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Methods Of Administering Pirfenidone Therapy - EP2506850

The patent EP2506850 was granted to Intermune on May 13, 2020. The application was originally filed on Dec 3, 2010 under application number EP10835207A. The patent is currently recorded with a legal status of "Revoked".

EP2506850

INTERMUNE
Application Number
EP10835207A
Filing Date
Dec 3, 2010
Status
Revoked
Feb 17, 2023
Grant Date
May 13, 2020
External Links
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Patent Summary

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Patent Family

Patent Oppositions (6)

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INTAS PHARMACEUTICALSFeb 15, 2021ACCORD HEALTHCAREWITHDRAWN
GENERICS UKFeb 12, 2021TER MEER STEINMEISTER & PARTNERWITHDRAWN
SANDOZFeb 11, 2021ELKINGTON AND FIFEWITHDRAWN
AERAFeb 3, 2021AERAWITHDRAWN
ALFRED E TIEFENBACHERJan 26, 2021HAMM & WITTKOPPWITHDRAWN
STADA ARZNEIMITTELJan 26, 2021HAMM & WITTKOPPWITHDRAWN

Patent Citations (16) New

Patent citations refer to prior patents cited during different phases such as opposition or international search.

Citation PhasePublication NumberPublication Link
DESCRIPTIONUS7566729
DESCRIPTIONWO9814169
INTERNATIONAL-SEARCH-REPORTEP1138329
INTERNATIONAL-SEARCH-REPORTUS2008287508
INTERNATIONAL-SEARCH-REPORTUS5310562
INTERNATIONAL-SEARCH-REPORTUS7566729
INTERNATIONAL-SEARCH-REPORTUS7605173
INTERNATIONAL-SEARCH-REPORTUS7816383
OPPOSITIONEP2324831
OPPOSITIONEP2702994
OPPOSITIONEP3275196
OPPOSITIONUS7566729
OPPOSITIONWO9814169
OTHEREP2324831
SEARCHUS7566729
SEARCHWO9814169

Non-Patent Literature (NPL) Citations (64) New

NPL citations refer to non-patent references such as research papers, articles, or other publications cited during examination or opposition phases.

