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Generated: April 29, 2017

DrugPatentWatch Database Preview

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. 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;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Astrazeneca Pharms
omeprazole magnesium
TABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 2003OTCYesYes6,403,616► 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
Sweden9803953► Subscribe
Sweden9803952► Subscribe
Portugal1131316► Subscribe
New Zealand511169► Subscribe
Norway321275► 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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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.

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