FDA Orange Book · active-ingredient family
Naldemedine tosylate
Naldemedine tosylate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:SYMPROIC · NDA 208854
1
Brand (NDA)
0
Generics (ANDA)
5
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SYMPROICRLD | BDSI | NDA 208854 | — | Mar 23, 2017 |
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| RE46375 | Oct 05, 2026 | in 4 mo | SubstanceProductU-1185 |
| RE46365 | Feb 24, 2031 | in 4 yr 9 mo | SubstanceProduct |
| 9108975 | Nov 11, 2031 | in 5 yr 6 mo | SubstanceProduct |
| 10952968 | May 13, 2033 | in 7 yr | SubstanceProduct |
| 12350377 | May 13, 2033 | in 7 yr | Product |
Naldemedine tosylate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
