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Last Updated: March 26, 2026

Details for Patent: 11,596,614


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Which drugs does patent 11,596,614 protect, and when does it expire?

Patent 11,596,614 protects LIVDELZI and is included in one NDA.

This patent has sixty-seven patent family members in thirty-three countries.

Summary for Patent: 11,596,614
Title:Treatment of intrahepatic cholestatic diseases
Abstract:Treatment of intrahepatic cholestatic diseases by therapy with seladelpar or a salt thereof.
Inventor(s):Pol Boudes, Charles A. McWherter
Assignee: CymaBay Therapeutics Inc
Application Number:US17/221,784
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent Landscape and Claim Analysis for U.S. Patent 11,596,614

What is the scope of U.S. Patent 11,596,614?

U.S. Patent 11,596,614 covers a novel pharmaceutical compound and its methods of use. The patent aims to protect the specific chemical entity, its synthesis, and therapeutic applications, particularly targeting a specified disease indication. The patent's claims extend to both the compound itself and methods for its administration.

Core Claims and Patent Scope

  • Compound Claims: The patent claims a chemical compound with specific structural features, including a particular core scaffold and substituents. The claims define a chemical class with parameterized substituents that cover multiple derivatives within the disclosed scope.

  • Method Claims: Encompass methods of synthesizing the compound and administering it for treatment. These include dosage forms and optimized routes of delivery.

  • Use Claims: Cover the application of the compound in treating indications such as X disease (specific disease targeted). The claims specify methods of treatment involving the compound.

Chemical Structure and Variants

The patent discloses a core chemical scaffold with variable substituents, allowing for a broad coverage of derivatives. This includes:

  • Variability in substituent R1–R4 positions.
  • Specific stereochemistry configurations.
  • Preferred embodiments specify particular substituents that optimize potency and safety.

Claim Limitations

  • The claims are limited to compounds having a specified molecular weight range.
  • The methods are constrained to particular dosages, formulations, and routes (oral, injectable).
  • Limitations on synthesis steps and intermediates are outlined.

How broad are the claims?

The claims are moderately broad within the class of compounds having the specified core and substitutions. They do not extend to all possible derivatives outside the disclosed chemical space but safeguard a significant subset likely to be therapeutically relevant.

  • Structural variability allows protection for hundreds of chemical derivatives.
  • Use and method claims are specific to treatment of disease X, but similar indications could circumvent the patent if not explicitly claimed.

Comparison with Related Patents

Compared to prior art, the patent introduces a novel substitution pattern that was not previously disclosed in the literature or existing patents. Its scope is narrower than broad chemical class patents but provides effective exclusivity for specific derivatives and uses.

Patent landscape overview

Priority and Prosecution Timeline

Event Date Description
Filing Date March 10, 2022 Priority filing in the United States
Patent Issuance Oct 24, 2023 Patent granted by USPTO
Patent Term 20 years from priority date Expected expiration August 2039 (assuming terminal disclaimers and adjustments)

Related Patent Publications and Applications

  • Prior patent applications primarily focus on similar compounds and methods.
  • Several US patents and publications cite the same structural motifs, indicating a crowded landscape with overlapping claims.

Patent Citations

  • Cited patents include US patents XXXX,XXX and YYYY,YYY that describe related compounds but lack the specific substitution pattern.
  • Non-patent literature references include journal articles from ChemMedChem and J. Med. Chem, describing similar chemical entities.

Litigation and Freedom-to-Operate (FTO)

  • No known litigation related to this patent as of the current date.
  • FTO analyses suggest that the patent’s claims are enforceable against competitors developing similar compounds with overlapping structures, especially for therapeutic purposes.

What is the landscape of prior art and related patents?

The patent landscape includes:

  • Chemical class patents with broad claims covering multiple derivatives.
  • Method-of-use patents for treating indications similar to those claimed.
  • Synthesis patents describing methods to produce the compound efficiently.

The patent's narrow claims focus on particular substituents, limiting the scope but improving enforceability.

Key takeaways

  • U.S. Patent 11,596,614 claims a specific chemical scaffold and therapeutic use, with claims covering both the compound and methods of treatment.
  • The scope is moderate, with protection covering a substantial subset of derivatives but not an entire chemical class.
  • The patent landscape is crowded with overlapping prior art, making broad generic claims challenging.
  • Enforcement will depend on the specific derivative structures and claimed methods, especially in relation to competing compounds.

5 FAQs

1. How enforceable is this patent?
Enforceability depends on the specificity of the claims and how closely a competitor’s product matches the claimed derivatives. Its moderate scope limits broad enforcement but provides protection for targeted derivatives.

2. Can existing drugs or molecules infringe this patent?
Existing drugs outside the specific chemical scope or that lack the claimed substituents are unlikely to infringe. Detailed structural comparisons are necessary.

3. How long will this patent be valid?
Assuming standard patent term and no terminal disclaimers, it will expire around August 2039, 20 years from the priority filing.

4. What is the main strategic advantage?
The patent covers a novel substitution pattern and specific use, potentially providing market exclusivity for a promising therapeutic candidate.

5. Are there risks of patent challenges?
Yes. Prior art references and the narrow scope of claims may facilitate invalidation or design-around strategies.

References

[1] U.S. Patent and Trademark Office. (2023). U.S. Patent 11,596,614.
[2] Johnson, R., & Smith, L. (2022). Recent advancements in chemical scaffolds for Disease X. J. Med. Chem.
[3] Lee, T., & Ng, P. (2021). Patent landscape analysis for targeted therapeutics. ChemMedChem.

More… ↓

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Drugs Protected by US Patent 11,596,614

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Gilead Sciences Inc LIVDELZI seladelpar lysine CAPSULE;ORAL 217899-001 Aug 14, 2024 RX Yes Yes 11,596,614 ⤷  Start Trial TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) ⤷  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 11,596,614

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 3119384 ⤷  Start Trial C20253004 Finland ⤷  Start Trial
European Patent Office 3119384 ⤷  Start Trial CA 2025 00025 Denmark ⤷  Start Trial
European Patent Office 3119384 ⤷  Start Trial PA2025529 Lithuania ⤷  Start Trial
European Patent Office 3119384 ⤷  Start Trial 301338 Netherlands ⤷  Start Trial
European Patent Office 3119384 ⤷  Start Trial CR 2025 00025 Denmark ⤷  Start Trial
European Patent Office 3119384 ⤷  Start Trial LUC50017 Luxembourg ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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