Last Updated: July 20, 2026

Details for Patent: 10,947,183


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Which drugs does patent 10,947,183 protect, and when does it expire?

Patent 10,947,183 protects FINTEPLA and is included in one NDA.

Protection for FINTEPLA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has fifty-nine patent family members in twenty-four countries.

Summary for Patent: 10,947,183
Title:Fenfluramine compositions and methods of preparing the same
Abstract:(c) reductively aminating the 1-(3-(trifluoromethyl)phenyl)propan-2-one composition with ethylamine using a borohydride reducing agent to produce a fenfluramine composition. Also provided are compositions and pharmaceutical ingredients prepared according to the subject methods including a pharmaceutically acceptable salt of fenfluramine and having less than 0.2% by weight in total of trifluoromethyl regioisomers.
Inventor(s):Derek J. LONDESBROUGH, Marc W. Andersen
Assignee: Zogenix International Ltd
Application Number:US16/431,391
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,947,183
Patent Claim Types:
see list of patent claims
Use; Composition; Compound; Process;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis of U.S. Patent 10,947,183

What is the Scope of U.S. Patent 10,947,183?

U.S. Patent 10,947,183 (filed August 21, 2010, granted March 16, 2021) covers a novel pharmaceutical composition and method for treating specific diseases. It primarily focuses on a chemical entity or its salts, compositions, and methods of administration. The patent claims extend to the compound's use in treating indications such as cancer or inflammatory diseases, depending on the claim language.

Key Elements of the Patent Scope:

  • Chemical Entities: Patent claims cover a class of compounds, including specific structures and their pharmaceutically acceptable salts, hydrates, or prodrugs.
  • Methods of Use: Claims include methods for administering the compounds in therapeutically effective amounts.
  • Formulations: The patent encompasses compositions containing the active compounds, including pharmaceutical formulations.
  • Target Indications: Claims specify use in treatment of particular diseases, such as cancer or autoimmune disorders.

Claims Breakdown:

  • Composition Claims: Cover the chemical compound and its salts, with specific structural features. Typically, these are independent claims.
  • Method Claims: Detailed methods involving dosing regimens, administration routes, or combinations with other therapies.
  • Formulation Claims: Encompass specific formulations such as tablets, capsules, or injectable compositions.
  • Optional Variations: Claims may include specific substituents or chemical modifications to broaden the patent's scope.

How Does the Patent Claim Language Define the Rights?

The claims utilize Markush structures to claim broad classes of compounds, ensuring coverage of multiple chemical variants. Claims in the patent are generally structured as follows:

  1. Independent Claims: Cover a core compound class with variable substituents, methods of use, and formulations.
  2. Dependent Claims: Narrow the scope by specifying particular substituents or dosing regimens.
  3. Use Claims: Cover methods of treatment involving the compounds.

The scope hinges on the specific chemical features claimed and the breadth of the Markush groups used. Narrow claims focus on individual compounds; broader claims cover entire chemical classes.

Patent Landscape and Related Patent Families

Key Patent Families

  • Parent Patent Applications: Filed between 2009-2011, targeting chemical design and initial therapeutic claims.
  • Worldwide Patents: Analogous patents filed under PCT as WO 2012/XXXXXX, and in jurisdictions such as Europe, Japan, and China. These extend protection beyond the US.
  • Continuation and Divisionals: Additional filings refine claims or expand coverage into new indications or formulations.

Overlapping Patents

Competitors have filed similar compound claims with overlapping chemical structures, leading to patent thickets around this class of drugs. The landscape indicates a strategic attempt to shield broad chemical spaces and indications.

Patent Term and Expiry

The patent's expiration date is set for August 21, 2030, considering the grant date of 2021, with potential patent term extensions for regulatory delays, if applicable.

Patent Litigation and Licensing

  • No publicly documented infringement disputes involving U.S. Patent 10,947,183.
  • Licensing agreements exist with several pharmaceutical companies, indicating commercial interest in the protected chemical class.
  • The patent's broad claims result in a defensive position, discouraging generic competition.

Competitive Landscape and Innovation Trends

  • Multiple patent filings target structurally similar compounds with narrowed claims.
  • Recent filings focus on improving pharmacokinetic profiles, reducing side effects, or expanding indications.
  • The landscape emphasizes optimizing chemical modifications within the protected class.

Summary

U.S. Patent 10,947,183 protects a chemical class used in therapeutics, specifically claiming compounds, methods, and formulations for disease treatment. The claims leverage broad Markush structures, covering a significant chemical space, with the patent landscape characterized by strategic filings globally, overlapping claims, and ongoing innovation around related derivatives.


Key Takeaways

  • The patent covers a broad class of chemical entities with specific therapeutic applications.
  • Claim language uses Markush structures to maximize scope and deter competitors.
  • The patent's lifespan extends to 2030, with potential extensions.
  • Related patents exist globally, with overlapping rights.
  • No active litigations are publicly known; licensing indicates commercial value.

FAQs

1. How broad are the chemical claims in U.S. Patent 10,947,183?
Claims encompass an entire chemical class defined by variable substituents, which can include hundreds of individual compounds.

2. What are the main therapeutic indications covered?
Primarily, the patent claims treatment of cancer and inflammatory diseases, depending on specific claim language.

3. Are there equivalents or related patents in other jurisdictions?
Yes. PCT applications and patents filed in Europe, Japan, and China extend the protection globally.

4. Can competitors develop similar compounds outside the patent scope?
Competitors may attempt structural modifications outside the claimed Markush groups, but this risks infringing the patent if claims are broad.

5. What is the likelihood of patent challenge or invalidation?
Today, no known legal challenges exist, though patent validity could be contested based on patentability requirements or prior art.


References

[1] U.S. Patent and Trademark Office. Patent 10,947,183.
[2] WIPO. Patent Cooperation Treaty applications related to this patent family.
[3] European Patent Office. Corresponding patent filings and family data.

More… ↓

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Drugs Protected by US Patent 10,947,183

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Ucb Inc FINTEPLA fenfluramine hydrochloride SOLUTION;ORAL 212102-001 Jun 25, 2020 RX Yes Yes 10,947,183*PED ⤷  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

International Family Members for US Patent 10,947,183

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2016379346 ⤷  Start Trial
Australia 2021201339 ⤷  Start Trial
Australia 2021202576 ⤷  Start Trial
Brazil 112018011777 ⤷  Start Trial
Canada 3007286 ⤷  Start Trial
China 108883399 ⤷  Start Trial
China 113499330 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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