.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for Patent: 9,023,391

« Back to Dashboard
Patent 9,023,391 protects OMEPRAZOLE and is included in one NDA. There has been one Paragraph IV challenge on Omeprazole. There is one tentative approval for the compound protected by this patent. Additional details are available via the generic ingredient links below.

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 Claim Types:
see list of patent claims
Composition; Formulation; Dosage form;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 62nd percentile
Forward Citations: 0th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Dexcel Pharma
OMEPRAZOLE
omeprazole
TABLET, DELAYED RELEASE;ORAL022032-001Dec 4, 2007OTCYes9,023,391► subscribeY
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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 Patents 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
7,255,878Stable benzimidazole formulation► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Patent: 9,023,391

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Israel147232► subscribe
Israel130602► subscribe
Spain2304349► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

For more information try a trial or see the database preview and plans and pricing

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 verifification 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.

`abc