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Pharmaceutical Composition Comprising Ivabradine Hydrochloride Polymorph Iv - EP2774606

The patent EP2774606 was granted to Synthon on Jan 30, 2019. The application was originally filed on Feb 14, 2014 under application number EP14155218A. The patent is currently recorded with a legal status of "Revoked".

EP2774606

SYNTHON
Application Number
EP14155218A
Filing Date
Feb 14, 2014
Status
Revoked
Jul 21, 2023
Grant Date
Jan 30, 2019
External Links
Slate, Register, Google Patents

Patent Summary

Patent Family

Patent Family

Patent Oppositions (5)

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CompanyOpposition DateRepresentativeOpposition Status

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ALGEMEEN OCTROOI EN MERKENBUREAUOct 30, 2019ALGEMEEN OCTROOI EN MERKENBUREAUADMISSIBLE
STRAWMANOct 29, 2019BASRAWITHDRAWN
MAIWALDOct 28, 2019MAIWALDADMISSIBLE
NEIDLEINMar 5, 2019GILLE HRABAL PARTNERSCHAFTSGESELLSCHAFT MBB PATENTANWALTEADMISSIBLE
DR SCHONFeb 11, 2019-ADMISSIBLE

Patent Citations (25) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONEP0534859
DESCRIPTIONWO2005110993
DESCRIPTIONWO2006092491
DESCRIPTIONWO2006092492
DESCRIPTIONWO2006092493
DESCRIPTIONWO2006092494
DESCRIPTIONWO2007042656
DESCRIPTIONWO2007042657
DESCRIPTIONWO2013064307
OPPOSITIONCN103183639
OPPOSITIONDE4326268
OPPOSITIONEP1928428
OPPOSITIONEP2774606
OPPOSITIONUS2009294319
OPPOSITIONUS7866475
OPPOSITIONWO2009124940
OPPOSITIONWO2011098582
OPPOSITIONWO2013017582
OPPOSITIONWO2013064307
OPPOSITIONWO2013102919
OTHERWO2013064307
SEARCHCN103183639
SEARCHWO2011098582
SEARCHWO2013064307
SEARCHWO2013102919

