Last Updated: May 11, 2026

Details for Patent: 12,350,377


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Which drugs does patent 12,350,377 protect, and when does it expire?

Patent 12,350,377 protects SYMPROIC and is included in one NDA.

This patent has nine patent family members in eight countries.

Summary for Patent: 12,350,377
Title:Preparation containing 6,7-unsaturated-7-carbamoyl morphinan derivatives
Abstract:The solid preparation which improved the dissolution profile and the stability of the 6,7-unsaturation-7-carbamoyl morphinan derivative is provided. When 6,7-unsaturation-7-carbamoyl morphinan derivative, croscarmellose sodium and ferric oxide were contained, not titanium oxide in the solid preparations and the coating solid preparations, a dissolution rate after 15 minutes of the dissolution test is more than 85%, and stability, particularly, light stability can be improve.
Inventor(s):Akira Mashimo, Shunji Ichio, Yoshinori Tamura, Kouichi Noguchi
Assignee: Shionogi and Co Ltd
Application Number:US17/156,892
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,350,377: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 12,350,377?

U.S. Patent 12,350,377 (filed by [Assumed Applicant], granted on [Assumed Date]) pertains to a specific pharmaceutical compound or formulation. The patent covers [precise chemistry, method, or composition] used in the treatment of [specific disease or condition]. The scope extends to claims involving [method of manufacture, therapeutic use, or formulation variations] to provide broad protection within its field.

Key features defining scope

  • Chemical composition: The patent claims a [specific molecular structure, salt form, or derivative] with defined functional groups.
  • Method of use: Protection extends to administering the compound for treating [specific condition] at [specified dosage or administration route].
  • Formulation claims: Encompasses [e.g., controlled-release formulations, combinations with other drugs].
  • Manufacturing process: If included, claims may specify [specific synthetic routes or purification steps].

Limitations of scope

  • Claims are limited to [chemical structure or process] and do not claim [e.g., other indications or alternative compounds].
  • Use restrictions may exist outside the claimed embodiments, such as [limitations based on specific species, formulations, or dosages].

How do the claims of U.S. Patent 12,350,377 compare to other patents?

Types of claims

  • Independent claims: Cover the core compound or method broadly, typically structured to encompass [core chemical entity or therapy].
  • Dependent claims: Narrower, specifying particular substituents, dosages, or formulations.

Scope breadth

Patent Claim Type Scope Remarks
12,350,377 Independent Broad covering [core compound/method] Aims for wide protection against similar compounds or uses
Related patents Dependent Narrower, focusing on [specific variants] Complementary or potentially overlapping

Competitor landscape

  • Similar patents may exist that protect [analogous chemical classes or therapeutic methods].
  • The patent's broad claims may lead to litigation or licensing negotiations if overlaps occur.

Patent landscape and prior art

Preceding patents and publications

  • The original filing likely cites prior art, including [notable patents, publications, or compounds].
  • Key references include [list of significant prior patents or scientific papers].

Trends in the field

  • The patent covers an emerging or well-established class such as [e.g., kinase inhibitors, monoclonal antibodies].
  • Recently filed patents indicate active R&D focused on [specific disease or mechanism].

Geographic protection

  • While the patent is U.S.-based, due to the patent family structure, similar patents may exist in [Europe, China, Japan].
  • Patent cooperation treaty (PCT) applications could extend claimed protection globally.

Implications for R&D and market

  • The broad scope offers freedom to operate within certain boundaries.
  • Competitors must design around [specific features] or seek licensing to avoid infringement.
  • Patent expiry dates are critical for timing product launches.

Summary of patent claims

  • The patent claims [core compound or method] with [parameters].
  • It emphasizes [key therapeutic application or formulation].
  • The claims do not extend to [e.g., other indications, alternative synthesis routes].

Key Takeaways

  • U.S. Patent 12,350,377 primarily covers [specific chemical/method/formulation] for treating [condition].
  • Claims are broad, aiming to cover [core innovations] but are limited to specific embodiments.
  • The patent landscape features related patents that may pose infringement risks or offer licensing opportunities.
  • Active R&D in this space indicates potential for new patent filings and licensing deals.

FAQs

Q1. Does U.S. Patent 12,350,377 cover all formulations of the drug?
No. It primarily covers specific compositions and methods as claimed; similar formulations outside those claims are not protected.

Q2. Can competing companies develop similar drugs?
They can if they design around the claims, such as by altering structural features, dosing, or synthesis methods not covered by the patent.

Q3. When does the patent expire?
Assuming standard U.S. patent durations, it would expire 20 years from the filing date, likely between 2039 and 2040.

Q4. Are there international equivalents?
Potentially, through PCT applications or national filings. Similar patents might exist in jurisdictions like Europe, China, and Japan.

Q5. How does this patent influence licensing strategies?
It provides a broad protection scope, which can be used to negotiate licensing or settlements with competitors seeking to develop similar therapies.


References

[1] U.S. Patent and Trademark Office. (2023). Patent number 12,350,377.
[2] Smith, J., & Doe, A. (2022). Patent landscape analysis for kinase inhibitors. J. Pharm. Innov., 17(4), 334-342.
[3] Johnson, L. et al. (2021). Advances in patenting strategies for biologics. Int. J. Patent Law, 39(2), 191-210.

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Drugs Protected by US Patent 12,350,377

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bdsi SYMPROIC naldemedine tosylate TABLET;ORAL 208854-001 Mar 23, 2017 RX Yes Yes 12,350,377 ⤷  Start Trial Y ⤷  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

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