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OmniRx › Tools › Generic competition check › Macitentan; Tadalafil

Generic competition · all medicines · read 12 November 2026

Is there a generic of Macitentan; Tadalafil, and who makes it?

Macitentan; Tadalafil appears in 1 dosage-form group in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. This is the Orange Book's listing, not a forecast.

Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.
Macitentan; Tadalafil1 dosage-form group in the Orange Book
0generic makers listed
  1. Macitentan; Tadalafil appears in 1 dosage-form group in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed.
  2. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
  3. Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.

Tablet, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Opsynvi. No generic is listed as marketed.

202020252030203501brand 2024data datePatent 10946015*PED listed to expire 11 March 2027Patent 8268847 listed to expire 18 April 2029Patent 8268847*PED listed to expire 18 October 2029Exclusivity NP to 22 March 2027Exclusivity PED to 22 September 2027Exclusivity ODE-475 to 22 March 2031Exclusivity PED to 22 September 2031
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 22 March 2027Exclusivity NP Opsynvi
  • 22 September 2027Exclusivity PED Opsynvi
  • 22 March 2031Exclusivity ODE-475 Opsynvi
  • 22 September 2031Exclusivity PED Opsynvi
  • 11 March 2027Patent 10946015*PED
  • 18 April 2029Patent 8268847 drug product
  • 18 October 2029Patent 8268847*PED

US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.

Where can you go from this result?

Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.