FDA Orange Book · active-ingredient family
Pimozide
Pimozide is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ORAP · NDA 017473
1
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
2
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ORAPRLD×2 | TEVA | NDA 017473 | — | Aug 27, 1997 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PIMOZIDE×2 | NOVITIUM PHARMA | ANDA 219897 | AB | Apr 13, 2026 | |
| PIMOZIDE×2 | PH HEALTH | ANDA 204521 | AB | Sep 28, 2015 |
Marketing exclusivity (2)
- CGTFDA marketing exclusivity
Oct 18, 2026
in 4 mo
- CGTFDA marketing exclusivity
Oct 18, 2026
in 4 mo
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.
Pimozide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
