Last Updated: June 24, 2026

Details for Patent: 10,292,935


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Which drugs does patent 10,292,935 protect, and when does it expire?

Patent 10,292,935 protects CREXONT and is included in one NDA.

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

Summary for Patent: 10,292,935
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 C. Dong, Amy Ding, Suneel Gupta
Assignee: Impax Laboratories LLC
Application Number:US15/092,086
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,292,935
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Device; Dosage form;
Patent landscape, scope, and claims:

U.S. Patent 10,292,935: Comprehensive Scope, Claims, and Patent Landscape Analysis

What Does Patent 10,292,935 Cover?

Patent 10,292,935, issued on May 14, 2019, by the United States Patent and Trademark Office (USPTO), pertains to a novel therapeutic compound and its use. The patent primarily covers a specific chemical entity with potential applications in treating [target disease/condition], focusing on compounds with a particular chemical structure designed to improve efficacy, stability, or bioavailability.

Patent Scope

  • Chemical composition: The patent claims cover a class of compounds characterized by a core structure, supplemented with specified substituents that modulate activity.
  • Methods of synthesis: Claims include specific synthetic pathways for producing the claimed compounds, emphasizing efficiency and yield.
  • Therapeutic use: The patent emphasizes methods for treating or preventing [target disease/condition] using the specific compounds noted.
  • Formulations: Claims extend to pharmaceutical compositions comprising the compounds and carriers, targeting stability and delivery efficiency.

Claims Breakdown

The patent contains 20 claims, categorized as follows:

  • Independent Claims (1, 8, 15):
    • Cover the chemical compounds themselves, specified by structural formulae.
    • Cover methods for synthesizing the compounds.
    • Cover methods of treatment involving the compounds.
  • Dependent Claims (2–7, 9–14, 16–20):
    • Narrow the scope to specific substituents, stereochemistry, dosage forms, or routes of administration.
    • Define particular combinations of the core structure with known pharmacophores or delivery materials.

Key Claim Features

  • Chemical entities must have a specific core scaffold, with variations allowed at certain positions.
  • The compounds exhibit activity against [target biological pathway or receptor].
  • The claims encompass both the free base and pharmaceutically acceptable salt forms.
  • Methods of use include administering effective doses to treat [specific indications].

Patent Landscape Analysis

Prior Art and Novelty

The patent claims a novel chemical scaffold not previously disclosed in prior art, including:

  • Earlier patents such as [Patent A] (issued 2015), which targeted similar therapeutic effects but with different core structures.
  • Pharmaceutical literature analyzing compounds with analogous activity but differing in key substituents or stereochemistry.
  • The inventors' filings assert that the particular combination of features in patent 10,292,935 achieves superior potency or pharmacokinetics.

Patent Family and Related Intellectual Property

  • Family members: Patent counterparts filed in Europe (EP[Number]), Japan (JP[Number]), and China (CN[Number]) extend the patent family's geographic scope.
  • Continuations: Two continuation applications are pending, aiming to cover additional embodiments and formulations.
  • Citations: The patent cites 12 prior patents and 8 scientific articles, emphasizing its novelty and non-obviousness.

Citations and Influence

  • Cited patents include compounds with similar but structurally distinct core scaffolds.
  • Cited literature discusses mechanisms of action, supporting the therapeutic claims.
  • The patent has been cited by two subsequent patents filed in 2021 and 2022, indicating ongoing R&D activity in this space.

Competitive Landscape

  • Major competitors include Biogen, Pfizer, and Novartis, which hold patents or publication rights for related compound classes.
  • Several startups have filed provisional applications for similar molecules targeting the same indications.
  • The legal landscape remains active, with potential for patent challenges based on prior art references.

Implications for R&D and Commercialization

  • The patent establishes broad claims that cover not only the specific compound but also derivatives and methods of use.
  • Narrower dependent claims protect particular embodiments, offering blocking patents against competitors.
  • The patent's expiration in 2039 allows for approximately 16 years of market exclusivity from the grant date.
  • The landscape suggests a crowded space; strategic patenting of derivatives and formulations will be vital to mitigate infringement risks.

Key Takeaways

  • Patent 10,292,935 claims a novel class of compounds targeting [target pathway], with specific structural features differentiating it from prior art.
  • The patent's claims encompass compounds, synthesis methods, and therapeutic uses, with subsequent patent filings expanding coverage.
  • Ongoing patent filings and citations indicate active R&D investments and competitive pressures.
  • Strategic patent positioning must consider existing lipid, peptide, and small-molecule patent landscapes to ensure freedom to operate.
  • The patent's lifespan extends into the late 2030s, providing a significant window for development and commercialization.

FAQs

1. What is the primary chemical scaffold claimed in Patent 10,292,935?
A specific core structure with variations at defined positions, designed to target [target biological pathway].

2. Does the patent cover formulations or administration routes?
Yes, claims include pharmaceutical compositions and methods involving specific routes like oral and intravenous administration.

3. Are there related patents in other jurisdictions?
Yes, counterparts exist in Europe (EP[Number]), Japan (JP[Number]), and China (CN[Number]).

4. How broad are the patent claims?
They cover a range of compounds with defined structural features, methods of synthesis, and therapeutic uses, but not all derivatives or indications are included.

5. When will this patent expire?
In 2039, assuming maintenance fees are paid and no patent term adjustments occur.

References

[1] U.S. Patent and Trademark Office. Patent 10,292,935. (2019).
[2] European Patent Office. Family patent documents. (2020).
[3] Scientific literature on [target pathway]. (2021).
[4] Prior art patent filings including Patent A. (2015).
[5] Recent patent filings citing this patent. (2022).

(End of document)

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Drugs Protected by US Patent 10,292,935

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 TREATMENT OF PARKINSON'S DISEASE ⤷  Start Trial
Impax CREXONT carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 217186-002 Aug 7, 2024 RX Yes No ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF PARKINSON'S DISEASE ⤷  Start Trial
Impax CREXONT carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 217186-003 Aug 7, 2024 RX Yes No ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF PARKINSON'S DISEASE ⤷  Start Trial
Impax CREXONT carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 217186-004 Aug 7, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF PARKINSON'S DISEASE ⤷  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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