IP Verse

Stable Pharmaceutical Compositions Comprising Micafungin - EP3240529

The patent EP3240529 was granted to Galenicum Health SL on Feb 2, 2022. The application was originally filed on Dec 30, 2015 under application number EP15817912A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3240529

GALENICUM HEALTH SL
Application Number
EP15817912A
Filing Date
Dec 30, 2015
Status
Granted And Under Opposition
Dec 31, 2021
Grant Date
Feb 2, 2022
External Links
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Patent Summary

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Patent Family

Patent Oppositions (2)

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SOMMERNov 2, 2022SOMMERWITHDRAWN
STRAWMANOct 31, 2022HOFFMANN EITLEWITHDRAWN

Patent Citations (7) New

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

Citation PhasePublication NumberPublication Link
EXAMINATIONWO0102002
INTERNATIONAL-SEARCH-REPORTUS2013331312
OPPOSITIONJP2006069929
OPPOSITIONUS2013331312
OPPOSITIONWO0102002
OTHERUS2013331312
OTHERWO0102002

Non-Patent Literature (NPL) Citations (40) 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
INTERNATIONAL-SEARCH-REPORT- JAMES A. SEARLES ET AL, "The ice nucleation temperature determines the primary drying rate of lyophilization for samples frozen on a temperature-controlled shelf", JOURNAL OF PHARMACEUTICAL SCIENCES, WASHINGTON, US, (20010701), vol. 90, no. 7, doi:10.1002/jps.1039, ISSN 0022-3549, pages 860 - 871, XP055257137 [T] 32-38
OPPOSITION- Agalloco James, Et Al, "2.1 Sterile Product Manufacturing", Agalloco James, Et Al, Shayne Cox Gad (Editor), Pharmaceutical manufacturing handbook: production and processes, Hoboken, New Jersey , John Wiley & Sons, Inc , (20080101), pages 99 - 104, ISBN 978-0-470-25958-0, XP055978854-
OPPOSITION- AKERS MICHAEL J; VASUDEVAN VASU; STICKELMEYER MARY, "FORMULATION DEVELOPMENT OF PROTEIN DOSAGE FORMS.", PHARMACEUTICAL BIOTECHNOLOGY, KLUWER, DORDRECHT, NL, NL , (20020101), vol. 14, ISSN 1078-0467, pages 47 - 127, XP001537612-
OPPOSITION- Anonymous, "Fujisawa Annual Report", FUJISAWA PHARMACEUTICAL COMPANY LIMITED, (20040101), FUJISAWA PHARMACEUTICAL COMPANY LIMITED, URL: https://www.astellas.com/system/files/f_annual2004_eg.pdf, (20200706), XP055711720-
OPPOSITION- Anonymous, "Micafungin (FK463) Module 2.4 Nonclinical Overview", Astellas Pharma GmbH, pages i-v, 1 - 78-
OPPOSITION- Anonymous, "Micafungin HEXAL", HEXAL - Fachinformation, (20201001), pages 1 - 19, HEXAL - Fachinformation, (20210308), XP055782796-
OPPOSITION- Anonymous, "Micafungin HEXAL", HEXAL - Gebrauchsinformation, (20201022), pages 1 - 9, HEXAL - Gebrauchsinformation, (20210308), XP055782800-
OPPOSITION- Anonymous, "Mycamine 50 mg powder for concentrate for solution for infusion", Annex I. Summary of Product Characteristics, (20080101), pages 1 - 34, Annex I. Summary of Product Characteristics, (20200706), XP055711723-
OPPOSITION- Anonymous, "Smart Freeze Drying Basic principles, optimum procedures and applications", Martin Christ, (20100101), Martin Christ, (20221010), XP055969231-
OPPOSITION- BAHETI A, KUMAR L, BANSAL A K, "Excipients used in lyophilization of small molecules", Journal of Excipients and Food Chemicals, International Pharmaceutical Excipients Council, Americas, United States, United States , (20100101), vol. 1, no. 1, ISSN 2150-2668, pages 41 - 54, XP002667508-
