Last Updated: November 13, 2026

Details for Patent: 12,343,348

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Which drugs does patent 12,343,348 protect, and when does it expire?

Patent 12,343,348 protects VYKAT XR and is included in one NDA.

This patent has sixty-two patent family members in twenty-one countries.

Summary for Patent: 12,343,348
Title:Methods for treating subjects with Prader-Willi syndrome or Smith-Magenis syndrome
Abstract:Provided are immediate or prolonged administration of certain potassium ATP (KATP) channel openers, optionally in combination with growth hormone, to a subject to achieve novel pharmacodynamic, pharmacokinetic, therapeutic, physiological, metabolic and compositional outcomes in the treatment of diseases or conditions involving KATP channels. Also provided are pharmaceutical formulations, methods of administration and dosing of KATP channel openers that achieve these outcomes and reduce the incidence of adverse effects in treated individuals. Further provided are methods of co-administering KATP channel openers with other drugs (e.g., in combination with growth hormone) to treat diseases of humans and animals (e.g., Prader-Willi Syndrome (PWS), Smith-Magenis syndrome (SMS), and the like.
Inventor(s):Neil M. Cowen
Assignee: Essentialis Inc
Application Number:US18/988,636
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 12,343,348
Patent Claim Types:
see list of patent claims
Use; Formulation;

Drugs Protected by US Patent 12,343,348

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Soleno VYKAT XR diazoxide choline TABLET, EXTENDED RELEASE;ORAL 216665-001 Mar 26, 2025 RX Yes No 12,343,348 ⤷  Start Trial TREATING HYPERPHAGIA AND REDUCING HYPERPHAGIC AGGRESSIVE BEHAVIORS IN PRADER-WILLI SYNDROME PATIENTS ⤷  Start Trial
Soleno VYKAT XR diazoxide choline TABLET, EXTENDED RELEASE;ORAL 216665-002 Mar 26, 2025 RX Yes No 12,343,348 ⤷  Start Trial TREATING HYPERPHAGIA AND REDUCING HYPERPHAGIC AGGRESSIVE BEHAVIORS IN PRADER-WILLI SYNDROME PATIENTS ⤷  Start Trial
Soleno VYKAT XR diazoxide choline TABLET, EXTENDED RELEASE;ORAL 216665-003 Mar 26, 2025 RX Yes Yes 12,343,348 ⤷  Start Trial TREATING HYPERPHAGIA AND REDUCING HYPERPHAGIC AGGRESSIVE BEHAVIORS IN PRADER-WILLI SYNDROME PATIENTS ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 12,343,348

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria E463249 ⤷  Start Trial
Australia 2005280058 ⤷  Start Trial
Australia 2010246520 ⤷  Start Trial
Australia 2015346196 ⤷  Start Trial
Australia 2019202906 ⤷  Start Trial
Brazil 112017009986 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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