Citation PhaseReference TextLink
OPPOSITION- Anonymous, "Guidance for Industry, Drug Interaction Studies - Study Design, Data Analysis, and Implications for dosing and Labeling", FDA, (20060900), pages 1 - 56, XP055783976-
OPPOSITION- Anonymous, "Pirfenidone Capsules, Briefing Document", SPONSOR'S BRIEFING DOCUMENT, (20100309), pages 1 - 117, URL: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/UCM203083.pdf, XP002580221-
OPPOSITION- Anonymous, "Report on the Deliberation Results by the Japanese Ministry of Health", Evaluation and licensing Division, Pharmaceutical and food safety bureau Ministry of Health, Labour and Welfare, (20080916), pages 1 - 68, XP009132612-
OPPOSITION- Anonymous, "Report on the deliberation results", Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare, (20080916), pages 1 - 68, XP055784126-
OPPOSITION- Anonymous, "Safety and efficacy of Pirfenidone in patients with idiopathic pulmonary fibrosis", Printout from clinicaltrials.gov of clinical study n : NCT00287729, (20090904), pages 1 - 19, XP055784112-
OPPOSITION- Anonymous, "SUMMARY OF PRODUCT CHARACTERISTICS- Esbriet 267 mg hard capsules", European Medicines Agency, (20150908), pages 1 - 14, XP055773823-
OPPOSITION- Anonymous, "SUMMARY OF PRODUCT CHARACTERISTICS- Esbriet 267mg hard capsules", European Medicines Agency, (20150908), pages 1 - 14, XP055773823-
OPPOSITION- ANONYMOUS, "SUMMARY OF PRODUCT CHARACTERISTICS- Esbriet 267 mg hard capsules", EUROPEAN MEDICINES AGENCY, (20150908), pages 1 - 14, XP055773823-
OPPOSITION- Banu A Karimi-Shah, "Clinical Review, NDA 22-535", DIVISION MEMORANDUM, (20120212), pages 1 - 19, URL: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/UCM203081.pdf, XP002580220-
OPPOSITION- Begriindet von W. Forth, 0. Henschler , W. Rummel, "Allgemeine und spezielle Pharmakologie und Toxikologie", Urban & Fisher, (20050000), pages 831 - 838, XP055784120-
OPPOSITION- "Esbriet 267 mg hard capsules", European Medicines Agency, (20150908), XP055787163-
OPPOSITION- Fda; Et Al, "Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling", Guidance for Industry, (200609), pages 1 - 55, XP055619684-
OPPOSITION- FDA; ET AL, "Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling", GUIDANCE FOR INDUSTRY, (200609), pages 1 - 55, XP055619684-
OPPOSITION- Fuhr U., E. M. Anders, G. Mahr, F. Sorgel, A. H. Staib, "Inhibitory Potency of Quinolone Antibacterial Agents against Cytochrome P 4501A2 Activity In Vivo and In Vitro", Antimicrobial Agents and Chemotherapy, (19920500), vol. 36, no. 5, pages 942 - 948, XP055783998-
OPPOSITION- GANESH RAGHU, W. CRAIG JOHNSON, DIANE LOCKHART, and YOLANDA MAGETO, "Treatment of Idiopathic Pulmonary Fibrosis with a New Antifibrotic Agent, Pirfenidone", American Journal of Respiratory and Critical Care Medicin, (19990401), vol. 159, pages 1061 - 1069, XP000878900-
OPPOSITION- "Guidance for Industry Drug Interaction Studies — Study Design, Data Analysis, and Implications for Dosing and Labeling", Clinical Pharmacology, (200609), XP055787173-
OPPOSITION- Hom J. R., Philip D. Hansten, "Get to know an enzyme : CYP1A2", Pharmacy Times- Drug Interactions, (20071101), pages 1 - 1, XP055784082-
OPPOSITION- Jeppesen U; Gram L F; Vistisen K; Loft S; Poulsen H E; Brosen K, "Dose-dependent inhibition of CYP1A2, CYP2C19 and CYP2D6 by citalopram, fluoxetine, fluvoxamine and paroxetine", EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY, (19960000), vol. 51, no. 1, pages 73 - 78, XP009132566-
