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Generated: November 21, 2017

DrugPatentWatch Database Preview

Details for Patent: 6,166,213

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Which drugs does patent 6,166,213 protect, and when does it expire?


Patent 6,166,213 protects PRILOSEC and NEXIUM and is included in two NDAs. There has been one Paragraph IV challenge on Nexium.

Protection for PRILOSEC has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has twenty-three patent family members in seventeen countries.

Summary for Patent: 6,166,213

Title: Omeprazole process and compositions thereof
Abstract:The present invention describes an improved process for the preparation, isolation, and purification of the anti-ulcer agent omeprazole whereby the sulfide precursor pyrmetazole is reacted subsurfacely with exactly one molar equivalent of meta-chloroperoxybenzoic acid in methylene chloride or toluene solution; residual organic solvent is removed from the aqueous layer by vacuum distillation; crude product is obtained by reactive crystallization with an alkyl formate and seeding; and pure product is isolated by recrystallization in methanol-water containing aqueous NaOH by subsurface addition of aqueous acetic acid to pH 9.0, seeding, filtration, washing, and drying. Compositions of omeprazole containing no chromatographically detectable levels of residual non-alcoholic organic reaction solvent are also described.
Inventor(s): Anousis; Nick (Albany, GA), McManus; James W. (Albany, GA), Banks; Benjamin Newton (Albany, GA), Zhou; Lingwen (North Brunswick, NJ), Liu; Hui (Greenbrook, NJ)
Assignee: Merck & Co., Inc. (Rahway, NJ)
Application Number:09/169,231
Patent Claim Types:
see list of patent claims
Use; Compound; Process;

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
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-003Oct 5, 1995DISCNYesNo► Subscribe► SubscribeY
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-001Sep 14, 1989DISCNYesNo► Subscribe► SubscribeY
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-002Jan 15, 1998DISCNYesNo► Subscribe► SubscribeY
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 2001ABRXYesNo► Subscribe► SubscribeY
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-002Feb 20, 2001ABRXYesYes► Subscribe► SubscribeY
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Non-Orange Book Patents for Patent: 6,166,213

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
6,147,103 Omeprazole process and compositions thereof► Subscribe
6,191,148 Omerazole process and compositions thereof► Subscribe
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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.

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International Patent Family for Patent: 6,166,213

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
World Intellectual Property Organization (WIPO)0009497► Subscribe
Portugal1104417► Subscribe
New Zealand509798► Subscribe
Norway321054► Subscribe
Norway20010677► Subscribe
Japan2003516985► Subscribe
Japan2002522537► Subscribe
Israel141324► Subscribe
Hong Kong1034510► Subscribe
Spain2285857► 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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Serving leading biopharmaceutical companies globally:

Queensland Health
Moodys
Merck
Julphar
Covington
QuintilesIMS
Cantor Fitzgerald
Harvard Business School
Baxter
Johnson and Johnson

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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