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Pharmaceutical Composition Containing Rifaximin Alpha & Delta - EP3434265

The patent EP3434265 was granted to Sandoz on Jul 7, 2021. The application was originally filed on Mar 22, 2017 under application number EP18193241A. The patent is currently recorded with a legal status of "Revoked".

EP3434265

SANDOZ
Application Number
EP18193241A
Filing Date
Mar 22, 2017
Status
Revoked
May 24, 2024
Grant Date
Jul 7, 2021
External Links
Slate, Register, Google Patents

Patent Summary

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Patent Family

Patent Oppositions (3)

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TEVA PHARMACEUTICALSApr 7, 2022D YOUNGADMISSIBLE
ALFRED E TIEFENBACHERApr 6, 2022HAMM & WITTKOPPADMISSIBLE
ALFASIGMAMar 21, 2022KRAUS & LEDERER PARTGMBBADMISSIBLE

Patent Citations (9) New

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

Citation PhasePublication NumberPublication Link
OPPOSITIONEP1557421
OPPOSITIONEP1698630
OPPOSITIONEP2927235
OPPOSITIONEP3294270
OPPOSITIONEP3373914
OPPOSITIONWO2005044823
OPPOSITIONWO2011107970
SEARCHEP1698630
SEARCHUS9018225

Non-Patent Literature (NPL) Citations (43) 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
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DESCRIPTION- Lexikon der Hilfsstoffe fur Pharmazie, Kosmetik und angrenzende Gebiete, H.P. Fielder-
DESCRIPTION- VISCOMI G. C. et al., Crystal forms of rifaximin and their effect on pharmaceutical properties, Royal Society of Chemistry, CrystEngComm, (20080000), vol. 10, pages 1074 - 1081-
OPPOSITION- ANNA KUPKA, "Rifaximin- REFERENCE TABLETS", SOLID CHEM, (20170719), XP055910188-
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OPPOSITION- Anonymous, "Normix® Riassunto Delle Caratteristiche Del Prodotto", Normix, (20000601), pages 1 - 6, XP055914262-
OPPOSITION- Anonymous, "Patient Information Leaflet Xifaxan® 550 MG Filmtabletten zur Anwendung bei Erwachsenen Rifaximin", Norgine, (20130100), pages 1 - 4, XP055913896-
OPPOSITION- Anonymous, "Photocopy of the carton and blister of the Xifaxan® tablet", Xifaxan, (20170400), pages 1 - 4, XP055913892-
OPPOSITION- Anonymous, "Tabletten compressi ", darreichungsformen , (19980101), XP055910145-
OPPOSITION- Anonymous, "Xifaxan 550mg ", FDA, (20110726), FDA, (20220407), XP055910157-
OPPOSITION- Anonymous, "Xifaxan 550mg Filmtabletten", Norgine GmbH, (20130206), pages 1 - 4, XP055913995-
OPPOSITION- ANONYMOUS, "Xifaxan 550mg Filmtabletten", NORGINE GMBH, (20130206), pages 1 - 4, XP055913995-
OPPOSITION- Anonymous, "XRPD Investigation on Rifaximn Reference Tablets", solid-chem report, (20170719), pages 1 - 14, XP055913908-
OPPOSITION- ANONYMOUS, "XRPD Investigation on Rifaximn Reference Tablets", SOLID-CHEM REPORT, (20170719), pages 1 - 14, XP055913908-
OPPOSITION- "Cellulose, Microcrystalline", Handbook of Pharmaceutical Excipients Fifth Edition, Pharmaceutical Press, (20060000), pages 132 - 135, XP055466201-
OPPOSITION- "CHARACTERISATION OF RIFAXIMIN", Dannalab B.V, (20151221), XP055910191-
OPPOSITION- Chen Yisheng, "Chapter 24: Packaging Selection for Solid Oral Dosage Forms", Chen Yisheng, Qiu Y. ET AL., Developing Solid Oral Dosage Forms Pharmaceutical Theory and Practice, Elsevier, (20090310), pages 1 - 16, XP055913976-
OPPOSITION- David B. Lewis, "xifaxin tablets ", center for drug evaluation and research, (20100301), center for drug evaluation and research , (20220407), XP055910164-
OPPOSITION- DOMINIQUE ANNA GOPALAKISHNAN ET AL, "Rifaximin- Rietveld Analysis", SOLID-CHEM GMBH, (20181123), pages 1 - 8, XP055910171-
OPPOSITION- "PVC/ PE /PVdC", ACG NORTH AMERICA-
