Details for Patent: 10,858,341

Which drugs does patent 10,858,341 protect, and when does it expire?

Patent 10,858,341 protects AZSTARYS and is included in one NDA.

This patent has twenty-three patent family members in seventeen countries.

Summary for Patent: 10,858,341

Title:	Compositions comprising methylphenidate-prodrugs, processes of making and using the same
Abstract:	The present technology is directed to compositions comprising d-threo-methylphenidate conjugates and unconjugated methylphenidate. The present technology also relates to compositions and oral formulations comprising d-threo-methylphenidate conjugated to nicotinoyl-L-serine, and/or a pharmaceutically acceptable salt thereof, and unconjugated methylphenidate and/or a pharmaceutically acceptable salt thereof. The present technology additionally relates to a pharmaceutical kit containing the composition comprising d-threo-methylphenidate conjugated to nicotinoyl-L-serine, and/or a pharmaceutically acceptable salt thereof, and unconjugated methylphenidate and/or a pharmaceutically acceptable salt thereof.
Inventor(s):	Mickle; Travis (Kissimmee, FL), Guenther; Sven (Coralville, IA), Chi; Guochen (Coralville, IA)
Assignee:	KemPharm, Inc. (Celebration, FL)
Application Number:	16/793,923
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Understanding the Scope and Claims of United States Patent 10,858,341

Introduction to Patent 10,858,341

United States Patent 10,858,341, titled "Compositions comprising methylphenidate-prodrugs, processes of making and using the same," is a patent that delves into the development and application of specific pharmaceutical compositions. Here, we will analyze the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Patent Number and Publication Details

• The patent number is US10,858,341B2, with the publication number US202016793923A[4].

Inventors and Assignees

• While the specific inventors and assignees are not detailed in the provided sources, this information can typically be found in the patent document itself.

Scope of the Patent

Subject Matter

• The patent focuses on compositions that include d-threo-methylphenidate conjugates and unconjugated methylphenidate. Methylphenidate is a well-known medication used primarily for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and certain cases of narcolepsy[4].

Pharmaceutical Applications

• The compositions described are designed to improve the delivery and efficacy of methylphenidate. This includes prodrugs, which are compounds that, after administration, are metabolized into the pharmacologically active drug. The use of prodrugs can enhance bioavailability, reduce side effects, and improve patient compliance[4].

Claims of the Patent

Claim Structure

• Patents typically include a set of claims that define the scope of the invention. These claims are categorized into independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims[3].

Specific Claims

• For Patent 10,858,341, the claims would detail the specific compositions, methods of preparation, and uses of the methylphenidate-prodrugs. For example, claims might include:
  • Compositions comprising d-threo-methylphenidate conjugates.
  • Methods for preparing these compositions.
  • Methods for using these compositions in the treatment of ADHD or other conditions[4].

Patent Landscape

Global Patent Trends

• The USPTO grants a significant number of patents annually, with a substantial portion coming from foreign inventors. In 2016, for instance, nearly half of the patents granted by the USPTO went to U.S. inventors, followed by Japan and the European Union[1].

Industry-Specific Patenting

• The pharmaceutical industry, where this patent resides, is highly active in patenting. High-technology manufacturing and commercial knowledge-intensive services industries, including pharmaceuticals, account for a large share of patents. In 2015, U.S. high-technology manufacturing industries received 61% of the patents granted to U.S. manufacturing industries[1].

Technology Areas

• The patent in question falls under the pharmaceuticals and biotechnology fields, which are among the top areas for university and industry patenting. These fields have seen significant growth in patenting activity over the years, reflecting the ongoing innovation in these areas[1].

Economic and Innovation Impact

Innovation Drivers

• Patents like US10,858,341 drive innovation by protecting intellectual property and encouraging investment in research and development. The detailed information on claims and scope helps in understanding the technological advancements and their potential applications[3].

Market Competition

• The pharmaceutical industry is highly competitive, and patents play a crucial role in market positioning. Companies that secure patents for novel compositions and methods can gain a competitive edge, influencing market dynamics and patient treatment options[1].

Legal and Regulatory Aspects

Patent Protection

• The USPTO is responsible for granting U.S. patents and ensuring that the inventions meet the criteria of being new, useful, and nonobvious. The protection provided by a patent allows the inventor or assignee to exclude others from making, using, or selling the invention for a specified period[2].

Global Compliance

• Patents are territorial, meaning they must be filed and granted in each country where protection is sought. The global patent landscape is complex, with different countries having their own patent laws and regulations. International cooperation and agreements, such as those facilitated by the World Intellectual Property Organization (WIPO), help in harmonizing these processes[1].

Conclusion

Patent 10,858,341 represents a significant advancement in the field of pharmaceuticals, particularly in the treatment of ADHD. Understanding the scope and claims of this patent provides insights into the innovative compositions and methods developed. The broader patent landscape highlights the importance of intellectual property protection in driving innovation and competition in the pharmaceutical industry.

Key Takeaways

• Patent Focus: The patent is on compositions comprising methylphenidate-prodrugs.
• Pharmaceutical Applications: Improves delivery and efficacy of methylphenidate.
• Claims Structure: Includes independent and dependent claims defining the invention.
• Industry Context: Part of the highly active pharmaceutical and biotechnology patenting fields.
• Economic Impact: Drives innovation and influences market competition.
• Legal Protection: Granted by the USPTO, providing territorial protection.

FAQs

1. What is the main subject of United States Patent 10,858,341? The main subject is compositions comprising d-threo-methylphenidate conjugates and unconjugated methylphenidate.

2. What are the potential benefits of the compositions described in the patent? The compositions aim to improve the delivery and efficacy of methylphenidate, potentially enhancing bioavailability and reducing side effects.

3. Which industries are most active in patenting similar technologies? High-technology manufacturing and commercial knowledge-intensive services, including pharmaceuticals and biotechnology, are highly active.

4. How do patents like US10,858,341 impact the pharmaceutical industry? They drive innovation, protect intellectual property, and influence market competition by providing exclusive rights to the inventors or assignees.

5. Where can one find detailed information on the claims and scope of a patent? Detailed information can be found in the patent document itself, typically available through the USPTO or patent search databases.

Sources

1. NSF Statistics: "Invention, Knowledge Transfer, and Innovation" - Chapter 8, NSF 2018.
2. USPTO: U.S. Patent and Trademark Office, USA.gov.
3. USPTO Economic Research: Patent Claims Research Dataset, USPTO.
4. Google Patents: US10858341B2 - Compositions comprising methylphenidate-prodrugs.

Drugs Protected by US Patent 10,858,341

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-001	May 7, 2021		RX	Yes	No						TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-002	May 7, 2021		RX	Yes	No						TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-003	May 7, 2021		RX	Yes	Yes						TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE

International Family Members for US Patent 10,858,341

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2017371327
Australia	2020239746
Brazil	112019011640