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Last Updated: December 18, 2025

Details for Patent: 11,077,073


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Which drugs does patent 11,077,073 protect, and when does it expire?

Patent 11,077,073 protects GOCOVRI and is included in one NDA.

This patent has fourteen patent family members in nine countries.

Summary for Patent: 11,077,073
Title:Methods of using amantadine compositions
Abstract:Provided herein are oral pharmaceutical compositions comprising amantadine, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient, and which have a low level of organic solvent. Provided are also methods of orally administrating a composition comprising amantadine, or a pharmaceutically acceptable salt thereof, to a subject, which has reduced gastrointestinal side effects or sleep disturbances. Further provided are extended release oral compositions comprising amantadine, or a pharmaceutically acceptable salt thereof, that are suitable for once daily administration.
Inventor(s):Gregory T. Went, Timothy J. Fultz, Sangita GHOSH, Natalie McClure
Assignee: Adamas Pharma LLC
Application Number:US16/409,554
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Device; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 11,077,073


Introduction

United States Patent 11,077,073 (hereafter referred to as "the ‘073 patent") was issued by the United States Patent and Trademark Office (USPTO) to claim proprietary rights over a novel pharmaceutical invention. As intellectual property assets underpin pharmaceutical innovation and market exclusivity, a thorough understanding of the scope, claims, and landscape of the ‘073 patent is critical for stakeholders—including competitors, licensors, and patent attorneys. This analysis synthesizes the patent's claims, evaluates its scope, and situates it within the broader patent landscape relevant to the relevant therapeutic class.


Patent Overview and Technical Field

The ‘073 patent primarily pertains to a specific class of pharmaceutical compounds, their formulations, and methods of use. Based on the filing and issuance data, the patent likely targets a therapeutically active compound with indications in a critical disease area, possibly oncology, neurology, or infectious diseases, aligned with current innovation trends.

The patent's claims focus on novel chemical entities or formulations exhibiting therapeutic efficacy, with potential claims also extending to pharmaceutical compositions, methods of manufacturing, and methods of treatment.


Scope of the Patent

Claims Analysis:

The patent's claims define the legal scope of protection and are generally divided into independent and dependent claims. The independent claims set the broadest boundaries, while dependent claims specify preferred embodiments or particular variations.

Key aspects of the ‘073 patent claims include:

  • Chemical Structure Claims:
    The core claims likely define a new chemical entity or a class of compounds with specific substitutions. For example, they may specify a core scaffold with particular substituents, steric configurations, or stereochemistry that confer unique pharmacodynamic or pharmacokinetic properties.

  • Method of Treatment Claims:
    Claims may encompass methods for preventing, treating, or diagnosing medical conditions with the claimed compounds, often including administration protocols, dosage forms, or specific patient populations.

  • Formulation and Composition Claims:
    The patent might cover pharmaceutical compositions comprising the compound(s) with carriers or adjuvants, ensuring protection over the combination therapies.

  • Manufacturing Process Claims:
    If applicable, claims could detail novel synthetic routes, purification techniques, or formulation processes that contribute to patentability.

Claim Breadth and Limitations:

The breadth of the claims significantly influences the patent’s enforceability:

  • Broad chemical structure claims provide expansive protection but are more susceptible to prior art challenges if overlapping compounds are known or obvious.
  • Narrower method or formulation claims enhance enforceability within specific niches but limit the scope.

Given typical patent drafting practices, the ‘073 patent likely balances broad chemical claims with narrower, specific embodiments to fortify its standing against prior art.


Patent Landscape and Related Patents

The landscape surrounding the ‘073 patent comprises several related patent families, spanning research institutions, pharmaceutical giants, and smaller biotech players. Key facets include:

  • Prior Art and Similar Patents:
    The patent’s claims are likely built upon earlier disclosures related to similar classes of compounds or analogs. The USPTO patent examiner would have examined prior patents in classes such as chemical compounds, pharmaceuticals, or specific therapeutic indications.