OPPOSITION- "Kapitel 36- Antibiotika und Chemotherapeutika", W. Forth, O. Henschler Und W. Rummel, Allgemeine und spezielle Pharmakologie und Toxikologie, 9., völlig überarbeitete Auflage, Elsevier GmbH, Urban & Fischer Verlag, (2005), pages 2pp, 831 - 838, XP055773863-
OPPOSITION- Karthik Venkatakrishnan, Lisa L. von Moltke, and David J. Greenblatt,, "Human drug metabolism and the cytochromes P450: application and relevance of in vitro models", J. Clin. Pharmacol, (20011100), vol. 41, no. 11, pages 1149 - 1179, XP055773848-
OPPOSITION- KARTHIK VENKATAKRISHNAN, LISA L. VON MOLTKE, AND DAVID J. GREENBLATT,, "Human drug metabolism and the cytochromes P450: application and relevance of in vitro models", J. Clin. Pharmacol, (20011100), vol. 41, no. 11, pages 1149 - 1179, XP055773848-
OPPOSITION- Kroon Lisa A, "Drug interactions with smoking", AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY, (20070915), vol. 64, no. 18, pages 1917 - 1921, XP009151842-
OPPOSITION- Lahu G. et al., "Abstract P2034", Annual Congress of the European Respiratory Society (ERS), (20090914), pages 1 - 4, XP055784062-
OPPOSITION- Landi M T; Sinha R; Lang N P; Kadlubar F F, "Human cytochrome P4501A2", IARC SCIENTIFIC PUBLICATIONS, (19990000), no. 148, pages 173 - 195, XP009132024-
OPPOSITION- MICHALETS, "Update: Clinically Significant Cytochrome P-450 Drug Interactions", Pharmacotherapy, (19980000), vol. 18, no. 1, XP055106914-
OPPOSITION- PEA et al., "Pharmacokinetic Aspects of Treating Infections in the Intensive Care Unit - Focus on Drug Interactions", Clinical Pharmacokinetics, (20010000), vol. 40, no. 11, pages 833 - 868, XP055777988-
OPPOSITION- PEA et al., "Pharmacokinetic Aspects of Treating Infections in the Intensive Care Unit Focus on Drug Interactions", Clinical Pharmacokinetics, (20010000), vol. 40, pages 833 - 868, XP055777988-
OPPOSITION- Pea Federico, Furlanut Mario, "Pharmacokinetic Aspects of Treating Infections in the Intensive Care Unit Focus on Drug Interactions", Clin Pharmacoklnet, (20010000), vol. 40, no. 11, pages 833 - 868, XP055777988-
OPPOSITION- "pirespa tablets 200 mg", Standard Commodity Classification No. of Japan 873999, (20081000), XP055787169-
OPPOSITION- "Report on the Deliberation Results, Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare", (20080916), pages 1 - 68, XP009132612-
OPPOSITION- Report on the Deliberation Results, Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, (20080916), pages 1 - 68, XP009132612-
OPPOSITION- "safety and efficacy of pirfenidone in patients with idiopathic pulmonary fibrosis", (20090900), URL: htpp://clinicaltrials.gov/ct2/show/nct00287729, XP055787199-
OPPOSITION- "Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis", (20090904), URL: https://web.archive.org/web/20090904055838/http://clinicaltrials.gov/ct2/show/NCT00287729, XP055777996-
OPPOSITION- Sandoz AG, "Case number T 0285/14", Datasheet for the decision, (20181218), pages 1 - 43, XP055784108-
OPPOSITION- Shionogi & Co Ltd, "Pirespa® Tablets 200 mg /Pirfenidone tablets/ "English translation enclosed"", (200810), pages 1 - 4, XP055394049-
OPPOSITION- SHIONOGI & CO LTD, "Pirespa® Tablets 200 mg /Pirfenidone tablets/ English translation enclosed/", (200810), pages 1 - 4, XP055394049-
OPPOSITION- Sonoko Nagai, Kunio Hamada, Michio Shigematsu, Masayosi Taniyama*, Shitotomo Yamauchi* and Takateru Izumi, "Open-label Compassionate Use One Year-treatment with Pirfenidone to Patients with Chronic Pulmonary Fibrosis", Internal Medicine, (20020906), vol. 41, no. 12, pages 1118 - 1123, XP055784040-
