FDA Orange Book · active-ingredient family
Naloxegol oxalate
Naloxegol oxalate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:MOVANTIK · NDA 204760
1
Brand (NDA)
0
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MOVANTIKRLD×2 | AVERITAS | NDA 204760 | — | Sep 16, 2014 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7786133 | Sep 16, 2028 | in 2 yr 3 mo | SubstanceProduct |
| 9012469 | Apr 02, 2032 | in 5 yr 10 mo | SubstanceProduct |
Naloxegol oxalate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
