BioTech IP Review

Pharmaceutical Composition of S‑Ketamine Hydrochloride

U.S. Patent No. 11,446,260 B2

Assignee: Janssen Pharmaceuticals, Inc. (a J&J subsidiary)
Issued: September 20, 2022
Focus: A pharmaceutical composition of S‑ketamine hydrochloride formulated for intranasal administration without an added antimicrobial preservative — a formulation forming the core of J&J’s SPRAVATO® treatment for depression and certain psychiatric indications.

What This Patent Covers

This patent protects an aqueous nasal spray formulation comprising S‑ketamine hydrochloride at specified concentrations and conditions such that:

  • No antimicrobial preservative is needed because the S‑ketamine itself provides sufficient antimicrobial properties at certain levels.
  • The composition improves stability, safety, and patient tolerability for intranasal delivery, which is crucial for its performance as a rapid‑acting antidepressant.
  • Claims include the specific formulation characteristics that make the nasal spray effective and safe for clinical use.

This formulation patent complements earlier and related patents on methods of treating depression and helps protect J&J’s overall IP position in the intranasal S‑ketamine therapeutic space.

Why It’s Important

1. Core IP for a Novel CNS Therapeutic

The patent is tied to SPRAVATO® (esketamine nasal spray) — the first rapid‑acting antidepressant for treatment‑resistant depression and depressive symptoms in adults with major depressive disorder. The formulation enabled intranasal delivery, which differentiates it from traditional oral or injectable antidepressants.

2. Significant Market Opportunity

Intranasal esketamine represents a high‑value CNS pharmaceutical category because it addresses treatment‑resistant depression (TRD), a major unmet need in psychiatry with substantial global prevalence and cost burden. The nasal formulation’s convenience and rapid onset contribute to broad clinical adoption and commercial value.

3. Legal & Lifecycle Support

This composition patent adds a layer of protection around the marketed product beyond method‑of‑treatment patents alone, helping extend market exclusivity and defend against generic or biosimilar competition. J&J has actively used this and related patents in legal actions to block or delay early generic versions of intranasal esketamine products.

4. Strategic IP Portfolio Reinforcement

Along with related patents (e.g., U.S. 11,173,134 B2 and U.S. 11,311,500 B2) covering dosing regimens and treatment methods for depression, this formulation patent forms part of a multi‑layered IP strategy that strengthens Janssen’s position in neuropsychiatric therapeutics.

Summary

  • Patent: U.S. Patent No. 11,446,260 B2
  • Issued: September 20, 2022
  • Assignee: Janssen Pharmaceuticals (Johnson & Johnson)
  • Focus: Novel intranasal formulation of S‑ketamine hydrochloride without added antimicrobial preservative
  • Importance: Protects the core composition behind SPRAVATO®, a high‑value treatment for treatment‑resistant depression and related conditions, supporting commercial exclusivity and reinforcing J&J’s therapeutic IP portfolio in CNS drug innovations.

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