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Johnson and Johnson

Last Updated: February 1, 2023

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

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

International Family Members for US Patent 9,023,391

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 390119 See Plans and Pricing
Australia 5423200 See Plans and Pricing
Canada 2377605 See Plans and Pricing
Germany 60038447 See Plans and Pricing
European Patent Office 1187599 See Plans and Pricing
Spain 2304349 See Plans and Pricing
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.