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EP About this file: EP2501384

EP2501384 - METHOD OF TREATING PROLIFERATIVE DISORDERS AND OTHER PATHOLOGICAL CONDITIONS MEDIATED BY BCR-ABL, C-KIT, DDR1, DDR2 OR PDGF-R KINASE ACTIVITY [Right-click to bookmark this link]
Status	Patent maintained as amended Status updated on 29.09.2023 Database last updated on 11.04.2026
Former	The patent has been granted Status updated on 16.05.2018
Most recent event Tooltip	29.09.2023	Patent maintained (B2 publication)	published on 01.11.2023 [2023/44]
Applicant(s)	For all designated states Novartis AG Lichtstrasse 35 4056 Basel / CH
	[2023/44]
Former [2012/39]	For all designated states Novartis AG Lichtstrasse 35 4056 Basel / CH
Inventor(s)	01 / GALLAGHER, Neil Novartis Pharma AG Postfach CH-4002 Basel / CH
	02 / YIN, Ophelia 66 Henning Terrace Denville New Jersey 07834 / US
	[2012/39]
Representative(s)	Aera A/S Niels Hemmingsens Gade 10, 5th Floor 1153 Copenhagen K / DK
	[2023/44]
Former [2016/07]	Roth, Peter Richard Novartis Pharma AG Patent Department 4002 Basel / CH
Former [2012/39]	Roth, Peter Richard Novartis Pharma AG Patent Department 4002 Basel / CH
Application number, filing date	10781781.9	17.11.2010
	[2016/07]
	WO2010US56926
Priority number, date	US20090261812P	17.11.2009 Original published format: US 261812 P
	[2012/39]
Filing language	EN
Procedural language	EN
Publication	Type:	A1 Application with search report
	No.:	WO2011062927
	Date:	26.05.2011
	Language:	EN
	[2011/21]
	Type:	A1 Application with search report
	No.:	EP2501384
	Date:	26.09.2012
	Language:	EN
	The application published by WIPO in one of the EPO official languages on 26.05.2011 takes the place of the publication of the European patent application.
	[2012/39]
	Type:	B1 Patent specification
	No.:	EP2501384
	Date:	17.02.2016
	Language:	EN
	[2016/07]
	Type:	B2 New European patent specification
	No.:	EP2501384
	Date:	01.11.2023
	Language:	EN
	[2023/44]
Search report(s)	International search report - published on:	EP	26.05.2011
Classification	IPC:	A61K31/506, A61P35/00, A61K9/00, C07D239/69	[2015/27]
	CPC:	A61K31/506 (EP,KR,RU,US); A61K9/0095 (EP,KR,US); A61P11/00 (EP); A61P11/06 (EP); A61P17/00 (EP); A61P17/06 (EP); (+) A61P19/02 (EP); A61P19/04 (EP); A61P25/00 (EP); A61P25/28 (EP); A61P29/00 (EP); A61P35/00 (EP); A61P35/02 (EP); A61P37/06 (EP); A61P43/00 (EP); A61P9/12 (EP); C07D239/69 (EP,KR,US); A61K31/505 (RU) (-)
	Former IPC [2012/39]	A61K31/506, A61P35/00, A61K9/00
Designated contracting states	AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LI, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR [2012/39]
Extension states	BA	18.06.2012
	ME	18.06.2012
Title	German:	VERFAHREN ZUR BEHANDLUNG VON DURCH BCR-ABL, C-KIT, DDR1, DDR2 ODER PDGF-R-KINASEAKTIVITÄT VERMITTELTEN PROLIFERATIVEN ERKRANKUNGEN UND ANDEREN KRANKHEITSZUSTÄNDEN	[2012/39]
	English:	METHOD OF TREATING PROLIFERATIVE DISORDERS AND OTHER PATHOLOGICAL CONDITIONS MEDIATED BY BCR-ABL, C-KIT, DDR1, DDR2 OR PDGF-R KINASE ACTIVITY	[2012/39]
	French:	MÉTHODE DE TRAITEMENT DE TROUBLES PROLIFÉRATIFS ET D'AUTRES AFFECTIONS PATHOLOGIQUES MÉDIÉS PAR BCR-ABL, C-KIT, DDR1, DDR2 OU L'ACTIVITÉ KINASE DU PDGF-R	[2012/39]
