (3)

US 10946015 · product, use U-1445 · 11 Sep 2026
US 7094781 · — · 5 Jun 2026
US 7094781 · substance, product · 5 Dec 2025