Is there a generic for Macitentan?

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.

What is the reference-listed drug for Macitentan?

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

What patents protect Macitentan?

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.

Does Macitentan have FDA marketing exclusivity?

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.

What dosage forms of Macitentan are approved?

Macitentan is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Macitentan

Macitentan: 1 brand, 12 generics; first approved Oct 18, 2013; generic available.

Generic available2 exclusivity periods

Generic status & protection

Generic available — 12 ANDA applications approved.

Earliest patent expiry Dec 05, 2025Latest exclusivity ends Aug 28, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Dec 05, 2025

7 mo ago

Originator applications

Brand (NDA) products

OPSUMITRLDRS

ACTELIONNDA 2044102013

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB

Abbreviated applications

Generic (ANDA) products (12)

MACITENTAN

AMNEALANDA 2110002026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB

MACITENTAN

TEVA PHARMS USA INCANDA 2111872026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB

MACITENTAN

MYLANANDA 2111612025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB

MACITENTAN

SEASONS BIOTECHANDA 2110262025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB

MACITENTAN

LAURUSANDA 2111202025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB

MACITENTAN

SUN PHARMANDA 2111232025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB

MACITENTAN

MSNANDA 2111362025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB

MACITENTAN

ALEMBICANDA 2111282025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB

MACITENTAN

TORRENTANDA 2111072024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB

MACITENTAN

APOTEXANDA 2111952024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB

MACITENTAN

AUROBINDO PHARMA LTDANDA 2111982023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB

MACITENTAN

ZYDUS LIFESCIENCESANDA 2112242021

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Rx	AB

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (2)

M-187New use / labeling-change exclusivity (3 years)
Feb 28, 2028
in 1 yr 8 mo
PEDPediatric exclusivity (adds 6 months)
Aug 28, 2028
in 2 yr 2 mo

Orange Book patent file

Listed patents

Listed patents (10)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7094781	Dec 05, 2025	7 mo ago	SubstanceProduct
7094781*PED	Jun 05, 2026	1 mo ago
10946015	Sep 11, 2026	in 2 mo	ProductU-1445
10946015*PED	Mar 11, 2027	in 8 mo
9265762	May 29, 2027	in 11 mo	ProductU-1820
9265762*PED	Nov 29, 2027	in 1 yr 5 mo
8367685	Oct 04, 2028	in 2 yr 3 mo	ProductU-1445
8367685*PED	Apr 04, 2029	in 2 yr 9 mo
8268847	Apr 18, 2029	in 2 yr 10 mo	U-1446
8268847*PED	Oct 18, 2029	in 3 yr 4 mo

FDA approval span

Approval history

First approval

Oct 18, 2013

12 yr 11 mo ago

Most recent approval

Jun 08, 2026

1 mo ago

Approvals span 2013–2026 across 13 FDA applications.

Brand (NDA) 18%

Generic (ANDA) 1292%

Macitentan — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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