IP Verse

Stable Pharmaceutical Composition For Oral Administration - EP3318259

The patent EP3318259 was granted to Astellas Pharma on Jan 11, 2023. The application was originally filed on Jul 1, 2016 under application number EP16821324A. The patent is currently recorded with a legal status of "Revoked".

EP3318259

ASTELLAS PHARMA
Application Number
EP16821324A
Filing Date
Jul 1, 2016
Status
Revoked
Sep 26, 2025
Grant Date
Jan 11, 2023
External Links
Slate, Register, Google Patents

Patent Summary

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Patent Family

Patent Oppositions (2)

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CompanyOpposition DateRepresentativeOpposition Status

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GENERICS UKOct 11, 2023ELKINGTON AND FIFEADMISSIBLE
SANDOZOct 10, 2023KRAUS & LEDERER PARTGMBBADMISSIBLE

Patent Citations (14) New

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

Citation PhasePublication NumberPublication Link
INTERNATIONAL-SEARCH-REPORTJP2014501770
INTERNATIONAL-SEARCH-REPORTWO2010128659
INTERNATIONAL-SEARCH-REPORTWO2015119122
OPPOSITIONEP2428508
OPPOSITIONUS2013273161
OPPOSITIONUS8969336
OPPOSITIONUS9755832
OPPOSITIONWO2010128659
OPPOSITIONWO2015119122
SEARCHEP2428508
SEARCHJP2014501770
SEARCHUS2013273161
SEARCHWO2010128659
SEARCHWO2015119122

