FDA Orange Book · active-ingredient family
Alprostadil
Alprostadil is approved as 6 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:EDEX · NDA 020649
6
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, suppository
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EDEXRLD×7 | ENDO OPERATIONS | NDA 020649 | AP | Jun 12, 1997 | |
| MUSERLD×4 | VIATRIS | NDA 020700 | — | Nov 19, 1996 | |
| CAVERJECTRLD×4 | PFIZER | NDA 020379 | — | Jun 27, 1996 | |
| PROSTIN VR PEDIATRICRLD | PFIZER | NDA 018484 | AP | Approved Prior to Jan 1, 1982 | |
| CAVERJECT IMPULSE×2 | PFIZER | NDA 021212 | — | Jun 11, 2002 | |
| CAVERJECT×3 | PFIZER | NDA 020755 | — | Oct 31, 1997 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ALPROSTADIL | MEITHEAL | ANDA 075196 | AP | Apr 30, 1999 | |
| ALPROSTADIL | HIKMA | ANDA 074815 | AP | Jan 20, 1998 |
Listed patents
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.
Alprostadil — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
