FDA Orange Book · active-ingredient family
Alprostadil
Alprostadil: 6 brands, 2 generics; first approved Jul 06, 1995; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 2 ANDA applications approved.
Brands (NDA)
6
Generics (ANDA)
2
Listed patents
0
Presentations
23
Brand (NDA) products
Originator applications
- EDEXRLDENDO OPERATIONSNDA 02064919977 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005MG/VIAL INJECTABLE INJECTION Discontinued — 0.01MG/VIAL INJECTABLE INJECTION Rx AP 0.02MG/VIAL INJECTABLE INJECTION Rx AP 0.04MG/VIAL INJECTABLE INJECTION Rx AP 0.01MG/VIAL INJECTABLE INJECTION Rx — 0.02MG/VIAL INJECTABLE INJECTION Rx — 0.04MG/VIAL INJECTABLE INJECTION Rx — - MUSERLDVIATRISNDA 02070019964 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.125MG SUPPOSITORY URETHRAL Discontinued — 0.25MG SUPPOSITORY URETHRAL Discontinued — 0.5MG SUPPOSITORY URETHRAL Discontinued — 1MG SUPPOSITORY URETHRAL Discontinued — - CAVERJECTRLDPFIZERNDA 02037919964 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.01MG/VIAL INJECTABLE INJECTION Rx AP 0.02MG/VIAL INJECTABLE INJECTION Rx AP 0.005MG/VIAL INJECTABLE INJECTION Discontinued — 0.04MG/VIAL INJECTABLE INJECTION Rx AP - PFIZERNDA 018484—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/ML INJECTABLE INJECTION Rx AP - PFIZERNDA 02121220022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.01MG/VIAL INJECTABLE INJECTION Rx — 0.02MG/VIAL INJECTABLE INJECTION Rx — - PFIZERNDA 02075519973 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005MG/ML INJECTABLE INJECTION Discontinued — 0.01MG/ML INJECTABLE INJECTION Discontinued — 0.02MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (2)
Abbreviated applications
- ALPROSTADILMEITHEALANDA 0751961999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/ML INJECTABLE INJECTION Rx AP - ALPROSTADILHIKMAANDA 0748151998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/ML INJECTABLE INJECTION Rx AP
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
31 yr 7 mo ago
Most recent approval
24 yr 6 mo ago
Approvals span 1995–2002 across 8 FDA applications.
Brand (NDA) 675%
Generic (ANDA) 225%
Alprostadil: 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.
