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Details for Patent: 6,350,468

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Patent 6,350,468 protects PYLERA and is included in one NDA. There has been one Paragraph IV challenge on Pylera  .

This patent has thirty patent family members in twenty-four countries.

Summary for Patent: 6,350,468

Title: Double capsule for the administration of active principles in multiple therapies
Abstract:A pharmaceutical dosage form particularly suitable for the administration of active principles in multiple therapies is disclosed. The pharmaceutical dosage form is a double capsule where in an internal capsule is placed inside an external one. Each internal and external capsule includes one or more active principles. A double capsule according to the invention is preferably used in triple or quadruple therapies against the microorganisms Helicobacter Pylori. Advantages of this pharmaceutical dosage form consist in providing a simple posology for administration of two and more active principles, allowing the active principles to activate at the right intervals of time and in the preestablished quantities, and preventing interactions between active principles. In a preferred embodiment of the invention, the pharmaceutical dosage form has an external capsule containing bismuth subcitrate and metronidazole, and an internal capsule containing tetracycline and optionally omeprazole, which is used in therapy for eradication of Helicobacter pylori.
Inventor(s): Sanso; Giovanni (Milan, IT)
Assignee: Axcan Pharma Inc. (Quebec, CA)
Application Number:09/581,721
Patent Claim Types:
see list of patent claims
Compound; Dosage form; Composition;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 28th percentile
Forward Citations: 1st percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Forest Labs Llc
PYLERA
bismuth subcitrate potassium; metronidazole; tetracycline
CAPSULE;ORAL050786-001Sep 28, 2006RXYes6,350,468► subscribe TREATMENT OF PATIENTS WITH H. PYLORI INFECTION AND DUODENAL ULCER DISEASE
Forest Labs Llc
PYLERA
bismuth subcitrate potassium; metronidazole; tetracycline
CAPSULE;ORAL050786-001Sep 28, 2006RXYes6,350,468► subscribe PYLERA CAPSULES, IN COMBINATION WITH OMEPRAZOLE ARE INDICATED FOR THE TREATMENT OF PATIENTS WITH HELICOBACTER PYLORI INFECTION AND DUODENAL ULCER DISEASE TO ERADICATE H. PYLORI
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Foreign Priority and PCT Information for Patent: 6,350,468

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
ItalyMI97A2788Dec 17, 1997
PCT Information
PCT FiledDecember 14, 1998PCT Application Number:PCT/EP98/08167
PCT Publication Date:June 24, 1999PCT Publication Number: WO99/30693

International Patent Family for Patent: 6,350,468

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina014126► subscribe
Austria254910► subscribe
Australia2413599► subscribe
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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.

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