Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2011-02-22
2011-02-22
Saeed, Kamal A (Department: 1626)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C548S444000
Reexamination Certificate
active
07893100
ABSTRACT:
The present invention relates to carvedilol phosphate salts, which include novel crystalline forms of carvedilol dihydrogen phosphate (i.e., dihydrogen phosphate salt of 1-(carbazol-4-yloxy-3-[[2-(o-methoxyphenoxy) ethyl]amino]-2-propanol) and/or carvedilol hydrogen phosphate, etc.), and/or solvates thereof, compositions containing the aforementioned salts and/or solvates, and methods of using the aforementioned salts and/or solvates to treat hypertension, congestive heart failure and angina, etc.
REFERENCES:
patent: 4503067 (1985-03-01), Wiedemann et al.
patent: 4985454 (1991-01-01), Leinert
patent: 5071868 (1991-12-01), Leinert
patent: 5308862 (1994-05-01), Ohlstein
patent: 5393772 (1995-02-01), Yue et al.
patent: 5405863 (1995-04-01), Barone et al.
patent: 5453436 (1995-09-01), Ohlstein
patent: 5643939 (1997-07-01), Ohlstein
patent: 5760069 (1998-06-01), Lukas-Laskey et al.
patent: 5902821 (1999-05-01), Lukas-Laskey et al.
patent: 6096777 (2000-08-01), Feuerstein et al.
patent: 6214854 (2001-04-01), Wang et al.
patent: 6358990 (2002-03-01), Howlett et al.
patent: 6403579 (2002-06-01), Heller
patent: 6515010 (2003-02-01), Franchini et al.
patent: 6699997 (2004-03-01), Hildesheim et al.
patent: 6852337 (2005-02-01), Gabel et al.
patent: 7056942 (2006-06-01), Hildesheim et al.
patent: 7126008 (2006-10-01), Hildesheim et al.
patent: 7268156 (2007-09-01), Brook et al.
patent: 7626041 (2009-12-01), Brook et al.
patent: 7750036 (2010-07-01), Brook et al.
patent: 7759384 (2010-07-01), Brook et al.
patent: 2001/0036959 (2001-11-01), Gabel et al.
patent: 2001/0036960 (2001-11-01), Decker et al.
patent: 2002/0052367 (2002-05-01), Heller
patent: 2002/0068740 (2002-06-01), Mylari
patent: 2002/0099013 (2002-07-01), Piccariello et al.
patent: 2002/0099046 (2002-07-01), Scott
patent: 2002/0107279 (2002-08-01), Barone et al.
patent: 2002/0115655 (2002-08-01), Mehanna et al.
patent: 2002/0143045 (2002-10-01), Hildesheim et al.
patent: 2002/0169199 (2002-11-01), Gruber et al.
patent: 2003/0004205 (2003-01-01), Gabel et al.
patent: 2003/0004206 (2003-01-01), Decker et al.
patent: 2003/0035836 (2003-02-01), Shanghvi et al.
patent: 2003/0036559 (2003-02-01), Beyer et al.
patent: 2003/0050301 (2003-03-01), Mylari
patent: 2003/0054041 (2003-03-01), Lemmens et al.
patent: 2003/0166702 (2003-09-01), Kor et al.
patent: 2004/0019096 (2004-01-01), Oh et al.
patent: 2004/0152756 (2004-08-01), Chen et al.
patent: 2004/0186158 (2004-09-01), Oh
patent: 2004/0220250 (2004-11-01), Oh
patent: 2005/0009897 (2005-01-01), Anderson et al.
patent: 2005/0148779 (2005-07-01), Oh et al.
patent: 2005/0169994 (2005-08-01), Burke et al.
patent: 2005/0175695 (2005-08-01), Castan et al.
patent: 2006/0182804 (2006-08-01), Burke et al.
patent: 2007/0238774 (2007-10-01), Brook et al.
patent: 2007/0244182 (2007-10-01), Brook et al.
patent: 2007/0259940 (2007-11-01), Brook et al.
patent: 2008/0096951 (2008-04-01), Chen et al.
patent: 2008/0262069 (2008-10-01), Brook et al.
patent: WO98/02157 (1998-01-01), None
patent: WO99/05105 (1999-02-01), None
patent: WO99/52526 (1999-10-01), None
patent: WO00/04902 (2000-02-01), None
patent: WO00/32174 (2000-06-01), None
patent: WO01/74356 (2001-10-01), None
patent: WO01/87837 (2001-11-01), None
patent: WO02/00216 (2002-01-01), None
patent: WO02/092078 (2002-11-01), None
patent: WO03/007962 (2003-01-01), None
patent: WO03/024426 (2003-03-01), None
patent: WO03/024429 (2003-03-01), None
patent: WO03/028645 (2003-04-01), None
patent: WO03/028718 (2003-04-01), None
patent: WO2004/009120 (2004-01-01), None
patent: WO2004/016249 (2004-02-01), None
patent: WO2004/041252 (2004-05-01), None
patent: WO2004/056336 (2004-07-01), None
Berge et al. J. Pharm. Sci. 66:1-18 (1977).
J. Pharm. Sci. 94:2111-20 (2005).
U.S. Appl. No. 10/513,234, filed May 3, 2002, Oh, PCT/US03/14021 Filed: May 3, 2002, WO03/092626 Pub. Date: Nov. 13, 2003, “Carvedilol Pharmasolve Solvate”.
