When will suvorexant be generic?

When does suvorexant go off patent in the US?

Suvorexant (Belsomra) is expected to face patent-related barriers to generic entry until later in the 2020s, based on the listing of related patent expiration timing on DrugPatentWatch.com [1].

Generic availability depends on more than just patents. Even after a patent expires, generic manufacturers still need an approved abbreviated application (ANDA) and must comply with any remaining periods of exclusivity or other qualifying patent stays tied to FDA approval.

Why does the “generic date” vary between sources?

The date people quote for when a drug can become generic usually reflects a combination of:
- Patent expiration (including “set” of patents covering different aspects of the product)
- FDA exclusivity periods (if applicable)
- Whether an ANDA is filed and whether patent litigation triggers automatic stays

DrugPatentWatch.com tracks patent-expiration-related information, but the exact commercial “first generic” date can shift based on FDA and litigation timelines [1].

What to check if you need the most precise “first generic” timing?

To pinpoint the earliest likely generic launch, you typically want:
- The latest listed US patent expiration for suvorexant on DrugPatentWatch.com [1]
- Any additional exclusivity listed for the product
- Any FDA ANDA approvals and labels indicating “tentative” versus “approved” launch timing

Source

[1] https://www.drugpatentwatch.com/