cliffwatch

tasimelteon · Vanda Pharms Inc · NDA 205677

Hetlioz

Earliest generic entry, as listed
21 Feb 2041

Blocked by patent: US 11759446. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 48 unexpired

PatentClaimsExpires
US 11759446use U-300321 Feb 2041
US 10179119use U-300329 Aug 2035
US 11266622use U-300329 Aug 2035
US 10376487use U-261527 Jul 2035
US 10376487use U-300727 Jul 2035
US 10071977substance, product12 Feb 2035
US 10829465substance, product12 Feb 2035
US 11566011substance, product12 Feb 2035
US 11760740substance, product12 Feb 2035
US 12049457substance, product12 Feb 2035
US 10610511use U-261510 Oct 2034
US 10610511use U-300710 Oct 2034
US 11141400use U-300710 Oct 2034
US 11141400use U-261510 Oct 2034
US 11786502use U-300710 Oct 2034
US 11786502use U-373910 Oct 2034
US 9730910use U-300517 May 2034
US 9730910use U-208517 May 2034
US 11918556use U-33427 Apr 2033
US 11918556use U-33437 Apr 2033
US 10149829use U-300625 Jan 2033
US 10149829use U-247725 Jan 2033
US 10449176use U-214925 Jan 2033
US 10610510use U-280525 Jan 2033
US 10610510use U-300925 Jan 2033
US 10945988use U-214925 Jan 2033
US 10980770use U-310725 Jan 2033
US 10980770use U-310625 Jan 2033
US 11285129use U-334325 Jan 2033
US 11285129use U-334225 Jan 2033
US 11633377use U-214925 Jan 2033
US 11633377use U-300325 Jan 2033
US 11826339use U-334325 Jan 2033
US 11826339use U-334225 Jan 2033
US 11833130use U-214925 Jan 2033
US 11833130use U-300325 Jan 2033
US 11850229use U-334225 Jan 2033
US 11850229use U-334325 Jan 2033
US 11918557use U-300325 Jan 2033
US 11918557use U-386525 Jan 2033
US 12201604use U-386525 Jan 2033
US 12201604use U-300325 Jan 2033
US 9060995use U-171025 Jan 2033
US 9539234use U-193425 Jan 2033
US 9539234use U-300425 Jan 2033
US 9549913use U-148625 Jan 2033
US 9855241use U-214925 Jan 2033
US RE46604use U-214725 Jan 2033

Exclusivities · 1 unexpired

ODE-330orphan drug (7 years)1 Dec 2027

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 1

NDA · productFormStrengthListed expiry
205677 · 001 · RLDcapsule, oral20MG21 Feb 2041