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Pharmaceutical Composition, Pharmaceutical Dosage Form, Process For Their Preparation, Methods For Treating And Uses Thereof - EP3150200

The patent EP3150200 was granted to Boehringer Ingelheim on Apr 10, 2024. The application was originally filed on Oct 1, 2010 under application number EP16195805A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3150200

BOEHRINGER INGELHEIM
Application Number
EP16195805A
Filing Date
Oct 1, 2010
Status
Granted And Under Opposition
Mar 8, 2024
Grant Date
Apr 10, 2024
External Links
Slate, Register, Google Patents

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Patent Family

Patent Oppositions (4)

Patent oppositions filed by competitors challenge the validity of a granted patent. These oppositions are typically based on claims of prior art, lack of novelty, or non-obviousness. They are a key part of the process for determining a patent's strength and enforceability.

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BRAND MURRAY FULLERJan 10, 2025ADMISSIBLE
MANSKEJan 10, 2025ADMISSIBLE
TER MEER STEINMEISTER & PARTNER PATENTANWALTE MBBJan 10, 2025ADMISSIBLE
ELKINGTON AND FIFEJan 8, 2025ADMISSIBLE

Patent Citations (26) New

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

Citation PhasePublication NumberPublication Link
EXAMINATIONWO2010092125
OPPOSITIONEP3150200
OPPOSITIONUS2007249544
OPPOSITIONWO03099836
OPPOSITIONWO2005070396
OPPOSITIONWO2005092877
OPPOSITIONWO2006117359
OPPOSITIONWO2007041053
OPPOSITIONWO2007128724
OPPOSITIONWO2008055940
OPPOSITIONWO2008101943
OPPOSITIONWO2008116179
OPPOSITIONWO2009022007
OPPOSITIONWO2009121945
OPPOSITIONWO2010092125
OPPOSITIONWO2011039337
OTHERWO03099836
OTHERWO2005070396
OTHERWO2008055940
OTHERWO2008101943
OTHERWO2008116179
OTHERWO2010092125
SEARCHWO03099836
SEARCHWO2008055940
SEARCHWO2008101943
SEARCHWO2008116179

