Details for Patent: 6,403,616

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Which drugs does patent 6,403,616 protect, and when does it expire?

Patent 6,403,616 protects PRILOSEC OTC and is included in one NDA. There have been two Paragraph IV challenges on Prilosec OTC.

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;

Glossary

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	RS	Patent No.	Patent Expiration
Astrazeneca Pharms	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003	OTC	Yes	Yes	► Subscribe	► 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
Sweden	9803952	Nov 18, 1998
Sweden	9803953	Nov 18, 1998

PCT Information
PCT Filed	November 15, 1999	PCT Application Number:	PCT/SE99/02093
PCT Publication Date:	May 25, 2000	PCT Publication Number:	WO00/28975

International Patent Family for Patent: 6,403,616

Country	Document Number	Estimated Expiration
Austria	271556	► Subscribe
Australia	1901700	► Subscribe
Australia	770633	► Subscribe
Brazil	9915421	► Subscribe
Canada	2347981	► Subscribe
China	100503598	► Subscribe
China	1326455	► Subscribe
Germany	69918854	► Subscribe
Denmark	1131316	► Subscribe
European Patent Office	1131316	► 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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