Entry into regional phase	18.06.2012	National basic fee paid
	18.06.2012	Designation fee(s) paid
	18.06.2012	Examination fee paid
Examination procedure	18.06.2012	Examination requested [2012/39]
	17.01.2013	Amendment by applicant (claims and/or description)
	10.07.2013	Despatch of a communication from the examining division (Time limit: M06)
	20.01.2014	Reply to a communication from the examining division
	02.04.2014	Observations by third parties
	08.04.2014	Observations by third parties
	19.09.2014	Despatch of a communication from the examining division (Time limit: M04)
	05.12.2014	Reply to a communication from the examining division
	13.08.2015	Communication of intention to grant the patent
	10.12.2015	Fee for grant paid
	10.12.2015	Fee for publishing/printing paid
	10.12.2015	Receipt of the translation of the claim(s)
Divisional application(s)	The date of the Examining Division's first communication in respect of the earliest application for which a communication has been issued is 10.07.2013
Opposition(s)	Opponent(s)	01 14.11.2016 17.11.2016 ADMISSIBLE Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg / DE Opponent's representative Fresenius Kabi Deutschland GmbH, et al, et al Patent Department Pharmaceuticals Division Borkenberg 14 61440 Oberursel / DE
		02 17.11.2016 23.11.2016 ADMISSIBLE Hamm&Wittkopp Patentanwälte PartmbB Jungfernstieg 38 20354 Hamburg / DE Opponent's representative Hamm&Wittkopp Patentanwälte PartmbB, et al, et al Jungfernstieg 38 20354 Hamburg / DE
		03 17.11.2016 23.11.2016 ADMISSIBLE TEVA PHARMACEUTICAL INDUSTRIES, LTD. 124 Dvora HaNevi'a St. 6944020 Tel Aviv / IL Opponent's representative D Young & Co LLP, et al, et al 3 Noble Street London EC2V 7BQ / GB
		04 17.11.2016 23.11.2016 ADMISSIBLE Intas Pharmaceuticals Ltd. 2nd Floor Chinubhai Centre Ashram Road Ahmedabad 380009 GUJ / IN Opponent's representative Isarpatent, et al, et al Patent- und Rechtsanwälte Barth Charles Hassa Peckmann & Partner mbB Friedrichstrasse 31 80801 München / DE
		05 17.11.2016 23.11.2016 ADMISSIBLE Generics (U.K.) Limited Station Close Potters Bar Hertfordshire EN6 1TL / GB Opponent's representative Elkington and Fife LLP, et al, et al Prospect House 8 Pembroke Road Sevenoaks, Kent TN13 1XR / GB
		[N/P]
	Former [2021/47]
	Opponent(s)	01 14.11.2016 17.11.2016 ADMISSIBLE Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg / DE Opponent's representative Fresenius Kabi Deutschland GmbH, et al, et al Patent Department Pharmaceuticals Division Borkenberg 14 61440 Oberursel / DE
		02 17.11.2016 23.11.2016 ADMISSIBLE Hamm&Wittkopp Patentanwälte PartmbB Jungfernstieg 38 20354 Hamburg / DE Opponent's representative Hamm&Wittkopp Patentanwälte PartmbB, et al, et al Jungfernstieg 38 20354 Hamburg / DE
		03 17.11.2016 23.11.2016 ADMISSIBLE TEVA PHARMACEUTICAL INDUSTRIES, LTD. 124 Dvora HaNevi'a St. 6944020 Tel Aviv / IL Opponent's representative D Young & Co LLP, et al, et al 120 Holborn London EC1N 2DY / GB
		04 17.11.2016 23.11.2016 ADMISSIBLE Intas Pharmaceuticals Ltd. 2nd Floor Chinubhai Centre Ashram Road Ahmedabad 380009 GUJ / IN Opponent's representative Isarpatent, et al, et al Patent- und Rechtsanwälte Barth Charles Hassa Peckmann & Partner mbB Friedrichstrasse 31 80801 München / DE