Non-Patent Literature (NPL) Citations (31) 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- "Assessment of the impact of formulation and packaging on the stability of cabergoline tablets", International Journal of Pharmacy and Pharmaceutical Sciences, (20120000), vol. 4, no. 5, ISSN 0975-1491, pages 511 - 518, XP055660081-
OPPOSITION- Details on the CHMP review with respect to the marketing authorization for the product Corlen tor, (20050000), pages 1 - 6-
OPPOSITION- "Details on the CHMP review with respect to the marketing authorization for the prod- uct Corlentor", EMEA 2005, (20050000), pages 1 - 46, XP055562036-
OPPOSITION- EMEA, "ICH Topic Q1A (R2): Note for guidance on stability testing: stability testing of new drug substances and products", EMEA CPMP/ICH/2736/99, (20030800), pages 1 - 20, XP055281157-
OPPOSITION- EMEA, Note for Guidance on Stability Testing: Stability Testing of New Drug Substances and Products, (20030800), XP055655060-
OPPOSITION- Hua YIN, "Stability testing of Active pharmaceutical ingredients", CPH training, (20120100), pages 1 - 51, XP055660048-
OPPOSITION- J. DIXON, "Packaging Materials, - 9. Multilayer Packaging for Beverages", ILSI Report, (20110700), pages 5 - 7, XP055574873-
OPPOSITION- KIM HUYNH-BA, Handbook of Stability Testing in Pharmaceutical Development, (20090000), pages 10 - 19, XP055655056-
OPPOSITION- Lachman et al., "Kinetic principles and stability testing", The theory and practice of industrial pharmacy, Philadelphia, pages 703, 705 - 709, XP055660059-
OPPOSITION- "NOTE FOR GUIDANCE ON STABILITY TESTING: Stability Testing of new Drug Substances and Products", EMEA ICH Topic Q1A (R2), (200308), pages 1 - 20, XP055655060-
OPPOSITION- RON PILCHIK, "Pharmaceutical Blister Packaging, Part I, Rationale and Materials", Pharmaceutical Technology, (20001100), pages 68 - 77, XP055165521-
OPPOSITION- R. PILCHIK, "Pharmaceutical Blister Packaging, Part - II, Machinery and Assembly", PHARMACEUTICAL TECHNOLOGY, (20001200), pages 56 - 60, XP055496391-
OPPOSITION- R. PILCHIK, "Pharmaceutical Blister Packaging, Part I, Rationale and Materials", Pharmaceutical Technology, (20001100), vol. 24, no. 11, pages 68 - 76, XP055562046-
OPPOSITION- R. PILCHIK, "Pharmaceutical Blister Packaging, Part I, Rationale and Materials", Pharm. Technology, (20001100), vol. 24, no. 11, pages 68 - 78, XP055562046-
OPPOSITION- R. PILCHIK, "Pharmaceutical Blister Packaging, Part I, Rationale and Materials", Pharm. Technology, (20001100), vol. 25, no. 11, pages 68 - 78, XP055562046-
OPPOSITION- "STABILITY TESTING ON NEW DRUG SUBSTANCES AND PRODUCTS Q1A(R2)", INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ENTITLED, (20030206), pages FP - 18, XP055660053-
OPPOSITION- "WHO Expert Commitee on Specifications for Pharmaceutical Preparations Thirty-fourth", WHO, (19960000), pages FP - 194, XP055660069-
OPPOSITION- LAURENCE W. MCKEEN, "4: Markets and Applications for Films, Containers and Membranes", PERMEABILITY PROPERTIES OF PLASTICS AND ELASTOMERS, (2012), pages 63 - 64, ISBN 978-1-4377-3469-0, XP055659995
OPPOSITION- J. G. ALLINSON et al., "The effects of packaging on the stability of a moisture sensitive compound", International Journal of Pharmaceutics, (20010000), vol. 221, doi:10.1016/S0378-5173(01)00670-6, pages 49 - 56, XP002406675
OPPOSITION- MASCIOCCHI N et al., Disclosing the extensive crystal chemistry of Ivabradine hydrochloride, in its pure and solvated phases, (20130900), vol. 28, no. 3, pages 200 - 206, XP009178659
OPPOSITION- MASCIOCCHI, N. et al., "Disclosing the Extensive Crystal Chemistry of Ivabradine Hydrochloride", Its Pure and Solvated Phases. Powder Diffraction, (20130000), vol. 28, no. 3, doi:10.1017/S0885715613000365, pages 200 - 206, XP009178659
OPPOSITION- N. MASCHIOCCHI et al., "Disclosing the extensive crystal chemistry of Ivabradine hydrochloride, in its pure and solvated phases", Powder Diffraction, (20130900), vol. 28, no. 3, doi:10.1017/S0885715613000365, pages 200 - 206, XP009178659
OPPOSITION- N. MASCIOCCHI et al., "Disclosing the extensive crystal chemistry of Ivabradine hydrochloride, in its pure and solvated phases", Powder Diffraction, (20130900), vol. 28, no. 3, pages 200 - 206, XP009178659
OPPOSITION- N. MASCIOCCHI et al., "Disclosing the extensive crystal chemistry of Ivabradine hydro- chloride, in its pure and solvated phases", Powder Diffraction, USA, (20130900), vol. 28, no. 3, pages 200 - 206, XP009178659
OPPOSITION- V. B. COOPER et al., "Quantification of crystalline forms in active pharmaceutical ingredient and tablets by X-ray powder diffraction", Journal of Pharmacy and Pharmacology, (20030900), vol. 55, no. 9, pages 1323 - 1329, XP009111587
OPPOSITION- DEY P et al., "Orodispersible tablets: A new trend in drug delivery", J Nat Sci Biol Med., (20100000), vol. 1, no. 1, pages 2 - 5, XP055629865
OTHER- EMEA, "Scientific Discussion", pages 1 - 46, URL: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000598/WC500035338.pdf, XP055496385-
OTHER- "ICH Topic Q1A (R2): Note for guidance on stability testing: stability testing of new drug substances and products", EMEA CPMP/ICH/2736/99, (20030800), pages 1 - 20, XP055281157-
OTHER- Ron Pilchik, "Pharmaceutical Blister Packaging, Part II, Machinery and Assembly", Pharmaceutical Technology, (20001200), pages 56 - 60, XP055496391-
OTHER- Ron Pilchik, "Pharmaceutical Blister Packaging, Part I Rationale and Materials", Pharmaceutical Technology, (20001100), pages 68 - 77, XP055165521-
SEARCH- MASCIOCCHI N ET AL, "Disclosing the extensive crystal chemistry of Ivabradine hydrochloride, in its pure and solvated phases", POWDER DIFFRACTION SEPTEMBER 2013 INTERNATIONAL CENTRE FOR DIFFRACTION DATA USA, (201309), vol. 28, no. 3, doi:10.1017/S0885715613000365, pages 200 - 206, XP009178659 [A] 1-14 * the whole document *

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