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

Patent landscape, scope, and claims:

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):	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), Faour; Joaquina (Buenos Aires, AR), Vergez; Juan A. (Buenos Aires, AR)
Assignee:	Osmotica Kereskedelmi es Szolgaltato, KFT (Budapest, HU)
Application Number:	11/287,882
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;

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
European Patent Office	1834638