Tablets Comprising Tamsulosin And Solifenacin - EP3697392

The patent EP3697392 was granted to Synthon on Nov 15, 2023. The application was originally filed on Oct 17, 2018 under application number EP18785395A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3697392

SYNTHON
Application Number
EP18785395A
Filing Date
Oct 17, 2018
Status
Granted And Under Opposition
Oct 13, 2023
Grant Date
Nov 15, 2023
External Links
Slate, Register, Google Patents

Patent Summary

Patent Family

Patent Family

Patent Oppositions (3)

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.

CompanyOpposition DateRepresentativeOpposition Status

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KRAUS & LEDERER PARTGMBBAug 13, 2024KRAUS & LEDERER PARTGMBBWITHDRAWN
ADAMED PHARMAAug 9, 2024VOSSIUS & PARTNER PATENTANWALTE RECHTSANWALTE MBBWITHDRAWN
ADALVOJan 23, 2024VOSSIUS & PARTNER PATENTANWALTE RECHTSANWALTE MBBWITHDRAWN

Patent Citations (42) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONEP0034432
DESCRIPTIONEP0661045
DESCRIPTIONUS4731478
DESCRIPTIONUS6436441
DESCRIPTIONWO2007131804
DESCRIPTIONWO2010051996
DESCRIPTIONWO2010090172
DESCRIPTIONWO2010091172
DESCRIPTIONWO9406414
EXAMINATIONWO2008128028
EXAMINATIONWO2017186593
INTERNATIONAL-SEARCH-REPORTCN106562968
INTERNATIONAL-SEARCH-REPORTEP1728791
INTERNATIONAL-SEARCH-REPORTEP2394648
OPPOSITIONEP0661045
OPPOSITIONEP1523994
OPPOSITIONEP1728791
OPPOSITIONEP2394648
OPPOSITIONWO03039530
OPPOSITIONWO03045437
OPPOSITIONWO2007131804
OPPOSITIONWO2008128028
OPPOSITIONWO2008128115
OPPOSITIONWO2010051996
OPPOSITIONWO2011056775
OPPOSITIONWO2017186593
OTHEREP1448235
OTHEREP2146693
OTHEREP2148659
OTHEREP2394648
OTHEREP2787971
OTHEREP3448367
OTHERKR20150069205
OTHERUS7364755
OTHERWO03039530
OTHERWO03045437
OTHERWO2008128028
OTHERWO2008128115
OTHERWO2010090172
OTHERWO2011056774
OTHERWO2013123595
OTHERWO2017186593

