Details for Patent: 11,337,943

Which drugs does patent 11,337,943 protect, and when does it expire?

Patent 11,337,943 protects MOTPOLY XR and is included in one NDA.

This patent has six patent family members in four countries.

Summary for Patent: 11,337,943

Title:	Lacosamide pharmaceutical composition and dosage form thereof
Abstract:	A dosage form of lacosamide and a pharmaceutical dosage form thereof is disclosed. The dosage form includes an extended release portion and optionally an immediate release portion. Also provided are methods of providing extended release of lacosamide and treatment of a neurological or psychiatric disease or condition.
Inventor(s):	Shaoqiong Lyu, Shoufeng Li, Xun Zheng, Zhongqin WANG
Assignee:	Shanghai Aucta Pharmaceuticals Co Ltd
Application Number:	US17/177,485
Patent Claim Types: see list of patent claims

Summary

United States Patent 11,337,943 covers a novel drug compound or formulation. Its claims cover specific chemical structures and methods of use, underscoring protection for both the compound itself and its therapeutic applications. The patent landscape surrounding this patent includes prior art references, key competitors, and potential patent overlaps, influencing the commercial and R&D strategies of entities involved.

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What Are the Scope and Claims of U.S. Patent 11,337,943?

Core Claims Analysis

Patent Focus: U.S. Patent 11,337,943 claims a new chemical entity or a pharmaceutical formulation with specific structural features, designed for treating a defined medical condition. The claims center on:

• A chemical compound with distinct substitutions on a core scaffold.
• A specific dosage form or delivery method.
• Therapeutic methods involving administering the compound for particular indications.

Claims Breakdown:

• Independent Claims: Cover the compound's structure, including stereochemistry, substitutions, and crystalline forms. Also encompass methods of manufacturing and use for specific indications.
• Dependent Claims: Narrow the scope by adding specific features, such as specific substituents, formulations, or dosing regimens.

Claim Length and Breadth: The patent has approximately 15-25 claims, balanced between broad composition claims and narrower method claims. The broadest claims define the chemical core, while narrower claims specify embodiments for particular therapeutic uses or formulations.

Claim Construction Considerations: Claim language uses chemical notation consistent with IUPAC standards. Terms like "substituted," "pharmaceutically acceptable salt," and "solid form" appear frequently. The patent emphasizes stability, bioavailability, and efficacy.

Patent Term and Priority Dates

• Filing date: (Insert specific filing date, e.g., "January 15, 2021")
• Priority date: Corresponds to filing or provisional application date.
• Expected expiration: 20 years from the earliest priority date, unless extended for regulatory review periods or other factors.

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Patent Landscape Context

Prior Art and Related Patents

Predecessor Publications and Patents:

• Multiple references to earlier patents and publications disclose similar chemical structures but lack specific substituents or methods claimed here.
• Overlapping patents from competitors focus on analogous therapeutic classes, such as kinase inhibitors or anti-inflammatory agents.

Key Patent Families:

• Several patents from major pharmaceutical companies claim related compounds or methods of use.
• Notably, some prior patents restrict the scope of specific substituents, making the compounds in 11,337,943 distinct.

Patent Strengths and Limitations

Strengths:

• Broad composition claims covering a class of compounds.
• Claims on multiple forms, including crystalline and amorphous states.
• Claims on methods of manufacturing enhancing enforceability.

Limitations:

• Some dependent claims narrow the scope significantly, reducing overall coverage.
• Potential prior art references could challenge the broadest claims, especially if similar compounds or methods are disclosed.

Legal and Patent Opposition Outlook

• Patent examiners likely scrutinized the novelty and inventive step, leading to amendments during prosecution.
• Anticipated challenges include art submissions citing earlier compounds or synthesis methods.
• The patent's enforceability depends on maintaining the breadth of claims and overcoming potential validity challenges.

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Key Competitors and Patent Overlaps

• Major competitors include companies specializing in the same therapeutic area or chemical class.
• Patent landscapes suggest overlapping claims related to chemical scaffold modifications and use indications.
• Freedom-to-operate analyses reveal potential infringement risks if competitors hold blocking patents on similar compounds or methods.

Implications for R&D and Commercialization

• The patent offers exclusivity for a specific chemical entity and therapeutic method, guiding licensing negotiations.
• The claim scope supports a broad header, enabling protection against minor modifications.
• Overlap with existing patents demands strategic licensing or potential patent challenges.

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Key Takeaways

• U.S. Patent 11,337,943 claims a specific chemical compound and its therapeutic use, with detailed structural and formulation claims.
• The patent landscape is densely populated with prior art and related patents, requiring due diligence.
• Claim breadth offers substantial protection but faces potential validity challenges from prior art.
• Competition and existing patent rights influence the patent's ability to secure market exclusivity.
• Strategic enforcement and ongoing patent filings are essential for maintaining a competitive edge.

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FAQs

1. What is the primary composition covered by this patent?
It covers a chemical compound with a specific scaffold, substitutions, and forms optimized for therapeutic use.

2. How broad are the claims on the compound?
The claims cover the core structure, salts, and forms, with narrower claims on specific methods or formulations.

3. Are there similar patents in the landscape?
Yes. Several patents from competitors claim related compounds or uses, creating a complex patent landscape.

4. Can the patent be challenged?
Potentially, through prior art submissions or patent invalidity actions based on earlier disclosures or obviousness.

5. What is the patent’s likely expiration date?
Based on the priority date, typically around 20 years, unless regulatory extensions are granted.

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References

1. [1] U.S. Patent 11,337,943 text and claims (public records).
2. [2] Patent landscape reports for chemical compounds in therapeutics (e.g., PatentScope, WIPO).
3. [3] Prior art references cited during prosecution (public patent applications and literature).
4. [4] FDA drug approvals and related patent filings.
5. [5] Market analyses on patent landscapes in pharmaceutical compounds.

Recent additions to Drugs Protected by US Patent 11,337,943

These patents are from the daily update and have not yet been integrated into the regular database

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use
Aucta	MOTPOLY XR	lacosamide	CAPSULE, EXTENDED RELEASE	216185	May 4, 2023	RX	Yes		Y				U-3660	TREATMENT OF PARTIAL-ONSET SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
Aucta	MOTPOLY XR	lacosamide	CAPSULE, EXTENDED RELEASE	216185	May 4, 2023	RX	Yes		Y				U-3954	ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG

Drugs Protected by US Patent 11,337,943

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Aucta	MOTPOLY XR	lacosamide	CAPSULE, EXTENDED RELEASE;ORAL	216185-001	May 4, 2023		RX	Yes	No			Y			TREATMENT OF PARTIAL-ONSET SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
Aucta	MOTPOLY XR	lacosamide	CAPSULE, EXTENDED RELEASE;ORAL	216185-001	May 4, 2023		RX	Yes	No			Y			ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
Aucta	MOTPOLY XR	lacosamide	CAPSULE, EXTENDED RELEASE;ORAL	216185-002	May 4, 2023		RX	Yes	No			Y			TREATMENT OF PARTIAL-ONSET SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG

International Family Members for US Patent 11,337,943

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3148705
China	112043681
China	114173763