		05 17.11.2016 23.11.2016 ADMISSIBLE Generics (U.K.) Limited Station Close Potters Bar Hertfordshire EN6 1TL / GB Opponent's representative Elkington and Fife LLP, et al, et al Prospect House 8 Pembroke Road Sevenoaks, Kent TN13 1XR / GB
	Former [2020/49]
	Opponent(s)	01 14.11.2016 17.11.2016 ADMISSIBLE Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg / DE Opponent's representative Fresenius Kabi Deutschland GmbH, et al, et al Patent Department Pharmaceuticals Division Borkenberg 14 61440 Oberursel / DE
		02 17.11.2016 23.11.2016 ADMISSIBLE Hamm&Wittkopp Patentanwälte PartmbB Jungfernstieg 38 20354 Hamburg / DE Opponent's representative Hamm&Wittkopp Patentanwälte PartmbB, et al, et al Jungfernstieg 38 20354 Hamburg / DE
		03 17.11.2016 23.11.2016 ADMISSIBLE Teva Pharmaceutical Industries Ltd 5 Basel Street P.O. Box 3190 49131 Petah Tiqva / IL Opponent's representative D Young & Co LLP, et al, et al 120 Holborn London EC1N 2DY / GB
		04 17.11.2016 23.11.2016 ADMISSIBLE Intas Pharmaceuticals Ltd. 2nd Floor Chinubhai Centre Ashram Road Ahmedabad 380009 GUJ / IN Opponent's representative Isarpatent, et al, et al Patent- und Rechtsanwälte Behnisch Barth Charles Hassa Peckmann & Partner mbB Friedrichstrasse 31 80801 München / DE
		05 17.11.2016 23.11.2016 ADMISSIBLE Generics (U.K.) Limited Station Close Potters Bar Hertfordshire EN6 1TL / GB Opponent's representative Elkington and Fife LLP, et al, et al Prospect House 8 Pembroke Road Sevenoaks, Kent TN13 1XR / GB
	Former [2018/52]
	Opponent(s)	01 14.11.2016 17.11.2016 ADMISSIBLE Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg / DE Opponent's representative Fresenius Kabi Deutschland GmbH, et al, et al Patent Department Pharmaceuticals Division Borkenberg 14 61440 Oberursel / DE
		02 17.11.2016 23.11.2016 ADMISSIBLE Hamm&Wittkopp Patentanwälte PartmbB Jungfernstieg 38 20354 Hamburg / DE Opponent's representative Hamm&Wittkopp Patentanwälte PartmbB, et al, et al Jungfernstieg 38 20354 Hamburg / DE
		03 17.11.2016 23.11.2016 ADMISSIBLE Teva Pharmaceutical Industries Ltd 5 Basel Street P.O. Box 3190 49131 Petah Tiqva / IL Opponent's representative D Young & Co LLP, et al, et al 120 Holborn London EC1N 2DY / GB
		04 17.11.2016 23.11.2016 ADMISSIBLE Intas Pharmaceuticals Ltd. 2nd Floor Chinubhai Centre Ashram Road Ahmedabad 380009 GUJ / IN Opponent's representative Accord Healthcare, S.L.U., et al, et al World Trade Center Moll de Barcelona s/n Edifici Est, 6ª planta 08039 Barcelona / ES
		05 17.11.2016 23.11.2016 ADMISSIBLE Generics (U.K.) Limited Station Close Potters Bar Hertfordshire EN6 1TL / GB Opponent's representative Elkington & Fife LLP, et al, et al Prospect House 8 Pembroke Road Sevenoaks, Kent TN13 1XR / GB
	Former [2016/52]
	Opponent(s)	01 14.11.2016 17.11.2016 ADMISSIBLE Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg / DE Opponent's representative Fresenius Kabi Deutschland GmbH, et al, et al Patent Department Pharmaceuticals Division Borkenberg 14 61440 Oberursel / DE
