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 · 31 unexpired

48 Orange Book listing rows for 31 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 11759446use U-3003 · sets the listed date21 Feb 2041
US 10179119use U-300329 Aug 2035
US 11266622use U-300329 Aug 2035
US 10376487use U-2615, U-300727 Jul 2035
US 10376487 listing rowuse U-261527 Jul 2035
US 10376487 listing rowuse U-300727 Jul 2035
US 10071977drug substance, drug product12 Feb 2035
US 10829465drug substance, drug product12 Feb 2035
US 11566011drug substance, drug product12 Feb 2035
US 11760740drug substance, drug product12 Feb 2035
US 12049457drug substance, drug product12 Feb 2035
US 10610511use U-2615, U-300710 Oct 2034
US 10610511 listing rowuse U-261510 Oct 2034
US 10610511 listing rowuse U-300710 Oct 2034
US 11141400use U-2615, U-300710 Oct 2034
US 11141400 listing rowuse U-261510 Oct 2034
US 11141400 listing rowuse U-300710 Oct 2034
US 11786502use U-3007, U-373910 Oct 2034
US 11786502 listing rowuse U-300710 Oct 2034
US 11786502 listing rowuse U-373910 Oct 2034
US 9730910use U-2085, U-300517 May 2034
US 9730910 listing rowuse U-208517 May 2034
US 9730910 listing rowuse U-300517 May 2034
US 11918556use U-3342, U-33437 Apr 2033
US 11918556 listing rowuse U-33427 Apr 2033
US 11918556 listing rowuse U-33437 Apr 2033
US 10149829use U-2477, U-300625 Jan 2033
US 10149829 listing rowuse U-247725 Jan 2033
US 10149829 listing rowuse U-300625 Jan 2033
US 10449176use U-214925 Jan 2033
US 10610510use U-2805, U-300925 Jan 2033
US 10610510 listing rowuse U-280525 Jan 2033
US 10610510 listing rowuse U-300925 Jan 2033
US 10945988use U-214925 Jan 2033
US 10980770use U-3106, U-310725 Jan 2033
US 10980770 listing rowuse U-310625 Jan 2033
US 10980770 listing rowuse U-310725 Jan 2033
US 11285129use U-3342, U-334325 Jan 2033
US 11285129 listing rowuse U-334225 Jan 2033
US 11285129 listing rowuse U-334325 Jan 2033
US 11633377use U-2149, U-300325 Jan 2033
US 11633377 listing rowuse U-214925 Jan 2033
US 11633377 listing rowuse U-300325 Jan 2033
US 11826339use U-3342, U-334325 Jan 2033
US 11826339 listing rowuse U-334225 Jan 2033
US 11826339 listing rowuse U-334325 Jan 2033
US 11833130use U-2149, U-300325 Jan 2033
US 11833130 listing rowuse U-214925 Jan 2033
US 11833130 listing rowuse U-300325 Jan 2033
US 11850229use U-3342, U-334325 Jan 2033
US 11850229 listing rowuse U-334225 Jan 2033
US 11850229 listing rowuse U-334325 Jan 2033
US 11918557use U-3003, U-386525 Jan 2033
US 11918557 listing rowuse U-300325 Jan 2033
US 11918557 listing rowuse U-386525 Jan 2033
US 12201604use U-3003, U-386525 Jan 2033
US 12201604 listing rowuse U-300325 Jan 2033
US 12201604 listing rowuse U-386525 Jan 2033
US 9060995use U-171025 Jan 2033
US 9539234use U-1934, U-300425 Jan 2033
US 9539234 listing rowuse U-193425 Jan 2033
US 9539234 listing rowuse 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