US010376507B2 (12 ) United States Patent (10 ) Patent No. : US 10 , 376 , 507 B2 Srinivasan et al. (45 ) Date of Patent: Aug. 13 , 2019 CRESEMBA® ( isavuconazonium sulfate ) , Highlights of Prescrib (54 ) METHOD OF TREATING A PATIENT WITH ing Information , Label ; Patient Information approved by the U . S . A CYP3A4 SUBSTRATE DRUG Food and Drug Administration ; Astellas Pharma US , Inc. ( Licensed from Basilea Pharmaceutics International Ltd . ) , Illinois, USA , Ini (71 ) Applicant: Bow River LLC , Corona Del Mar , CA tial U . S . Approval: 2015 , Revised Mar. 2015 , Reference ID : 3712237, ( US ) 28 pages . DIFLUCAN® ( fluconazole ), Label ; Patient Information , Reference ( 72 ) Inventors : Sundar Srinivasan , Corona Del Mar, ID : 3650838 , Roerig , Division of Pfizer Inc ., New York , NY, Revised Mar. 2013 , 35 pages. CA (US ) ; Christina Chow , Seattle , WA NIZORAL® (ketoconazole )Label ; Patient Information approved by (US ) the U . S . Food and Drug Administration , Reference ID : 3458324 , Copyright 2014 Janssen Pharmaceuticals, Inc . , New Jersey, USA , ( 73 ) Assignee : BOW RIVER LLC , Corona del Mar , Revised Feb . 2014 , 23 pages . NOXAFIL® (posaconazole ) , Highlights of Prescribing Informa CA (US ) tion , Label ; Patient Information approved by the U . S . Food and Drug Administration ; Copyright © 2006 , 2010 , 2013 , 2014 Merck ( * ) Notice : Subject to any disclaimer , the term of this Sharp & Dohme Corp . , a subsidiary of Merck & Co ., Inc ., New patent is extended or adjusted under 35 Jersey , USA , Revised Sep . 2016 , Reference ID : 3983525, 37 pages . U . S . C . 154 (b ) by 0 days. ORAVIG® (miconazole ) , Highlights of Prescribing Information , Label ; Patient Information approved by the U . S . Food and Drug Administration ; Copyright 2012 Praelia Pharmaceuticals , Inc . , North (21 ) Appl. No. : 15/ 596 ,585 Carolina, USA (Manufactured For : Vestiq Pharmaceuticals , Inc. , North Carolina , USA ) , Initial U . S . Approval : Jan . 1974 , Revised ( 22 ) Filed : May 16 , 2017 Aug. 2012 , Reference ID : 3270873 , 2 pages. SPORANOX® ( itraconazole ) , Label ; Patient Information approved (65 ) Prior Publication Data by the U . S . Food and Drug Administration , Reference ID : 4071289 , Copyright 2001 Janssen Pharmaceutical Companies , New Jersey , US 2018 /0333409 A1 Nov. 22 , 2018 USA , Revised Mar. 2017 , 40 pages . VFEND® (voriconazole ) , Highlights of Prescribing Information , (51 ) Int. Ci. Label ; Patient Information approved by the U . S . Food and Drug A61K 31 /496 ( 2006 .01 ) Administration , Roerig , Division of Pfizer Inc ., New York , NY, Initial U . S . Approval : 2002 , Revised Feb . 2015 , Reference ID : A61K 31/ 4985 ( 2006 . 01 ) 3696601 , 42 pages. A61K 31/ 495 ( 2006 .01 ) “ Drug Development and Drug Interactions: Table of Substrates , ( 52 ) U . S . CI. Inhibitors , and Inducers .” US Food and Drug Administration . Avail able at : https: / /www . fda . gov /drugs /developmentapprovalprocess / CPC . .. A61K 31/ 496 (2013 .01 ) ; A61K 31/ 495 developmentresources /druginteractionslabeling /ucm093664 .htm (2013 .01 ) ; A61K 31/ 4985 ( 2013 .01 ) Accessed Dec . 13, 2017 , 16 pages . ( 58 ) Field of Classification Search Center for Drug Research and Evaluation , Food and Drug Admin None istration . Application No . 2075000rigls000 / 2075010rigls000 . See application file for complete search history . Clinical Pharmacology and Biopharmaceutics Review ( s ) .NDA207500 ( Trade Name: Cresemba , Generic Name: Isavuconazonium sulfate ) , Dosage Form / Strength : Capsules / 186 . 3 mg of isavuconazonium ( 56 ) References Cited sulfate ( equivalent to 100 mg isavuconazole ) , Submission Date : Jul. U . S . PATENT DOCUMENTS 8 , 2014 ( Original Submission ), Sep . 26 , 2014 ( Sequence 0006 ) , Oct . 8 , 2014 ( Sequence 0008 ) , Dec . 11 , 2014 (Sequence 0015 ) , Dec . 18 , 2014 /0221424 AL 8 / 2014 Zha 2014 ( Sequence 0017 ) , Date of Review : Dec . 23 , 2014 , Reference 2014 / 0350060 A1 * 11/ 2014 Bradford .. .. .. A61K 31/ 15 ID : 3606431. Available at : https :/ / www .accessdata . fda . gov /drugsatfda _ 514 / 345 docs/ nda /2015 /2075000rig12075010rig1s000ClinPharmR .pdf 2017 /0100331 A1 4 /2017 Klein et al . Accessed Dec. 13 , 2017 , 78 pages . 2017 / 0258720 A19 / 2017 Pottier et al . 2018 / 0333410 AL 11/ 2018 Srinivasan et al . ( Continued ) 2018 /0333411 AL 11/ 2018 Srinivasan et al . 2019 /0076425 A1 3 / 2019 Srinivasan et al. Primary Examiner — Jeffrey S Lundgren Assistant Examiner — William Y Lee FOREIGN PATENT DOCUMENTS ( 74 ) Attorney , Agent, or Firm — Cooley LLP WO WO 2007 / 140299 A2 12 / 2007 WO WO - 2007140299 A2 * 12 /2007 . A61K 31427 (57 ) ABSTRACT WO WO 2017 / 165635 AL 9 / 2017 The present disclosure provides for methods of treating a WO WO 2018 /089687 A1 5 /2018 patient with a CYP3A4 substrate drug contraindicated for WO WO 2018 /212764 A1 11 / 2018 concomitant administration with a strong CYP3A4 inhibitor, wherein the patient is treated with multiple doses of posa OTHER PUBLICATIONS conazole , stops posaconazole treatment, and then is treated Bawa et al. ( Innovations in Clinical Neuroscience 2015 ; 12 ( 1 - 2 ) : with the CYP3A4 substrate drug . In some embodiments , 21 - 23 ) . * treatment with the CYP3A4 substrate drug is delayed for Brill et al. ( Clin Pharmacokinet 2012 : 51 ( 5 ) : 277 - 304 ). * about 2 -21 after stopping posaconazole . In some embodi Krishna et al . ( Clinical Therapeutics /vol . 31, No . 2 , 2009 , pp . ments , the patient is treated with or prescribed a reduced 286 - 298 ). * dose of the CYP3A4 substrate drug for about 2 - 21 after Loebel et al. ( Am J Psychiatry. 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