FDA Orange Book · active-ingredient family
Naltrexone
Naltrexone is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VIVITROL · NDA 021897
1
Brand (NDA)
1
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · for suspension, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VIVITROLRLD | ALKERMES | NDA 021897 | — | Apr 13, 2006 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NALTREXONE | TEVA PHARMS USA INC | ANDA 213195 | — | Jul 06, 2023 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7919499 | Oct 15, 2029 | in 3 yr 4 mo | U-1124 |
Naltrexone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
