Form of S-omeprazole

Organic compounds -- part of the class 532-570 series – Organic compounds – Heterocyclic carbon compounds containing a hetero ring...

Reexamination Certificate

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C514S338000

Reexamination Certificate

active

07411070

ABSTRACT:
The present invention relates to a novel form of the (−)-enantiomer of 5-methoxy-2[[(4-methoxy-3,5-dimethyl-2-pyridinyl)-methyl]sulfinyl]-1H-benzimidazole, i.e. S-omeprazole. More specifically, it relates to a novel form of the magnesium salt of the S-enantiomer of omeprazole trihydrate. The present invention also relates to processes for preparing such a form of the magnesium salt of S-omeprazole and pharmaceutical compositions containing it. Furthermore, the present invention also relates to new intermediates used in the process.

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Opposition filed by Torrent Pharmaceuticals Limited against Indian Patent Application No. 1344/DEL/98.
X-ray powder diffraction pattern of Mg-salt of S-omeprazole trihydrate depicted by Torrent obtained by method of WO 94/27988.
NDA 21-153/S-020 for Nexium® (esomeprazole magnesium) Delayed Release Capsule.
NDA 21-153/21-154 entitled “Medical Review(s)”.
Statement with Exhibits A-C on Behalf of the Applicant, AstraZeneca AB, to the Opposition filed by Ranbaxy Laboratories Limited against Indian Patent Application No. 1344/DEL/98.
Statement with Exhibits A-D on Behalf of the Applicant, AstraZeneca AB, to the Opposition filed by Torrent Pharmaceuticals Limited against Indian Patent Application No. 1344/DEL/98.
Decision of the Pre-grant Opposition filed by Ranbaxy Laboratories Limited against Indian Patent Application No. 1344/DEL/98.
Decision of the Pre-grant Opposition filed by Torrent Pharmaceuticals Limited against Indian Patent Application No. 1344/DEL/98.
Notice of Allegation, dated Nov. 13, 2007, pursuant to thePatented Medicines(Notice of Compliance)Regulationswith respect to Canadian Letters Patent No. 2,290,963.

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