FDA Orange Book · active-ingredient family
Primidone
Primidone is approved as 1 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MYSOLINE · NDA 009170
1
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MYSOLINERLD×2 | VALEANT | NDA 009170 | AB | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PRIMIDONE×2 | CARNEGIE | ANDA 218366 | AB | Jan 23, 2024 | |
| PRIMIDONE×3 | RUBICON RESEARCH | ANDA 214896 | AB | Jun 28, 2022 | |
| PRIMIDONE×2 | CHARTWELL RX | ANDA 040862 | — | Oct 03, 2008 | |
| PRIMIDONE×2 | AMNEAL PHARM | ANDA 040866 | AB | Apr 23, 2008 | |
| PRIMIDONE×2 | IMPAX LABS | ANDA 040717 | — | Feb 12, 2008 | |
| PRIMIDONE×2 | HIKMA INTL PHARMS | ANDA 040667 | — | Jul 27, 2006 | |
| PRIMIDONE×2 | TP ANDA HOLDINGS | ANDA 040626 | AB | Sep 29, 2005 | |
| PRIMIDONE×2 | OXFORD PHARMS | ANDA 040586 | AB | Feb 24, 2005 | |
| PRIMIDONE×2 | LANNETT | ANDA 084903 | AB | May 24, 2001 | |
| PRIMIDONE | WATSON LABS | ANDA 083551 | AB | Approved Prior to Jan 1, 1982 | |
| PRIMIDONE | WATSON LABS | ANDA 085052 | — | Approved Prior to Jan 1, 1982 |
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.
Primidone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
