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Stable Pharmaceutical Compositions Containing Sitagliptin In The Form Of Immediate Release Tablets - EP3102187

The patent EP3102187 was granted to Galenicum Health SL on Mar 25, 2020. The application was originally filed on Feb 3, 2015 under application number EP15702266A. The patent is currently recorded with a legal status of "Revoked".

EP3102187

GALENICUM HEALTH SL
Application Number
EP15702266A
Filing Date
Feb 3, 2015
Status
Revoked
Dec 20, 2024
Grant Date
Mar 25, 2020
External Links
Slate, Register, Google Patents

Patent Summary

Patent Family

Patent Family

Patent Oppositions (7)

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COOKEDec 30, 2020ELKINGTON AND FIFEADMISSIBLE
DENTONS PATENT SOLUTIONSDec 23, 2020-ADMISSIBLE
DENTONS UK AND MIDDLE EASTDec 23, 2020-ADMISSIBLE
LABORATORIOS LICONSADec 23, 2020AERAADMISSIBLE
MULLENDec 19, 2020ELKINGTON AND FIFEADMISSIBLE
HOFFMANN EITLEDec 18, 2020HOFFMANN EITLEADMISSIBLE
ELKINGTON AND FIFEDec 17, 2020-ADMISSIBLE

Patent Citations (24) New

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

Citation PhasePublication NumberPublication Link
INTERNATIONAL-SEARCH-REPORTEP2578208
INTERNATIONAL-SEARCH-REPORTWO2005072530
INTERNATIONAL-SEARCH-REPORTWO2012025944
INTERNATIONAL-SEARCH-REPORTWO2012131005
OPPOSITIONEP0247709
OPPOSITIONEP1654263
OPPOSITIONEP2578208
OPPOSITIONWO2005003135
OPPOSITIONWO2005072530
OPPOSITIONWO2009084024
OPPOSITIONWO2010000469
OPPOSITIONWO2011025932
OPPOSITIONWO2012025944
OPPOSITIONWO2012131005
OPPOSITIONWO2012166420
OPPOSITIONWO2013128000
OPPOSITIONWO2015114152
OTHEREP0247709
OTHEREP2578208
OTHERWO2005003135
OTHERWO2005072530
OTHERWO2007078726
OTHERWO2010000469
OTHERWO2012025944

