Question 1

Is there a generic for Macitentan?

Accepted Answer

Yes. The FDA Orange Book lists 12 approved generic (ANDA) applications for Macitentan, referencing the brand OPSUMIT. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Macitentan?

Accepted Answer

OPSUMIT (NDA 204410, ACTELION) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Macitentan?

Accepted Answer

The Orange Book lists 10 patents against Macitentan products, with the earliest listed expiry in 2025. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Macitentan have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Macitentan. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Macitentan are approved?

Accepted Answer

Macitentan is approved in the following dosage form: tablet.

Product	Applicant	Application	TE	Approved
MACITENTAN	AMNEAL	ANDA 211000	AB	Jun 08, 2026
MACITENTAN	TEVA PHARMS USA INC	ANDA 211187	AB	Jun 08, 2026
MACITENTAN	MYLAN	ANDA 211161	AB	Dec 03, 2025
MACITENTAN	SEASONS BIOTECH	ANDA 211026	AB	Dec 03, 2025
MACITENTAN	LAURUS	ANDA 211120	AB	Nov 05, 2025
MACITENTAN	SUN PHARM	ANDA 211123	AB	Aug 26, 2025
MACITENTAN	MSN	ANDA 211136	AB	Aug 20, 2025
MACITENTAN	ALEMBIC	ANDA 211128	AB	Aug 18, 2025
MACITENTAN	TORRENT	ANDA 211107	AB	Aug 05, 2024
MACITENTAN	APOTEX	ANDA 211195	AB	Jan 09, 2024
MACITENTAN	AUROBINDO PHARMA LTD	ANDA 211198	AB	Apr 18, 2023
MACITENTAN	ZYDUS LIFESCIENCES	ANDA 211224	AB	Apr 06, 2021

Patent	Expires	In	Type
7094781	Dec 05, 2025	7 mo ago	SubstanceProduct
7094781*PED	Jun 05, 2026	14 d ago
10946015	Sep 11, 2026	in 3 mo	ProductU-1445
10946015*PED	Mar 11, 2027	in 9 mo
9265762	May 29, 2027	in 11 mo	ProductU-1820
9265762*PED	Nov 29, 2027	in 1 yr 6 mo
8367685	Oct 04, 2028	in 2 yr 4 mo	ProductU-1445
8367685*PED	Apr 04, 2029	in 2 yr 10 mo
8268847	Apr 18, 2029	in 2 yr 10 mo	U-1446
8268847*PED	Oct 18, 2029	in 3 yr 5 mo

Macitentan

Brand (NDA) products · tablet

Generic (ANDA) products (12)

Marketing exclusivity (2)

Listed patents (10)

Macitentan — frequently asked questions

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