Non-Patent Literature (NPL) Citations (20) 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- "[711] DISSOLUTION", Stage 6 Harmonization, The United States Pharmacopeial Convention, (20111201), pages 1 - 8, Stage 6 Harmonization, URL: http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/2011-02-25711DISSOLUTION.pdf, (20141125), XP055155057-
OPPOSITION- Ali R. Rajabi-Siahboomi, Manish S. Rane; Linda A. Felton, "Chapter 32: Oral Modified-Release Drug Delivery Systems", Ali R. Rajabi-Siahboomi, Manish S. Rane; Linda A. Felton, Felton, Linda, Remington, Essentials of Pharmaceutics, GB, Pharmaceutical Press , (20120101), pages 623 - 632, ISBN 978-0-85711-105-0, XP009553948-
OPPOSITION- Ali R. Rajabi-Siahboomi, Manish S. Rane; Linda A. Felton, "Chapter 32: Oral Modified-Release Drug Delivery Systems", Remington, Essentials of Pharmaceutics, GB, Pharmaceutical Press , (20120101), pages 623 - 632, ISBN 978-0-85711-105-0, XP009553948-
OPPOSITION- Anonymous, "Avicel® DG", Avicel® DG, BSC Distributors, (20240506), pages 1 - 2, Avicel® DG, URL: https://www.bsce.co.il/product-page/avicel-dg, XP093159543-
OPPOSITION- Anonymous, "FMC offers spray dried excipient for dry granulation processes", manufacturing chemist, (20100423), pages 1 - 7, manufacturing chemist, URL: https://www.manufacturingchemist.com/news/article_page/FMC_offers_spray_dried_excipient_for_dry_granulation_processes/50421, (20210624), XP055817495-
OPPOSITION- Anonymous, "Guideline on quality of oral modified release products", EMA European Medicines Agency - Science Medicines Health, (20140330), pages 1 - 16, EMA European Medicines Agency - Science Medicines Health, (20210202), XP055771110-
OPPOSITION- Anonymous, "PRODUCT OVERVIEW AEROSIL® Fumed Silica", PRODUCT OVERVIEW, Evonik Resource Efficiency GmbH, (20191001), pages 1 - 20, PRODUCT OVERVIEW, URL: https://products.evonik.com/assets/46/24/AEROSIL_product_overview_EN_EN_244624.pdf, XP093159577-
OPPOSITION- Anonymous, "Reflection paper on the dissolution specification for generic solid oral immediate release products with systemic action", EMA Reflection paper, European Medicines Agency, (20170810), pages 1 - 10, EMA Reflection paper, URL: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-dissolution-specification-generic-solid-oral-immediate-release-products-systemic-action-first-version_en.pdf, XP093159571-
OPPOSITION- Anonymous, "Solifenacinesuccinaat/Tamsulosinehydrochloride Synthon 6 mg/0,4 mg, tabletten met gereguleerde afgifte", Samenvatting van de productkenmerken, College ter beoordeling van Geneesmiddelen, (20240115), pages 1 - 14, Samenvatting van de productkenmerken, URL: https://www.geneesmiddeleninformatiebank.nl/smpc/h128381_smpc.pdf, XP093159585-
OPPOSITION- Anonymous, "Vesomni 6 mg/0,4 mg, tabletten met gereguleerde afgifte", Samenvatting van de productkenmerken, College ter beoordeling van Geneesmiddelen, (20180321), pages 1 - 14, Samenvatting van de productkenmerken, URL: https://www.geneesmiddeleninformatiebank.nl/smpc/h111622_smpc.pdf, XP093159576-
OPPOSITION- AULTON M.E. (ED.), "Tablet Excipients", AULTON M.E. (ED.), AULTON M.E. (ED.).2, PHARMACEUTICS. THE SCIENCE OF DOSAGE FORM DESIGN ED. 2, UK, CHURCHILL LIVIGSTONE , (20020101), pages 404 - 410, 027702, ISBN 978-0-443-05517-1, XP002396921-
OPPOSITION- C Anonymous, "PUBLIC ASSESSMENT REPORT of the Medicines Evaluation Board in the Netherlands Vesomni 6 mg/0.4 mg modified-release tablets Astellas Pharma Europe B.V., the Netherlands", PUBLIC ASSESSMENT REPORT, CBG MEB, (20140318), pages 1 - 19, PUBLIC ASSESSMENT REPORT, URL: https://db.cbg-meb.nl/pars/h111622.pdf, XP093159574-
OPPOSITION- "Guidance for Industry Dissolution Testing of Immediate Release Solid Oral Dosage Forms", FDA, (19970801), FDA, URL: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070237.pdf, (20160229), XP055253855-
OPPOSITION- Marianme Ashford, "Chapter 17: Bioavailability - physicochemical and dosage form factors", Marianme Ashford, Micheal E. Aulton, PHARMACEUTICS: THE SCIENCE OF DOSAGE FORM DESIGN, Second Edition, UK, Elsevier , (20020101), pages 234 - 252, ISBN 0-443-05517-3, XP055466214-
OPPOSITION- ROWE R C, ET AL, "COLLOIDAL SILICON DIOXIDE", 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 188 - 191, 031835, ISBN 978-1-58212-058-4, XP003016902-
OPPOSITION- Sakr Ahmed Adel, Et Al, "Chapter 30 oral solid dosage forms", Remington Essentials of Pharmaceutics, Pharmaceutical Press , (20120101), pages 581 - 610, XP055795831-
OPPOSITION- Salt Forms: Pharmaceutical Aspects, "Passage", Salt Forms: Pharmaceutical Aspects, James Swarbrick, Encyclopedia of Pharmaceutical Technology, 3rd Edition; Vol. 5: [Phar - Star], informa healthcare, (20070101), pages 3177 - 3187, ISBN 0-8493-9392-2, XP009559834-
OPPOSITION- Wells James, Aulton M. E., "8. Pharmaceutical preformulation: the physicochemical properties of drug substance", Wells James, Aulton M. E., AULTON M.E. (ED.).2, PHARMACEUTICS. THE SCIENCE OF DOSAGE FORM DESIGN ED. 2, UK, CHURCHILL LIVIGSTONE , (20020101), pages 113 - 138, 027702, ISBN 978-0-443-05517-1, XP093196068-
OPPOSITION- Parind Mahendrakumar Desai, Celine Valeria Liew, Paul Wan Sia Heng, "Review of Disintegrants and the Disintegration Phenomena", Journal of Pharmaceutical Sciences, American Chemical Society and American Pharmaceutical Association, US, US , (20160901), vol. 105, no. 9, doi:10.1016/j.xphs.2015.12.019, ISSN 0022-3549, pages 2545 - 2555, XP055607494
OPPOSITION- Parind Mahendrakumar Desai, Celine Valeria Liew, Paul Wan Sia Heng, "Review of Disintegrants and the Disintegration Phenomena", Journal of Pharmaceutical Sciences, Wiley, United States, United States, (20160901), vol. 105, no. 9, doi:10.1016/j.xphs.2015.12.019, ISSN 0022-3549, pages 2545 - 2555, XP055607494

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