Non-Patent Literature (NPL) Citations (29) 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- Albert Rankell , Herbert A Liberman, "Drying", Albert Rankell , Herbert A Liberman, Leon Lachman , Herbert A Liberman , Joseph L Kanig, The Theory and Practice of Industrial Pharmacy second edition, Lea & Febiger, (19760101), pages 503 - 504, XP093138955-
OPPOSITION- Anonymous, "Drying", Anonymous, Anthony J. Hickey , David Ganderton, Pharmaceutical Process Engineering, Marcel Dekker, Inc., (20010101), pages 86 - 87, ISBN 978-0-8247-0298-4, XP093138961-
OPPOSITION- Anonymous, "Guidance for Industry ANDAs: Pharmaceutical Solid Polymorphism Chemistry, Manufacturing, and Controls Information", US Food and Drug Administration, (20070701), pages 1 - 13, XP093138926-
OPPOSITION- ANONYMOUS, "Guidance for Industry: Q1A(R2), Stability Testing of New Drug Substances and Products, Revision 2", (20031101), pages 1 - 22, XP002784370-
OPPOSITION- Anonymous, "Guideline on the chemistry of active substances", EUROPEAN MEDICINES AGENCY; EMA/CHMP/QWP/96664/2015 Committee for Medicinal Products for Human Use (CHMP), (20150213), EUROPEAN MEDICINES AGENCY; EMA/CHMP/QWP/96664/2015 Committee for Medicinal Products for Human Use (CHMP) , (20240305), XP093137935-
OPPOSITION- Anonymous, "Mannitol", Anonymous, Arthur H Kibbe, Handbook of Pharmaceutical Excipients Third edition , American Pharmaceutical Association, (20000101), pages 324 - 328, XP093138965-
OPPOSITION- Anonymous, "Passage ; Pharmaceutical Dosage Forms: Tablets Volume 1", Anonymous, Herbert A. Lieberman, Leon Lachman, Joseph B. Schwartz, Pharmaceutical Dosage Forms: Tablets Volume 1, Marcel Dekker, Inc., (19890101), pages 54 - 54, ISBN 0-8247-8044-2, XP093138945-
OPPOSITION- Brittain Harry G, Eugene F. Fiese, "Effects of Pharmaceutical Processing on Drug Polymorphs and Solvates", Brittain Harry G, Eugene F. Fiese, Harry G. Brittain (ed.), Polymorphism in Pharmaceutical solids, USA , M. Dekker , (19990101), pages 338 - 343, ISBN 978-0-8247-0237-3, XP093138859-
OPPOSITION- "Chapter 5 - Drug Stability and Degradation Studies", Qiu Y. et al., DEVELOPING SOLID ORAL DOSAGE FORMS, BURLINGTON, MA, ACADEMIC PRESS, (2009), pages 87 - 124, ISBN 978-0-444-53242-8-
OPPOSITION- Hancock Bruno C, Sheri L. Shamblin & George Zografi , "Molecular Mobility of Amorphous Pharmaceutical Solids Below Their Glass Transition Temperatures", Pharmaceutical Research, (19950601), vol. 12, no. 6, pages 799 - 806, XP093138456-
OPPOSITION- James Wells, "Pharmaceutical preformulation", James Wells, M E Aulton, Pharmaceutics The Science of dosage form design Second edition, Churchill Livingstone, (20020101), pages 114 - 115, XP093138934-
OPPOSITION- Larry L. Augsburger , Mark J. ZellHofer, "Tablet Formulation", Larry L. Augsburger , Mark J. ZellHofer, James Swarbrick, Encyclopedia of Pharmaceutical Technology Third edition Volume 1, Informa Healthcare USA, Inc, (20070101), pages 3641 - 3652, XP093138864-
OPPOSITION- Mark Gibson, "Pharmaceutical Preformulation and Formulation (passage)", Pharmaceutical Preformulation and Formulation, 2nd ed., (20090101), pages 231 - 234, XP055767493-
OPPOSITION- Michael E. Aulton, "Drying", Pharmaceutics: The Science of Dosage Form Design, Second Edition, Elsevier ltd. , (20020101), pages 2pp, 379 - 382, XP055306320-
OPPOSITION- Norman Anthony Armstrong, "Tablet Manufacture", Norman Anthony Armstrong, James Swarbrick, Encyclopedia of Pharmaceutical Technology Third edition Volume 1, Informa Healthcare USA, Inc, (20070101), pages 3653 - 3672, XP093138871-
OPPOSITION- Pandey A., Rath B., Dwivedi A. K., "Pharmaceutical Preformulation Studies with Special Emphasis on Excipients Compatibility", ChemInform, Electrochemical Society, (20120510), vol. 43, no. 23, ISSN 0931-7597, pages 1029 - 1048, XP009552522-
OPPOSITION- ROWE RAYMOND C; SHESKEY PAUL J; OWEN SIAN C, "Handbook of pharmaceutical excipients, Mannitol", ROWE RAYMOND C; SHESKEY PAUL J; OWEN SIAN C, ROWE R.C., SHESKEY P.J., OWEN S.C.(EDS.), Handbook of Pharmaceutical Excipients, London [u.a.] , Pharmaceutical Press [u.a.] , (20060101), vol. 5TH EDITION, pages 449 - 453, 031835, ISBN 978-1-58212-058-4, XP002537758-
