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Last Updated: April 17, 2026

Details for Patent: 12,208,092


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Which drugs does patent 12,208,092 protect, and when does it expire?

Patent 12,208,092 protects PALSONIFY and is included in one NDA.

This patent has eleven patent family members in eleven countries.

Summary for Patent: 12,208,092
Title:Compositions and methods for administering paltusotine to patients with hepatic impairment
Abstract:Provided are compositions and methods for administering paltusotine, or a pharmaceutically acceptable salt thereof, to a patient having hepatic impairment.
Inventor(s):Lance GOULET, William Humphreys, Ajay Madan, Sha Luo
Assignee: Crinetics Pharmaceuticals Inc
Application Number:US18/615,512
Patent Claim Types:
see list of patent claims
Use; Delivery; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,208,092: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 12,208,092?

U.S. Patent 12,208,092 covers a novel drug compound, its specific chemical structure, and formulations involving this compound. The patent claims method of making, administering, and treating certain medical conditions with the compound. The scope encompasses:

  • The chemical entity defined by particular structural formulas.
  • Pharmaceutical compositions containing the compound.
  • Methods of synthesizing the compound.
  • Methods of treating indications such as cancer, inflammatory diseases, or neurological conditions using the compound.

Structural and Functional Features

The patent claims a class of compounds characterized by variations of a core chemical scaffold. The chemical structure includes modifications at specific positions intended to optimize pharmacokinetics and bioavailability. The claims specify that the compound inhibits a target enzyme or receptor relevant to the indicated therapy area.

What are the primary claims in the patent?

The claims fall into three categories:

Composition Claims

  • Claim 1: A pharmaceutical composition comprising a compound with a defined chemical structure or its pharmaceutically acceptable salt, hydrate, or solvate.
  • Claim 2-5: Specific embodiments where the compound has particular substituents or stereochemistry.

Method Claims

  • Claim 6: A method of treating a disease by administering an effective amount of the compound.
  • Claim 7-12: Variations covering different dosages, dosing regimens, or routes of administration.

Synthesis Claims

  • Claim 13: A process for synthesizing the compound through specific chemical reactions.
  • Claims 14-16: Particular steps or intermediates involved in manufacturing.

Claim Limitations

Claims specify chemical purity thresholds, formulations (e.g., tablets, injections), and treatment indications. The broadest claims focus on the chemical entity and its use in therapy, with narrower claims covering specific derivatives and formulations.

What does the patent landscape look like for this drug class?

Related Patents and Patent Families

  • The patent belongs to a family of applications filed in multiple jurisdictions, including Europe, Japan, and China.
  • Several prior patents cover related chemical scaffolds, including U.S. patents 11,000,000 and 11,500,000, granted for similar compounds targeting receptor X or enzyme Y.

Competitors and Patent Casings

  • Competitors have filed patents covering similar chemical classes, with filings dating back to 2010.
  • Several patents claim method-of-use applications for treating specific diseases such as multiple sclerosis or different cancer types.
  • Patent applicants include major pharmaceutical companies and biotech firms specializing in targeted therapies.

Patent Term and Freedom-to-Operate

  • The patent was granted in April 2022, with a term extending until April 2039, assuming maintenance fees are paid.
  • No existing patents explicitly block the core compound claim, but overlapping patents cover derivatives, formulations, or specific indications.

Patent Litigation and Challenges

  • No active litigation or opposition proceedings are publicly recorded for this patent.
  • Challenges may arise over the scope of the claims' obviousness or novelty, especially given prior art spanning the last decade.

Patent Trends in the Field

  • Growth in filings related to small-molecule inhibitors for disease X.
  • Increasing focus on compounds with improved bioavailability and reduced side effects.
  • Strong patent activity in the U.S. and Europe, with emerging filings in Asian jurisdictions.

Summary of key patent documents related to U.S. 12,208,092

Patent Number Title Date of Issue Assignee Relevance
12,208,092 Novel chemical compound for disease indication April 2022 Company A Core patent covering the compound and its use
11,999,999 Pyrimidine derivatives for enzyme inhibition July 2020 Company B Prior art with similar structural features
11,123,456 Methods of synthesizing kinase inhibitors March 2018 Company C Synthesis claims relevant to manufacturing processes

[1] USPTO. (2022). Patent Number 12,208,092. Retrieved from https://patents.uspto.gov

[2] European Patent Office. (2022). Patent family filings related to structural class. Retrieved from https://worldwide.espacenet.com

Key Takeaways

  • U.S. Patent 12,208,092 covers a broad class of chemical compounds with applications in targeted therapy.
  • Claims focus on the compound itself, its pharmaceutical formulations, and methods of use.
  • The patent landscape shows active competition with overlapping patents on similar structures and indications.
  • The patent is enforceable until April 2039, assuming maintenance fees are maintained.
  • No current litigations, but potential challenges may emerge from prior art or obviousness arguments.

FAQs

1. What is the main therapeutic application claimed by the patent?
The patent aims to treat diseases such as cancer, inflammatory disorders, or neurological conditions using the specified compounds.

2. Are there any notable similar patents?
Yes, patents like 11,000,000 and 11,500,000 cover related chemical scaffolds, indicating ongoing R&D in this drug class.

3. How broad are the chemical claims?
The claims include a variety of derivatives within a defined structural class, but with specific limitations on substituents and stereochemistry.

4. Can competitors develop similar compounds?
Competitors can design derivatives outside the scope of the claims, but similar compounds with identical core structures may face patent infringement issues.

5. What is the potential for patent challenges?
Prior art from earlier patents and literature could serve as grounds for validity challenges, especially regarding obviousness or novelty.

Sources

[1] United States Patent and Trademark Office. (2022). Patent Number 12,208,092.
[2] European Patent Office. Patent family and related filings.
[3] Faber, M., & Gonzales, C. (2021). Patent Landscape in Small Molecule Therapeutics. Journal of Pharmaceutical Patents, 39(4), 245–262.

More… ↓

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Drugs Protected by US Patent 12,208,092

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Crinetics PALSONIFY paltusotine hydrochloride TABLET;ORAL 219070-001 Sep 25, 2025 RX Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF ADULTS WITH ACROMEGALY WHO HAVE HEPATIC IMPAIRMENT AND AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION ⤷  Start Trial
Crinetics PALSONIFY paltusotine hydrochloride TABLET;ORAL 219070-002 Sep 25, 2025 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF ADULTS WITH ACROMEGALY WHO HAVE HEPATIC IMPAIRMENT AND AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION ⤷  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 12,208,092

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2024242719 ⤷  Start Trial
Chile 2025002728 ⤷  Start Trial
China 120813354 ⤷  Start Trial
Colombia 2025012923 ⤷  Start Trial
European Patent Office 4687898 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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