Is Belsomra still available?

Yes. Belsomra (NDA 204569) is listed with marketing status Prescription in the FDA Orange Book.

Does Belsomra have a generic?

The FDA Orange Book does not currently list an approved generic (ANDA) sharing Belsomra's active ingredient (Suvorexant).

When do Belsomra's patents expire?

The FDA Orange Book lists 3 patents against Belsomra, with the last listed patent expiring May 29, 2033. A generic launching before a listed patent expires generally must file a Paragraph IV certification.

What is Belsomra's FDA application number?

Belsomra is approved under NDA 204569, held by Merck Sharp Dohme.

Orange Book product · Brand (NDA)

Belsomra

Suvorexant

Brand (NDA)NDA 204569RLD Merck Sharp Dohme

Approved

Aug 13, 2014

Application

Brand (NDA)

TE code

Not listed

Listed patents

Belsomra (Suvorexant) is Merck Sharp Dohme's brand-name drug, approved by the FDA under NDA 204569 in 2014. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. The FDA Orange Book lists 3 patents against it, the last expiring 2033.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Aug 13, 2014
12 yr 1 mo ago
Today
Patent 7951797 expires
Listed drug substance patent expiration.
Nov 20, 2029
in 3 yr 5 mo
Patent 10098892 expires
Listed drug product patent expiration.
May 29, 2033
in 7 yr
Patent 11980623 expires
Listed drug product patent expiration.
May 29, 2033
in 7 yr

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

FDA product record

Pharmaceutical detail

Active ingredient

SUVOREXANT

Strength

20MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 204569

Product number

004

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Same application

Other strengths in NDA 204569

Brand + generics

Active-ingredient family

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

No other applications share this active ingredient.

View full Suvorexant family

Orange Book patent file

Listed patents

Listed patents (3)

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 5 mo	SubstanceProductU-620
10098892	May 29, 2033	in 7 yr	Product
11980623	May 29, 2033	in 7 yr	Product

Belsomra — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Suvorexant active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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