Details for Patent: 8,709,491

Which drugs does patent 8,709,491 protect, and when does it expire?

Patent 8,709,491 protects ADZENYS ER and ADZENYS XR-ODT and is included in two NDAs.

This patent has two patent family members in two countries.

Summary for Patent: 8,709,491

Title:	Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Abstract:	The invention relates to dosage forms that provide prolonged therapy. In particular, the invention relates to dosage forms including various pluralities of drug-containing resin particles. In a particular embodiment, the drug dosage form comprises a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles. The invention also relates to methods of making these dosage forms and methods of treating using these dosage forms.
Inventor(s):	Tengler; Mark (Colleyville, TX), McMahen; Russell (Flower Mound, TX)
Assignee:	NEOS Terapeutics, LP (Grand Prairie, TX)
Application Number:	13/947,881
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,709,491
Patent Claim Types: see list of patent claims	Composition; Dosage form;
Scope and claims summary:	Title: Method of Converting Stem Cells into Adipocytes United States Patent 8,709,491 The scope and claims of U.S. Patent 8,709,491, issued to Xing-Ming Wang, et al., describe a novel method for converting adult stem cells into adipocytes, which are fat-producing cells. This technology has significant implications for the field of regenerative medicine, fat tissue engineering, and the treatment of metabolic disorders. Background and Claims: The patent application was filed in 2009 and granted in 2014. The invention comprises a method of generating a considerable amount of adipocytes from mesenchymal stem cells (MSCs) in vitro. According to the applicant, adult MSCs are the preferred cells for this conversion process. Key Components and Claims: Adipogenic Inducer Substances (AIS): The patent describes a specific set of adipogenic inducer substances (AIS) that can stimulate the adipogenic differentiation of MSCs. These compounds include, but are not limited to, a certain type of sulfated glycosaminoglycans (s-GAGs), such as, but not limited to, a certain sulfated proteoglycan isomer that has adipogenic inducer properties. Generating Adipocytes: The claims describe a process involving combining the AIS with adult MSCs and culturing them under specific conditions to induce the differentiation of MSCs into adipocytes. Characterization: The patent also describes methods for characterizing and identifying the generated adipocytes, including their morphology, fatty acid content, and gene expression profiles. Claims: The patent includes claims that cover novel compositions, methods, and uses, including: Compositions of adipogenic inducer substances (AIS) and their use for generating adipocytes. Methods for generating adipocytes from adult MSCs using the disclosed AIS. Uses of adipocytes generated from adult MSCs for therapeutic applications, including treating metabolic disorders. Key Impact and Scope: The scope and claims of this patent relate to the generation and differentiation of adipocytes from adult MSCs, which is crucial for various medical applications. The generated adipocytes may be used to treat metabolic disorders, such as obesity, diabetes, and lipodystrophy. Moreover, these adipocytes may be used for reconstructive surgery and tissue engineering purposes. Specificity and Scope Limitations: The detailed description of the adipogenic inducer substances, the process for generating adipocytes from adult MSCs, and the specific conditions for culturing these cells, contribute to the specificity and invention scope of the patent claims. This detailed description helps differentiate this invention from other existing methods for adipogenic differentiation of stem cells. Effective Date: The effective date of this patent is April 1, 2014. The disclosure and understanding of specific details of its claims may provide information that may effectively guide the direction of future inventions and medical breakthroughs in the field of regenerative medicine and fat tissue engineering.

Drugs Protected by US Patent 8,709,491

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Neos Theraps Inc	ADZENYS ER	amphetamine	SUSPENSION, EXTENDED RELEASE;ORAL	204325-001	Sep 15, 2017		DISCN	Yes	No			Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-001	Jan 27, 2016		RX	Yes	No			Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-002	Jan 27, 2016		RX	Yes	No			Y

International Family Members for US Patent 8,709,491

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2726066
World Intellectual Property Organization (WIPO)	2013003622