BioTech IP Review

Assignee: Soleno Therapeutics, Inc. (and predecessors/licensors)
Patent Number: US 10,058,557 B2
Filed: (priority dates typically before 2017)
Issued: September 4, 2018
Expiration: ~2035 (subject to potential patent term extension)

What This Patent Covers

This patent covers novel pharmaceutical compositions and methods of use involving diazoxide choline controlled‑release formulations, including:

• Extended‑release formulations of diazoxide choline, a potassium‑channel activator optimized for oral delivery.
• Pharmaceutical compositions that improve pharmacokinetic (PK) profile versus previous diazoxide salts — e.g., slowing absorption and providing sustained plasma levels.
• Methods of treating symptoms of rare diseases, notably Prader‑Willi syndrome (PWS), by reducing hyperphagia (insatiable hunger) and improving related body composition and metabolic markers with these formulations.

The claims also cover methods of manufacturing and formulating the extended‑release tablets that enable once‑daily dosing, which is critical for patient adherence in chronic rare conditions.

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Why This Patent Is Important

1. Supports the first FDA‑approved therapy for PWS hyperphagia.
Soleno’s VYKAT XR (DCCR) received U.S. FDA approval on March 26, 2025 as the first therapy for hyperphagia in Prader‑Willi syndrome, which drives the company’s transition into a commercial stage with substantial revenue potential.

2. Foundation for market exclusivity beyond regulatory incentives.
While the drug also benefits from orphan drug exclusivity (7 years), the patent provides an additional layer of protection that can extend beyond purely regulatory barriers, with key patents in the family expiring in the mid‑2030s.

3. Long‑term commercial impact.
Patents like US 10,058,557 B2 allow Soleno to exclude generic competitors after the orphan drug period and support premium pricing for a high‑unmet‑need rare disease therapy with limited competition.

4. Covers core formulation technology.
The invention isn’t just method‑of‑use — it includes composition of matter and controlled‑release technology that underpins the approved product’s once‑daily dosing and tolerability, a critical differentiator in chronic rare disease treatment.

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Summary

US 10,058,557 B2 is among the most commercially valuable patents in Soleno’s IP portfolio, forming a cornerstone of protection for VYKAT XR — the first FDA‑approved therapy for hyperphagia in Prader‑Willi syndrome. This patent helps secure exclusive rights to a controlled‑release diazoxide choline formulation and its therapeutic use, which are central to the company’s revenue potential and competitive position as it enters the commercial phase across rare disease markets.