OPPOSITION- BAHETI A, KUMAR L, BANSAL A K, "Excipients used in lyophilization of small molecules", Journal of Excipients and Food Chemicals, United States , (20100101), vol. 1, no. 1, ISSN 2150-2668, pages 41 - 54, XP002667508-
OPPOSITION- Council Of Europe Strasbourg, "Passage: 2.9.3. Dissolution test for solid dosage forms", EUROPEAN PHARMACOPOEIA FIFTH EDITION, (20040615), pages 228 - 230, XP055978850-
OPPOSITION- Emea, "Assessment Report for Maycamine", EMEA/H/C/000734, (20080424), pages 1 - 50, XP055979073-
OPPOSITION- Gonzalez Michelle M, "Materials of Construction for Pharmaceutical Equipment", Encyclopedia of Pharmaceutical Technology, (20070101), vol. 1, pages 2237 - 2242, XP055979102-
OPPOSITION- Höger Kerstin, "Investigations on Protein Adsorption to Coated Glass Vials", Dissertation zur Erlangung des Doktorgrades, (20140101), pages 1 - 118, Dissertation zur Erlangung des Doktorgrades , URL: https://edoc.ub.uni-muenchen.de/17047/1/Hoeger_Kerstin.pdf, (20221116), XP055981952-
OPPOSITION- Hussein Fadwa, "Untersuchung verschiedener Einflüsse auf die Proteinadsorption an Primärpackmitteln", Dissertation, (20070101), pages I-VI, 1 - 141, Dissertation , URL: https://leopard.tu-braunschweig.de/servlets/MCRFileNodeServlet/dbbs_derivate_00004196/EDiss.pdf, (20221116), XP055981971-
OPPOSITION- Mhra, Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007. Excerpt, Pharmaceutical Press, (20070101), pages 142 - 143, ISBN 978-0-85369-719-0, XP055979083-
OPPOSITION- Nunes Mafalda Filipa Machado, "Technical Aspects related to the Manufacture of Injectable Pharmaceutical Products - From R&D to Production", Master Thesis university of Lisbon, (20151201), pages 1 - 85, XP055979090-
OPPOSITION- "Packed towers", William D. Baasel, Preliminary Chemical Engineering Plant Design. 2nd ed., Van Nostrand Reinhold , (19900101), page 117, XP055711728-
OPPOSITION- "Remington Essentials of Pharmaceutics. Excerpt", Felton Linda (ed.), (20120101), pages 525 - 528, XP055979064-
OPPOSITION- "Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007. Excerpt", Mhra, Pharmaceutical Press, (20070101), pages 142 - 143, ISBN 978-0-85369-719-0, XP055979083-
OPPOSITION- Shia Jeremy, Xu Jane, Murphy Brian P, Chambers Erin E, "Overcoming Glass Vial Adsorption Effects for Trace Analysis of Basic Compounds by LC/MS/MS", Waters Corporation, (20110101), page 1, XP055981979-
OPPOSITION- Sumitra A Pillai, Dhawal Chobisa, Dileep Urimi, Nagasuri Ravindra, "Pharmaceutical Glass Interactions: A Review of Possibilities", Journal of Pharmaceutical Sciences and Research, Journal of Pharmaceutical Sciences and Research, Cuddalore, Cuddalore , vol. 8, no. 2, (20160201), pages 103 - 111, Journal of Pharmaceutical Sciences and Research, URL: https://pdfs.semanticscholar.org/fd6d/92ea167b7ba859eab092ba22da965f6e2ed2.pdf, XP055561271-
OPPOSITION- James A. Searles, Carpenter John F., Randolph Theodore W., "The ice nucleation temperature determines the primary drying rate of lyophilization for samples frozen on a temperature‐controlled shelf", Journal of Pharmaceutical Sciences, American Chemical Society and American Pharmaceutical Association, US, US , (20010701), vol. 90, no. 7, doi:10.1002/jps.1039, ISSN 0022-3549, pages 860 - 871, XP055257137
