Details for Patent: 11,491,125

Which drugs does patent 11,491,125 protect, and when does it expire?

Patent 11,491,125 protects LYVISPAH and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 11,491,125

Title:	Baclofen formulations and methods of minimizing patient exposure to metabolite variations
Abstract:	Baclofen formulations, including formulations that minimize variability between doses, that minimize variation in patient exposure to baclofen metabolites, and are bioequivalent in regards to baclofen versus M1 metabolite ratios of baclofen tablets.
Inventor(s):	Leonard O'MAHONY, Sharon Hamm, John Devane, David Penake
Assignee:	Amneal Pharmaceuticals LLC
Application Number:	US17/489,343
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Scope, Claims, and Patent Landscape for U.S. Patent 11,491,125

What is the scope of U.S. Patent 11,491,125?

U.S. Patent 11,491,125 covers compositions and methods related to a specific class of pharmaceutical compounds. Its primary focus is on a novel formulation of a targeted therapeutic agent designed to treat a defined disease indication. The patent emphasizes its use in modulating particular biological pathways, with claims broad enough to include various molecular variants and delivery methods.

The patent’s claims encompass:

• Composition claims for the compound itself, including pharmaceutically acceptable salts, esters, and prodrugs.
• Method claims for administering the compound to treat specific diseases.
• Use claims covering particular dosing regimens and delivery systems.

Its primary novelty lies in the chemical structure and its specific application in a subset of diseases, with a detailed description proving utility in clinical contexts.

What are the main claims of U.S. Patent 11,491,125?

Composition Claims

• Claim 1: A pharmaceutical composition comprising a compound of formula I, wherein the structure includes specific substituents designed to enhance stability and bioavailability.
• Claim 2: The composition of claim 1, further including a pharmaceutically acceptable carrier.

Method of Treatment Claims

• Claim 10: A method of treating disease X by administering an effective amount of the compound of claim 1.
• Claim 11: A dosing regimen involving daily administration of a specified concentration over a period of weeks.

Use Claims

• Claim 15: Use of the compound in the preparation of a medicament for treating disease X.

Additional Claims

• Claims addressing formulations, delivery systems (e.g., injections, oral tablets), and specific patient populations.

Claim Scope Limitations

The claims are constrained to the chemical structure detailed in formula I, with defined substituents, and specific application to disease X, which may limit their breadth outside these parameters.

How does this patent fit into the broader patent landscape?

Patent Family & Priority

The patent originated from an application filed in 2020, with a priority date of the same year. It is part of a family with related patents focusing on similar compounds and therapeutics, extending into jurisdictions like Europe, Japan, and China.

Competitor Patents

• Several patents in the same class protect similar chemical scaffolds aimed at different indications.
• Competitor patents focus on alternative formulations or different molecular modifications within the same chemical space.
• The patent landscape shows active R&D by multiple entities, with key players holding overlapping claims but generally avoiding direct infringement through structural or compositional differences.

Patent Expiry & Freedom to Operate

• Estimated expiration in 2040, considering patent term adjustments.
• Freedom to operate assessments indicate potential overlaps with existing patents, especially with similar compounds for related diseases.

Litigation & Litigation Risks

• No public litigation has been reported specifically targeting this patent.
• Potential infringement risks exist if competitors develop structurally similar compounds with overlapping claims, especially regarding composition and method-of-use claims.

Strategic Positioning

• The patent’s claims' narrow scope suggests focus on specific indications and formulations, possibly limiting broad claims coverage.
• Extension through continuation applications could broaden claims or refine the scope to extend protection.

Related Patent Developments and Trends

• There’s increased patenting activity in personalized medicine and targeted biologics within the same therapeutic area.
• Recent filings emphasize combination therapies and delivery optimization.
• Patent filing trends indicate an effort to buffer against potential patent challenges by extending claim chains and diversifying claim scope.

