cliffwatch

tasimelteon · Vanda Pharms Inc · NDA 214517

Hetlioz Lq

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 · 27 unexpired

PatentClaimsExpires
US 11759446use U-3003 · sets the listed date21 Feb 2041
US 11202770drug product11 Dec 2040
US 12447141use U-300311 Dec 2040
US 10179119use U-300329 Aug 2035
US 11266622use U-300329 Aug 2035
US 10376487use 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-300710 Oct 2034
US 11141400use U-300710 Oct 2034
US 11786502use U-300710 Oct 2034
US 9730910use U-300517 May 2034
US 11918556use U-33427 Apr 2033
US 10149829use U-300625 Jan 2033
US 10610510use U-300925 Jan 2033
US 10980770use U-310625 Jan 2033
US 11285129use U-334225 Jan 2033
US 11633377use U-300325 Jan 2033
US 11826339use U-334225 Jan 2033
US 11833130use U-300325 Jan 2033
US 11850229use U-334225 Jan 2033
US 11918557use U-300325 Jan 2033
US 12201604use U-300325 Jan 2033
US 9539234use U-300425 Jan 2033

Exclusivities · 1 unexpired

ODE-329orphan 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
214517 · 001 · RLDsuspension, oral4MG/ML21 Feb 2041