FDA Orange Book · active-ingredient family
Epoprostenol sodium
Epoprostenol sodium: 2 brands, 4 generics; first approved Sep 20, 1995; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 4 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
4
Listed patents
2
Next patent expiry
Feb 02, 2027
in 3 mo
Brand (NDA) products
Originator applications
- VELETRIRLDACTELIONNDA 02226020122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1.5MG BASE/VIAL INJECTABLE INJECTION Rx AP2 EQ 0.5MG BASE/VIAL INJECTABLE INJECTION Rx AP2 - FLOLANRLDGLAXOSMITHKLINE LLCNDA 02044419952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE/VIAL INJECTABLE INJECTION Discontinued - EQ 1.5MG BASE/VIAL INJECTABLE INJECTION Discontinued -
Generic (ANDA) products (4)
Abbreviated applications
- EPOPROSTENOL SODIUMGLANDANDA 21923720252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE/VIAL INJECTABLE INJECTION Rx AP2 EQ 1.5MG BASE/VIAL INJECTABLE INJECTION Rx AP2 - EPOPROSTENOL SODIUMMYLANANDA 21391320242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE/VIAL INJECTABLE INJECTION Rx AP2 EQ 1.5MG BASE/VIAL INJECTABLE INJECTION Rx AP2 - EPOPROSTENOL SODIUMRSSUN PHARMANDA 21047320212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE/VIAL INJECTABLE INJECTION Rx AP2 EQ 1.5MG BASE/VIAL INJECTABLE INJECTION Rx AP2 - EPOPROSTENOL SODIUMMEITHEALANDA 07839620082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.5MG BASE/VIAL INJECTABLE INJECTION Discontinued - EQ 1.5MG BASE/VIAL INJECTABLE INJECTION Discontinued -
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8598227 | in 3 mo | ||
| 8318802 | in 5 mo | Product |
Approval history
FDA approval span
First approval
31 yr 7 mo ago
Most recent approval
10 mo ago
Approvals span 1995–2025 across 6 FDA applications.
Brand (NDA) 233%
Generic (ANDA) 467%
Epoprostenol sodium: 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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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