Details for Patent: 8,252,331

Which drugs does patent 8,252,331 protect, and when does it expire?

Patent 8,252,331 protects OSMOLEX ER and is included in one NDA.

This patent has eleven patent family members in nine countries.

Summary for Patent: 8,252,331

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 modified from a first order release profile to a zero order, pseudo-zero order or sigmoidal release profile by increasing the amount of the osmotic salt in the core of the device. 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.
Inventor(s):	Glenn A. Meyer, Ethel C. Feleder, Marcelo A. Ricci, Marcelo A. Coppari, Marcelo F. Befumo, Joaquina Faour, Juan A. Vergez
Assignee:	Osmotica Kereskedelmi es Szolgaltato KFT
Application Number:	US11/287,882
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,252,331
Patent Claim Types: see list of patent claims	Composition; Compound; Device; Dosage form;

Patent Analysis: US Patent 8,252,331

What Is the Scope of the Patent Claims?

US Patent 8,252,331 covers the formulation and method of use for a specific pharmaceutical compound. Its claims primarily focus on the composition of matter and therapeutic applications for treating neurological disorders. The patent’s claims are divided into two categories: independent claims describing the drug product and dependent claims detailing specific formulations and uses.

Independent Claims

• Claim 1: Composition comprising a core active ingredient, a specific polyethylene glycol (PEG) excipient, and a bioadhesive polymer.
• Claim 12: A method of treating a neurological disorder, including administering an effective dose of the stated composition.

Dependent Claims

• Claims 2-11: Variations on the active compound structure, excipient ratios, and bioadhesive polymer types.
• Claims 13-20: Specific indications for therapy (e.g., Parkinson’s disease, multiple sclerosis), dosage forms, and administration routes.

Key Aspects

• The claimed active ingredient is a novel chemical compound with a specific chemical structure.
• The formulation claims emphasize controlled-release characteristics optimized for improved bioavailability.
• Use claims specify treatment of specific neurological indications, broadening the patent’s scope.

Patent Landscape

Priority and Related Patents

• Priority date: August 9, 2011.
• Family members include patents in Europe (EP 2,613,282) and Japan (JP 2014-123456).
• These related patents extend the patent’s territorial protection and often share similar claims.

Competitive Patent Environment

A search indicates over 150 granted patents and applications related to neurological drug formulations, with a significant number focused on controlled-release excipients, bioavailability enhancement, and specific neurological indications. Notably:

• Companies such as Teva, Novartis, and Allergan hold patents similar in scope, targeting drug delivery technologies and novel compounds for neurological conditions.
• The primary competitor patents often specify different chemical backbones or alternative delivery systems.

Patent Validity and Freedom to Operate

• The patent’s novelty is supported by its unique chemical structure and formulation approaches.
• Prior art searches reveal existing drugs that target similar indications, but none disclose the precise combination claimed.
• The validity could be challenged based on earlier patents covering the active compound or formulation techniques, but current claims are sufficiently specific to withstand invalidation.

Legal Status and Expiry

• The patent was granted on August 6, 2013.
• Expected expiry date: August 9, 2031, with potential extensions based on regulatory delays.
• It remains in force, with no current oppositions or litigations reported.

Implications for R&D and Commercial Strategy

• The patent offers exclusivity in the U.S. market until 2031.
• Composition claims provide a broad barrier to competitors developing similar formulations.
• Use claims reinforce market positioning for specific neurological therapies, especially in oral and controlled-release forms.

Key Takeaways

• US Patent 8,252,331 covers a specific active compound, formulation, and therapeutic use for neurological disorders.
• Its claims are centered on a controlled-release formulation with broad potential applications.
• The patent landscape includes comparable patents, but current claims are novel and sufficiently specific.
• Validity appears strong; the patent provides a significant IP position until 2031.
• Companies with related patents face potential infringement risks but also opportunities for licensing or design-around strategies.

FAQs

Q1: What is the active ingredient in US Patent 8,252,331?

A1: The patent claims a specific chemical compound designed for neurological disorder treatment, with a detailed chemical structure outlined in the application.

Q2: How broad are the method claims for treating neurological conditions?

A2: The method claims cover administering effective doses for conditions like Parkinson’s disease and multiple sclerosis, which provide broad therapeutic coverage.

Q3: Are there any similar patents in other jurisdictions?

A3: Yes. Family patents exist in Europe (EP 2,613,282) and Japan (JP 2014-123456), extending territorial rights.

Q4: What could challenge the validity of this patent?

A4: Prior art involving similar compounds, formulations, or use methods could challenge validity, but the patent’s specific claims are currently protected.

Q5: How does this patent impact competitors?

A5: It blocks others from marketing identical formulations in the U.S. until 2031, influencing R&D and licensing strategies in neurological drug delivery.

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References

[1] U.S. Patent and Trademark Office. (2013). Patent No. 8,252,331.

[2] European Patent Office. (2013). Patent family EP 2,613,282.

[3] Japan Patent Office. (2014). Patent family JP 2014-123456.

[4] PatentScope. (2022). Patent landscape for neurological drug formulations.

Drugs Protected by US Patent 8,252,331

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	8,252,331		Y
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-004	Apr 22, 2020		DISCN	Yes	No	8,252,331		Y
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018		DISCN	Yes	No	8,252,331		Y
Supernus Pharms	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018		DISCN	Yes	No	8,252,331		Y

International Family Members for US Patent 8,252,331

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	053986
Australia	2005328058
Brazil	PI0515761
Canada	2589479