Details for Patent: 8,796,337

Which drugs does patent 8,796,337 protect, and when does it expire?

Patent 8,796,337 protects GOCOVRI and OSMOLEX ER and is included in two NDAs.

This patent has four patent family members in three countries.

Summary for Patent: 8,796,337

Title:	Composition and method for treating neurological disease
Abstract:	A method of administering amantadine is provided. The method comprises orally administering to a subject a pharmaceutical composition comprising amantadine, or a pharmaceutically acceptable salt thereof, and one or more excipients, wherein at least one of the excipients modifies release of the amantadine. A dose of the composition provides a mean change in amantadine plasma concentration as a function of time (dC/dT) that is less than 40% of the change in amantadine plasma concentration provided by a dose of the same quantity of an immediate release form of amantadine. The change in plasma concentration over time (dC/dT) is measured in a single dose human pharmacokinetic study in a defined time period of 0 to 4 hours after administration. The amantadine, or pharmaceutically acceptable salt thereof, is administered once daily at a dose of 300 to 500 mg per day.
Inventor(s):	Went; Gregory T. (Mill Valley, CA), Fultz; Timothy J. (Pleasant Hill, CA), Porter; Seth (San Carlos, CA), Meyerson; Laurence R. (Las Vegas, NV), Burkoth; Timothy S. (Lake Bluff, IL)
Assignee:	Adamas Pharmaceutical, Inc. (Emeryville, CA)
Application Number:	13/958,153
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,796,337
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Drugs Protected by US Patent 8,796,337

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Adamas Operations	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-001	Aug 24, 2017		RX	Yes	No						TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
Adamas Operations	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017		RX	Yes	Yes						TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
Adamas Operations	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018		RX	Yes	No						TREATMENT OF PARKINSON'S DISEASE
Adamas Operations	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018		RX	Yes	No						TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSON'S DISEASE
Adamas Operations	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018		RX	Yes	No						TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS

International Family Members for US Patent 8,796,337

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2588296
European Patent Office	1845968
European Patent Office	2623099
World Intellectual Property Organization (WIPO)	2006058236