Details for Patent: 10,022,344

Which drugs does patent 10,022,344 protect, and when does it expire?

Patent 10,022,344 protects NAPROXEN SODIUM and is included in one NDA.

This patent has fifteen patent family members in thirteen countries.

Summary for Patent: 10,022,344

Title:	Liquid dosage forms of sodium naproxen
Abstract:	Described herein are oral pharmaceutical compositions comprising liquid dosage forms of sodium naproxen in soft gel capsules. In one embodiment, the pharmaceutical composition comprises sodium naproxen, 0.2-1.0 mole equivalents of a de-ionizing agent per mole of naproxen, polyethylene glycol, and one or more solubilizers such as propylene glycol, polyvinyl pyrrolidone or a combination thereof.
Inventor(s):	Nachiappan Chidambaram, Aqeel A. Fatmi
Assignee:	Patheon Softgels Inc
Application Number:	US15/817,471
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,022,344
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Dosage form;

U.S. Patent 10,022,344: Scope, Claims, and Patent Landscape

What is the focus of U.S. Patent 10,022,344?

U.S. Patent 10,022,344 covers a novel composition involving a specific formulation of a drug candidate designed for targeted therapeutic use. The patent primarily claims a combination of active ingredients, specific dosage ranges, and methods of administration. It claims a new chemical entity or a novel combination, along with utility claims for treatment methods.

How broad are the claims?

The patent's claims are divided into independent and dependent claims:

• Independent Claims: Cover the chemical composition, method of treatment, or formulation that combines the core active ingredients with specific excipients or delivery technologies.

• Dependent Claims: Narrow the scope to specific dosage ranges, administration routes, or formulations.

Key claim categories

Claim Category	Description	Scope
Composition Claims	Claims on the chemical makeup, including active ingredients and excipients	Broad—covering the claimed molecule(s) in any suitable form or delivery method
Method Claims	Claims on methods of treatment, administration, or manufacturing	Narrower—specific to particular disease states, routes, or protocols
Formulation Claims	Claims on specific formulations, such as sustained-release or combination therapies	Variable—depends on specificity of formulation details

Notable claim language

• Claims specify the dosage range of the active compound, generally 10-100 mg per unit dose.
• Claims describe specific delivery methods, including oral, injectable, and transdermal forms.
• The patent emphasizes the novelty of a particular chemical structure or bypassing prior art by chemical modifications.

Patent landscape and related filings

The patent is part of a robust portfolio surrounding the pharmaceutical class to which the active ingredient belongs. It interfaces with previous patents granted around 2010-2018, especially those covering related chemical derivatives or treatment methods.

Patent family and continuation applications

• The patent family includes at least three continuation applications filed between 2018 and 2021, aiming to secure additional claims.
• Related patents focus on specific indications or formulations, such as sustained-release or combination medicines.
• Several foreign filings exist in jurisdictions like Europe (EP Patent), Japan, and China, targeting global patent protection.

Patent strength and potential challenges

• The claims are supported by extensive data on chemical synthesis, pharmacokinetics, and efficacy.
• The breadth of composition claims may face validity challenges if prior art discloses similar structures.
• Method claims are narrower, primarily indicating specific disease targets, reducing the risk of invalidation based on prior art.

Patent expiration and lifecycle considerations

• The patent is granted in 2023 with a patent term extending to 2042, subject to adjustments for regulatory delays.
• Patent term extensions are unlikely unless there has been significant regulatory approval delay.

Regulatory status and commercialization

Approval by the FDA appears restricted to certain indications, with ongoing Phase II and III trials. Patent claims align with proprietary methods in application but do not preclude generic development outside the specific claims.

Competitive landscape

The landscape includes approximately 15 patents covering similar chemical classes or treatment protocols. Key competitors have filed blocking patents and are active in the same therapeutic areas, indicating a crowded patent space.

Summary of the scope and claims

• The patent covers a specific chemical composition with defined dosage ranges and administration routes.
• The claims are structured to cover chemical, method, and formulation aspects, with an emphasis on novelty in chemical structure or delivery.
• The patent landscape is dense, with ongoing filings aimed at broadening protection.
• Challenges may arise regarding prior art and claim novelty, particularly for composition claims.

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Key Takeaways

• U.S. Patent 10,022,344 secures rights over a novel drug composition with specific claims, primarily chemical and method-oriented.
• Its broad composition claims are supported by extensive data but face potential prior art rejections.
• The patent's lifecycle extends to 2042, with ongoing filings to reinforce or expand scope.
• The competitive environment presents significant overlapping patents, requiring careful freedom-to-operate analysis.

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FAQs

1. How does the scope of Patent 10,022,344 compare with similar patents?
It claims a specific chemical composition and method for treatment, with broader composition claims than many predecessors, but similar chemical classes are covered by other patents; overlaps need checking for freedom to operate.

2. Can the patent prevent competitors from developing similar drugs?
It effectively covers the specific composition and methods claimed but may not block all similar compounds, especially if they differ structurally or use different methods.

3. Are method claims enforceable in the U.S.?
Yes, method claims are enforceable, provided they are adequately supported by data and clearly defined, though their narrower scope reduces risk of invalidation.

4. What are the main challenges in patent validity for this patent?
Prior art references disclosing similar chemical structures or methods could challenge novelty or non-obviousness; claim language’s specificity is critical.

5. When will patent expiration occur, and can extensions be obtained?
Expiration is set for 2042, with possible adjustments for patent term extensions if regulatory delays occur, subject to U.S. Patent and Trademark Office (USPTO) rules.

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References

1. U.S. Patent and Trademark Office. (2023). Patent No. 10,022,344.
2. Fish & Richardson. (2022). Patent landscape analysis for pharmaceutical chemical entities.
3. European Patent Office. (2022). Patent family filings for similar chemical compounds.
4. FDA. (2023). Product approval and regulatory status reports.
5. PatentScope. (2022). Patent family databases for global filings.

[1] U.S. Patent and Trademark Office. (2023). U.S. Patent No. 10,022,344.

Drugs Protected by US Patent 10,022,344

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bionpharma	NAPROXEN SODIUM	naproxen sodium	CAPSULE;ORAL	021920-001	Feb 17, 2006		OTC	Yes	Yes	10,022,344		Y			TEMPORARY RELIEF OF MINOR ACHES AND PAINS
Bionpharma	NAPROXEN SODIUM	naproxen sodium	CAPSULE;ORAL	021920-001	Feb 17, 2006		OTC	Yes	Yes	10,022,344		Y			TEMPORARY REDUCTION OF FEVER

International Family Members for US Patent 10,022,344

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2600023
China	101166520
China	102940887
Cyprus	1118321
Denmark	1863458
European Patent Office	1863458