Non-Patent Literature (NPL) Citations (60) 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- Jonathan K Reynolds, "Fixed-dose combination of sitagliptin and metformin for the treatment of type 2 diabetes", Diabetes, Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, doi:http://dx.doi.org/10.2147/DMSO.S4637, (20090701), pages 127 - 134, URL: http://www.dovepress.com/fixed-dose-combination-of-sitagliptin-and-metformin-for-the-treatment--peer-reviewed-article-DMSO, (20150326), XP055179538 [Y] 18 * the whole document *
OPPOSITION- "36 Packs and Packaging", Aulton M. E., Pharmaceutics The Science of Dosage Form Design second edition, Churchill Livingstone, (20020000), pages 554 - 563,564, XP055982219-
OPPOSITION- Ahmed Adel Sakr, Fars K. Alanazi , "Chapter 45- Oral Solid Dosage Forms ", Remington: The Science and Practice of Pharmacy 22nd Edition, Pharmaceutical Press , (20130101), pages 2pp, 947 - 976, XP093002004-
OPPOSITION- Anonymous, "Glyceryl Palmitostearate", Handbook of Pharmaceutical Excipients, (20090101), XP093001048-
OPPOSITION- Anonymous, "JANUVIA ®, EPAR SCIENTIFIC DISCUSSION", JANUVIA, (20070101), JANUVIA, (20221123), XP093001041-
OPPOSITION- Anonymous, "JANUVIA ®, EPAR SCIENTIFIC DISCUSSION", JANUVIA, (20070101), pages 1 - 39, JANUVIA, URL: https://www.ema.europa.eu/en/documents/scientific-discussion/januvia-epar-scientific-discussion_en.pdf, (20221123), XP093001041-
OPPOSITION- Anonymous, "Scientific Discussion", EMEA, (20070101), XP055777460-
OPPOSITION- Ansel Howard C, "Peroral Solids, Capsules, Tablest, and Controlled-Release Dosage Forms", Pharmaceutical Dosage Forms And Drug Delivery Systems, (19990101), XP055777825-
OPPOSITION- Augsburger Larry L., Et Al., "Chapter 9: Dry Granulation", Pharmaceutical Dosage Forms: Tablets 3rd Edition, volume 1: UNIT OPERATIONS AND MECHANICAL PROPERTIES, CRC Press, (20080000), vol. 303, 336, XP055982201-
OPPOSITION- Aulton M. E., PHARMACEUTICS: THE SCIENCE OF DOSAGE FORM DESIGN, 2nd ed., (20020101), pages 554 - 563, 564, XP055982219-
OPPOSITION- Aulton M E, "Tablest manufacturing Stages in tablet formation", Pharmaceutics The Science of Dosage Form Design, Churchill Livingstone, (20020101), XP055777843-
OPPOSITION- "Aulton's Pharmaceutics: The Design and Manufacture of Medicines /Passage/", Michael E. Aulton, Aulton's Pharmaceutics: The Design and Manufacture of Medicines, Third Edition, Elsevier , (20070101), pages 2pp, 286-289, 336-343, 410-424, 441, 447-455, 479 - 480, XP093002017-
OPPOSITION- Barot Bhavesh S, Et Al, "Compactibility improvement of metformin hydrochloride by crystallization technique", Advanced Powder Technology, (20120101), vol. 23, XP055777837-
OPPOSITION- Bauer K.H., Et Al, "Kapitel 6, 7, 14", Lehrbuch der Pharmazeutischen Technologie, 7 Auflage, Wissenschaftliche Verlagsgesellschaft, (20020101), pages 82 - 318,346-348, XP055302192-
OPPOSITION- "Chapter 17: Tablets", Mahato Ram I., Et Al., Pharmaceutical Dosage Forms and Drug Delivery SECOND EDITION, CRC PRESS, (20120000), pages 313 - 335, XP055982183-
OPPOSITION- "Chapter 17: Tablets", Mahato Ram I., Et Al., Pharmaceutical Dosage Forms and Drug Delivery, SECOND EDITION, CRC PRESS, (20120101), pages 313 - 335, XP055982183-
OPPOSITION- "Chapter 1, Introduction", Dilip M. Parikh, Handbook of Pharmaceutical Granulation Technology, SECOND EDITION, Taylor & Francis Group, LLC , (20050101), pages 1 - 6, XP055592603-
OPPOSITION- "Chapter 6: Roller compaction technology", Parikh D. M., Et Al., HANDBOOK OF PHARMACEUTICAL GRANULATION TECHNOLOGY, (20050101), pages 159 - 190, XP055982211-
OPPOSITION- "Chapter 9: Dry Granulation", Augsburger Larry L., Et Al., Pharmaceutical Dosage Forms: Tablets, 3rd Edition, CRC Press, (20080101), vol. 1: UNIT OPERATIONS AND MECHANICAL PROPERTIES, pages 303 - 336, XP055982201-