		02 17.11.2016 23.11.2016 ADMISSIBLE Hamm&Wittkopp Patentanwälte PartmbB Jungfernstieg 38 20354 Hamburg / DE Opponent's representative Hamm & Wittkopp Patentanwälte PartmbB, et al, et al Jungfernstieg 38 20354 Hamburg / DE
		03 17.11.2016 23.11.2016 ADMISSIBLE Teva Pharmaceutical Industries Ltd 5 Basel Street P.O. Box 3190 49131 Petah Tiqva / IL Opponent's representative D Young & Co LLP, et al, et al 120 Holborn London EC1N 2DY / GB
		04 17.11.2016 23.11.2016 ADMISSIBLE Intas Pharmaceuticals Ltd. 2nd Floor Chinubhai Centre Ashram Road Ahmedabad 380009 GUJ / IN Opponent's representative Accord Healthcare, S.L.U., et al, et al Department: Intellectual Property Europe World Trade Center Moll de Barcelona s/n Edifici Est, 6ª planta 08039 Barcelona / ES
		05 17.11.2016 23.11.2016 ADMISSIBLE Generics (U.K.) Limited Station Close Potters Bar Hertfordshire EN6 1TL / GB Opponent's representative Cooke, Richard Spencer, et al, et al Elkington and Fife LLP Patents Department 3-4 Holborn Circus London EC1N 2HA / GB
	Former [2016/51]
	Opponent(s)	01 14.11.2016 17.11.2016 ADMISSIBLE Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg / DE Opponent's representative Fresenius Kabi Deutschland GmbH, et al, et al Patent Department Pharmaceuticals Division Borkenberg 14 61440 Oberursel / DE
	09.01.2017	Invitation to proprietor to file observations on the notice of opposition
	18.05.2017	Reply of patent proprietor to notice(s) of opposition
	24.04.2018	Date of oral proceedings
	17.05.2018	Despatch of minutes of oral proceedings
	17.05.2018	Despatch of communication that the patent will be revoked
	23.01.2023	Despatch of a communication from the opposition division (Time limit: M02)
	19.05.2023	Despatch of interlocutory decision in opposition
	29.05.2023	Legal effect of interlocutory decision in opposition
	18.09.2023	Despatch of communication that the patent will be maintained as amended
Appeal following opposition	09.07.2018	Appeal received No. T1806/18
	27.09.2018	Statement of grounds filed
	21.10.2021	Result of appeal procedure: maintenance in amended form
	25.11.2022	Despatch of the decision of the Board of Appeal
	21.10.2021	Date of oral proceedings
Fees paid	Renewal fee
	13.11.2012	Renewal fee patent year 03
	18.11.2013	Renewal fee patent year 04
	10.11.2014	Renewal fee patent year 05
	10.11.2015	Renewal fee patent year 06
Opt-out from the exclusive Tooltip competence of the Unified Patent Court	See the Register of the Unified Patent Court for opt-out data
	Responsibility for the accuracy, completeness or quality of the data displayed under the link provided lies entirely with the Unified Patent Court.
Lapses during opposition Tooltip	SM	08.06.2018
	MC	30.11.2018
	[2019/33]
Former [2018/40]	SM	08.06.2018
Cited in	International search	[XI] WO2004005281 (NOVARTIS AG et al.) [X] 10 * abstract * * page 2, line 11 - page 13 * * page 63; example 92 * * claims 1,12-14 *[I] 1-11
		[XI] WO2006119154 (NOVARTIS AG et al.) [X] 10 * abstract * * page 2, line 5 - page 10, line 8 * * page 14, paragraph last * * claims 1-10 *[I] 1-11
