Is there a generic for Macitentan; tadalafil?

The FDA Orange Book does not currently list an approved generic (ANDA) for Macitentan; tadalafil. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Macitentan; tadalafil?

OPSYNVI (NDA 218490, ACTELION) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Macitentan; tadalafil?

The Orange Book lists 6 patents against Macitentan; tadalafil 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; tadalafil have FDA marketing exclusivity?

Yes. The Orange Book records 8 marketing-exclusivity periods for Macitentan; tadalafil. 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; tadalafil are approved?

Macitentan; tadalafil is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Macitentan; tadalafil

Macitentan; tadalafil: 1 brand, 0 generics; first approved Mar 22, 2024; on patent until Dec 05, 2025.

On patent8 exclusivity periods

Generic status & protection

Protected until Dec 05, 2025 (earliest listed patent expiry).

Earliest patent expiry Dec 05, 2025Latest exclusivity ends Sep 22, 2031

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Dec 05, 2025

7 mo ago

Originator applications

Brand (NDA) products

OPSYNVIRLD

ACTELIONNDA 21849020242 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG;20MG	TABLET	ORAL	Rx	—
10MG;40MG	TABLET	ORAL	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (8)

NPNew product exclusivity (3 years)
Mar 22, 2027
in 8 mo
ODE-475Orphan-drug exclusivity (7 years)
Mar 22, 2031
in 4 yr 9 mo
PEDPediatric exclusivity (adds 6 months)
Sep 22, 2027
in 1 yr 3 mo
PEDPediatric exclusivity (adds 6 months)
Sep 22, 2031
in 5 yr 3 mo
NPNew product exclusivity (3 years)
Mar 22, 2027
in 8 mo
ODE-475Orphan-drug exclusivity (7 years)
Mar 22, 2031
in 4 yr 9 mo
PEDPediatric exclusivity (adds 6 months)
Sep 22, 2027
in 1 yr 3 mo
PEDPediatric exclusivity (adds 6 months)
Sep 22, 2031
in 5 yr 3 mo

Orange Book patent file

Listed patents

Listed patents (6)

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-3881
10946015*PED	Mar 11, 2027	in 8 mo
8268847	Apr 18, 2029	in 2 yr 10 mo	ProductU-3882
8268847*PED	Oct 18, 2029	in 3 yr 4 mo

FDA approval span

Approval history

First approval

Mar 22, 2024

2 yr 4 mo ago

Most recent approval

Mar 22, 2024

2 yr 4 mo ago

All 1 application were approved in 2024.

Brand (NDA) 1100%

Generic (ANDA) 00%

Macitentan; tadalafil — 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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