FDA Orange Book
Is there a generic for Belsomra?
Belsomra contains suvorexant. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Belsomra (suvorexant). The Orange Book shows its last listed patent expires May 29, 2033.
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Belsomra products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 15MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 20MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 5MG | Marketed (Rx) | None | 0 | None |
NDA 204569, held by MERCK SHARP AND DOHME CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Belsomra patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7951797 | November 20, 2029 | Drug substance, Drug product | U-620 | 204569 |
| 10098892 | May 29, 2033 | Drug product | None | 204569 |
| 12599610 | May 29, 2033 | Drug product | None | 204569 |
| 11980623 | May 29, 2033 | Drug product | None | 204569 |
Belsomra NDC codes
Questions
Is there a generic for Belsomra?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Belsomra (suvorexant). The Orange Book shows its last listed patent expires May 29, 2033.
What is the generic name for Belsomra?
The active ingredient in Belsomra is suvorexant, per the FDA Orange Book.
When does the Belsomra patent expire?
The last patent listed for Belsomra in the Orange Book expires May 29, 2033. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
More on Belsomra and Suvorexant
- What is Belsomra used for?FDA label uses
- Is Belsomra a controlled substance?Schedule IV
- Is Suvorexant a controlled substance?Schedule IV
- Orexin Receptor Antagonists listFDA drug class
- NDC 0006-0005Belsomra NDC record
- NDC 0006-0033Belsomra NDC record
- NDC 0006-0325Belsomra NDC record
- Schedule IV drugs listDEA schedule