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Crystalline Eravacycline Bis-Hydrochloride - EP3390358

The patent EP3390358 was granted to Sandoz on Sep 23, 2020. The application was originally filed on Jan 20, 2017 under application number EP17701668A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3390358

SANDOZ
Application Number
EP17701668A
Filing Date
Jan 20, 2017
Status
Granted And Under Opposition
Aug 21, 2020
Grant Date
Sep 23, 2020
External Links
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TETRAPHASE PHARMACEUTICALSJun 22, 2021GILL JENNINGS & EVERYWITHDRAWN

Patent Citations (5) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONWO2010017470
DESCRIPTIONWO2012021829
INTERNATIONAL-SEARCH-REPORTWO2012021829
OPPOSITIONWO2012021829
OPPOSITIONWO2018075767

Non-Patent Literature (NPL) Citations (17) 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
DESCRIPTION- VITALIJ K. PECHARSKY; PETER Y. ZAVALIJ, Fundamentals of Powder Diffraction and Structural Characterization of Materials, KLUWER ACADEMIC PUBLISHERS, (2003), page 3-
DESCRIPTION- XIAO, "Fluorocyclines. 1. 7-Fluoro-9-pyrrolidinoacetamido-6-demethyl-6-deoxytetracycline: A Potent, Broad Spectrum Antibacterial Agent", J. MED. CHEM, (2012), vol. 55, doi:doi:10.1021/jm201465w, pages 597 - 605, XP055259585
DESCRIPTION- RONN ET AL., "Process R&D of Eravacycline: The First Fully Synthetic Fluorocycline in Clinical Development", ORG. PROCESS RES. DEV., (2013), vol. 17, doi:doi:10.1021/op4000219, pages 838 - 845, XP055254495
INTERNATIONAL-SEARCH-REPORT- MAGNUS RONN ET AL, "Process R&D of Eravacycline: The First Fully Synthetic Fluorocycline in Clinical Development", ORGANIC PROCESS RESEARCH AND DEVELOPMENT, US, (20130517), vol. 17, no. 5, doi:10.1021/op4000219, ISSN 1083-6160, pages 838 - 845, XP055254495 [ID] 1-13 * page 842, paragraph 3 - column 2 * * page 844, paragraph 2 - column 2 *
OPPOSITION- BAVIN M, "Polymorphism in Process Development", Chemistry & Industry, SOCIETY OF CHEMICAL INDUSTRY. LONDON., GB, GB, (19890821), ISSN 0009-3068, pages 527 - 529, XP001180136-
OPPOSITION- "Crystallization", L.M. HARWOOD et al., Experimental Organic Chemistry, Principles and Practice, Blackwell Science, (19890000), pages 127 - 139, XP055823116-
OPPOSITION- FDA, "Guide To Inspections Of Lyophilization Of Parenterals (7/93)", US FDA, (20141111), URL: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/lyophilization-parenteral-793, XP055823148-
OPPOSITION- Gennaro A. R., "Chapter 13 and 83", Remington: The Science and Practice of Pharmacy. 19th ed., Mack Publishing, (19950101), pages 168,1452 - 1453, XP055475015-
OPPOSITION- "Guidance for Industry. ANDAs: Pharmaceutical Solid Polymorphism Chemistry, Manufacturing, and Controls Information", U.S. Department od Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER), (20070701), pages 1 - 13, URL: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072866.pdf, (20131206), XP055092048-
OPPOSITION- "Solid-state properties", Michael E. Aulton, Aulton's Pharmaceutics. 4th ed., Elsevier, (20130000), pages 59, 127 - 131, 390-392, XP055823149-
OPPOSITION- "Solutions and solubility", J. W. MULLIN, Crystallization. 4th ed., Butterworth-Heinemann, (2001), pages 86 - 88, 197-199, 300-302, XP055823125-
OPPOSITION- "Tablettenbestandteile", W. RITSCHEL et al., Die Tablette: Handbuch der Entwicklung, Herstellung und Qualitätssicherung, Editio Cantor Verlag, (20020000), pages 60 - 62, XP055823128-
OPPOSITION- "the organic solid state", Mark Gibson, Pharmaceutical Preformulation and Formulation, informa healthcare, (20090000), pages 25, 34 - 43, 61-65, 91-98, XP055823122-
OPPOSITION- MINO R. CAIRA, "Crystalline Polymorphism of Organic Compounds", Topics in Current Chemistry, (19980000), vol. 198, doi:10.1007/3-540-69178-2_5, pages 163 - 208, XP008166276
OPPOSITION- RAW ANDRE S ET AL, "Regulatory considerations of pharmaceutical solid polymorphism in Abbreviated New Drug Applications (ANDAs).", Advanced Drug Delivery Reviews, Elsevier, Amsterdam , NL, Amsterdam , NL, (20040223), vol. 56, no. 3, doi:10.1016/j.addr.2003.10.011, ISSN 0169-409X, pages 397 - 414, XP002422195
OPPOSITION- RONN et al., "Process R&D of Eravacycline: The First Fully Synthetic Fluorocycline in Clinical Development", Org. Process Res. Dev., (20130000), vol. 17, doi:10.1021/op4000219, pages 838 - 845, XP055254495
OPPOSITION- Stephen Byrn; Pfeiffer Ralph; Ganey Michael; Hoiberg Charles; Poochikian Guirag, "Pharmaceutical Solids: A strategic Approach to Regulatory Considerations", Pharmaceutical Research, Springer New York LLC, US, US, (19950701), vol. 12, no. 07, doi:10.1023/A:1016241927429, ISSN 0724-8741, pages 945 - 954, XP000996386

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