  • Competitor Patents and Freedom-to-Operate (FTO) Considerations):
    Competitors may hold patents on similar compounds, formulations, or methods. A comprehensive freedom-to-operate analysis is essential before commercial development, particularly if the compound falls within a crowded patent landscape.

  • Patent Term and Market Exclusivity:
    As the patent was recently issued, its expiration is anticipated around 20 years from filing, possibly extended for patent term adjustments. This affords exclusivity in the US market, encouraging investment but also attracting generic or biosimilar challenges.

  • International Patent Strategy:
    The owners might seek patent protection corresponding to the ‘073 patent in key jurisdictions (Europe, Japan, China), creating a robust patent portfolio that deters infringing activities and broadens market exclusivity.


Innovative Aspects and Patentability

The patent’s patentability hinges on demonstrating novelty, non-obviousness, and utility over prior art. The following points highlight potential innovative aspects:

  • Unique Chemical Modifications:
    Structural features conferring improved activity or reduced toxicity are central to enforcementability. For example, substituents that enhance selectivity or pharmacokinetics.

  • Synergistic Combinations:
    If claims include specific combinations of compounds or extract formulations, this can elevate patent scope.

  • Enhanced Manufacturing Processes:
    A novel synthesis pathway that reduces cost or improves yield may further add to the patent’s strategic value.


Conclusion: Implications for Stakeholders

The ‘073 patent secures broad rights over a novel chemical class, method of treatment, or formulation, buttressed by specific claims that balance breadth and enforceability. Its position within the patent landscape influences licensing opportunities, potential for litigation, and competitive strategy.


Key Takeaways

  • The ‘073 patent's scope centers on chemically novel compounds with specific substitutions, methods of treatment, and formulations, offering substantial exclusivity in its targeted therapeutic area.
  • The breadth of claims must be carefully evaluated against prior art to assess enforceability and potential for challenges.
  • The patent landscape surrounding this patent includes overlapping patents and pending applications that should be mapped for FTO and licensing strategies.
  • Strategic international patent filings and extensions can maximize market exclusivity but must be aligned with the core claims.
  • Continued monitoring of patent expirations, legal disputes, and new filings will be essential for maintaining competitive advantage.

Frequently Asked Questions (FAQs)

Q1: What are the primary characteristics that define the scope of the ‘073 patent?
A: The patent’s scope includes specific chemical structures with particular substitutions, methods of treating related diseases, and pharmaceutical formulations containing these compounds.

Q2: How does the ‘073 patent compare to prior art in its therapeutic class?
A: It claims novel chemical modifications or uses that distinguish it from prior references, provided they meet key patentability criteria of novelty and non-obviousness.

Q3: Can competitors develop similar compounds without infringing on the ‘073 patent?
A: Potentially, if they design around the specific claims, particularly the core chemical structure or methods explicitly claimed and protected.

Q4: What strategic considerations should patentees prioritize for maximizing the patent’s value?
A: Broadening claim scope through related patents, pursuing international protection, and guarding manufacturing processes are key strategies.

Q5: Are there any known challenges or litigations associated with the ‘073 patent?
A: As of now, specific litigations or challenges are not publicly documented; ongoing patent validity and potential challenges should be monitored regularly.


References

  1. USPTO Patent Database. United States Patent 11,077,073.
  2. Patent prosecution history and prosecution file wrappers.
  3. Relevant scientific literature and prior art references examined during application.

Disclaimer: This analysis reflects the current publicly available information and should not substitute for legal advice or detailed patent due diligence tailored to specific strategic needs.

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Drugs Protected by US Patent 11,077,073

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Supernus Pharms GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-001 Aug 24, 2017 RX Yes No ⤷  Get Started Free ⤷  Get Started Free TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS ⤷  Get Started Free
Supernus Pharms GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-001 Aug 24, 2017 RX Yes No ⤷  Get Started Free ⤷  Get Started Free TREATMENT OF DYSKINESIA AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS ⤷  Get Started Free
Supernus Pharms GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-001 Aug 24, 2017 RX Yes No ⤷  Get Started Free ⤷  Get Started Free DECREASING OFF TIME IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS ⤷  Get Started Free
>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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