U.S. Appl. No. 10/513,235, filed Nov. 2, 2004, Oh et al., PCT/US03/14020 Filed: May 3, 2002, WO03/092626 Pub. Date: Nov. 13, 2003, “Carvedilol Formulations”.
U.S. Appl. No. 10/518,206, filed Dec. 16, 2004, Chen et al., PCT/US03/20346 Filed: Jun. 27, 2002, WO04/002472 Pub. Date: Jan. 8, 2004, “Carvedilol Hydrobromide”.
U.S. Appl. No. 10/997,230, filed Nov. 24, 2004, Brook et al., PCT/US04/039528 Filed: Nov. 24, 2004, WO05/051383 Pub. Date: Jun. 9, 2005, “Carvedilol Salts, Corresponding Compositions, Methods of Treatment”.
U.S. Appl. No. 11/137,261, filed May 25, 2005, Burke et al., CIP U.S. Appl. No. 10/996,904, filed Nov. 24, 2004.
New Drug Application (NDA) for Coreg CR (carvedilol phosphate) Extended Release Capsules, NDA 22-012 Excerpt, Section m3.2.S.4.5, Justification of Specification, submitted Dec. 21, 2005, Approved Oct. 20, 2006, pp. 3-5.
Chemical & Engineering News, Feb. 24, 2003, pp. 32-35.
Jain et al., “Polymorphism in Pharmacy”, Indian Drugs, 23 (6), 1986, pp. 315-329.
Medline Plus, Carvedilol, 2007.
U.S.P.T.O. Biotechnology/Chemical/Pharmaceutical Customer Partnership Meeting, Jun. 13, 2006, Slide Lecture on: ‘Polymorphs in Pharmaceutical Products, Presenter: Christopher Low, tQAS, TC1600’.
Concise Encyclopedia Chemistry, 1994, p. 873.
Phadnis et al., “Identification of Drugs in Pharmaceutical Dosage Forms by X-Ray Powder Diffractometry”, J. of Pharm. and Biomed. Analysis, 1997,15, 929-943.
Taday et al., “Using Terahertz Pulse Spectroscopy to Study the Crystalline Structure of a Drug: A Case Study of the Polymorphs of Ranitidine Hydrochloride”, J. of Pharm. Sci., 2003, vol. 92, No. 4, 831-838 (2003).
Chakravarty et al., Crystal Forms of Tolbutamide from Acetonitrile and 1-Octanol: Effect of Solvent, Humidity and Compression Pressure, Intern.'1 J. of Pharmaceutics, 2005, 288, 335-348.
TransForm Pharmaceuticals, “Carvedilol Phosphate Solid Form Screening, Final Report”, Apr. 19, 2004, pp. 1-67.
Ksrv.Teleflex, Wikipedia, The Free Encyclopedia, pp. 1-3 (see Footnote 6 at p. 3, lines 14-17).
Brittain, et al. “Effects of Pharmaceutical Processing on Drug Polymorphs and Solvates” in Polymorphism in Pharmaceutical Solids, vol. 95, p. 331-361.
U.S. Office Action of U.S. Appl. No. 11/767,581, Dated: Apr. 10 and Nov. 26, 2008 and Jul. 29, 2009 (.
U.S. Office Action of U.S. Appl. No. 11/767,586, Dated: Mar. 31 and Dec. 1, 2008 and Jul. 29, 2009.
U.S. Office Action of U.S. Appl. No. 11/767,566, Dated: Apr. 4, 2008; Dec. 18, 2008 and Mar. 16, 2010.
Express Pharma Online (http://www.expresspharmaonline.com/20031023/edit—02.shtml) (2003).
Hypertension, http://www.nature.com/aih/journal/v11
ls/abs/ajh1998251a.html (1989).
Congestive-heart-failure, http://en.wikipedia.org/wiki/Carvedillol (2010).
Angina, http://eurheartj.oxfordjournal.org/cgi/content/abstract/12/1/60 (2010).
U.S. Office Action of U.S. Appl. No. 11/767,566, dated Jul. 24, 2009.
Vogt, et al.Crystal Growth & Design, 10(6): 2713-2733 (2010).
U.S. Office Action of U.S. Appl. No. 11/767,566, dated Jul. 20, 2010.
U.S. Office Action of U.S. Appl. No. 10/997,836, dated Oct. 29, 2008.
U.S. Office Action of U.S. Appl. No. 10/997,836, dated Aug. 7, 2009.
U.S. Office Action of U.S. Appl. No. 10/997,836, dated Aug. 19, 2010.
U.S. Office Action of U.S. Appl. No. 11/137,261, dated Apr. 2, 2008.
U.S. Office Action of U.S. Appl. No. 11/137,261, dated Jan. 15, 2009.
Brook Christopher S.
Chen Wei
Dell'Orco Philip C.
Katrincic Lee M.
Louvet Ann Marie
Barker Michael
Hsu Grace C.
Kinzig Charles M.
Lemanowicz John
Saeed Kamal A
LandOfFree
Carvedilol phosphate salts and/or solvates thereof,... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Carvedilol phosphate salts and/or solvates thereof,..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Carvedilol phosphate salts and/or solvates thereof,... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2632006