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Pharmaceutical Formulations Containing Dapagliflozin Propylene Glycol Hydrate - EP2139494

The patent EP2139494 was granted to Astrazeneca on Mar 11, 2020. The application was originally filed on Mar 21, 2008 under application number EP08732695A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP2139494

ASTRAZENECA
Application Number
EP08732695A
Filing Date
Mar 21, 2008
Status
Granted And Under Opposition
Feb 7, 2020
Publication Date
Mar 11, 2020
External Links
Slate, Register, Google Patents

Patent Summary

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Patent Family

Patent Oppositions (6)

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GALENICUM HEALTH SLUDec 11, 2020GALENICUM HEALTH SLUADMISSIBLE
GEDEON RICHTERDec 11, 2020DR SCHONADMISSIBLE
GENERICS UKDec 11, 2020TER MEER STEINMEISTER & PARTNERADMISSIBLE
KRAUS & LEDERER PARTGMBBDec 11, 2020KRAUS & LEDERER PARTGMBBADMISSIBLE
STADA ARZNEIMITTELDec 11, 2020KERNEBECKADMISSIBLE
ZENTIVADec 10, 2020AERAADMISSIBLE

Patent Citations (21) New

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

Citation PhasePublication Number
INTERNATIONAL-SEARCH-REPORTWO03099836
INTERNATIONAL-SEARCH-REPORTWO2008002824
OPPOSITIONCA1101840
OPPOSITIONCA2588963
OPPOSITIONUS2007015841
OPPOSITIONUS2008004336
OPPOSITIONUS2016347731
OPPOSITIONUS3970651
OPPOSITIONUS9006188
OPPOSITIONWO0127128
OPPOSITIONWO0168603
OPPOSITIONWO02083066
OPPOSITIONWO02085898
OPPOSITIONWO03099836
OPPOSITIONWO2004060347
OPPOSITIONWO2004063209
OPPOSITIONWO2005117841
OPPOSITIONWO2006034489
OPPOSITIONWO2008002824
OPPOSITIONWO2008116179
OTHERUS2007015841

Non-Patent Literature (NPL) Citations (25) New

NPL citations refer to non-patent references such as research papers, articles, or other publications cited during examination or opposition phases.

