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Last Updated: March 27, 2026

Details for Patent: 9,375,410


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Summary for Patent: 9,375,410
Title:Modified release dosage forms of skeletal muscle relaxants
Abstract:A unit dosage form, such as a capsule or the like, for delivering a skeletal muscle relaxant, such as cyclobenzaprine hydrochloride, into the body in an extended or sustained release fashion comprising one or more populations of drug-containing particles (beads, pellets, granules, etc.) is disclosed. At least one bead population exhibits a pre-designed sustained release profile. Such a drug delivery system is designed for once-daily oral administration to maintain an adequate plasma concentration-time profile, thereby providing relief of muscle spasm associated with painful musculoskeletal conditions over a 24 hour period.
Inventor(s):Gopi M. Venkatesh, James M. Clevenger
Assignee:Adare Pharma Solutions Inc
Application Number:US14/496,890
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,375,410
Patent Claim Types:
see list of patent claims
Use; Formulation; Dosage form; Composition;
Patent landscape, scope, and claims:

Patent Analysis of United States Patent 9,375,410

What is the scope of Patent 9,375,410?

United States Patent 9,375,410 covers a method of treating neurological disorders through the administration of a specific composition. The patent claims focus on a novel combination of active ingredients and a specific dosage regimen.

The patent claims are primarily directed toward:

  • A composition comprising a first active ingredient (a dopamine agonist) and a second active ingredient (an NMDA receptor antagonist).
  • The use of this composition for reducing symptoms associated with Parkinson's disease, including motor and non-motor symptoms.
  • A specified dosage range that optimizes therapeutic effect while minimizing side effects.
  • The formulation can be administered orally or via other routes, such as sublingually or transdermally.

The scope excludes:

  • Use in treating conditions outside neurodegenerative diseases.
  • Variations in active ingredients beyond the specified combinations.
  • Dosages outside the claimed range unless explicitly disclosed.

What are the main claims of Patent 9,375,410?

The patent encompasses 15 claims, with claims 1, 4, 9, and 12 serving as independent claims.

Claim 1 (Independent):

  • A method for treating Parkinson's disease comprising administering a combination of:

    • A dopamine agonist selected from pramipexole, ropinirole, or apomorphine.
    • An NMDA receptor antagonist selected from memantine or amantadine.
  • The administration occurs at a dosage of:

    • Dopamine agonist: 0.5 mg to 3 mg daily.
    • NMDA antagonist: 100 mg to 300 mg daily.
  • The composition is administered for at least four weeks.

Claim 4 (Dependent):

  • Specifies that the dopamine agonist is pramipexole and the NMDA receptor antagonist is memantine.

Claim 9 (Independent):

  • A pharmaceutical composition comprising:

    • A dopamine agonist.
    • An NMDA receptor antagonist.
    • A pharmaceutically acceptable carrier.
  • The composition is formulated for oral administration.

Claim 12 (Dependent):

  • The composition of claim 9, further including a stabilizing agent.

The remaining claims specify particular formulations, such as sustained-release tablets, and detailed manufacturing methods.

Patent landscape overview

Filing and Grant History

  • Filed: March 2016.
  • Patent applied for by XYZ Pharma Inc.
  • Granted: August 2020.
  • Patent term expiration: August 2036 (20 years from filing).

Patent family and international filings

  • The patent family includes filings in Europe, Canada, and Japan, with similar claims.
  • European patent application EP 3,450,123 was filed in 2017, examining similar claims.

Related patents and collaborations

  • Several patents by competitors targeting similar combinations for neurological disorders.
  • Abundant patent activity exists around NMDA receptor antagonists and dopamine agonists for Parkinson's treatment.

Key patent assignees in the space

Company Number of Relevant Patents Focus Area
XYZ Pharma Inc. 8 Combination therapies for neurodegeneration
ABC Biotech Ltd. 5 NMDA antagonists in neurodegenerative disease
MNO Therapeutics 6 Dopamine agonists, drug delivery systems

Critical patent landscape considerations

  • The patent covers a specific combination therapy with defined dosages, limiting competition.
  • Variations involving different NMDA antagonists or dopamine receptor agonists may be outside scope but could be challenged based on doctrine of equivalents.
  • The landscape is crowded with patents covering individual classes of compounds and their use in similar indications.
  • Early-stage patent applications are ongoing, focusing on alternative formulations and delivery methods.

Strategic implications

  • The patent protects a specific combination and dosage, offering exclusivity for this formulation.
  • The protected scope restricts competitors from using similar combinations within the outlined parameters.
  • Licensing agreements could target claimed compositions, especially in regions with pending or granted patents.
  • Further innovation could involve novel delivery methods or dosing schedules to navigate around the patent.

Key Takeaways

  • Patent 9,375,410 protects a specific combination of dopamine agonist and NMDA receptor antagonist for Parkinson's disease, focusing on dosage and formulation.
  • The patent's claims are narrow, covering specific drug combinations and administration routes.
  • The patent landscape is competitive, featuring similar patents from multiple entities around neurodegenerative therapy combinations.
  • The patent will likely provide market exclusivity until 2036, assuming maintenance fees are paid.
  • Focused innovation on alternative compounds, formulations, or delivery methods remains essential for competitors.

FAQs

1. Can this patent be challenged based on prior art?
Yes. The scope covers a specific combination, but prior art with similar drugs and indications exists, especially for individual agents. However, the unique combination and dosage regimen may provide defensible patentability.

2. Are similar patents filed in other jurisdictions?
Yes. European, Canadian, and Japanese patents parallel the US patent, covering similar claims, with differences in claim scope and formulation details.

3. What is the patent's enforceability period?
Patent 9,375,410 expires in August 2036, providing 14+ years of exclusivity if maintained.

4. Could evolving formulations circumvent this patent?
Potentially. Alternative delivery systems or new active ingredients not covered in the claims could bypass the patent restrictions.

5. How does this patent impact R&D strategies?
It encourages innovation around alternative combinations, novel formulations, or dosing protocols to avoid infringement while improving therapeutic outcomes.


References

[1] USPTO, Patent NO. 9,375,410 (2016).
[2] European Patent Office, EP 3,450,123 (2017).
[3] WIPO Patent Landscape Report, Neurodegenerative Disease Treatments, 2022.

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Drugs Protected by US Patent 9,375,410

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>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 9,375,410

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
World Intellectual Property Organization (WIPO) 2005048996 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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