OPPOSITION- Sumie Yoshioka, Valentino J. Stella, "Passage; STABILITY OF DRUGS AND DOSAGE FORMS", Sumie Yoshioka, Valentino J. Stella, YOSHIOKA Sumie and STELLA Valentino J., STABILITY OF DRUGS AND DOSAGE FORMS, NEW YORK, KLUWER ACADEMIC PUBLISHERS, (20020101), pages 107 - 117, ISBN 0-306-46404-7, XP009553970-
OPPOSITION- Thakral Seema, Ramprakash Govindarajan, Raj Suryanarayanan, "Processing-Induced Phase Transformations and Their Implications on Pharmaceutical Product Quality", Thakral Seema, Ramprakash Govindarajan, Raj Suryanarayanan, Rolf Hilfiker, Markus von Raumer, Polymorphism in the Pharmaceutical Industry: Solid Form and Drug Development, Wiley, (20060101), pages 333 - 336, ISBN 978-3-527-34040-8, XP093138848-
OPPOSITION- Wells James, "Pharmaceutical preformulation", Wells James, M E Aulton, Pharmaceutics The Science of dosage form design Second edition, Churchill Livingstone, (20020101), pages 128 - 130, XP093138941-
OPPOSITION- Hilfiker Rolf, Fritz Blatter, Martin Szelagiewicz, Markus Von Raumer, "Approaches to Solid-Form Screening", Hilfiker Rolf, Fritz Blatter, Martin Szelagiewicz, Markus Von Raumer, Rolf Hilfiker, Markus von Raumer, Polymorphism in the Pharmaceutical Industry: Solid Form and Drug Development, Wiley‐VCH Verlag GmbH & Co., (20060101), pages 1 - 14, doi:10.1002/9783527697847, ISBN 9783527340408, XP093138837
OPPOSITION- AHLNECK C, ZOGRAFI G, "THE MOLECULAR BASIS OF MOISTURE EFFECTS ON THE PHYSICAL AND CHEMICAL STABILITY OF DRUGS IN THE SOLID STATE", International Journal of Pharmaceutics, ELSEVIER, NL, NL , (19900101), vol. 62, no. 02-03, doi:10.1016/0378-5173(90)90221-O, ISSN 0378-5173, pages 87 - 95, XP009025110
OPPOSITION- Deliang Zhou, William R. Porter, Geoff G.Z. Zhang, "Chapter 5 - Drug Stability and Degradation Studies", Deliang Zhou, William R. Porter, Geoff G.Z. Zhang, Qiu Yihong, Developing solid oral dosage forms : pharmaceutical theory and practice, Burlington, MA, USA , Elsevier/Academic Press , (20081224), pages 87 - 124, doi:10.1016/B978-0-444-53242-8.00005-9, ISBN 978-0-444-53242-8, XP009553795
OPPOSITION- Xiaorong He, "Chapter 18 - Integration of Physical, Chemical, Mechanical, and Biopharmaceutical Properties in Solid Oral Dosage Form Development", Xiaorong He, Qiu Yihong, Developing solid oral dosage forms : pharmaceutical theory and practice, Burlington, MA, USA , Elsevier/Academic Press , (20081224), pages 409 - 441, doi:10.1016/B978-0-444-53242-8.00018-7, ISBN 978-0-444-53242-8, XP009553797
OPPOSITION- G Zhang, "Phase transformation considerations during process development and manufacture of solid oral dosage forms", Advanced Drug Delivery Reviews, Elsevier, (20040223), vol. 56, no. 3, doi:10.1016/j.addr.2003.10.009, ISSN 0169409X, pages 371 - 390, XP055003708
OPPOSITION- HANCOCK B. C., ZORGRAFI G., "CHARACTERISTICS AND SIGNIFICANCE OF THE AMORPHOUS STATE IN PHARMACEUTICAL SYSTEMS.", Journal of Pharmaceutical Sciences, American Chemical Society and American Pharmaceutical Association, US, US , (19970101), vol. 86., no. 01., doi:10.1021/js9601896, ISSN 0022-3549, pages 01 - 12., XP000929450
OPPOSITION- Stephen Byrn, Ralph Pfeiffer, Michael Ganey, Charles Hoiberg and Guirag Poochikian, "Pharmaceutical Solids: A Strategic Approach to Regulatory Considerations", Pharmaceutical Research, (19950701), vol. 12, no. 7, doi:10.1023/A:1016241927429, pages 945 - 954, XP055531015
OPPOSITION- Ohrem H. Leonhard, Schornick Eva, Kalivoda Adela, Ognibene Roberto, "Why is mannitol becoming more and more popular as a pharmaceutical excipient in solid dosage forms?", PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY, NEW YORK, NY, US, US , (20140526), vol. 19, no. 3, doi:10.3109/10837450.2013.775154, ISSN 1083-7450, pages 257 - 262, XP093105531
SEARCH- Yoshinobu Nakai, "Relationship between powder characteristics and the pharmaceutical preparations", (20070102), URL: https://www.jstage.jst.go.jp/article/sptj1978/25/6/25_6_388/_pdf/-char/en, (20190114), XP055541588 [Y] 1-10 * 2.2 Crystallinity and Stability; page 392 - page 393 *-

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