Details for Patent: 9,079,928

Which drugs does patent 9,079,928 protect, and when does it expire?

Patent 9,079,928 protects AZSTARYS and is included in one NDA.

This patent has fifty-four patent family members in twenty-eight countries.

Summary for Patent: 9,079,928

Title:	Methylphenidate-oxoacid conjugates, processes of making and using the same
Abstract:	The present technology is directed to prodrugs and compositions for the treatment of various diseases and/or disorders comprising methylphenidate, or methylphenidate derivatives, conjugated to at least one alcohol, amine, oxoacid, thiol, or derivatives thereof. In some embodiments, the conjugates further include at least one linker. The present technology also relates to the synthesis of methylphenidate, or methylphenidate derivatives, conjugated to at least one alcohol, amine, oxoacid, thiol, or derivatives thereof or combinations thereof.
Inventor(s):	Guenther; Sven (Coralville, IA), Chi; Guochen (Coralville, IA), Bera; Bindu (Blacksburgh, VA), Mickle; Travis (Coralville, IA), Bera; Sanjib (Blacksburg, VA)
Assignee:	KemPharm, Inc. (Coralville, IA)
Application Number:	14/234,440
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

Understanding the Scope and Claims of United States Patent 9,079,928

Introduction

United States Patent 9,079,928, titled "Methylphenidate-oxoacid conjugates, processes of making and using the same," is a significant patent in the pharmaceutical industry, particularly in the development of treatments involving methylphenidate. This patent, assigned to KemPharm, Inc., protects innovative compositions and processes related to methylphenidate prodrugs.

Patent Overview

Issuance and Expiration

The patent was issued on July 14, 2015, and is set to expire on July 27, 2032, unless extended or adjusted under 35 U.S.C. 154(b)[2][4].

Inventors and Assignee

The inventors listed on the patent include Sven Guenther, Guochen Chi, Bindu Bera, Travis Mickle, and Sanjib Bera. The patent is assigned to KemPharm, Inc., based in Coralville, IA[4].

Scope of the Patent

Prodrugs and Compositions

The patent is directed to prodrugs and compositions for the treatment of various diseases and disorders, specifically those involving methylphenidate or its derivatives. These prodrugs are conjugated to at least one alcohol, amine, oxoacid, thiol, or derivatives thereof. In some embodiments, these conjugates further include at least one linker[4].

Specific Conjugates

The patent details compositions comprising methylphenidate conjugated to oxoacids, among other functional groups. For example, it includes methylphenidate conjugated to nicotinoyl-L-serine, which is a key component in the formulation of drugs like Azstarys[1][4].

Claims of the Patent

Composition Claims

The patent includes claims related to the composition of the prodrugs, which involve the conjugation of methylphenidate to various functional groups. These claims are specific to the chemical structures and the methods of synthesizing these conjugates[4].

Process Claims

In addition to composition claims, the patent also covers the processes of making these prodrugs. This includes the synthesis of methylphenidate derivatives conjugated to alcohols, amines, oxoacids, thiols, or their derivatives, and the use of linkers in these conjugates[4].

Pharmaceutical Kits

The patent further claims pharmaceutical kits containing these compositions. These kits are designed to facilitate the administration of the prodrugs in a controlled and effective manner[1][4].

Patent Landscape

Related Patents

The patent is part of a broader portfolio of patents held by KemPharm, Inc., related to methylphenidate prodrugs. Other patents, such as US10584112, US10759778, and US10954213, also cover similar compositions and processes, with expiration dates set for December 9, 2037[1][2].

Exclusivities and Generic Availability

The exclusivities granted to Azstarys, a drug that utilizes the technology described in this patent, play a crucial role in delaying the launch of generic or bioequivalent versions. These exclusivities, combined with the active patents, ensure that no other company can market a generic version until these protections expire[2].

Impact on Innovation and Competition

Patent Scope and Quality

The scope of this patent, measured by metrics such as independent claim length and count, is significant. However, debates around patent quality suggest that broader claims can sometimes lead to increased licensing and litigation costs, potentially diminishing innovation incentives[3].

Market Protection

The patent and associated exclusivities provide strong market protection for KemPharm, Inc., allowing the company to maintain a monopoly on the use of these specific methylphenidate prodrugs until the patent expires. This protection is critical for the company's revenue and innovation strategies.

Conclusion

United States Patent 9,079,928 is a pivotal patent in the field of pharmaceuticals, particularly for treatments involving methylphenidate. It protects innovative compositions and processes that are essential for drugs like Azstarys. The patent's scope, claims, and the broader patent landscape ensure significant market protection for KemPharm, Inc., until the patent expires in 2032.

Key Takeaways

• Patent Scope: Covers prodrugs and compositions involving methylphenidate conjugated to various functional groups.
• Claims: Include composition, process, and pharmaceutical kit claims.
• Expiration: Set to expire on July 27, 2032.
• Related Patents: Part of a broader portfolio of patents held by KemPharm, Inc.
• Market Protection: Provides strong market protection through exclusivities and active patents.
• Impact on Innovation: Can influence innovation incentives due to the breadth and quality of the patent claims.

FAQs

Q: What is the main focus of United States Patent 9,079,928? A: The patent focuses on prodrugs and compositions involving methylphenidate conjugated to alcohols, amines, oxoacids, thiols, or their derivatives.

Q: Who are the inventors listed on the patent? A: The inventors include Sven Guenther, Guochen Chi, Bindu Bera, Travis Mickle, and Sanjib Bera.

Q: When is the patent set to expire? A: The patent is set to expire on July 27, 2032.

Q: What is the significance of the patent in the pharmaceutical industry? A: The patent is significant because it protects innovative compositions and processes essential for drugs like Azstarys, providing strong market protection for KemPharm, Inc.

Q: How does the patent impact generic availability? A: The patent, combined with exclusivities granted to Azstarys, delays the launch of generic or bioequivalent versions until the patent and exclusivities expire.

Sources

1. Generic Azstarys Availability - Drugs.com
2. Azstarys patent expiration - Pharsight - GreyB
3. Patent Claims and Patent Scope - Hoover Institution
4. United States Patent - googleapis.com

Drugs Protected by US Patent 9,079,928

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	9,079,928		Y
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-002	May 7, 2021		RX	Yes	No	9,079,928		Y
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-003	May 7, 2021		RX	Yes	Yes	9,079,928		Y

Foreign Priority and PCT Information for Patent: 9,079,928

PCT Information
PCT Filed	July 27, 2012	PCT Application Number:	PCT/US2012/048641
PCT Publication Date:	January 31, 2013	PCT Publication Number:	WO2013/016668

International Family Members for US Patent 9,079,928

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	087390
Australia	2012286683
Brazil	112014002084
Canada	2837732
Canada	2984544
Canada	3123900