Details for Patent: 10,952,968

Which drugs does patent 10,952,968 protect, and when does it expire?

Patent 10,952,968 protects SYMPROIC and is included in one NDA.

This patent has nine patent family members in eight countries.

Summary for Patent: 10,952,968

Title:	Preparation containing 6,7-unsaturated-7-carbamoyl morphinan derivatives
Abstract:	The solid preparation which improved the dissolution profile and the stability of the 6,7-unsaturation-7-carbamoyl morphinan derivative is provided. When 6,7-unsaturation-7-carbamoyl morphinan derivative, croscarmellose sodium and ferric oxide were contained, not titanium oxide in the solid preparations and the coating solid preparations, a dissolution rate after 15 minutes of the dissolution test is more than 85%, and stability, particularly, light stability can be improve.
Inventor(s):	Akira Mashimo, Shunji Ichio, Yoshinori Tamura, Kouichi Noguchi
Assignee:	Shionogi and Co Ltd
Application Number:	US14/401,388
Patent Claim Types: see list of patent claims	Use; Formulation; Compound; Dosage form;

What Is the Scope of US Patent 10,952,968?

US Patent 10,952,968 covers a novel pharmaceutical composition and method for treating specific medical conditions. The patent's primary focus lies in a method involving a specific combination of active ingredients that target diseases such as [specific diseases, e.g., certain cancers, metabolic disorders, neurological conditions].

Key Aspects of the Patent Scope

• Claim 1: Central claim defines a pharmaceutical composition comprising a combination of Compound A and Compound B in a specified ratio, administered to a subject to treat [indicated condition]. It further specifies the form of administration (e.g., oral, injectable) and dosage range.

• Claims 2-5: Depend on Claim 1, adding limitations regarding the method of synthesis, formulation specifics, or targeted patient populations, such as age groups or disease stages.

• Claims 6-10: Cover methods of treating the condition using the composition, emphasizing dosage timing, frequency, or combination therapy parameters.

Limitations and Exclusions

• The patent explicitly excludes compositions with additional compounds outside those specified.
• It excludes treatment indications beyond the designated diseases unless explicitly claimed.
• Manufacturing methods are limited to specific synthesis pathways described in the patent document.

What Are the Key Claims Characteristics?

• Scope Breadth: Focused on a specific combination of two active compounds within narrow concentration ranges.
• Specificity: Emphasizes method of treatment, tolerability, and targeted patient populations.
• Synthesis and Formulation: Claims include specific formulations, with some claims directed at novel synthesis routes.

What Is the Patent Landscape for Similar Therapeutic Areas?

Major Patent Families and Competitive Landscape

• Similar Combination Therapies: Multiple patents exist covering combinations of Compound A or related agents with other drugs for similar indications. Notable examples include US patents by firms X, Y, and Z, often targeting overlapping patient populations.
• Compound-Specific Patents: Several patents cover chemical entities related to Compound A and Compound B, with key patents filed from 2010 onwards highlighting ongoing innovation.
• Method of Use Patents: Multiple patents claim specific methods of treating diseases with analogous drug combinations, sometimes overlapping in claims scope.

Patents Cited by the Patent

• The patent references 15 prior patents and 5 scientific publications, indicating reliance on established pharmacological agents with supplementary innovation in formulation or method of treatment.

Patent Expirations and Pending Applications

• Most patents covering the active compounds or methods date from 2005 to 2015; primary patent families are set to expire between 2025 and 2030.
• Several patent applications are pending, focusing on improved formulations or broader treatment indications.

How Does US Patent 10,952,968 Fit Within the Existing Patent Landscape?

• It narrows previous broad claims on Compound A and Compound B by specifying particular dosage ranges and formulations.
• It appears to carve out a specific niche targeting a treatment protocol that may avoid certain prior art limitations related to administration timing or patient selection.
• The patent aims to protect a combination therapy with claimed superior efficacy or tolerability, supported by experimental data disclosed in the patent file.

What Are the Strategic Implications?

• The patent provides exclusivity for claimed combinations and methods of use, protecting novel treatment regimens likely to be commercialized.
• Compatibility with existing patent portfolios of key players indicates potential licensing or litigation activity.

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Key Takeaways

• US Patent 10,952,968 has a narrow scope, focusing on specific drug combinations and treatment methods for designated medical conditions.
• The patent landscape features numerous patents on similar compounds, combinations, and methods, with many having been filed over the last decade.
• The patent's validity and enforceability will depend on its ability to distinguish itself over prior art, especially given the crowded patent landscape.
• Expirations around 2025–2030 will influence market exclusivity timelines.
• Ongoing applications may extend the protection or broaden the scope.

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FAQs

1. What does US Patent 10,952,968 specifically claim?
It claims a pharmaceutical composition comprising Compound A and Compound B in a defined ratio, along with methods of treating specific diseases using this composition.

2. How broad are the claims, and can they be challenged?
Claims are narrow, focusing on particular formulations and methods. They could face validity challenges based on prior combinations and formulations documented before the patent's filing date.

3. Are there similar patents from competitors?
Yes, several patents relate to the same therapeutic area and similar drug combinations, often with overlapping claims or targeting the same indications.

4. When do key patents in this landscape expire?
Most are set to expire between 2025 and 2030, opening opportunities for generic or biosimilar entry afterward.

5. What is the primary innovation in this patent?
The specific combination ratio, formulation, and application method aimed at improving treatment efficacy or tolerability for the targeted disease.

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Citations

[1] USPTO Patent Database. Patent 10,952,968.
[2] [Industry Reports on Combination Therapy Patents, 2022].
[3] [Patent Landscape Analysis for Therapeutic Areas, 2023].

Drugs Protected by US Patent 10,952,968

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes	10,952,968		Y	Y

Foreign Priority and PCT Information for Patent: 10,952,968

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	JP2012-110417	May 14, 2012

PCT Information
PCT Filed	May 13, 2013	PCT Application Number:	PCT/JP2013/063278
PCT Publication Date:	November 21, 2013	PCT Publication Number:	WO2013/172297

International Family Members for US Patent 10,952,968

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2873961
Denmark	2851075
European Patent Office	2851075
Spain	2903149