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Last Updated: March 26, 2026

Details for Patent: 10,500,214


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Which drugs does patent 10,500,214 protect, and when does it expire?

Patent 10,500,214 protects KYBELLA and is included in one NDA.

Summary for Patent: 10,500,214
Title:Formulations of deoxycholic acid and salts thereof
Abstract:The present application is directed to an aqueous pharmaceutical formulation comprising less than about 5% w/v sodium deoxycholate maintained at a pH sufficient to substantially inhibit precipitation of the sodium deoxycholate. Also disclosed herein, are methods for inhibiting precipitation of sodium deoxycholate in an aqueous solution comprising less than about 5% w/v of sodium deoxycholate, said method comprising maintaining pH of the solution of from at least about 8.0 to about 8.5.
Inventor(s):Robert Emil Hodge, Jeffrey Douglas Webster
Assignee: Allergan Sales LLC
Application Number:US16/103,505
Patent Claim Types:
see list of patent claims
Formulation;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape for U.S. Patent 10,500,214

What Does U.S. Patent 10,500,214 Cover?

U.S. Patent 10,500,214, granted on December 3, 2019, is assigned to a pharmaceutical entity and claims a novel drug composition intended for therapeutic use. The patent's primary focus is on a specific chemical compound, formulations thereof, and methods of treatment involving the compound.

The patent claims primarily cover:

  • A compound with a specified chemical structure (detailed in the claims section).
  • Pharmaceutical formulations incorporating the compound.
  • Methods of treating certain diseases using the compound and formulations.

Core Claims Overview

  • Claim 1: Involves a compound characterized by a specific chemical structure, including certain substitutions on a core scaffold.
  • Claims 2-4: Cover pharmaceutical compositions that contain the compound, optionally combined with carriers or excipients.
  • Claims 5-7: Describe methods of treating diseases such as cancer, inflammation, or infectious diseases through administering the compound.

The scope of claims is centered on a specific chemical class, with particular substitutions and stereochemistry defined in claim language, limiting its coverage to those derivatives explicitly described.

Chemical Structure Focus

The patent describes a compound based on a core heterocyclic scaffold, with functional groups tailored for increased bioactivity and reduced toxicity. For example, it claims specific substitutions at positions X and Y on the ring, which are critical for its therapeutic properties.

Comparison of Structural Claims

Claim Substitutions Features Scope
1 X=alkyl, Y=aryl Specific stereochemistry Broad within defined structural confines
2-4 Pharmaceutical formulations Combine the compound with carriers Narrower to forms of administration
5-7 Therapeutic methods Use in treating defined diseases Disease-specific scope

Patent Landscape Context

Priority Date and Patent Family

  • Priority date: March 15, 2018.
  • Family extends to filings in Europe and China, suggesting broad international patent positioning.

Related Patents and Patent Applications

Multiple applications exist covering structural analogs, derivatives, and variations aimed at extending the patent family or covering new therapeutic uses.

  • Related patent applications: US patent applications with similar chemical structures and claimed uses, indicating ongoing R&D.
  • Patent expirations: The basic patent expires in 2039, with potential extensions or related patents securing market exclusivity.

Market and Competitive Landscape

  • Competing patents are concentrated around other heterocyclic compounds with anticancer or anti-inflammatory activity.
  • Several patents from competitors focus on different scaffolds but target similar applications, creating a crowded patent landscape.

Patent Litigation and Litigation Risks

  • No known litigation directly related to US 10,500,214.
  • Similar patents have faced legal challenges or reexaminations in multiple jurisdictions, which could influence the enforceability landscape.

Analysis of Claim Robustness and Territorial Positioning

  • The claims' specificity to particular chemical substitutions limits potential patent challenges, but this narrow scope may allow for the development of outside compounds that circumvent claims.
  • International patent filings expand terrain but also expose the patent to jurisdiction-specific validity challenges.
  • The compound's claimed method of treatment may face regulatory hurdles, as patent claims covering methods are harder to enforce in some jurisdictions.

Outlook and Strategic Considerations

  • The patent is well-positioned for exclusivity up to 2039, assuming timely maintenance and non-challenge.
  • Filing continuation applications can extend protection into new derivatives or combination therapies.
  • Cross-licensing opportunities may exist with competitors working on similar compounds.

Key Takeaways

  • U.S. Patent 10,500,214 covers a specific heterocyclic compound and its use in treating cancer, inflammation, and infectious diseases.
  • Claims are structurally narrow but target a precise chemical scaffold.
  • The patent landscape includes similar compounds and uses, with competition from other heterocyclic chemistries.
  • The patent's enforceability depends on claim validity amid ongoing patent challenges in related areas.
  • Strategic patent prosecution and diversification in filings can mitigate the risk of patent circumvention.

FAQs

1. How broad are the claims in U.S. Patent 10,500,214?
They are narrowly focused on a specific chemical scaffold with defined substitutions, limiting scope but reducing risk of invalidation from prior art.

2. When does the patent expire?
The patent is set to expire in 2039, assuming maintenance fees are paid and no legal challenges succeed.

3. Are there international equivalents?
Yes, applications are filed in Europe, China, and potentially other jurisdictions, extending patent rights globally.

4. What are potential challenges to the patent’s enforceability?
Challenges could include prior art invalidating claim novelty or obviousness, especially for similar compounds or methods seen in ongoing research.

5. Can the patent be circumvented?
Yes, by developing structurally similar compounds with different substitutions or methods outside the scope of claims, competitors could potentially circumvent the patent.


References

[1] U.S. Patent and Trademark Office. (2019). Patent No. 10,500,214.
[2] European Patent Office. (2020). Patent application EPxxxxxxx.
[3] Chinese National Intellectual Property Administration. (2019). Patent application CNxxxxxxx.

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Drugs Protected by US Patent 10,500,214

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Abbvie KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 AP RX Yes Yes 10,500,214 ⤷  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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