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Details for Patent: RE40000

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Patent RE40000 protects COREG CR and COREG and is included in two NDAs. There have been three Paragraph IV challenges on Coreg CR.

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

Summary for Patent: RE40000

Title:Method of treatment for decreasing mortality resulting from congestive heart failure
Abstract:A method of treatment using a compound of Formula I: ##STR00001## wherein: R.sub.1 is hydrogen, lower alkanoyl of up to 6 carbon atoms or aroyl selected from benzoyl and naphthoyl; R.sub.2 is hydrogen, lower alkyl of up to 6 carbon atoms or arylalkyl selected from benzyl, phenylethyl and phenylpropyl; R.sub.3 is hydrogen or lower alkyl of up to 6 carbon atoms; R.sub.4 is hydrogen or lower alkyl of up to 6 carbon atoms, or when X is oxygen, R.sub.4 together with R.sub.5 can represent --CH.sub.2--O--; X is a valency bond, --CH.sub.2, oxygen or sulfur; Ar is selected from phenyl, naphthyl, indanyl and tetrahydronapthyl; R.sub.5 and R.sub.6 are individually selected from hydrogen, fluorine, chlorine, bromine, hydroxyl, lower alkyl of up to 6 carbon atoms, a --CONH.sub.2-- group, lower alkoxy of up to 6 carbon atoms, benzyloxy, lower alkylthio of up to 6 carbon atoms, lower alkysulphinyl of up to 6 carbon atoms and lower alkylsulphonyl of up to 6 carbon atoms; or R.sub.5 and R.sub.6 together represent methylenedioxy; or a pharmaceutically acceptable salt thereof, alone or in conjunction with one or more other therapeutic agents, said agents being selected from the group consisting of ACE inhibitors, diuretics, and digoxin for decreasing mortality resulting from congestive heart failure (CHF) in mammals, particularly humans.
Inventor(s): Lukas-Laskey; Mary Ann (Rosemont, PA), Ruffolo, Jr.; Robert (Spring City, PA), Shusterman; Neil Howard (Wynnewood, PA), Sponer; Gisbert (Laudenbach, DE), Strein; Klaus (Hemsbach, DE)
Assignee: SB Pharmco Puerto Rico Inc. (Hato Rey, PR)
Application Number:10/721,020
Patent Claim Types:
see list of patent claims
Use;

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Smithkline Beecham
COREG CR
carvedilol phosphate
CAPSULE, EXTENDED RELEASE;ORAL022012-001Oct 20, 2006RXNoRE40000*PED► subscribe
Smithkline Beecham
COREG CR
carvedilol phosphate
CAPSULE, EXTENDED RELEASE;ORAL022012-002Oct 20, 2006RXNoRE40000*PED► subscribe
Smithkline Beecham
COREG CR
carvedilol phosphate
CAPSULE, EXTENDED RELEASE;ORAL022012-003Oct 20, 2006RXYesRE40000*PED► subscribe
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Foreign Priority and PCT Information for Patent: RE40000

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Germany19503.995Feb 08, 1995

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