Non-Patent Literature (NPL) Citations (54) 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- Allen, Loyd V. ; Popovich, Nicholas G. ; Ansel, Howard C, "Chapter 10 • Ointments, Creams, and Gels", Allen, Loyd V. ; Popovich, Nicholas G. ; Ansel, Howard C, Allen, Loyd V. ; Popovich, Nicholas G. ; Ansel, Howard C., [Pharmaceutical dosage forms and drug delivery systems] Ansel's pharmaceutical dosage forms and drug delivery systems, US , Lippincott Williams & Wilkins , (20050101), pages 276 - 297, ISBN 0-7817-4612-4, XP009559634-
OPPOSITION- Allen, Loyd V. ; Popovich, Nicholas G. ; Ansel, Howard C. , "Chapter 6 • Powders and Granules", Allen, Loyd V. ; Popovich, Nicholas G. ; Ansel, Howard C. , Allen et al., Ansel's Pharmaceutical Dosage forms and Drug Delivery Systems, 8th Edition, Lippincott Williams & Wilkins , (20050101), pages 186 - 203, ISBN 0781746124, XP009559619-
OPPOSITION- Allen, Loyd V. ; Popovich, Nicholas G. ; Ansel, Howard C, " Chapter 7: Capsules", [Pharmaceutical dosage forms and drug delivery systems] Ansel's pharmaceutical dosage forms and drug delivery systems, Lippincott Williams & Wilkins, US, US , (20050101), ISBN 0-7817-4612-4, pages 204 - 226, XP009559618-
OPPOSITION- Allen, Loyd V. ; Popovich, Nicholas G. ; Ansel, Howard C., "Chapter 9 • Modified-Release Solid Dosage Forms and Drug Delivery Systems", Allen, Loyd V. ; Popovich, Nicholas G. ; Ansel, Howard C., Allen, Loyd V. ; Popovich, Nicholas G. ; Ansel, Howard C., [Pharmaceutical dosage forms and drug delivery systems] Ansel's pharmaceutical dosage forms and drug delivery systems, US , Lippincott Williams & Wilkins , (20050101), pages 260 - 275, ISBN 0-7817-4612-4, XP009559630-
OPPOSITION- Anonymous, "ACTOPLUSMET™ (ak-TO-plus-met) (pioglitazone hydrochloride and metformin hydrochloride) tablet - Patient Information", FDA, CENTER FOR DRUG EVALUATION AND RESEARCH, APPLICATIONNUMBER: 21-842, APPROVED LABELING, (20050808), vol. 7, no. 2, doi:10.1021/acssensors.1c02113, pages 453 - 459, XP093253144-
OPPOSITION- Anonymous, "Annex 5 - Guidelines for registration of fixed-dose combination medicinal products", World Health Organization WHO Technical Report Series, No. 929, vol. 85, no. 3, doi:10.1021/acs.joc.9b02548, pages 94 - 142, World Health Organization WHO Technical Report Series, No. 929, URL: https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/guidelines/inspections/trs929-annex5-guidelines-for-registration-of-fixed-dose-combination-medical-products.pdf?sfvrsn=99717b5b_4&download=true, XP093253138-
OPPOSITION- Anonymous, "Assessment report Jardiance: International non-proprietary name: empagliflozin; Procedure No. EMEA/H/C/002677/0000", Assessment Report EMA/CHMP/137741/2014, European Medicines Agency, (20140320), pages 1 - 99, XP093166086-
OPPOSITION- Anonymous, "AVANDAMET™ brand ofrosiglitazone maleate and metformin hydrochloride tablets - Prescribing Information", FDA; CENTER FOR DRUG EVALUATION AND RESEARCH, Application Number 21-410, FINAL PRINTED LABELING, (20021001), pages 1891 - 1895, XP093253141-
OPPOSITION- Anonymous, "Endocrine system", British National Formulary, BMJ Group, (20080501), pages 358 - 359, XP055980827-
OPPOSITION- Anonymous, "Fragen und Antworten zum Ruhen der Zulassung rosiglitazonhaltiger Arzneimittel (Avandia, Avandamet und Avaglim) ", Ergebnis eines Verfahrens nach Artikel 20 der Verordnung (EG) Nr. 726/2004, (20040101), XP093253142-
OPPOSITION- Anonymous, "GLUCOVANCE® (Glyburide and Metformin HCI Tablets) 1.25 mg/250 mg 2.5 mg/500 mg 5 mg/500 mg", Bristol-Myers Squibb company, (20020930), page 32PP, XP055591676-
OPPOSITION- Anonymous, "JANUMET™ (sitagliptin/metformin HCI) tablets - HIGHLIGHTS OF PRESCRIBING INFORMATION ", FDA, CENTER FOR DRUG EVALUATION AND RESEARCH, APPLICATIONNUMBER: 22-044, LABELING, (20080201), XP093253145-