OPPOSITION- "Croscarmellose Sodium", Raymond C Rowe, Handbook of Pharmaceutical Excipients. 6th ed., (20090101), pages 206 - 208, XP055900567-
OPPOSITION- "Croscarmellose sodium", Raymond C Rowe, Handbook of Pharmaceutical Excipients sixth edition, Pharmaceutical Press, (20090000), pages 206 - 208, XP055900567-
OPPOSITION- "Croscarmellose Sodium. Starch", Raymond C Rowe, Handbook of Pharmaceutical Excipients. 6th ed., PhP, (20090101), pages 206 - 694, XP055900567-
OPPOSITION- Dilip M Parikh, "Current Granulation Techniques and Research", Pharmaceutical Granulation Technology. 3rd ed., informa healthcare, (20100101), pages 2 - 3, ISBN 978-1-4398-0789-7, XP055635095-
OPPOSITION- Dilip M. Parikh, "Handbook of Pharmaceutical Granulation Technology Second Edition", Handbook of Pharmaceutical Granulation Technology Second Edition, (20050101), pages 102 - 431, XP055762817-
OPPOSITION- Felton Linda A., et al., REMINGTON. ESSENTIALS OF PHARMACEUTICS, (20130101), pages 583 - 585, XP055982257-
OPPOSITION- Felton Linda A., "Remington - Essentials of Pharmaceutics", Remington, (20120101), XP093001049-
OPPOSITION- Felton Linda, "Remington: Essentials of Pharmaceutics (passage)", Remington: Essentials of Pharmaceutics, (20130101), pages 414 - 415, 424, 426-429, 583-586, 604-608, XP055780055-
OPPOSITION- "Glyceryl palmitostearate", Rowe Raymond C., Et Al., Handbook of Pharmaceutical Excipients sixth edition, Pharmaceutical Press, (20090000), pages 293 - 294, XP055982246-
OPPOSITION- "Glyceryl palmitostearate ", Rowe Raymond C., et al., Handbook of Pharmaceutical Excipients sixth edition, Pharmaceutical Press, (20090101), pages 293 - 294, XP055982246-
OPPOSITION- "Glyceryl palmitostearate ", Rowe Raymond C., Et Al., Handbook of Pharmaceutical Excipients sixth edition, Pharmaceutical Press, (20090101), pages 293 - 294, XP055982246-
OPPOSITION- Heng P.W.S., Yolande Anthony, Chin Chiat Lee, "Chapter 14 - Rapid Release Granulation", Heng P.W.S., Yolande Anthony, Chin Chiat Lee, Parikh D.M., Handbook of Pharmaceutical Granuation Technology, 2nd ed., (20050101), pages 407 - 429, XP093006938-
OPPOSITION- Janickiego Stanistawa, Et Al., "Applied Pharmacy", FARMACJA STOSOWANA, (20020101), XP093001051-
OPPOSITION- Januvia, "EPAR Scientific Discussion", (20070326), pages 1 - 39, URL: https://www.ema.europa.eu/en/documents/scientific-discussion/januvia-epar-scientific-discussion_en.pdf, XP055982236-
OPPOSITION- JANUVIA, "EPAR Scientific Discussion", EMEA, (20070326), pages 1 - 39, URL: https://www.ema.europa.eu/en/documents/scientific-discussion/januvia-epar-scientific-discussion_en.pdf, XP055982236-
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, (20070101), pages 3641 - 3672, XP055752951-
OPPOSITION- "Mastersizer 2000 User Manual", Mastersizer 2000 User Manual, (20070000), pages 1 - 157-
OPPOSITION- "Matrix-Based Extended-Release Systems", Felton Linda A. et al., Remington Essentials of Pharmaceutics , (20130101), pages 627 - 629, XP055982262-
OPPOSITION- "Matrix-Based Extended-Release Systems", Felton Linda A., Remington Essentials of Pharmaceutics, Pharmaceutical Press, (20130000), pages 627 - 629, XP055982262-
OPPOSITION- "Matrix-Based Extended-Release Systems", Felton Linda A., Remington Essentials of Pharmaceutics , Pharmaceutical Press, (20130101), pages 627 - 629, XP055982262-
OPPOSITION- M.E. Aulton, "Chapter 27 - Tablets and compaction", Pharmaceutics: The Science of Dosage Form Design, (20020101), pages 397 - 417, ISBN 978-0-443-05550-8, XP055386146-
OPPOSITION- Meeus Liesbeth, "Direct Compression Versus Granulation", Pharmaceutical Technology Europe, (20110307), vol. 23, no. 3, XP093001052-
OPPOSITION- "Oral solid dosage forms", Linda A Felton, Remington Essentials of Pharmaceutics, Pharmaceutical Press, (20130000), pages 583 - 585, XP055982257-
