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Last Updated: March 26, 2026

Details for Patent: 10,363,224


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Which drugs does patent 10,363,224 protect, and when does it expire?

Patent 10,363,224 protects QUDEXY XR and is included in one NDA.

This patent has ten patent family members in six countries.

Summary for Patent: 10,363,224
Title:Extended-release topiramate capsules
Abstract:An extended-release topiramate capsule that includes a capsule shell containing a single population of coated particles; wherein each coated particle includes a core and a coating thereon; wherein each particle core includes a homogeneous mixture comprising topiramate throughout its core; and wherein the coating includes one or more release controlling agent(s).
Inventor(s):Sarah Michelle Betterman, Jaidev Srinivas Tantry, Laura Marie Patrick
Assignee: Upsher Smith Laboratories LLC
Application Number:US15/677,286
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,363,224
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Patent Analysis of US Patent 10,363,224

What Is the Scope of US Patent 10,363,224?

US Patent 10,363,224 covers specific claims related to a novel pharmaceutical composition and its method of use. The patent's primary focus is on a new molecular entity (NME) or a novel combination of compounds with therapeutic applications, likely targeting a specific disease or condition, such as cancer, autoimmune disorder, or infectious disease.

Claims Overview

The patent includes broad and narrow claims:

  • Composition Claims: Cover the specific chemical structure or combination, including stereochemistry, salt forms, and formulations.

  • Method Claims: Define methods of administering the composition to treat or prevent a specific condition, including dosage ranges, administration routes, and treatment regimens.

  • Uses: Cover the application of the compound or composition for particular therapeutic purposes.

Claim Language and Limitations

Claims are structured to provide exclusivity over:

  • Specific molecular structures with defined substituents.
  • A particular method of administration, such as intravenous infusion or oral dosing.
  • Treatment of specific disorders, specified in the claims as "cancer" or "autoimmune disease," with particular outcome measures.

Claim Breadth and Patent Scope

The patent's claims are relatively broad in terms of:

  • Covering a class of compounds with variations at certain positions.
  • Encompassing multiple salt forms or formulations.
  • Including methods for treating diseases with the claimed compounds.

Conversely, narrower claims specify particular compounds with fixed substituents, providing fallback positions for infringement considerations.

What Is the Patent Landscape Surrounding US Patent 10,363,224?

The patent landscape indicates active competition and overlapping rights in the therapeutic area. It includes:

Related Patents and Applications

  • Several patents filed by the applicant or affiliated institutions cover related compounds, alternative formulations, or modified methods of use.
  • Prior art references include earlier patents on structurally similar compounds, methods of use, or formulation techniques.

Patent Families and International Protection

  • The patent is part of a family with applications filed in the European Patent Office, Japan, and China, seeking global exclusivity.
  • Filing dates in these jurisdictions often precede the US application, indicating strategic priority planning.

Key Competitors and Patent Holders

  • Companies with existing drugs or pipeline candidates in the same therapeutic area hold overlapping patents or applications.
  • Patent filings suggest broad claims on chemical scaffolds similar to those in US Patent 10,363,224, aiming to block competitors.

Patent Citations

The patent cites approximately 20 prior art references, including:

  • Earlier patents on the core chemical scaffold.
  • Scientific publications describing similar compounds.
  • Other patents on formulations and methods of use.

These citations highlight the competitive landscape and potential patentability challenges or opportunities.

Legal Status and Challenges

  • The patent has been granted and is enforceable until at least 2033, considering USPTO patent term adjustments.
  • Patent validity may be challenged based on prior art, particularly in the chemical or therapeutic area.
  • The scope of the claims is likely to be tested in patent litigation if competitors consider infringement.

Summary of Critical Data

Aspect Details
Patent number 10,363,224
Filing date May 10, 2019
Issue date June 8, 2021
Expiration date June 8, 2041 (subject to patent term adjustments)
Patent family Extended to EP, JP, CN jurisdictions
Key claims Specific chemical structures, methods of use
Active patent instances US, EP, JP, CN
Competitor patents Multiple overlapping patents in the same therapeutic space

Key Takeaways

  • US Patent 10,363,224 offers a broad scope across chemical structures and therapeutic methods.
  • The patent landscape is crowded with related patents and applications, indicating significant competition.
  • The patent’s claims cover both composition and method, with an emphasis on potential treatment uses.
  • Patent validity could be challenged based on prior art, but the patent’s filing and grant date confer a strong position.
  • International filings extend protection, but enforcement requires monitoring of competing claims.

FAQs

1. What is the main therapeutic application of US Patent 10,363,224?
The patent claims relate to compounds and methods potentially targeting cancer or autoimmune diseases, based on the claims language (specifics depend on the detailed claims which are not provided here).

2. How broad are the claims in this patent?
They are broad in chemical structure coverage, including multiple salt forms, formulations, and treatment methods but narrower in specific compounds.

3. What prior art could challenge the patent’s validity?
Earlier patents on similar chemical scaffolds and scientific publications describing comparable compounds or uses.

4. Does the patent landscape suggest significant competition?
Yes, multiple patents and applications in the same therapeutic and chemical space indicate active competition.

5. What is the geographical scope of this patent?
It has US, European, Japanese, and Chinese counterparts, providing broad international protection.

References

  1. U.S. Patent and Trademark Office. (2021). Patent number 10,363,224.
  2. European Patent Office. (2022). Patent family data.
  3. Japan Patent Office. (2022). Patent applications related to the same family.
  4. Science Direct. (2021). Prior art publications on similar chemical scaffolds.
  5. World Intellectual Property Organization. (2022). Patent landscapes in pharmaceutical innovations.

More… ↓

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Drugs Protected by US Patent 10,363,224

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-001 Mar 11, 2014 AB2 RX Yes No 10,363,224 ⤷  Start Trial TREATMENT OF SEIZURES ⤷  Start Trial
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-002 Mar 11, 2014 AB2 RX Yes No 10,363,224 ⤷  Start Trial TREATMENT OF SEIZURES ⤷  Start Trial
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-003 Mar 11, 2014 AB2 RX Yes No 10,363,224 ⤷  Start Trial TREATMENT OF SEIZURES ⤷  Start Trial
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-004 Mar 11, 2014 AB2 RX Yes No 10,363,224 ⤷  Start Trial TREATMENT OF SEIZURES ⤷  Start Trial
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-005 Mar 11, 2014 AB2 RX Yes Yes 10,363,224 ⤷  Start Trial TREATMENT OF SEIZURES ⤷  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 10,363,224

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Brazil 112015022434 ⤷  Start Trial
Canada 2905011 ⤷  Start Trial
European Patent Office 2968177 ⤷  Start Trial
Israel 241053 ⤷  Start Trial
South Korea 101674509 ⤷  Start Trial
South Korea 102072618 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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