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Details for Patent: 6,403,616

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Patent 6,403,616 protects PRILOSEC OTC and is included in one NDA. There have been two Paragraph IV challenges on Prilosec OTC. 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 twenty-one patent family members in nineteen countries.

Summary for Patent: 6,403,616

Title: Chemical process and pharmaceutical formulation
Abstract:Process for the manufacturing of slightly soluble or less soluble alkaline salts of substituted sulphinyl heterocycles containing an imidazole moiety with formula I ##STR1## preferably alkaline salts of a proton pump inhibitor compound, wherein the process comprises the step of reacting the substituted sulphinyl heterocycle of Formula I with a source of the cation in the presence of a base, characterized by a washing step in which the prepared alkaline salt of the substituted sulphinyl compound is washed with a basic aqueous solvent mixture. The obtained bulk drug substance resulting in a bulk product that in an aqueous suspension of the substituted sulphinyl heterocycle having a pH not significantly lower than that of a saturated water solution of the pure compound prepared. Alternatively, the process for manufacturing a pharmaceutical dosage form comprising the active substance could be adjusted. For instance the pH of an aqueous suspension of the active substance is adjusted to a pH not significantly lower than that of a saturated water solution of the pure compound. The processes are preferably useful in the manufacturing of omeprazole magnesium salt or magnesium salt of one of its single enantiomers used in pharmaceutical dosage forms.
Inventor(s): Erickson; Magnus (Vastra Frolunda, SE), Gustavsson; Anders (Nykvarn, SE), Josefsson; Lars (Savedalen, SE)
Assignee: AstraZeneca AB (Sodertalje, SE)
Application Number:09/485,897
Patent Claim Types:
see list of patent claims
Compound; Process; Dosage form; Use;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 10th 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
Astrazeneca Pharms
PRILOSEC OTC
omeprazole magnesium
TABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 2003OTCYes6,403,616► subscribe
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Foreign Priority and PCT Information for Patent: 6,403,616

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Sweden9803952Nov 18, 1998
Sweden9803953Nov 18, 1998
PCT Information
PCT FiledNovember 15, 1999PCT Application Number:PCT/SE99/02093
PCT Publication Date:May 25, 2000PCT Publication Number: WO00/28975

International Patent Family for Patent: 6,403,616

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria271556► subscribe
Australia1901700► subscribe
Australia770633► 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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