Orange Book product · Brand (NDA)

BELSOMRA

SUVOREXANT

Brand (NDA)NDA 204569RX MERCK SHARP DOHME

Aug 13, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Aug 13, 2014
12 yr ago
Today
Patent 7951797 expires
Listed drug substance patent expiration.
Nov 20, 2029
in 3 yr 6 mo
Patent 10098892 expires
Listed drug product patent expiration.
May 29, 2033
in 7 yr 1 mo
Patent 11980623 expires
Listed drug product patent expiration.
May 29, 2033
in 7 yr 1 mo

Active ingredient

SUVOREXANT

Strength

5MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 204569

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
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