		[XI] HAZARIKA MAITREYEE ET AL: "Tasigna for chronic and accelerated phase Philadelphia chromosome--positive chronic myelogenous leukemia resistant to or intolerant of imatinib.", CLINICAL CANCER RESEARCH : AN OFFICIAL JOURNAL OF THE AMERICAN ASSOCIATION FOR CANCER RESEARCH 1 SEP 2008 LNKD- PUBMED:18765523, vol. 14, no. 17, 1 September 2008 (2008-09-01), pages 5325 - 5331, XP002621031, ISSN: 1078-0432 [X] 10 * abstract * * page 5327, column l, line 31 - column r, line 30 * * page 5330, column r, line 33 - line 48 [I] 1-11 DOI:* http://dx.doi.org/10.1158/1078-0432.CCR-08-0308
		[XI] C. TANAKA, T. SMITH, H. KANTARJIAN, F. GILES, O. OTTMANN, K. BHALLA, K. GROUSS, V. SETHURAMAN, K. THOMAS AND H. SCHRAN: "Clinical pharmacokinetics (PK) of AMN107, a novel inhibitor of Bcr-Abl, in healthy subjects and patients with imatinib resistant or intolerant chronic myelogenous leukemia (CML) or relapsed/refractory Ph+ acute lymphocytic leukemia (Ph+ALL)", J. CLIN. ONCOL. 2006 ASCO ANNUAL MEETING PROCEEDINGS PART. I, vol. 24, no. 18S, 2006, pages 3095, XP009144277 [X] 10 * abstract *[I] 1-11
		[XI] VAN ERP N P ET AL: "Clinical pharmacokinetics of tyrosine kinase inhibitors", CANCER TREATMENT REVIEWS, SAUNDERS, US, vol. 35, no. 8, 5 September 2009 (2009-09-05), pages 692 - 706, XP026774941, ISSN: 0305-7372, [retrieved on 20090905] [X] 10 * the whole document *[I] 1-11
		[IP] YIN OPHELIA Q P ET AL: "Effect of Grapefruit Juice on the Pharmacokinetics of Nilotinib in Healthy Participants", JOURNAL OF CLINICAL PHARMACOLOGY, LIPPINCOTT CO, HAGERSTOWN, MD, US, vol. 50, no. 2, 1 February 2010 (2010-02-01), pages 188 - 194, XP009144100, ISSN: 0091-2700, DOI: DOI:10.1177/0091270009336137 [IP] 1-11 * the whole document * DOI: http://dx.doi.org/10.1177/0091270009336137
		[XP] YIN O ET AL: "EFFECT OF YOGURT AND APPLESAUCE ON THE ORAL BIOVAILABILITY OF NILOTINIB IN HEALTHY SUBJECTS", JOURNAL OF CLINICAL PHARMACOLOGY, LIPPINCOTT CO, HAGERSTOWN, MD, US, vol. 50, no. 9, 1 September 2010 (2010-09-01), pages 1089, XP009144158, ISSN: 0091-2700 [XP] 1-11 * the whole document *
	Examination	OPHELIA Q. P. YIN ET AL: "Effects of Yogurt and Applesauce on the Oral Bioavailability of Nilotinib in Healthy Volunteers", THE JOURNAL OF CLINICAL PHARMACOLOGY, vol. 51, no. 11, 1 November 2011 (2011-11-01), pages 1580 - 1586, XP055121223, ISSN: 0091-2700, DOI: 10.1177/0091270010384116 [P] DOI: http://dx.doi.org/10.1177/0091270010384116
		ROBERT G. STRICKLEY ET AL: "Pediatric drugs-a review of commercially available oral formulations", JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 97, no. 5, 1 May 2008 (2008-05-01), pages 1731 - 1774, XP055121290, ISSN: 0022-3549, DOI: 10.1002/jps.21101 DOI: http://dx.doi.org/10.1002/jps.21101
		YADY MANRIQUE ET AL: "Crushed Tablets: Does the Administration of Food Vehicles and Thickened Fluids to Aid Medication Swallowing Alter Drug Release?", J PHARM PHARM SCI, 1 May 2014 (2014-05-01), pages 207 - 219, XP055121285, Retrieved from the Internet [retrieved on 20140603] [P]
	by applicant	WO2004005281
		EP1533304
		WO2007015871
		WO2007015870
		WO2008037716
		YIN OQ; GALLAGHER N; LI A ET AL., J CLIN PHARMACOL., vol. 50, 2010, pages 188 - 194 [IP] 1-11 * the whole document *
		LARSON RA; LE COUTRE PD; REIFFERS J ET AL., J CLIN ONCOL, vol. 28, 2010, pages 7S [XP] 1-11 * the whole document *