OPPOSITION- Anonymous, "Jardiance (Empagliflozin (BI 10733))", FDA Center for Drug Evaluation and Research, application no. 204629Orig1s000, Clinical Pharmacology and Biopharmaceutics Review(s), vol. 3, no. 3, doi:10.1111/j.2042-7158.1997.tb00240.x, pages 147 - 151, FDA Center for Drug Evaluation and Research, application no. 204629Orig1s000, Clinical Pharmacology and Biopharmaceutics Review(s), URL: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204629Orig1s000ClinPharmR.pdf, XP093253123-
OPPOSITION- Anonymous, "Metformin hydrochloride 500 mg film-coated tablets (PL 16363/0601) - Summary of Product Characteristics", EMC, EMC, URL: https://www.medicines.org.uk/emc/product/7347/smpc/print, XP093253134-
OPPOSITION- Anonymous, " METFORMIN HYDROCHLORIDE", British National Formulary 60, (20100901), pages 421 - 422, XP093253127-
OPPOSITION- Anonymous, "PrandiMet (repaglinide and metformin HCI) Tablets - HIGHLIGHTS OF PRESCRIBING INFORMATION", FDA, CENTER FOR DRUG EVALUATION AND RESEARCH, APPLICATIONNUMBER: 22-386, LABELING, (20080601), XP093253146-
OPPOSITION- Anonymus, "Dosage form design and manufacture", Pharmaceutics: The Science of Dosage Form Design, Churchill Livingstone, pages 404 - 408, Pharmaceutics: The Science of Dosage Form Design, (20200303), XP055673015-
OPPOSITION- Aulton, Michael E., "Chapter 28: Coating of Tablets and Multiparticulates", Aulton, Michael E., M. E. Aulton, Pharmaceutics - The Science of Dosage Form Design, 2nd Edition, Churchill Livingstone , (20020101), pages 441 - 448, ISBN 9780443055171, XP009559624-
OPPOSITION- "Copovidone", Royal Pharmaceutical Society of Great Britain, Handbook of Pharmaceutical Excipients, UK/USA , Pharmaceutical Press; The American Pharmacists Association , (20060101), pages 201 - 203, ISBN 0-85369-618-7, XP009559620-
OPPOSITION- D12 - Parent application EP10759923.5 - request for further processing dated 31 October 2014 including supporting data-
OPPOSITION- D25 - Gebrauchsinformation Met® 1000 mg, Filmtabletten, Metforminhydrochlorid; Betapharm-
OPPOSITION- D32a - Zulassungsschreiben Glucovance® in den USA-
OPPOSITION- D33a - Zulassungsschreiben Avandamet® in den USA-
OPPOSITION- D34 - Beipackzettel Metaglip®, US-
OPPOSITION- D35a - Zulassungsschreiben Actoplus Met® in den USA-
OPPOSITION- D36a - Zulassungsschreiben JanumetR in den USA-
OPPOSITION- D37a - Zulassungsschreiben PrandiMet R in den USA-
OPPOSITION- D38 - H.A. Lieberman et al., „Pharmaceutical Dosage Forms: Tablets Vol. 1, 1989, S. 160-
OPPOSITION- Deodatt A Wadke, Abu T M Serajuddin And Harold Jacobson, "1 Preformulation Testing", Pharmaceutical Dosage Forms: Tablets volume 1, (19890101), pages 1 - 24, XP055565212-
OPPOSITION- Hapgood K P, "Colloidal Silicon Dioxide", Hapgood K P, Raymond C Rowe; Paul J Sheskey; Marian E Quinn (eds.), Handbook of Pharmaceutical Excipients, UK , Pharmaceutical Press , (20090203), pages 185 - 188, ISBN 978-0-85369-792-3, XP055959239-
OPPOSITION- Joseph P. Remington, Alfonso R. Gennaro, "Chapter 89: Oral Solid Dosage Forms ", Remington's Pharmaceutical Sciences, Easton, MACK PUBLISHING COMPANY, (19900101), pages 1633 - 1665, ISBN 0912734043, XP009559625-
OPPOSITION- Peter Davies, " Oral Solid Dosage Forms", Peter Davies, M. Gibson, Pharmaceutical Preformulation and Formulation, 2nd Edition, New York, Informa Healthcare, (20090623), pages 367 - 430, ISBN 9781420073171, XP009559621-
OPPOSITION- Raymond C Rowe, Paul J Shesky And Sian C Owen, "Magnesium Stearate", Handbook of Pharmaceutical Excipients fifth edition, (20060101), pages 430 - 433, XP055591638-
OPPOSITION- R. Gokhale, Y. Sun, A. Shukla, " High-Shear Granulation ", R. Gokhale, Y. Sun, A. Shukla, Dilip M. Parikh, Handbook of Pharmaceutical Granulation Technology, Taylor & Francis , (20050101), pages 191 - 228, ISBN 978-0-8247-2647-8, XP009559622-
OPPOSITION- Richter Margret, "Oldtimer als Newcomer - Biguanide", Govi Pharmazie, Govi Pharmazie, URL: https://www.pharmazeutische- zeitung.de/pharm1-12-2000/, XP093253133-