OPPOSITION- Stephen Fowler, Hongjian Zhang, "In Vitro Evaluation of Reversible and Irreversible Cytochrome P450 Inhibition: Current Status on Methodologies and their Utility for Predicting Drug-Drug Interactions", APPS Journal, (20080600), vol. 10, no. 2, pages 410 - 424, XP055784073-
OPPOSITION- U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, "Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling", Guidance for Industry, (20060900), XP055619684-
OPPOSITION- VENKATAKRISHNAN KARTHIK et al., "Human drug metabolism and the cytochromes P450: application and relevance of in vitro models", J Clin Pharmacol., (20010000), pages 1149 - 1179, XP055773848-
OPPOSITION- Venkatakrishnan Karthik, Lisa L. Von Moltke, David J. Greenblatt, "Human Drug Metabolism and the Cytochromes P450: Application and Relevance of In Vitro Models", J. Clin. Pharmacol., (20011101), vol. 41, no. 11, pages 1149 - 1179, XP055773848-
OPPOSITION- W. Forth, 0. Henschler und W. Rummel, Allgemeine und spezielle Pharmakologie und Toxikologie, 9., völlig überarbeitete Auflage, Munchen, Elsevier GmbH, Urban & Fischer Verlag, (20050000), pages 2pp, 831 - 838, XP055773863-
OPPOSITION- W. Forth et al, "chinolone", Allgemeine und spezielle Pharmakologie und Toxikologie, (20050000), vol. 9, pages 831 - 838, XP055787179-
OPPOSITION- Olavi Pelkonen, Miia Turpeinen , Jukka Hakkola, "Inhibition and induction of human cytochrome P450 enzymes: current status", Archives of Toxicology., (20081107), vol. 82, no. 10, pages 667 - 715, XP019652578
OPPOSITION- Olavi Pelkonen; Miia Turpeinen; Jukka Hakkola; Paavo Honkakoski; Janne Hukkanen; Hannu Raunio, "Inhibition and induction of human cytochrome P450 enzymes: current status", Arch. Toxicol., (20080000), vol. 82, pages 667 - 715, XP019652578
OPPOSITION- OLAVI PELKONEN; MIIA TURPEINEN; JUKKA HAKKOLA; PAAVO HONKAKOSKI; JANNE HUKKANEN; HANNU RAUNIO, "Inhibition and induction of human cytochrome P450 enzymes: current status", Arch. Toxicol., (20080000), vol. 82, pages 667 - 715, XP019652578
OPPOSITION- PELKONEN, OLAVI et al., "§Inhibition and induction of human cytochrome P450 enzymes: current status", Arch Toxicol ., (20080000), doi:10.1007/s00204-008-0332-8, pages 667 - 715, XP019652578
OPPOSITION- Rubino C. M., S.M. Bhavnani, P.G. Ambrose, A. Forrest, J.S. Loutit, "Effect of food and antacids on the pharmacokinetics of pirfenidone in older healthy adults", Pulmonary Pharmacology & Therapeutics, (20090327), vol. 22, pages 279 - 285, XP026139221
OPPOSITION- KINZIG-SCHIPPERS et al., "Interaction of Pefloxacin and Enoxacin with the Human Cytochrome P450 Enzyme CYPIA2", Clinical Pharmacology & Therapeutics, (19990300), vol. 65, no. 3, doi:10.1016/S0009-9236(99)70105-0, XP005168127
OPPOSITION- Arata Azuma, Toshihiro Nukiwa, Eiyasu Tsuboi, Moritaka Suga, Shosaku Abe, Koichiro Nakata, Yoshio Taguchi, Sonoko Nagai, Harumi Itoh, Motoharu Ohi, Atsuhiko Sato, and Shop Kudoh for the members of the Research Group for Diffuse Lung Diseases in Japan; and Ganesh Raghu, "Double-blind, Placebo-controlled Trial of Pirfenidonein Patients with Idiopathic Pulmonary Fibrosis", American Journal of Respiratory and Critical Care Medicine, (20050501), vol. 171, pages 1040 - 1047, XP002476129
OPPOSITION- Shi Shaojun, Jianhong Wu, Huating Chen, Hui Chen, Jun Wu, Fandian Zeng, "Single- and Multiple-Dose Pharmacokineticsof Pirfenidone, an Antifibrotic Agent, in Healthy Chinese Volunteers", Clin. Pharmacol., (20071001), vol. 47, no. 10, pages 1268 - 1276, XP055135884
OPPOSITION- Zhang Lei, Yuanchao (derek) Zhang, Ping Zhao, Shiew-Mei Huang, "Predicting Drug-Drug Interactions: An FDA Perspective", The AAPS Journal, (20090506), vol. 11, no. 2, pages 300 - 306, XP035719024
