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Last Updated: December 22, 2024

Details for Patent: 8,574,626

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Which drugs does patent 8,574,626 protect, and when does it expire?

Patent 8,574,626 protects OSMOLEX ER and is included in one NDA.

This patent has eleven patent family members in nine countries.

Summary for Patent: 8,574,626

Title:	Osmotic device containing amantadine and an osmotic salt
Abstract:	The osmotic devices of the present invention contain a unitary core comprising a salt of amantadine and an osmotic salt, wherein the two salts have an ion in common. The release rate of the amantadine is a sigmoidal release. The osmotic device includes a semipermeable membrane having a controlled porosity that can be adapted as needed to cooperate with the osmotic salt in providing a predetermined drug release profile. The osmotic salt need not be coated and it is in admixture with the amantadine salt. The osmotic device further includes a drug-containing coat external to the semipermeable membrane. The osmotic device can include one or more additional drugs in the core and/or the drug-containing coat.
Inventor(s):	Vergez; Juan A. (Buenos Aires, AR), Faour; Joaquina (Buenos Aires, AR), Pastini; Ana C. (Buenos Aires, AR), Bigatti; Guido S. (Buenos Aires, AR), Meyer; Glenn A. (Wilmington, NC), Feleder; Ethel C. (Buenos Aires, AR), Ricci; Marcelo A. (Buenos Aires, AR), Coppari; Marcelo A. (Buenos Aires, AR), Befumo; Marcelo F. (Buenos Aires, AR)
Assignee:	Osmotica Kereskedelmi es Szolgaltato KFT (Budapest, HU)
Application Number:	13/551,755
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,574,626
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Device;
Patent landscape, scope, and claims:	United States Patent 8,574,626: A Detailed Analysis of Scope and Claims Introduction United States Patent 8,574,626, titled "Osmotic device containing amantadine and an osmotic salt," is a significant patent in the field of pharmaceuticals, particularly in the development of osmotic devices for drug delivery. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention. Patent Overview Publication Number and Authority The patent, numbered US8574626B2, was granted by the United States Patent and Trademark Office (USPTO) and is classified under the jurisdiction of the United States[4]. Inventors and Assignees While the specific inventors and assignees are not detailed in the provided sources, such information can typically be found in the patent document itself or through a search on the USPTO database. Prior Art and Related Patents The patent cites several prior art references, including U.S. Pat. Nos. 5,674,895, 5,840,754, 5,912,268, 6,124,355, and 6,262,115, as well as U.S. Patent Application Nos. 20010005728 and 20010009995. These references indicate that the invention builds upon existing knowledge in the field of osmotic devices and drug delivery systems[4]. Scope of the Invention Osmotic Device Design The patent describes an osmotic device containing a unitary core that comprises a salt of amantadine and an osmotic salt. The design ensures a controlled release of the drug over a prolonged period. The core is encapsulated by a semipermeable membrane, which allows water to enter the device, causing the osmotic salt to dissolve and release the amantadine[4]. Key Components Unitary Core: The core contains a salt of amantadine and an osmotic salt, which are chosen for their ability to maintain a consistent osmotic pressure. Semipermeable Membrane: This membrane is crucial for controlling the rate of water entry into the device, thereby regulating the drug release. External Coat: The patent also describes an optional external coat that can be designed for immediate release of a second active ingredient, such as an anti-Parkinsonian drug, antidepressant, or anxiolytic agent[4]. Claims Independent Claims The patent includes several independent claims that define the scope of the invention. These claims typically cover the composition of the unitary core, the structure of the semipermeable membrane, and the optional external coat. Dependent Claims Dependent claims further specify the details of the independent claims, such as the types of osmotic salts used, the composition of the semipermeable membrane, and the specific drugs that can be included in the external coat. Patent Landscape Global Context The invention is part of a broader landscape of osmotic drug delivery systems. Similar patents and applications exist globally, reflecting the ongoing research and development in this field. Tools like the Global Dossier provided by the USPTO can help in tracking related applications and patents across different jurisdictions[1]. Competitive Environment The pharmaceutical industry is highly competitive, with numerous companies and researchers working on advanced drug delivery systems. Patents like US8574626B2 are crucial for companies to protect their innovations and maintain a competitive edge. Legal and Regulatory Considerations The legal status of the patent is active, indicating that it is currently enforceable. However, the legal status can change over time due to various factors such as litigation, expiration, or amendments. It is essential to monitor the patent's status through official channels like the USPTO[4]. Economic and Research Implications Data and Statistics Research datasets like the Patent Claims Research Dataset provided by the USPTO can offer insights into the trends and scope of patent claims in the pharmaceutical sector. These datasets can help in understanding the broader economic implications of such patents and their impact on innovation[3]. Industry Impact Patents in the pharmaceutical sector can significantly influence the development of new drugs and delivery systems. They encourage innovation by providing a period of exclusivity to the inventors, allowing them to recoup their investment in research and development. Expert Insights Industry experts and legal practitioners often provide valuable insights into the implications of such patents. For instance, studies by the Administrative Conference of the United States (ACUS) on small claims patent courts highlight the need for efficient and cost-effective mechanisms for resolving patent disputes, which can be particularly relevant for pharmaceutical patents[2]. Key Takeaways Invention Scope: The patent covers an osmotic device with a unitary core containing amantadine and an osmotic salt, encapsulated by a semipermeable membrane. Claims: The patent includes independent and dependent claims that specify the composition and structure of the device. Patent Landscape: The invention is part of a global landscape of osmotic drug delivery systems, with significant competitive and legal implications. Economic Impact: The patent can influence innovation and investment in the pharmaceutical sector. Regulatory Considerations: The patent's legal status and potential changes need to be monitored. FAQs What is the main purpose of the osmotic device described in US8574626B2? The main purpose is to provide a controlled release of the drug amantadine over a prolonged period. How does the semipermeable membrane function in this device? The semipermeable membrane allows water to enter the device, causing the osmotic salt to dissolve and release the amantadine. Can the osmotic device include an external coat? Yes, the patent describes an optional external coat for immediate release of a second active ingredient. What are some examples of second active ingredients that can be included in the external coat? Examples include anti-Parkinsonian drugs, antidepressants, and anxiolytic agents like citalopram and buspirone. How can one track related patents and applications globally? Tools like the Global Dossier provided by the USPTO can help in tracking related applications and patents across different jurisdictions. Sources USPTO: Search for patents - USPTO ACUS: U.S. Patent Small Claims Court USPTO: Patent Claims Research Dataset Google Patents: US8574626B2 - Osmotic device containing amantadine and an osmotic salt More… ↓ ⤷ Subscribe

Drugs Protected by US Patent 8,574,626

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe	Y			A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT	⤷ Subscribe
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe	Y			A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT	⤷ Subscribe
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe	Y			A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT	⤷ Subscribe
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe	Y			A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

International Family Members for US Patent 8,574,626

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Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	053986	⤷ Subscribe
Australia	2005328058	⤷ Subscribe
Brazil	PI0515761	⤷ Subscribe
Canada	2589479	⤷ Subscribe
European Patent Office	1834638	⤷ Subscribe
European Patent Office	2965753	⤷ Subscribe
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

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