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Last Updated: November 18, 2019

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-five 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 Submissiondate
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 AB RX Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-002 Feb 20, 2001 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-003 Oct 5, 1995 DISCN Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-001 Sep 14, 1989 DISCN Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-002 Jan 15, 1998 DISCN Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 6,166,213

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 360626   Start Trial
Australia 2084001   Start Trial
Australia 5470999   Start Trial
Australia 764642   Start Trial
Brazil 9912883   Start Trial
Canada 2338967   Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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