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(12) United States Patent (10) Patent No.: US 9,132,089 B2 Dudley Et Al

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(12) United States Patent (10) Patent No.: US 9,132,089 B2 Dudley Et Al US009132089B2 (12) United States Patent (10) Patent No.: US 9,132,089 B2 Dudley et al. (45) Date of Patent: *Sep. 15, 2015 (54) PHARMACEUTICAL COMPOSITION AND 47/12: A61K 47/14: A61 K9/0014; A61 K9/06 METHOD FOR TREATING HYPOGONADISM See application file for complete search history. (71) Applicants: Besins Healthcare Inc., Herndon, VA (US); Unimed Pharmaceuticals, LLC, (56) References Cited Marietta, GA (US) U.S. PATENT DOCUMENTS (72) Inventors: Robert E. Dudley, Kenilworth, IL (US); 2,155,658 A 4, 1939 Herrman et al. Dominique Drouin, Verrieres le Buisson 3,068,188 A 12/1962 Beste et al. (FR) 3,121,042 A 2f1964 Ercoli 3,164,520 A 1, 1965 Huber (73) Assignees: BESINS HEALTHCARE INC., 36 A 1 & g MitsOS ESSENGERSEc Abb 3,888,995 A 6/1975 Katz et al. 9 s Ott 3,913,789 A 10, 1975 Miller Park, IL (US) 3,939,111 A 2/1976 Schollenberger et al. - 3,989,816 A 1 1/1976 Rajadhyaksha (*) Notice: Subject to any disclaimer, the term of this 4,009,254 A 2, 1977 Renold patent is extended or adjusted under 35 4,078,060 A 3, 1978 Benson et al. U.S.C. 154(b) by 0 days. 4,083,973 A 4, 1978 Van der Vies 4,161,948 A 7, 1979 Bichon This patent is Subject to a terminal dis- 4,197,316 A 4, 1980 Yu et al. claimer. 4,299,826 A 11/1981 Luedders 4,346,709 A 8, 1982 Schmitt (21) Appl. No.: 13/942,245 4.424,363 A 1/1984 Plath et al. 4,440,777 A 4, 1984 Zupan (22) Filed: Jul. 15, 2013 4,442,094. A 4, 1984 Atkinson et al. 4,447.562 A 5/1984 Ivani (65) Prior Publication Data 4,478,822 A 10, 1984 Haslam et al. 4,496.455 A 1/1985 Linder et al. US 2013/O3O35O1 A1 Nov. 14, 2013 4,496.556 A 1/1985 Orentreich 4.557,934. A 12/1985 Cooper 4,563,473 A 1/1986 Hofman et al. Related U.S. Application Data 4,615,697 A 10/1986 Robinson 4,631,188 A 12/1986 Stoy et al. (63) Continuation of application No. 10/867,445, filed on Jun. 14, 2004, now abandoned, which is a continuation (Continued) of application No. 10/248.267, filed on Jan. 3, 2003, now abandoned, which is a continuation of application FOREIGN PATENT DOCUMENTS No. 09/651,777, filed on Aug. 30, 2000, now Pat. No. AU 4998.490 9, 1990 6,503,894. AU 914 1391 6, 1992 (51) Int. Cl. (Continued) A6 IK3I/568 (2006.01) A6 IK3I/565 (2006.01) OTHER PUBLICATIONS A6 IK3I/475 (2006.01) U.S. Appl. No. 13/965.499, Aug. 2013, Dudley et al.* A6 IK3I/485 (2006.01) inued A6 IK3I/52 (2006.01) (Continued) A 6LX3/557 (2006.01) A6 IK 47/10 (2006.01) A6 IK 47/12 (2006.01) Primary Examiner — Kara R McMillian A6 IK 47/4 (2006.01) (74) Attorney, Agent, or Firm — Lisa V. Mueller; Michael A6 IK9/06 (2006.01) Best & Friedrich LLP A6 IK9/00 (2006.01) A61 K3I/5685 (2006.01) (52) U.S. Cl. (57) ABSTRACT CPC ................. A61 K9/06 (2013.01); A61 K9/0014 (2013.01); A61 K3I/565 (2013.01); A61 K A pharmaceutical composition useful for treating hypogo 3 1/568 (2013.01); A61K47/10 (2013.01); nadism is disclosed. The composition comprises an andro A61K47/12 (2013.01); A61K 47/14 (2013.01); genic or anabolic steroid, a C1-C4 alcohol, a penetration A6 IK3I/5685 (2013.01) enhancer Such as isopropyl myristate, and water. Also dis (58) Field of Classification Search closed is a method for treating hypogonadism utilizing the CPC ............ A61K 2300/00; A61 K31/568: A61 K composition. 31/5685; A61K 47/10; A61 K9/006; A61 K 3 1/565; A61K 31/415: A61K 31/475; A61 K 31/485; A61 K31/52: A61K 31/557: A61 K 7 Claims, 40 Drawing Sheets US 9,132,089 B2 Page 2 (56) References Cited 5,656,286 8, 1997 Miranda et al. 5,662.925 9, 1997 Ebert et al. 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