grepcent public filings, reorganized for comparison

HETLIOZ LQ — FDA application NDA214517

Application NDA214517 · type NDA · FDA status: approved · original approval 2020-12-01

Listed sponsor: VANDA PHARMS INC · VNDA company profile · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

FDA application facts

ProductFDA-listed trade nameActive ingredientDosage formRouteStrengthMarketing statusTE codeRLD
001HETLIOZ LQTASIMELTEONSUSPENSIONORAL4MG/MLPrescriptionnot listedYes
002HETLIOZ LQTASIMELTEONSUSPENSIONORAL4MG/MLPrescriptionnot listednot listed

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

Orange Book patent and exclusivity listings

ListingProductDescriptive dateFlags/code
Patent 10149829001listed patent expiry date: 2033-01-25U-3006
Patent 10610510001listed patent expiry date: 2033-01-25U-3009
Patent 10980770001listed patent expiry date: 2033-01-25U-3106
Patent 11285129001listed patent expiry date: 2033-01-25U-3342
Patent 11633377001listed patent expiry date: 2033-01-25U-3003
Patent 11826339001listed patent expiry date: 2033-01-25U-3342
Patent 11833130001listed patent expiry date: 2033-01-25U-3003
Patent 11850229001listed patent expiry date: 2033-01-25U-3342
Patent 11918557001listed patent expiry date: 2033-01-25U-3003
Patent 12201604001listed patent expiry date: 2033-01-25U-3003
Patent 9539234001listed patent expiry date: 2033-01-25U-3004
Patent 11918556001listed patent expiry date: 2033-04-07U-3342
Patent 9730910001listed patent expiry date: 2034-05-17U-3005
Patent 10610511001listed patent expiry date: 2034-10-10U-3007
Patent 11141400001listed patent expiry date: 2034-10-10U-3007
Patent 11786502001listed patent expiry date: 2034-10-10U-3007
Patent 10071977001listed patent expiry date: 2035-02-12drug substance, drug product
Patent 10829465001listed patent expiry date: 2035-02-12drug substance, drug product
Patent 11566011001listed patent expiry date: 2035-02-12drug substance, drug product
Patent 11760740001listed patent expiry date: 2035-02-12drug substance, drug product
Patent 12049457001listed patent expiry date: 2035-02-12drug substance, drug product
Patent 10376487001listed patent expiry date: 2035-07-27U-3007
Patent 10179119001listed patent expiry date: 2035-08-29U-3003
Patent 11266622001listed patent expiry date: 2035-08-29U-3003
Patent 11202770001listed patent expiry date: 2040-12-11drug product
Patent 12447141001listed patent expiry date: 2040-12-11U-3003
Patent 11759446001listed patent expiry date: 2041-02-21U-3003
Exclusivity ODE-329001listed exclusivity date: 2027-12-01FDA code as listed
NDA214517 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA214517 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA214517 FDA listing datesDescriptive regulatory dates only; no relationship to revenue or future sales is stated or implied.Source: Drugs@FDA and FDA Orange Book.Listed dateDated listing marker0.001.002.002020-12-011.002027-12-011.002033-01-251.002033-04-071.002034-05-171.002034-10-101.002035-02-121.002035-07-271.002035-08-291.002040-12-111.002041-02-211.00

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

Compound cross-links

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

Related pages

Sponsor company · FDA-approved application index

Peer clusters: No published peer-cluster link for this sponsor.

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.