	Opposition	WO2008037716
		WO2004005281
		WO2008037716
		WO2004005281
		WO2006119154
		WO2004005281
		WO2006119154
		EUROPEAN MEDICINES AGENCY, PUBLICATION OF A DECISION ON A PAEDIATRIC INVESTIGATION PLAN COVERING NILOTINIB (TASIGNA, 18 May 2009 (2009-05-18), Retrieved from the Internet [retrieved on 20161005] [P]
		VICKI NIBLETT: "A Nurse's Guide to Dosage Calculation: Giving Medications Safely", 2006, LIPPINCOTT WILLIAMS & WILKINS, article CHAPTER 10, pages: 127 - 131, XP055326437 [P]
		CAROLYN SIMPSONS ET AL.: "Rx: Reading and Following the Directions for all Kinds of Medication", 1994, THE LIFESKILLS LIBRARY, New York, pages: 42 - 43, XP055326443
		MARY ANNE KODA-KIMBLE ET AL.: "Handbook of Applied Therapeutics. 8th ed.", 2005, LIPPINCOTT WILLIAMS WILKINS, article "Chapter 91", XP055326448
		FDA: "Food-effect Bioavailability and Fed Bioequivalence Studies", GUIDANCE FOR INDUSTRY, December 2002 (2002-12-01), XP008138108, Retrieved from the Internet
		MAITREYEE HAZARIKA ET AL.: "Tasigna for Chronic and Accelerated Phase Philadelphia Chromosome - Positive Chronic Myelogenous Leukemia Resistant to or Intolerant of Imatinib", CLINICAL CANCER RESEARCH, vol. 14, no. 17, September 2008 (2008-09-01), pages 5325 - 5331, XP002621031 [P] DOI: http://dx.doi.org/10.1158/1078-0432.CCR-08-0308
		MARTIN A. CHAMPAGNE ET AL.: "Imatinib mesylate (ST1571) for treatment of children with Philadelphia chromosome-positive leukemia: results from a Children's Oncology Group phase 1 study", BLOOD, vol. 104, no. 9, 1 July 2004 (2004-07-01), pages 2655 - 2660, XP055324466 DOI: http://dx.doi.org/10.1182/blood-2003-09-3032
		EUROPEAN MEDICINES AGENCY (EMA): "Tasigna - Scientific Discussion", EMEA/161203/2009, 27 March 2007 (2007-03-27), pages 1 - 10, XP055324489, Retrieved from the Internet
		ROBERT G. STRICKLEY ET AL.: "Pediatric Drugs - A Review of Commercially Available Oral Formulations", JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 97, no. 5, May 2008 (2008-05-01), pages 1731 - 1773, XP055121290 DOI: http://dx.doi.org/10.1002/jps.21101
		"Sheik Hosenbocus MD , et al., A Review of Long-Acting Medications for ADHD in Canada", JOURNAL OF THE CANADIAN ACADEMY OF CHILD AND ADOLESCENT PSYCHIATRY, vol. 18, no. 4, November 2009 (2009-11-01), pages 331 - 339, XP055324471
		ANAND SISTLA ET AL.: "Powder-in-Bottle Formulation of SU 011248. Enabling Rapid Progression into Human Clinical Trials", DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, vol. 30, no. 1, 2 January 2004 (2004-01-02), pages 19 - 25, XP055324473 DOI: http://dx.doi.org/10.1081/DDC-120027507
		FARIBA NAVID ET AL.: "Stability of Sunitinib in Oral Suspension", THE ANNALS OF PHARMACOTHERAPY, vol. 42, no. 7, July 2008 (2008-07-01), pages 962 - 966, XP008101835 DOI: http://dx.doi.org/10.1345/APH.1K654
		"Summary of Product Characteristics", TASIGNA, 2007, pages 1 - 50, XP055327738
