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FDA Orange Book · active-ingredient family

Macitentan; tadalafil

Macitentan; tadalafil is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:OPSYNVI · NDA 218490

1

Brand (NDA)

0

Generics (ANDA)

6

Listed patents

8

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
OPSYNVIRLD×2ACTELIONNDA 218490—Mar 22, 2024

Marketing exclusivity (8)

  • NPNew product exclusivity (3 years)

    Mar 22, 2027

    in 9 mo

  • ODE-475Orphan-drug exclusivity (7 years)

    Mar 22, 2031

    in 4 yr 10 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 4 mo

  • NPNew product exclusivity (3 years)

    Mar 22, 2027

    in 9 mo

  • ODE-475Orphan-drug exclusivity (7 years)

    Mar 22, 2031

    in 4 yr 10 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 4 mo

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7094781Dec 05, 20257 mo ago
SubstanceProduct
7094781*PEDJun 05, 202614 d ago
10946015Sep 11, 2026in 3 mo
ProductU-3881
10946015*PEDMar 11, 2027in 9 mo
8268847Apr 18, 2029in 2 yr 10 mo
ProductU-3882
8268847*PEDOct 18, 2029in 3 yr 5 mo

Macitentan; tadalafil — frequently asked questions

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

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