OPPOSITION- Hemeryck Alex; Belpaire Frans M, "Selective serotonin reuptake inhibitors and cytochrome P-450 mediated drug-drug interactions: An update", CURRENT DRUG METABOLISM, (20020201), vol. 3, no. 1, pages 13 - 37, XP009157243
OPPOSITION- Levy R; Hachad H; Yao C; Ragueneau-Majlessi, "Relationship Between Extent of Inhibition and Inhibitor Dose: Literature Evaluation Based on the Metabolism and Transport Drug Interaction Database", Current Drug Metabolism, (20030000), vol. 4, pages 371 - 380, XP055394041
OPPOSITION- Levy R; Hachad H; Yao C; Ragueneau-Majless, "Relationship Between Extent of Inhibition and Inhibitor Dose: Literature Evaluation Based on the Metabolism and Transport Drug Interaction Database", Current Drug Metabolism, (20030000), vol. 4, pages 371 - 380, XP055394041
OPPOSITION- LEVY R. H. et al., "Relationship Between Extent of Inhibition and Inhibitor Dose: Literature Evaluation Based on the Metabolism and Transport Drug Interaction Database", Current Drug Metabolism, (20030000), doi:10.2174/1389200033489325, pages 371 - 380, XP055394041
OPPOSITION- Levy R. H., H. Hachad., C. Yao, I. Ragueneau-Majlessi, "Relationship Between Extent of Inhibition and Inhibitor Dose: Literature Evaluation Based on the Metabolism and Transport Drug Interaction Database", Current Drug Metabolism, (20030000), vol. 4, pages 371 - 380, XP055394041
SEARCH- Banu A. Karimi-Shah, MD, "Clinical Review, NDA 22-535", (20100212), URL: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/UCM203081.pdf, (20100429), XP002580220 [XP] 1-15 * Division Summary, paragraph linking pages 4-5 * * Clinical Briefing Document, page 17, Section 4.4.2; page 17 * * Clinical Briefing Document, page 87, Section 7.5.3 *-
SEARCH- Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, "Report on the Deliberation Results", (20080916), URL: http://www.pmda.go.jp/english/service/pdf/Pirespa-Pirfenidone.pdf, (20100422), XP009132612 [AD] 1-15 * pages 25-26: section 3.(ii).A.(3).5 * * page 27: section 3.(ii).A.(5) * * pages 43-44: section 4.(i).B * * page 63 - page 64 *-
SEARCH- "Intermune, Inc; Pirfenidone Briefing Document", (20100309), URL: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/UCM203083.pdf, (20100429), XP002580221 [XP] 1-15 * Sections: "Elimination" and "3.2 Drug-Drug Interactions"; page 37 *-
SEARCH- JEPPESEN U ET AL, "Dose-dependent inhibition of CYP1A2, CYP2C19 and CYP2D6 by citalopram, fluoxetine, fluvoxamine and paroxetine", EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY, SPRINGER VERLAG, DE, (19960101), vol. 51, no. 1, ISSN 0031-6970, pages 73 - 78, XP009132566 [AD] 1-15 * the whole document *-
SEARCH- KROON LISA A, "Drug interactions with smoking", AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY, AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS, UNITED STATES, (20070915), vol. 64, no. 18, ISSN 1079-2082, pages 1917 - 1921, XP009151842 [A] 1-15 * the whole document *-
SEARCH- LANDI M T ET AL, "Human cytochrome P4501A2.", IARC SCIENTIFIC PUBLICATIONS 1999 LNKD- PUBMED:10493258, (1999), no. 148, ISSN 0300-5038, pages 173 - 195, XP009132024 [A] 1-15 * abstract * * page 176, column left, paragraph L * * Page 185: "Clinical implications" *-
SEARCH- HEMERYCK ALEX ET AL, "Selective serotonin reuptake inhibitors and cytochrome P-450 mediated drug-drug interactions: An update", CURRENT DRUG METABOLISM, (200202), vol. 3, no. 1, ISSN 1389-2002, pages 13 - 37, XP009157243 [AD] 1-15 * the whole document *

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