		HAZARIKA MAITREYEE ET AL.: "Tasigna for chronic and accelerated phase Philadelphia chromosome-positive chronic myelogenous leukemia resistant to or intolerant of imatinib.", CLINICAL CANCER RESEARCH : AN OFFICIAL JOURNAL OF THE AMERICAN ASSOCIATION FOR CANCER RESEARCH 1 SEP 2008 LNKD- PUBMED:18765523, vol. 14, no. 17, 1 September 2008 (2008-09-01), pages 5325 - 5331, XP002621031, ISSN: 1078-0432 [P] DOI: http://dx.doi.org/10.1158/1078-0432.CCR-08-0308
		C. TANAKA ET AL.: "Clinical pharmacokinetics (PK) of AMN107, a novel inhibitor of Bcr-Abl, in healthy subjects and patients with imatinib resistant or intolerant chronic myelogenous leukemia (CML) or relapsed/refractory Ph+ acute lymphocytic leukemia (Ph+ALL", J. CLIN. ONCOL. 2006 ASCO ANNUAL MEETING PROCEEDINGS PART. I, vol. 24, no. 18S, 2006, pages 3095, XP009144277
		VAN ERP N P ET AL.: "Clinical pharmacokinetics of tyrosine kinase inhibitors", CANCER TREATMENT REVIEWS, vol. 35, no. 8, 5 September 2009 (2009-09-05), US, pages 692 - 706, XP026774941, ISSN: 0305-7372, [retrieved on 20090905]
		YIN OPHELIA Q P ET AL.: "Effect of Grapefruit Juice on the Pharmacokinetics of Nilotinib in Healthy Participants", JOURNAL OF CLINICAL PHARMACOLOGY, vol. 50, no. 2, 1 February 2010 (2010-02-01), HAGERSTOWN. MD , US, pages 188 - 194, XP009144100, ISSN: 0091-2700 DOI: http://dx.doi.org/10.1177/0091270009336137
		YIN O ET AL.: "EFFECT OF YOGURT AND APPLESAUCE ON THE ORAL BIOVAILABILITY OF NILOTINIB IN HEALTHY SUBJECTS", JOURNAL OF CLINICAL PHARMACOLOGY, vol. 50, no. 9, 1 September 2010 (2010-09-01), HAGERSTOWN, MD , US, pages 1089, XP009144158, ISSN: 0091-2700
		WEISBERG E ET AL.: "Characterization of AMN107, a selective inhibitor of native and mutant Bcr-Abl", CANCER CELL ., vol. 7, no. 2, February 2005 (2005-02-01), pages 129 - 141, XP002489105 DOI: http://dx.doi.org/10.1016/j.ccr.2005.01.007
		WELLS KA ET AL.: "In vitro stability, potency, and dissolution of duloxetine enteric- coated pellets after exposure to applesauce, apple juice, and chocolate pudding;", CLIN THER., vol. 30, no. 7, 2008, pages 1300 - 1308, XP023612209 DOI: http://dx.doi.org/10.1016/S0149-2918(08)80054-9
		"Esomeprazole magnesium DR capsules; patient information leaflet;", ESOMEPRAZOLE MAGNESIUM DR CAPSULES; PATIENT INFORMATION LEAFLET;, 2006, pages 1 - 37, XP055327779
		"Methylphenidate HCI XR Capsules; patient information leaflet;", METHYLPHENIDATE HCI XR CAPSULES; PATIENT INFORMATION LEAFLET;, April 2009 (2009-04-01), pages 1 - 22, XP055327785
		"Morphine sulfate extended-release capsules; patient information leaflet;", MORPHINE SULFATE EXTENDED-RELEASE CAPSULES; PATIENT INFORMATION LEAFLET;, March 2007 (2007-03-01), pages 1 - 25, XP055327791
		RIFAMPIN: "Drug Information: Rifampin", MEDLINE PLUS, 2003, XP055327809, Retrieved from the Internet
		EMBEDA CAPSULES PIL, 2009, XP055327816
		MONTELUKAST SODIUM PIL, 2008, XP055328331
		EFFEXOR XR PIL, 2008, pages 1 - 51, XP055328338
		"US FDA Draft Guidance on Diltiazem Hydrochloride", US FDA, 2008, XP055329201
		"HIGHLIGHT OF PRESCRIBING INFORMATION", DEPAKOTE SPRINKLE PIL, 2009, XP055329206
		"HIGHLIGHT OF PRESCRIBING INFORMATION", COLAZAL PIL, 2007, XP055329210
		"HIGHLIGHT OF PRESCRIBING INFORMATION", FOCALIN XR PIL, 2009, XP055329211
		"HIGHLIGHT OF PRESCRIBING INFORMATION", PREVACID PIL, 2009, XP055329215
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