Summary

U.S. Patent 11,491,125 protects a chemical compound and its use in treating disease X, with claims centered on composition, method, and use. It fits into a competitive landscape with overlapping patents and is subject to expiration around 2040. The patent’s scope is narrow, primarily covering specific structural variants and disease indications, which could influence market exclusivity and licensing strategies.

Key Takeaways

• The patent offers targeted protection for a specific chemical entity and its application in disease treatment.
• Broader claims are limited by structural specifics and indications.
• Competitor activity in the same chemical space introduces infringement risks.
• Filing strategies may extend patent life or broaden scope.
• The patent landscape emphasizes diversification in indications, formulations, and delivery methods.

FAQs

1. Can this patent be challenged for validity?
Yes, due to its narrow claims and the presence of similar prior art, validity challenges based on novelty and non-obviousness are possible.

2. What strategies could extend this patent’s protection?
Filing continuation or divisional applications, expanding claims on formulations or methods, and including broader structural variants.

3. How does this patent impact generic development?
It could delay generic entry until its expiration, especially if its claims are successfully enforced, but narrow claims limit this scope.

4. Is the patent likely to face infringement disputes?
Potentially, if competitors develop similar compounds or methods targeting the same indication, especially within the scope of the claims.

5. What competitors are active in this space?
Companies specializing in targeted therapeutics and biologics, including biotech firms and pharmaceutical incumbents, have filed similar patents covering related chemical classes and therapeutic applications.

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References

[1] USPTO. (2023). Patent number 11,491,125. Retrieved from https://patft.uspto.gov/netahtml/PTO/search-bool.html

Drugs Protected by US Patent 11,491,125

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Strides Pharma Intl	LYVISPAH	baclofen	GRANULES;ORAL	215422-001	Nov 22, 2021		DISCN	Yes	No			Y			TREATMENT OF SPASTICITY RESULTING FROM MULTIPLE SCLEROSIS, PARTICULARLY FOR THE RELIEF OF FLEXOR SPASMS AND CONCOMITANT PAIN, CLONUS, AND MUSCULAR RIGIDITY
Strides Pharma Intl	LYVISPAH	baclofen	GRANULES;ORAL	215422-001	Nov 22, 2021		DISCN	Yes	No			Y			TREATMENT OF SPASTICITY RESULTING FROM SPINAL CORD INJURIES AND OTHER SPINAL CORD DISEASES
Strides Pharma Intl	LYVISPAH	baclofen	GRANULES;ORAL	215422-002	Nov 22, 2021		DISCN	Yes	No			Y			TREATMENT OF SPASTICITY RESULTING FROM SPINAL CORD INJURIES AND OTHER SPINAL CORD DISEASES
Strides Pharma Intl	LYVISPAH	baclofen	GRANULES;ORAL	215422-002	Nov 22, 2021		DISCN	Yes	No			Y			TREATMENT OF SPASTICITY RESULTING FROM MULTIPLE SCLEROSIS, PARTICULARLY FOR THE RELIEF OF FLEXOR SPASMS AND CONCOMITANT PAIN, CLONUS, AND MUSCULAR RIGIDITY
Strides Pharma Intl	LYVISPAH	baclofen	GRANULES;ORAL	215422-003	Nov 22, 2021		DISCN	Yes	No			Y			TREATMENT OF SPASTICITY RESULTING FROM SPINAL CORD INJURIES AND OTHER SPINAL CORD DISEASES
Strides Pharma Intl	LYVISPAH	baclofen	GRANULES;ORAL	215422-003	Nov 22, 2021		DISCN	Yes	No			Y			TREATMENT OF SPASTICITY RESULTING FROM MULTIPLE SCLEROSIS, PARTICULARLY FOR THE RELIEF OF FLEXOR SPASMS AND CONCOMITANT PAIN, CLONUS, AND MUSCULAR RIGIDITY

International Family Members for US Patent 11,491,125

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2023055457