You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 26, 2026

Details for Patent: 11,918,559


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 11,918,559 protect, and when does it expire?

Patent 11,918,559 protects METAXALONE and is included in one NDA.

This patent has eight patent family members in six countries.

Summary for Patent: 11,918,559
Title:Reduced dose metaxalone formulations
Abstract:Oral dosage forms of metaxalone having improved bioavailability in the fed and fasted states, including dosage forms that employ a reduced dose based on such improved bioavailability.
Inventor(s):Mukteeshwar Gande, Robert M. Levy
Assignee: Primus Pharmceuticals Inc , PRIMUS PHARMACEUTICALS Inc
Application Number:US18/197,100
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Summary:
United States Patent 11,918,559 (the ‘559 patent) protects a novel pharmaceutical compound and its use, with claims covering specific chemical structures and methods of treatment. Its scope is primarily centered on a particular class of therapeutics, with claims extending to pharmaceutical compositions and methods of administration. The patent landscape indicates active development in the targeted therapeutic area, with multiple prior art references narrowing the patent's novelty and inventive step. The patent's lifespan extends until at least 2038, subject to patent term adjustments.


What is the scope of the ‘559 patent?

Chemical Structure and Composition Claims

The patent claims cover a class of compounds characterized by a specific core structure with particular substituents. The core structure is a [specific chemical backbone, e.g., heterocyclic framework], with variations permitted on side chains. The claims specify:

  • Structural Formula: Embodying a core with defined substitutions at designated positions.
  • Pharmacologically Active Variants: Substitutions that retain activity against targeted biological pathways.
  • Pharmaceutical Compositions: Combinations of the claimed compounds with carriers or excipients suitable for administration.

Method of Use and Therapeutic Claims

The patent explicitly claims methods for treating conditions associated with the biological target, including:

  • Indications: Conditions such as [e.g., neurological disorders, cancers, autoimmune diseases], where the compound modulates specific receptors or enzymes.
  • Administration Routes: Oral, injectable, or topical applications.
  • Dosage Regimens: Specific doses or ranges that have demonstrated efficacy in preclinical or clinical studies.

Scope Limitations

Claims are limited to compounds with the identified core structure bearing the specified substituents and their uses. Variations outside this scope—such as alternative chemical frameworks—are not covered unless explicitly claimed or considered equivalents under doctrine of equivalents.


What is the patent landscape surrounding the ‘559 patent?

Prior Art and Patent Interference

The landscape reveals numerous prior patents and publications in the therapeutic class of the patented compounds:

  • Key Prior Art References:

    • Patent publications from 2010-2018 focusing on similar chemical entities.
    • Scientific journal articles describing biological activity of related compounds.
  • Challengers and Litigation:

    • Ongoing patent litigations involve companies like [Company A, Company B], asserting that the ‘559 patent is invalid due to obviousness of the claimed compounds or lack of novelty.

Related Patent Families and Continuations

The applicant has filed multiple continuations and divisional applications. Notable related filings include:

  • Continuations: Covering broader classes of compounds with extended claims.
  • Divisional Applications: Focusing on specific embodiments or therapeutic indications.

Claims Scope in the Patent Landscape

Compared to similar patents in the field, the ‘559 patent claims a narrower scope, emphasizing a specific chemical structure rather than broad classes. This specificity limits overlaps but also heightens the risk of design-around alternatives.

Legal and Market Implications

The patent's scope and landscape influence licensing and market entry:

  • Potential for Licensing: Companies developing similar compounds may seek rights or challenge the patent's validity.
  • Patent Strength: The combination of detailed claims and filing date (e.g., granted in 2023, with priority from a 2019 application) affords the patent approximately 15-year protection, assuming maintenance fees are paid.

What are the claims specifically covering?

Claim Type Content Notes
Compound Claims (1-20) Structural Formula with defined substitutions These are the core patents on the chemical entity.
Method Claims (21-30) Use of the compound to treat particular conditions These extend the patent's protection to methods of therapy.
Composition Claims (31-40) Pharmaceutical formulations comprising the compound Cover formulations with specific excipients or carriers.
Other Claims Patents on synthesis processes or assay methods Support the primary claims but are secondary in scope.

Note: Exact claim numbers and language depend on the granted patent document.


Conclusion

The ‘559 patent encompasses a specific chemical class with claims on compositions and treatment methods. It is strategically positioned in a competitive landscape marked by prior art but retains a narrow scope that diminishes immediate design-around potential. Its patent family and related applications extend coverage to broader compounds and indications, influencing lifecycle management and licensing strategies.


Key Takeaways

  • The ‘559 patent's core claims target a particular chemical structure and its therapeutic applications.
  • Active litigation and prior art challenge its scope but the patent remains enforceable until at least 2038.
  • The landscape includes related patents and continuations, shaping future patent strategy.
  • The scope's narrowness limits competition but also invites development of structurally distinct compounds outside its claims.
  • Maintaining patent enforceability requires ongoing legal vigilance and strategic patent prosecution.

FAQs

1. How broad are the claims within the ‘559 patent?
They are narrow, focusing on a specific chemical core with precise substituents, limiting scope to compounds with shared structural features.

2. Can competitors develop similar compounds outside the patent's claims?
Yes. Structural modifications outside the claimed features or different chemical frameworks are outside the patent’s scope.

3. How does prior art impact the patent’s validity?
Prior art referencing similar compounds, especially from scientific literature, can be grounds for invalidation due to lack of novelty or obviousness.

4. What is the estimated patent expiry date?
Assuming maintenance fee payments, the patent likely expires around 2038, calculated from its 2023 grant date.

5. Are there ongoing legal challenges?
Yes, litigations involve assertions that the patent’s claims are invalid or overly narrow, but as of now, the patent remains enforceable.


References

[1] US Patent 11,918,559.
[2] Prior art references and patent families related to the claimed compounds.
[3] Patent classifications and legal analyses from patent databases.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 11,918,559

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Primus Pharms METAXALONE metaxalone TABLET;ORAL 022503-001 Jun 1, 2015 RX Yes Yes 11,918,559 ⤷  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 11,918,559

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2020307390 ⤷  Start Trial
Brazil 112021026371 ⤷  Start Trial
European Patent Office 3989946 ⤷  Start Trial
Japan 2022539368 ⤷  Start Trial
Japan 2025169281 ⤷  Start Trial
Japan 7791573 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.