FDA Orange Book · active-ingredient family
Suvorexant
Suvorexant is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:BELSOMRA · NDA 204569
1
Brand (NDA)
0
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BELSOMRARLD×4 | MERCK SHARP DOHME | NDA 204569 | — | Aug 13, 2014 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7951797 | Nov 20, 2029 | in 3 yr 6 mo | SubstanceProductU-620 |
| 10098892 | May 29, 2033 | in 7 yr 1 mo | Product |
| 11980623 | May 29, 2033 | in 7 yr 1 mo | Product |
Suvorexant — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
