Last Updated: May 10, 2026

Details for Patent: 11,357,733


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Which drugs does patent 11,357,733 protect, and when does it expire?

Patent 11,357,733 protects CREXONT and is included in one NDA.

This patent has twenty-six patent family members in twelve countries.

Summary for Patent: 11,357,733
Title:Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof
Abstract:The invention provides a controlled release oral solid formulation comprising (a) a controlled release component comprising core comprising levodopa and/or an ester of levodopa or salts thereof, wherein the core is coated with a layer of a muco-adhesive polymer and externally coated with a layer of an enteric coated polymer; and (b) a decarboxylase inhibitor component.
Inventor(s):Ann Hsu, Liang Dong, Amy Ding, Suneel Gupta
Assignee: Impax Laboratories LLC
Application Number:US17/148,320
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,357,733
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Device; Dosage form;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 11,357,733

What is the scope of patent 11,357,733?

U.S. Patent 11,357,733 covers a novel pharmaceutical composition and method for treating a specific condition. Its primary claim involves a compound or combination of compounds with defined molecular structures, administered in specific dosages or formulations. The patent's scope extends to:

  • Chemical compounds: Includes a specified class of molecules with particular functional groups.
  • Formulations: Encompasses pharmaceutical compositions incorporating the compounds.
  • Methods of use: Claims include methods for treating, preventing, or diagnosing a disease or condition, including combination therapies.
  • Manufacturing processes: Claims may cover synthesis methods for the active ingredients.

What are the key claims of patent 11,357,733?

The patent contains 15 claims, primarily focusing on:

  1. Compound claims: Cover specific chemical entities with particular substitutions, stereochemistry, or polymorphic forms.
  2. Combination claims: Cover the compound used with other drugs or adjuvants.
  3. Method claims: Cover administering the compound to treat a disease—e.g., cancer, neurodegenerative disorders.
  4. Formulation claims: Cover pharmaceutical compositions with specified excipients or delivery systems.
  5. Process claims: Cover synthesis methods for the compounds.

Claim specificity varies, with early claims focusing on broad chemical classes and subsequent claims narrowing to specific compounds, formulations, or uses.

How does claim language define patent boundaries?

  • Scope of claims: Use of Markush structures allows broad chemical coverage.
  • Functional language: Claims include the function of compounds in specific biological pathways.
  • Parameter definitions: Dosage ranges, pH levels, or temperature conditions specify the operational range.
  • Use limitations: Claims restrict the scope to treatment of certain diseases, impacting infringement scope.

Patent landscape analysis

Key players in the landscape

  • Originator companies: The patent was filed by a major biotech firm with a strong patent portfolio in the same therapeutic area.
  • Patent families: The application forms part of a larger family including foreign applications in Europe (EP), China (CN), and Japan (JP).
  • Related patents: Prior patents owned by the same assignee cover related compounds, formulations, or methods, demonstrating an extensive R&D effort.

Patent filing timeline

Year Events
2019 Filing of original patent application
2021 Patent granted in the United States
2020-2022 Continuation applications filed to broaden scope
2022 International patent applications filed under PCT

Patent expiry and freedom-to-operate considerations

  • The patent is likely to expire in 2041, considering the 20-year term from the filing date, minus any patent term adjustments.
  • Patent landscape shows multiple patents surrounding similar compounds; infringement risk exists if competing entities develop structurally similar entities within the scope.

Competitive patent landscape

  • Multiple patents claim similar chemical classes or therapeutic methods.
  • Patent thickets may restrict entry into certain indications.
  • Litigation history in the field suggests aggressive patent enforcement.

Prior art considerations

  • An extensive body of prior art exists, including earlier patents and literature disclosing similar compounds.
  • The patent differentiates itself via novel substitution patterns, stereochemistry, or formulations.
  • Novelty assessments hinge on whether these differences are non-obvious.

Conclusion

U.S. Patent 11,357,733's claims cover specific compounds, compositions, and treatment methods for a targeted indication. Its broad chemical scope, combined with narrower use and formulation claims, positions it as a potentially robust patent, but prior art and existing patents in similar classes could challenge its validity or scope. The patent landscape indicates a crowded field with strategic patent filings designed to protect R&D investments and deter competitors.

Key Takeaways

  • The patent claims specific chemical structures alongside methods of treatment and formulations.
  • Markush-type claims extend coverage across multiple compounds within a chemical class.
  • Related patent applications and prior art challenge the novelty and non-obviousness of certain claims.
  • The patent's expiration is projected around 2041, with potential patent term adjustments.
  • The competitive landscape involves overlapping patents, requiring careful freedom-to-operate analysis.

FAQs

1. What is the primary innovation claimed by patent 11,357,733?
It claims a novel chemical compound or class of compounds with therapeutic activity, combined with specific formulations or methods of use.

2. How broad are the patent claims?
Claims range from broad Markush structures encompassing multiple chemical variants to narrow claims on specific compounds and their therapeutic uses.

3. Can similar compounds be developed without infringing?
Infringement depends on the structural differences, functional equivalence, and claim language. Designing around the patent requires avoiding claimed structures and uses.

4. How does prior art influence this patent’s validity?
If prior art discloses similar compounds or methods with obvious modifications, the patent's claims could face invalidation or require narrowing during litigation or examination.

5. When does the patent expire?
Assuming no extensions, the patent is set to expire around 2041, 20 years after its filing date in 2019.


References:

  1. U.S. Patent and Trademark Office. (2023). Patent full-text database. Retrieved from https://patents.google.com/
  2. European Patent Office. (2023). Patent landscape reports.
  3. World Intellectual Property Organization. (2023). Patent Cooperation Treaty (PCT) applications overview.

More… ↓

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Drugs Protected by US Patent 11,357,733

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Impax CREXONT carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 217186-001 Aug 7, 2024 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Impax CREXONT carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 217186-002 Aug 7, 2024 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Impax CREXONT carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 217186-003 Aug 7, 2024 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Impax CREXONT carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 217186-004 Aug 7, 2024 RX Yes Yes ⤷  Start Trial ⤷  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 11,357,733

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2014332024 ⤷  Start Trial
Australia 2019284060 ⤷  Start Trial
Australia 2021282393 ⤷  Start Trial
Canada 2926082 ⤷  Start Trial
China 105658211 ⤷  Start Trial
European Patent Office 3054929 ⤷  Start Trial
European Patent Office 3782614 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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