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Pharmaceutical Formulations Containing Dapagliflozin Propylene Glycol Hydrate - EP2508188

The patent EP2508188 was granted to Astrazeneca on May 10, 2023. The application was originally filed on Mar 21, 2008 under application number EP12153939A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP2508188

ASTRAZENECA
Application Number
EP12153939A
Filing Date
Mar 21, 2008
Status
Granted And Under Opposition
Apr 7, 2023
Grant Date
May 10, 2023
External Links
Slate, Register, Google Patents

Patent Summary

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Patent Family

Patent Oppositions (5)

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GALENICUM HEALTH SLUFeb 9, 2024GALENICUM HEALTH SLUADMISSIBLE
GEDEON RICHTERFeb 9, 2024DR SCHONADMISSIBLE
GENERICS UKFeb 9, 2024TER MEER STEINMEISTER & PARTNERADMISSIBLE
KRAUS & LEDERER PARTGMBBFeb 9, 2024KRAUS & LEDERER PARTGMBBADMISSIBLE
WUESTHOFF & WUESTHOFF PATENTANWALTE PARTG MBBFeb 6, 2024SONNENHAUSERADMISSIBLE

Patent Citations (20) New

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

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OPPOSITIONCA1101840
OPPOSITIONEP2139494
OPPOSITIONUS2003064935
OPPOSITIONUS2007015841
OPPOSITIONUS2016347731
OPPOSITIONUS3970651
OPPOSITIONUS6414126
OPPOSITIONUS6515117
OPPOSITIONWO0127128
OPPOSITIONWO0168603
OPPOSITIONWO02083066
OPPOSITIONWO03099836
OPPOSITIONWO2004060347
OPPOSITIONWO2004063209
OPPOSITIONWO2006034489
OPPOSITIONWO2008002824
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OTHERUS2007015841
SEARCHWO03099836
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Non-Patent Literature (NPL) Citations (23) 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- Agne Kucinskaite , Wiesław Sawicki, Vitalis Briedis, Małgorzata Sznitowska, "Fast disintegrating tablets containing Rhodiola rosea L. extract", ACTA Polonia phamaceutica - drug research, PL , (20070101), vol. 64, no. 1, ISSN 0001-6837, pages 63 - 67, XP093164913-
OPPOSITION- Anonymous, "Assessment report - Forxiga", European Medicines Agency science medicines health, (20120908), no. EMEA/H/C/002322, pages 1 - 182, XP093164897-
OPPOSITION- Anonymous, "A Trial of BMS-512148 in Patients With Type 2 Diabetes Mellitus", Clinical Trial NCT00263276, (20051208), URL: https://clinicaltrials.gov/ct2/show/record/NCT00263276?term=NCT00263276&draw=2&rank=1, XP093165343-
OPPOSITION- Anonymous, "Passage ; Die Tablette - Handbuch der Entwicklung, Herstellung und Qualitätssicherung", Anonymous, Annette Bauer-Brandl , Wolfgang A. Ritschel, Die Tablette - Handbuch der Entwicklung, Herstellung und Qualitätssicherung, ECV Editio Cantor Verlag, (20120101), pages 1 - 10, ISBN 978-3-87193-407-0, XP093164911-
OPPOSITION- "CELLULOSE, MICROCRYSTALLINE", ROWE R.C., SHESKEY P.J., OWEN S.C.(EDS.), Handbook of Pharmaceutical Excipients, London [u.a.] , Pharmaceutical Press [u.a.] , (20060101), pages 132 - 135, 031835, ISBN 978-1-58212-058-4, XP002520963-
OPPOSITION- "Chapter 45 - Oral Solid Dosage Forms", Alfonso R. Gennaro Et Al, Remington: The Science and Practice of Pharmacy, (20000101), pages 858 - 871, XP055301374-
OPPOSITION- "Chapters 1, 3 and 4", D. M. Parikh, Handbook of Pharmaceutical Granulation Technology, (20050101), pages 1 - 6, 79 - 128, XP055762796-
OPPOSITION- "Crospovidone", Rowe Raymond C, Sheskey Paul J, Owen Siân C, Handbook of Pharmaceutical Excipients, Fifth Edition, PHARMACEUTICAL PRESS, (20060101), pages 214 - 216, XP055924624-