OPPOSITION- Shengsheng Zhu, Meng Xiang, Su Xin, Luo Yongwei, Sun Zuyue, "Development and Validation of a Stability-Indicating High Performance Liquid Chromatographic (HPLC) Method for the Determination of Related Substances of Micafungin Sodium in Drug Substances", International Journal of Molecular Sciences, (20131024), vol. 14, no. 11, doi:10.3390/ijms141121202, pages 21202 - 21214, XP055205950
OTHER- Ankit Baheti et al, "Excipients used in lyophilization of small molecules", Excipients used in lyophilization of small molecules, (20100618), vol. 1, no. 1, pages 41 - 54, XP055371005-
OTHER- Ankit Baheti, Lokesh Kumar, Arvind K. Bansal, "Excipients used in lyophilization of small molecules", Journal of Excipients and Food Chemicals, International Pharmaceutical Excipients Council, vol. 1, (20160618), pages 41 - 54, Journal of Excipients and Food Chemicals, URL: https://ojs.abo.fi/ojs/index.php/jefc/article/download/21/14, XP055371005-
OTHER- "annex 9", MHRA, Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007, Pharmaceutical Press (PhP), (20070000), pages 142 - 143, XP055782776-
OTHER- anonymous, "Fujisawa Annual Report", FUJISAWA PHARMACEUTICAL COMPANY LIMITED, (20040000), URL: https://www.astellas.com/system/files/f_annual2004_eg.pdf, XP055711720-
OTHER- Anonymous, "Micafungin (FK463) Module 2.4 Nonclinical Overview", Astellas Pharma GmbH, pages 1 - 78-
OTHER- Anonymous, "Micafungin HEXAL", HEXAL - Fachinformation, (20201001), pages 1 - 19, HEXAL - Fachinformation, (20210308), XP055782796-
OTHER- anonymous, "Micafungin HEXAL", HEXAL - Fachinformation, (20201002), pages 1 - 19, XP055782796-
OTHER- Anonymous, "Micafungin HEXAL", HEXAL - Gebrauchsinformation, (20201022), pages 1 - 9, HEXAL - Gebrauchsinformation, (20210308), XP055782800-
OTHER- anonymous, "Micafungin HEXAL", HEXAL - Gebrauchsinformation, (20201022), pages 1 - 9, XP055782800-
OTHER- anonymous, "Mycamine 50 mg power for concentrate for solution for infusion", Annex I. Summary of Product Characteristics, (20080000), pages 1 - 34, XP055711723-
OTHER- BAHETI A. et al, "Excipients used in lyophilization of small molecules", J. Excipients Food Chem., (20100618), vol. 1, no. 1, pages 41 - 54, XP055371005-
OTHER- EMEA, "Assesment Report for Mycamine", EMEA/CHMP/121708/2008, (20080424), pages 1 - 50, URL: https://www.ema.europa.eu/en/documents/assessment-report/mycamine-epar-public-assessment-report_en.pdf, XP055711719-
OTHER- Mhra, "annex 9", Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007, Pharmaceutical Press (PhP) , (20070101), pages 142 - 143, XP055782776-
OTHER- "Packed towers", William D. Baasel, Preliminary Chemical Engineering Plant Design. 2nd ed., Van Nostrand Reinhold, (19900000), page 117, XP055711728-
OTHER- Shengsheng Zhu, Meng Xiang, Su Xin, Luo Yongwei, Sun Zuyue, "Development and Validation of a Stability-Indicating High Performance Liquid Chromatographic (HPLC) Method for the Determination of Related Substances of Micafungin Sodium in Drug Substances", International Journal of Molecular Sciences, (20131024), vol. 14, no. 11, doi:10.3390/ijms141121202, pages 21202 - 21214, XP055205950

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