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FDA Orange Book · active-ingredient family

Epoprostenol sodium

Epoprostenol sodium is approved as 2 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:VELETRI · NDA 022260

2

Brand (NDA)

4

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
VELETRIRLD×2ACTELIONNDA 022260AP2Jun 28, 2012
FLOLANRLD×2GLAXOSMITHKLINE LLCNDA 020444—Sep 20, 1995

Generic (ANDA) products (4)

ProductApplicantApplicationTEApproved
EPOPROSTENOL SODIUM×2GLANDANDA 219237AP2Dec 29, 2025
EPOPROSTENOL SODIUM×2MYLANANDA 213913AP2Jun 12, 2024
EPOPROSTENOL SODIUM×2SUN PHARMANDA 210473AP2Jan 15, 2021
EPOPROSTENOL SODIUM×2MEITHEALANDA 078396—Apr 23, 2008

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8598227Feb 02, 2027in 8 mo
8318802Mar 15, 2027in 9 mo
Product

Epoprostenol sodium — frequently asked questions

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

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