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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Colorcon
US Army
Dow
Accenture
Teva
Chubb
Cantor Fitzgerald
Medtronic

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for Patent: 9,023,391

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

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

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Israel130602Jun 22, 1999

Non-Orange Book US Patents Family Members for Patent 9,023,391

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,255,878 Stable benzimidazole formulation ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Family Members for US Patent 9,023,391

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Israel 147232 ➤ Try a Free Trial
Israel 130602 ➤ Try a Free Trial
Spain 2304349 ➤ Try a Free Trial
European Patent Office 1187599 ➤ Try a Free Trial
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
US Department of Justice
UBS
Julphar
Covington
Queensland Health
Moodys
Chinese Patent Office
QuintilesIMS

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