Details for Patent: 9,023,391

Which drugs does patent 9,023,391 protect, and when does it expire?

Patent 9,023,391 protects OMEPRAZOLE and is included in one NDA.

This patent has nine patent family members in eight countries.

Summary for Patent: 9,023,391

Title:	Stable benzimidazole formulation
Abstract:	A stable composition with a benzimidazole derivative, such as Omeprazole, which does not contain a separating layer between the active compound and an enteric coating layer. Instead, the enteric coating layer is applied as a solution with a pH value of at least 6.5, and more preferably in a range of from about 7 to about 10, directly to the benzimidazole derivative substrate. This solution, with the optional addition of a plasticizer, can be directly coated onto the substrate without any necessity for an intermediate layer. Furthermore, in this pH range, the enteric coating is optionally applicable in an aqueous solution, thereby obviating the need for organic solvents for dissolving the enteric coating material. The resultant formulation maintains the stability of the benzimidazole derivative during storage and at the same time protects the product during passage through the acidic environment of the stomach. The problem of interaction between the enteric coat and the alkaline core is thus completely eliminated as the enteric coat at this stage is no longer acidic.
Inventor(s):	Lahav; Raffael (Qiriat Bialik, IL), Azoulay; Valerie (Pardes Hana, IL)
Assignee:	Dexcel Ltd. (Or-Akiva, IL)
Application Number:	11/785,300
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,023,391
Patent Claim Types: see list of patent claims	Composition; Formulation; Dosage form;

Drugs Protected by US Patent 9,023,391

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Dexcel Pharma	OMEPRAZOLE	omeprazole	TABLET, DELAYED RELEASE;ORAL	022032-001	Dec 4, 2007		OTC	Yes	Yes			Y

Foreign Priority and PCT Information for Patent: 9,023,391

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Israel	130602	Jun 22, 1999

International Family Members for US Patent 9,023,391

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	390119
Australia	5423200
Canada	2377605
Germany	60038447