OPPOSITION- ROWE R C ET AL, "CELLULOSE, MICROCRYSTALLINE", ROWE R C ET AL, 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- R. Schroeder and K. Steffens, " Continuous Granulation Technologies", R. Schroeder and K. Steffens, Dilip M. Parikh, Handbook of Pharmaceutical Granulation Technology, Taylor & Francis , (20050101), pages 451 - 452, ISBN 978-0-8247-2647-8, XP009559623-
OPPOSITION- W.A Ritschel, A. Bauer-Brandl, "Die Tablette", Die Tablette Handbuch der Entwicklung, Herstellung und Qualitätssicherung, Edito Cantor Verlag , (20020101), page 68, ISBN 978-3-87193-228-1, XP055464317-
OPPOSITION- Bailey Clifford J., "Metformin: historical overview", Diabetologia, Springer Berlin Heidelberg, Berlin/Heidelberg, Berlin/Heidelberg, (20170803), vol. 60, no. 9, doi:10.1007/s00125-017-4318-z, ISSN 0012-186X, pages 1566 - 1576, XP036296567
OPPOSITION- SETTER S M, ET AL., "METFORMIN HYDROCHLORIDE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS: A CLINICAL REVIEW WITH A FOCUS ON DUAL THERAPY", Clinical Therapeutics, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20031201), vol. 25, no. 12, doi:10.1016/S0149-2918(03)90089-0, ISSN 0149-2918, pages 2991 - 3026, XP009071684
OPPOSITION- HAUSMAN D S, "COMPARISON OF LOW SHEAR, HIGH SHEAR, AND FLUID BED GRANULATION DURING LOW DOSE TABLET PROCESS DEVELOPMENT", Journal Drug Development and Industrial Pharmacy, NEW YORK, NY, US, US , (20040301), vol. 30, no. 03, doi:10.1081/DDC-120030419, ISSN 0363-9045, pages 259 - 266, XP009050681
OPPOSITION- Idris I; Donnelly R, "Sodium-glucose co-transporter-2 inhibitors: An emerging new class of oral antidiabetic drug", Diabetes, Obesity and Metabolism, Blackwell Science, GB, GB , (20090201), vol. 11, no. 2, doi:10.1111/j.1463-1326.2008.00982.x, ISSN 1462-8902, pages 79 - 88, XP007915350
OPPOSITION- C. J. Bailey, C. Day, "Fixed-dose single tablet antidiabetic combinations", Diabetes, Obesity and Metabolism, Blackwell Science, GB, GB , (20090601), vol. 11, no. 6, doi:10.1111/j.1463-1326.2008.00993.x, ISSN 1462-8902, pages 527 - 533, XP055588773
OPPOSITION- Strack Thomas, "Metformin: A review", DRUGS OF TODAY, Prous Science, ES, ES , (20080101), vol. 44, no. 4, doi:10.1358/dot.2008.44.4.1138124, ISSN 1699-3993, pages 303 - 314, XP055817998
OPPOSITION- American Diabetes Association, "Standards of Medical Care in Diabetes—2009", DIABETES CARE, AMERICAN DIABETES ASSOCIATION, ALEXANDRIA, VA, US, US , (20090101), vol. 32, no. Supplement_1, doi:10.2337/dc09-S013, ISSN 0149-5992, pages S13 - S61, XP093121256
OTHER- AMERICAN DIABETES ASSOCIATION, "Standards of Medical Care in Diabetes - 2009", Diabetes Care, (200901), vol. 32, no. suppl.1, pages S13 - S61, XP055817995-
OTHER- AULTON M. E., Pharmaceutics The Science of Dosage Form Design, 2nd ed., Churchill Livingstone, (20020000), pages 404 - 409, XP002396921-
OTHER- BMJ GROUP, British National Formulary, (20080300), vol. 55, pages 358 - 359, XP055817990-
OTHER- M GIBSON, Pharmaceutical Preformulation and Formulation, Informa Healthcare, (20090000), pages 402 - 407, XP093004649-
OTHER- Swarbrick James, "Typical Granulation Processes", Handbook of Pharmaceutical Granulation Technology, TAYLOR FRANCIS, (20050101), pages 451 - 452, XP093004652-
OTHER- Setter et al., "METFORMIN HYDROCHLORIDE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS: A CLINICAL REVIEW WITH A FOCUS ON DUAL THERAPY", Clinical Therapeutics, (2003), vol. 25, no. 12, pages 2991 - 3026, XP009071684
OTHER- HAUSMAN D S, "COMPARISON OF LOW SHEAR, HIGH SHEAR, AND FLUID BED GRANULATION DURING LOW DOSE TABLET PROCESS DEVELOPMENT", Journal Drug Development and Industrial Pharmacy, NEW YORK, NY, US, US , (20040301), vol. 30, no. 03, doi:10.1081/DDC-120030419, ISSN 0363-9045, pages 259 - 266, XP009050681
OTHER- I. IDRISR. DONNELLY, "Sodium-glucose co-transporter-2 inhibitors: an emerging new class of oral antidiabetic drug", Diabetes, Obesity and Metabolism, (20090000), doi:10.1111/j.1463-1326.2008.00982.x, pages 79 - 88, XP007915350
OTHER- T. STRACK, "Metformin: A Review", Drugs of Today, (20080000), vol. 44, pages 303 - 314, XP055817998

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