OPPOSITION- SCHUBNELL et al., "Moisture content, water content, loss on drying, Part 1: What exactly is meant and how are these quantities determined?", Mettler Toledo Thermal Analysis UserCom51-
OPPOSITION- V.A. Kogan, "Quantification of Forms of Rifaximin in FDF", Dannalab B.V. Final Report AET_241-5, (20190218), pages 1 - 14, XP055615071-
OPPOSITION- V.A. KOGAN, "Quantification of Forms of Rifaximin in FDF", DANNALAB B.V. FINAL REPORT AET_241-5, (20190218), pages 1 - 14, XP055615071-
OPPOSITION- WILL, GEORG, "Chapter 1 and Chapter 2", Powder Diffraction, Springer, (20060126), pages 1 - 74, XP055913986-
OPPOSITION- Wolfgang A. Ritschel, Annette Bauer-Brandl, "Kapitel 10 /Passage/", DIE TABLETTE HANDBUCH DER ENTWICKLUNG, HERSTELLUNG UND QUALITÄTSSICHERUNG, Editio Cantor Verlag Aulendorf , (20020101), pages 2pp, 598 - 601, XP055615966-
OPPOSITION- Xifaxan 200, (20170800), XP055910126-
OPPOSITION- "Xifaxan 550 mg", NORGINE GMBH FACHINFORMATION-
OPPOSITION- KHADKA et al., "Pharmaceutical particle technologies: An approach to improve drug solubility, dissolution and bioavailability", Asian Journal of Pharmaceutical Sciences, (20140000), vol. 9, doi:10.1016/j.ajps.2014.05.005, pages 304 - 316, XP055270350
OPPOSITION- G. C. Viscomi, M. Campana, M. Barbanti, F. Grepioni, M. Polito, D. Confortini, G. Rosini, P. Righi, V. Cannata and D. Braga, "Crystal forms of rifaximin and their effect on pharmaceutical properties", CRYSTENGCOMM, ROYAL SOCIETY OF CHEMISTRY, CAMBRIDGE, GB, GB , (20080101), vol. 10, doi:10.1039/B717887E, ISSN 1466-8033, pages 1074 - 1081, XP009152378
OPPOSITION- Viscomi G. C., Campana M., Barbanti M., Grepioni F., Polito M., Confortini D., Rosini G., Righi P., Cannata V., Braga D., "Crystal forms of rifaximin and their effect on pharmaceutical properties", CrystEngComm, (20080000), vol. 10, pages 1074 - 1081, XP009152378
OPPOSITION- BASS et al., "Rifaximin Treatment in Hepatic Encephalopathy", N Engl J Med, (20100000), vol. 362, doi:10.1056/NEJMoa0907893, pages 1071 - 81, XP055616660
OPPOSITION- PIMENTEL et al., "Rifaximin Therapy for Patients with Irritable Bowel Syndrome without Constipation", N Engl J Med, (20110000), vol. 364, doi:10.1056/NEJMoa1004409, pages 22 - 32, XP002735664
OPPOSITION- AARONS L. et al., "Optimal Design of Pharmacokinetic Studies", Basic & Clinical Pharmacology & Toxicology, (20100000), vol. 106, pages 250 - 255, XP055910130
OPPOSITION- TURNER et al., "Prospective, Controlled Study of Acyclovir Pharmacokinetics in Obese Patients", Antimicrobial Agents and Chemotherapy, (20160000), vol. 60, no. 3, pages 1830 - 1833, XP055910119
OPPOSITION- DAVIT et al., "Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration", The AAPS Journal, (20120000), vol. 14, no. 4, doi:10.1208/s12248-012-9406-x, pages 915 - 924, XP035127468
OPPOSITION- Carmelo Scarpignato, Corrado Blandizzi, Giuseppe Claudio Viscomi, "Impact of crystal polymorphism on the systemic bioavailability of rifaximin, an antibiotic acting locally in the gastrointestinal tract, in healthy volunteers", Drug Design, Development and Therapy, doi:10.2147/DDDT.S72572, page 1, XP055297628
OPPOSITION- SAVJANI et al., "Drug Solubility: Importance and Enhancement Techniques", International Scholarly Research Network, (20120000), doi:10.5402/2012/195727, pages 1 - 10, XP055328944
SEARCH- VISCOMI G C ET AL, "Crystal forms of rifaximin and their effect on pharmaceutical properties", CRYSTENGCOMM, ROYAL SOCIETY OF CHEMISTRY, CAMBRIDGE, GB, vol. 10, doi:10.1039/B717887E, ISSN 1466-8033, (20080101), pages 1074 - 1081, (20080528), XP009152378 [AD] 1-14 * table 7 *

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