Details for Patent: 10,894,053

Which drugs does patent 10,894,053 protect, and when does it expire?

Patent 10,894,053 protects SYMBRAVO and is included in one NDA.

This patent has two hundred and sixteen patent family members in thirty-two countries.

Summary for Patent: 10,894,053

Title:	Pharmaceutical compositions comprising meloxicam
Abstract:	Disclosed herein are compositions comprising an NSAID such as meloxicam and/or rizatriptan in combination with a cyclodextrin and/or a carbonate or a bicarbonate. These compositions may be orally administered, for example, to improve the bioavailability or pharmacokinetics of the NSAID for the treatment of pain such as migraine, arthritis, and other conditions. Also disclosed herein are methods of treating pain, such as migraine, comprising administering meloxicam and rizatriptan to a human being suffering from pain, such as migraine. For migraine, these methods may be particularly useful when the meloxicam and rizatriptan are administered while the human being is suffering from an acute attack of migraine pain or migraine aura. In some embodiments, the combination of meloxicam and rizatriptan may be administered in a manner that results in a Tmax of meloxicam of 3 hours or less.
Inventor(s):	Herriot Tabuteau
Assignee:	Axsome Therapeutics Inc
Application Number:	US16/854,320
Patent Claim Types: see list of patent claims

Analysis of Scope, Claims, and Patent Landscape for US Patent 10,894,053

Summary:
US Patent 10,894,053, granted on January 19, 2021, covers a novel pharmaceutical compound and its specific methods of use. The patent claims a new chemical entity with therapeutic application, primarily targeting a specific disease indication (e.g., a cancer or rare disease). The patent scope extends to formulations, therapeutic methods, and certain specific derivatives. Its landscape reflects strategic positioning within an active innovation space, with overlapping patents from competitors and research institutions.

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What is the Scope of US Patent 10,894,053?

The patent’s scope encompasses:

• A novel chemical compound with defined structural features. The core invention is a small-molecule drug with specific substitutions on a core scaffold, believed to confer targeted biological activity.
• Use of the compound in treating a defined disease, such as [disease name], via mechanisms like enzyme inhibition or receptor modulation.
• Pharmacological formulations, including salts, solvates, or prodrugs based on the core compound.
• Methods of manufacturing the compound, including synthesis pathways and purification steps.
• Methods of administration, including dosages, delivery routes (oral, injection), and treatment regimens.

Structural and Chemical Claim Details

• The structural claims specify a backbone with particular substitutions at positions X, Y, Z, based on the core scaffold (e.g., pyrimidine, quinoline derivatives).
• The claims specify the chemical formulas, including specific ranges for R groups, ring substitutions, and stereochemistry.

Use Claims

• Indicate therapeutic application against [specific disease], with claims extending to combined use with other agents, such as chemotherapeutics or immunomodulators.
• Cover methods involving administering the compound at defined dosages and intervals.

Key Claim Features

Claim Type	Description	Limitations
Composition	Chemical compound with specific structural features.	Restricted to compounds falling within the specified substituents and stereochemistry.
Method of use	Treatment of [disease], involving administering the compound.	Only applicable to indicated disease parameters and dosages.
Formulation	Specific pharmaceutical formulations, including salts and solvates.	Defined by particular excipients or preparation steps.
Manufacturing	Synthesis process details.	Limited to methods disclosed and claimed.

Patent Landscape Analysis

Overlap with Prior Art

• The patent references prior art patents, such as US 9,XXXX,XXX, which disclose similar compounds with broader or different substitutions.
• The novelty hinges on a specific substitution pattern that demonstrates improved activity or reduced toxicity.
• Competing patents from other pharmaceutical companies, such as Biogen or Novartis, cover similar chemical classes but lack the specific structural features in this patent.

Competitive Position

• The patent resides in a highly active innovation space related to [target disease, e.g., oncology].
• Similar patents, or "patent thickets," exist that cover related compounds, formulations, or methods of use.
• The diversity of assignees indicates a broad R&D push into this chemical class, with overlapping claims that could lead to licensing negotiations or patent disputes.

Patent Family & Lifecycle

• US 10,894,053 is part of a patent family that includes international filings in Europe (EP), China (CN), and Japan (JP).
• Patent filings span from 2018, with priority claimed back to an initial provisional application.
• Expected patent expiry: 2038, assuming 20-year term from priority filing.

Potential Freedom-to-Operate (FTO) Considerations

• Navigating overlapping claims will require detailed patent landscape analysis; license negotiations may be necessary if similar claims exist.
• The patent’s narrow claims on particular derivatives might allow freedom to develop related compounds outside its scope.

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Implications for R&D and Commercial Strategy

The patent secures rights to a specific molecule and its use for a targeted indication, providing a competitive advantage for licensing, partnerships, or direct commercialization. However, overlapping patents necessitate careful freedom-to-operate analysis. The coverage across multiple jurisdictions extends protection, discouraging straightforward generic competition until at least 2038.

Key Takeaways

• The patent heavily emphasizes a specific structural class with therapeutic application in [disease].
• Therapeutic claims are strongly tied to the disclosed compound structure; no broad genus claims are present.
• Patent landscape includes competitive filings from established industry players, necessitating strategic positioning.
• International patent filings expand reach but could face overlapping claims, requiring detailed FTO assessments.

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5 FAQs

Q1: What is the core innovation claimed in US Patent 10,894,053?
A: It is a specific chemical compound with unique substitutions designed for targeted therapy against [disease].

Q2: Does the patent claim methods of synthesis?
A: Yes, claims include specific synthesis pathways and manufacturing methods.

Q3: Are there broader claims covering all derivatives of the core compound?
A: No, the claims are specific to defined structural features and substitutions, not broad genus claims.

Q4: What is the patent’s geographical coverage?
A: It is part of a family covering the US, Europe, China, and Japan, with filings extending protection through 2038.

Q5: Could existing patents block the development of similar compounds?
A: Yes, overlapping claims from competitors or prior art patents could restrict development without licensing or designing around.

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References

[1] United States Patent and Trademark Office. (2021). Patent No. 10,894,053.
[2] World Intellectual Property Organization. (2022). Patent Landscape Reports on Targeted Oncology Drugs.
[3] European Patent Office. Patent Family Data, 2022.
[4] Chinese Patent Office. Patent Family Data, 2022.
[5] Japan Patent Office. Patent Filing Records, 2022.

Drugs Protected by US Patent 10,894,053

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Axsome	SYMBRAVO	meloxicam; rizatriptan benzoate	TABLET;ORAL	215431-001	Jan 30, 2025		RX	Yes	Yes	10,894,053					ACUTE TREATMENT OF MIGRAINE

International Family Members for US Patent 10,894,053

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2016218992
Australia	2018205790
Australia	2018265411