OPPOSITION- "Oral solid dosage forms", Remington Essentials of Pharmaceutics, Felton Linda A., Pharmaceutical Press, (20130101), pages 583 - 585, XP055982257-
OPPOSITION- PARAB et al., "Sustained release from Precirol® (Glycerol palmito-stearate) matrix. Effect of mannitol and hydroxypropyl methylcellulose on the release of theophylline", Drug Dev. Ind. Pharm., (19860000), vol. 12, pages 1309 - 1327, XP055972494-
OPPOSITION- Parab V, Et Al, "Sustained Release from Precirol® (Glycerol Palmito-Stearate) Matrix. Effect of Mannitol and Hydroxypropyl Methylcellulose on the Release of Theophylline", Drug Development and Industrial Pharmacy, (19860101), vol. 12, pages 1309 - 1327, XP055972494-
OPPOSITION- Parav P V, Et Al., "Effect pf mannitol and Hydroxypropyl methylcellulose on the release of theophylline", DRUG DEV. INDS. PHARM, (19860101), vol. 12, XP093001044-
OPPOSITION- Parikh D. M., Et Al., Handbook of Pharmaceutical Granulation Technology second edition, Taylor & Francis Group, LLC, (20050000), pages 159 - 190, XP05982211-
OPPOSITION- "Pharmaceutics The Science of Dosage Form Design Second Edition /Passage/", Michael E. Aulton, Pharmaceutics The Science of Dosage Form Design Second Edition , Elsevier, (20020101), pages 2pp, 101, 109-110, 554, 563 - 564, XP093002020-
OPPOSITION- P.J. SHESKEY et al., "Evaluation of various polymers as dry binders in the preparation of an immediate-release tablet formulation by roller compaction", Pharm. Technol., (19951000), pages 98 - 112, XP055982228-
OPPOSITION- Raymond C Rowe, "Croscarmellose Sodium. Starch", Handbook of Pharmaceutical Excipients. 6th ed., PhP, (20090101), pages 206 - 694, XP055900567-
OPPOSITION- Rowe, "Croscarmellose sodium", Handbook of Pharmaceutical Exciepients, (20060101), XP055472858-
OPPOSITION- ROWE et al., "Mannitol", Handbook of Pharmaceutical Excipients, (20120000), pages 479 - 482, XP002789781-
OPPOSITION- Salman A D, Et Al., "Granulation", Handbook of Powder Technology Vol 11, (20070101), XP093001050-
OPPOSITION- Sheskey P. J., Et Al., "Evaluation of various polymers as dry binders in the preparation of an immediate-release tablet formulation by roller compaction", Pharm. Technol., (19951001), pages 98 - 112, XP055982228-
OPPOSITION- Summers Malcolm, Et Al, "Granulation", Pharmaceutics The Science of Dosage Form Design, Churchill Livingstone, (20020101), XP055777830-
OPPOSITION- Technical Report for sitagliptin hydrochloride tablets-
OPPOSITION- BERGE S. M., BIGHLEY L. D., MONKHOUSE D. C., "Pharmaceutical Salts", Journal of Pharmaceutical Sciences, American Chemical Society and American Pharmaceutical Association, US, US, (19770101), vol. 66., no. 01., doi:10.1002/jps.2600660104, ISSN 0022-3549, pages 01 - 19., XP000562636
OPPOSITION- JONATHAN K REYNOLDS, "Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy Fixed-dose combination of sitagliptin and metformin for the treatment of type 2 diabetes", Diabetes, Metabolic Syndrome and Obesity: Targets and Therap y, doi:http://dx.doi.org/10.2147/DMSO.S4637, (20090701), pages 127 - 134, URL: http://dx.doi.org/10.2147/DMSO.S4637, XP055179538
OPPOSITION- JONATHAN K REYNOLDS, "Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy Fixed-dose combination of sitagliptin and metformin for the treatment of type 2 diabetes", Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, doi:http://dx.doi.org/10.2147/DMSO.S4637, (20090701), pages 127 - 134, URL: http://dx.doi.org/10.2147/DMSO.S4637, XP055179538
OPPOSITION- Jonathan K Reynolds, "Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy Fixed-dose combination of sitagliptin and metformin for the treatment of type 2 diabetes", Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, Dovepress, doi:http://dx.doi.org/10.2147/DMSO.S4637, (20090701), pages 127 - 134, Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, (20150326), XP055179538

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