USOO9693953B2 (12) United States Patent (10) Patent No.: US 9,693.953 B2 Chollet et al. (45) Date of Patent: *Jul. 4, 2017 (54) METHOD OF TREATING ATROPHIC 6,593,317 B1 7/2003 DeZiegler et al. VAGNITIS 6,613,796 B2 9, 2003 MacLean et al. 6,660,726 B2 12/2003 Hill et al. (76) Inventors: Janet A. Chollet, Newton Center, MA 2. R 23. Me et al. (US); Fred H. Mermelstein, West 6,855,703 B1 2/2005 Hill et al. Newton, MA (US); Bernadette 6,911.438 B2 6/2005 Wright Klamerus, Carmichaels, PA (US) 7,018,992 B2 3/2006 Koch et al. s s 7,186,706 B2 3/2007 Rosario-Jansen et al. (*) Notice: Subject to any disclaimer, the term of this 7,414,0437,405.303 B2 8/20087/2008 KSNiHoekstra et c al. al. patent is extended or adjusted under 35 7,429,576 B2 9, 2008 Labrie U.S.C. 154(b) by 372 days. 7,442,833 B2 10/2008 Eaddy, III et al. 2001/0031747 A1 10/2001 DeZiegler et al. This patent is Subject to a terminal dis- 2002fOO12710 A1 1/2002 Lansky claimer. 2002fOO13327 A1 1/2002 Lee et al. 2002/0103223 A1 8, 2002 Tabor (21) Appl. No.: 11/757,787 2002/O128276 A1 9, 2002 Day. et al. 2002.0137749 A1 9/2002 Levinson et al. 2002fO16915.0 A1 11/2002 Pickar (22) Filed: Jun. 4, 2007 2002/0173499 A1 11, 2002 Pickar O O 2002/017351.0 A1 11/2002 Levinson et al. (65) Prior Publication Data 2002fO198179 A1 12/2002 Labrie 2003/0021859 A1 1/2003 Tabor US 2008/0026035 A1 Jan. 31, 2008 2003/004051.0 A1 2/2003 Labrie 2003, OO65008 A1 4/2003 Labrie O O 2003/0083228 A1 5/2003 Carpino et al. Related U.S. Application Data 2003/01253 19 A1 7/2003 Day et al. 2004/OOO9994 A1 1/2004 MacLean et al. (60) Provisional application No. 60/810,715, filed on Jun, 2004/0044080 A1 3/2004 Place et al. ................... 514/573 2, 2006, provisional application No. 60/917,800, filed 2004/0092583 A1 5/2004 Shanahan-Prendergast on May 14, 2007. 2004/0101557 A1 5, 2004 Gibson et al. (Continued) (51) Int. Cl. A6 IK 9/02 (2006.01) FOREIGN PATENT DOCUMENTS A6 IK 3L/25 (2006.01) A6IP 5/02 (2006.01) CN 15394.10 10, 2004 A6 IK3I/56 (2006.01) ES 5:30 A is: A6 IK 9/00 (2006.01) EP O 955 042 A1 11, 1999 A6 IK 47/02 (2006.01) EP 1652 535 A1 5, 2006 A6 IK 47/4 (2017.01) EP 1199069 10, 2006 A6 IK 47/22 (2006.01) WO WO 92,04310 3, 1992 WO WO95/07699 A1 3, 1995 A 6LX 3/57 (2006.01) WO WO 98,20917 A2 5, 1998 (52) U.S. Cl. WO WO O1/O5415 1, 2001 CPC .............. A61K 9/0034 (2013.01); A61K 9/02 (Continued) (2013.01); A61K 3L/215 (2013.01); A61 K 3 1/56 (2013.01); A61K 3 1/57 (2013.01); A61 K 47/02 (2013.01); A61K 47/14 (2013.01); A61 K OTHER PUBLICATIONS “722 (2013.01) US 6,214,374, 04/2001, Schmirler et al. (withdrawn) (58) Field of Classification Search Tamoxifen Citrate. Drug Facts and Comparisons, 2002, p. 2072.* None Tamoxifen Citrate, Dru Facts and Comparisions, 202, p. 2072.* See application file for complete search history. Bachmann et al. “Diagnosis and Treatment of Atrophic Vaginitis'. American Family Physician, 61 (10), 2000.* (56) References Cited (Continued) U.S. PATENT DOCUMENTS Primary Examiner — Melissa Javier (74) Attorney, Agent, or Firm — Marianne Fuierer; Moore 4,894.373 A * 1/1990 Young ........................ 514,239.2 & Van Allen, PLLC 5,189,212 A * 2/1993 Ruenitz ......................... 562/468 s 5,543,150 A 8/1996 Bologna et al. (57) ABSTRACT 5,558,877 A * 9/1996 Matlin et al. ................. 424/432 5,610,167 A 3, 1997 Cullinan The present invention provides novel pharmaceutical com 5,747,058 A 5/1998 Tipton et al. positions containing triphenylethylene derivative com 5,789,442 A 8, 1998 Garfield et al. pounds, and methods of using the composition for treatment 5,977,158. A 1 1/1999 Rasmussen of symptoms associated with atrophic vaginitis. 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