OPPOSITION- "Deformulation/Reverse Engineering of Pharmaceuticals & Consumer Products", URL: https://aurigaresearch.com/pharmaceutical-testing/deformulation-reverse-engineering-for-pharma-and-consumer-products/-
OPPOSITION- Edward M Rudnic , Joseph D Schwartz, "Oral Solid Dosage Forms", Remington: The Science and Practice of Pharmacy, Lippincott Williams & Wilkins , (20000101), pages 858 - 871, ISBN 978-0-683-30647-7, XP093164906-
OPPOSITION- Ema, "Forxiga", Assessment report EMEA/H/C/002322, (20120918), pages 1 - 170, XP093165359-
OPPOSITION- Emea, "GUIDELINE ON THE REQUIREMENTS TO THE CHEMICAL AND PHARMACEUTICAL QUALITY DOCUMENTATION CONCERNING INVESTIGATIONAL MEDICINAL PRODUCTS IN CLINICAL TRIALS", CHMP/QWP/185401/2004 final, (20060331), pages 1 - 31, XP093165381-
OPPOSITION- Emea, "ICH Topic Q 6 A - Specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances", CPMP/ICH/367/96, (20000501), pages 1 - 32, XP055966494-
OPPOSITION- Heinz Sucker, Pharmazeutische Technologie, (19780101), pages 372 - 373, 377, XP093165320-
OPPOSITION- Henck Jan-Olav, Grieser J., Burger Arthur, "Polymorphie von Arzneistoffen. Eine wirtschaftliche Herausforderung?", Phar. Ind., (19970101), vol. 59, pages 165 - 169, XP055822418-
OPPOSITION- Kurt H. Bauer, Lehrbuch der pharmazeutischen Technologie, (20020101), page 167, 172, XP055762777-
OPPOSITION- Leon Lachman, The Theory and Practice of Industrial Pharmacy, 3rd ed., (19860101), pages 293, 294, 324 - 333, XP093165315-
OPPOSITION- Voigt, Pharmazeutische Technologie, (20000101), pages 165 - 166, XP055672956-
OPPOSITION- Rubino, J.T. ; Thomas, E., "Influence of solvent composition on the solubilities and solid-state properties of the sodium salts of some drugs", International Journal of Pharmaceutics, ELSEVIER, NL, NL , (19901128), vol. 65, no. 1-2, doi:10.1016/0378-5173(90)90020-5, ISSN 0378-5173, pages 141 - 145, XP023725856
OPPOSITION- Wei Meng , Bruce A Ellsworth, Alexandra A Nirschl, Peggy J McCann, Manorama Patel, Ravindar N Girotra, Gang Wu, Philip M Sher, Eamonn P Morrison, Scott A Biller, Robert Zahler, Prashant P Deshpande, Annie Pullockaran, Deborah L Hagan, Nathan Morgan, Joseph R Taylor, Mary T Obermeier, William G Humphreys, Ashish Khanna, Lorell Discenza, James G Robertson, Aiying Wang, Songping Han, John R Wetterau, Evan B Janovitz, Oliver P Flint, Jean M Whaley, William N Washburn, "Discovery of dapagliflozin: A potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes", Journal of Medicinal Chemistry, US , (20080301), vol. 51, no. 5, doi:10.1021/jm701272q, ISSN 0022-2623, pages 1145 - 1149, XP002491733
OPPOSITION- Tirmenstein M; Dorr T E; Janovitz E B; Hagan D; Abell L M; Onorato J M; Whaley J M; Graziano M J; Reilly T P, "Nonclinical toxicology assessments support the chronic safety of dapagliflozin, a first-in-class sodium-glucose cotransporter 2 inhibitor", INTERNATIONAL JOURNAL OF TOXICOLOGY, Sage Publications, Inc., US, US , (20130901), vol. 32, no. 5, doi:10.1177/1091581813505331, ISSN 1091-5818, pages 336 - 350, XP008175509
OPPOSITION- J. F. List, V. Woo, E. Morales, W. Tang, F. T. Fiedorek, "Sodium-Glucose Cotransport Inhibition With Dapagliflozin in Type 2 Diabetes", Diabetes care, American Diabetes Association, (20090401), vol. 32, no. 4, doi:10.2337/dc08-1863, ISSN 01495992, pages 650 - 657, XP055012106
SEARCH- MENG WEI ET AL, "Discovery of dapagliflozin: A potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes", JOURNAL OF MEDICINAL CHEMISTRY, (200803), vol. 51, no. 5, ISSN 0022-2623, pages 1145 - 1149, XP002491733 [PI] 1-18 * the whole document *

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