Citation PhaseReference Text
INTERNATIONAL-SEARCH-REPORT- 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 [PX] 1-25 * the whole document *
OPPOSITION- Abdel-Magid, Caron Stepane, "Polymorph screening and determination", Fundamentals of early clinical drug development from synthesis design to formulation, (20060000), pages 241 - 242, XP055762819
OPPOSITION- Anonymous, "Clinical trial protocol for the clinical trial with identifier NCT00263276", clinicaltrials.gov, (20200715), pages 1 - 8, XP055762823
OPPOSITION- Anonymous, "Dapagliflozin EPAR Assessment report", European Medicines Agency Science Medicines Health, (20120918), pages 1 - 4, XP055762822
OPPOSITION- Anonymous, "EMA Forxiga Assessment Report", European Medicines Agency Science Medicines Health, (20120000), pages 1 - 4, XP055762822
OPPOSITION- Anonymous, "GUIDELINE ON THE REQUIREMENTS TO THE CHEMICAL AND PHARMACEUTICAL QUALITY DOCUMENTATION CONCERNING INVESTIGATIONAL MEDICINAL PRODUCTS IN CLINICAL TRIALS", EMA, (20060000), pages 1 - 31, XP055762828
OPPOSITION- Anonymous, "ICH Topic q 6 A Specifications: Test procedures and acceptance criteria for new drug substances and new drug products : chemical substances", European Medicines Agency- EMEA, (20000500), pages 1 - 32, XP055211303
OPPOSITION- Anonymous, "Synopsis", Clinical Study Report MB102008, pages 1 - 4, URL: http://filehosting.pharmacm.com/DownloadService.ashx?client= CTR_MED_7111 &studyid=3632&filename=MB102- 008%20_ CSR_ synopsis.pdf, XP055762824
OPPOSITION- BASU D. et al., "Mechanism of increased LDL and decreased triglycerides with SGL T2 inhibition", Arterioscler. Thromb. Vase. Biol., (20180900), vol. 38, no. 9, pages 2207 - 2216, XP055762604
OPPOSITION- BAUER et al., "Kapitel 6", Pharmazeutische Technologie, (19970000), pages 163 - 164, XP055762798
OPPOSITION- BAUER, KURT H., "Kapitel 6", Lehrbuch der pharmazeutischen Technologie, Stuttgart, (20020000), pages 167 - 172, XP055762777
OPPOSITION- "Handbook of Pharmaceutical Granulation Technology Second Edition", Handbook of Pharmaceutical Granulation Technology Second Edition, (20050000), pages 102 - 431, XP055762817
OPPOSITION- J.-O. HENC K et al., "Polymorphie von Arzneistoffen", Pharm. Ind., (19970000), vol. 59, pages 165 - 169, XP055762801
OPPOSITION- LACHMAN, L. et al., "The Theory and Practice of Industrial Pharmacy", Philadelphia, (19860000), vol. 293, no. 294, pages 324 - 333, XP055762791
OPPOSITION- "Oral Solid Dosage Forms", Remington textbook, (20000000), pages 858 - 871, XP055762833
OPPOSITION- PARIKH, D. M., "Chapters 1, 3 and 4", Handbook of Pharmaceutical Granulation Technology, (20050000), pages 1-6 - 79-104, XP055762796
OPPOSITION- REMINGTON, "Chapter 34 and 54", The Science and Practice of Pharmacy, (20050000), pages 676 - 679,1040, XP055762812
OPPOSITION- SUCKER, H. et al., "Pharmazeutische Technologie", Pharmazeutische Technologie, (19780000), pages 372 - 373,377, XP055762778
OPPOSITION- VOIGT, R., "Kapitel 9", Pharmazeutische Technologie, (20000000), vol. 9, pages 165 - 166, XP055672956
OPPOSITION- RUBINO J. et al., "Influence of solvent composition on the solubilities and solid-state properties of the sodium salts of some drugs", International Journal of Pharmaceutics, (19901100), vol. 65, doi:10.1016/0378-5173(90)90020-5, pages 141 - 145, XP025568676
OPPOSITION- Huang Y-B; Tsai Y-H; Yang W-C; Chang J-S; Wu P-C; Takayama K, "Once-daily propranolol extended-release tablet dosage form: formulation design and in vitro/in vivo investigation", European Journal of Pharmaceutics and Biopharmaceutics, (20040000), vol. 58, no. 3, pages 607 - 614, XP004586441
OPPOSITION- Meng Wei , 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, And William N. Washburn, "Discovery of Dapagliflozin: A Potent, Selective Renal Sodium-Dependent Glucose Cotransporter 2 (SGLT2) Inhibitor for the Treatment of Type 2 Diabetes", J.Med.Chem., (20080000), vol. 51, pages 1145 - 1149, XP002491733
OPPOSITION- TIRMENSTEIN et al., "Nonclinical toxicology assessments support the chronic safety of dapagliflozin, a first-in-class sodium-glucose cotransporter 2 inhibitor", Int. J. Toxicol, (20130000), vol. 32, pages 336 - 350, XP008175509
OPPOSITION- A. L. HANDLON et al., "Sodium glucose co-transporter 2 (SGLT2) inhibitors as potential antidiabetic agents", Expert Opinion on Therapeutic Patents, (20050000), vol. 15, pages 1531 - 1540, XP002477436
OPPOSITION- List J F; Woo V; Morales E; Tang W; Fiedorek F T, "Sodium-Glucose cotransport inhibition with dapagliflozin in type 2 diabetes", Diabetes Care, (20090000), vol. 32, pages 650 - 657, XP055012106

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