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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Chinese Patent Office
Fuji
US Army
Farmers Insurance
Fish and Richardson
US Department of Justice
McKinsey
Queensland Health

Generated: June 25, 2018

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 NEXIUM and PRILOSEC and is included in two NDAs.

Protection for NEXIUM 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 Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,166,213
Patent Claim Types:
see list of patent claims
Use; Compound; Process;

Drugs Protected by US Patent 6,166,213

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-002 Feb 20, 2001 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-003 Oct 5, 1995 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-001 Sep 14, 1989 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted

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Non-Orange Book US Patents Family Members 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 ➤ Sign Up
6,191,148 Omerazole process and compositions thereof ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Healthtrust
Accenture
Farmers Insurance
Fish and Richardson
Federal Trade Commission
McKesson
US Department of Justice
Chubb

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