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Ribociclib Tablet - EP3283058

The patent EP3283058 was granted to Novartis on Nov 16, 2022. The application was originally filed on Apr 14, 2016 under application number EP16718020A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3283058

NOVARTIS
Application Number
EP16718020A
Filing Date
Apr 14, 2016
Status
Granted And Under Opposition
Oct 14, 2022
Grant Date
Nov 16, 2022
External Links
Slate, Register, Google Patents

Patent Summary

Patent Family

Patent Family

Patent Oppositions (3)

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CompanyOpposition DateRepresentativeOpposition Status

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STADA ARZNEIMITTELAug 16, 2023HAMM & WITTKOPPADMISSIBLE
ADALVOAug 15, 2023SLAVIKADMISSIBLE
GENERICS UKAug 15, 2023ELKINGTON AND FIFEADMISSIBLE

Patent Citations (11) New

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

Citation PhasePublication Number
DESCRIPTIONWO2010020675
DESCRIPTIONWO2012064805
INTERNATIONAL-SEARCH-REPORTEP2742940
INTERNATIONAL-SEARCH-REPORTWO2012064805
INTERNATIONAL-SEARCH-REPORTWO2014097125
OPPOSITIONEP2742940
OPPOSITIONUS5885617
OPPOSITIONWO2012064805
OPPOSITIONWO2014097125
OPPOSITIONWO2016166703
OPPOSITIONWO2022064805

Non-Patent Literature (NPL) Citations (45) 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
EXAMINATION- Daniel To ET AL, "A Novel Method to Evaluate On-Tablet Moisture Barrier Performance of Opadry� Film Coating Systems", AAPS Poster Reprint, (20140101), URL: https://www.colorcon.com/es/products-formulation/all-products/download/512/2233/34?method=view, (20210315), XP055785542
EXAMINATION- GIRON D, "Characterisation of salts of drug substances", JOURNAL OF THERMAL ANALYSIS AND CALORIMETRY, KLUWER ACADEMIC PUBLISHERS, DORDRECHT, NL, (20030801), vol. 73, no. 2, ISSN 1572-8943, pages 441 - 457, XP019254693
EXAMINATION- Jeffrey Gimbel ET AL, "Evaluation of a Novel, PEG-free Immediate Release Opadry� Aqueous Moisture Barrier Film Coating with High Productivity", AAPS Poster Reprint, (20140101), URL: https://www.colorcon.com/jp/products-formulation/all-products/download/511/2245/34?method=view, (20210315), XP055785541
OPPOSITION- Alderborn Goran, "Tablets and compaction", Alderborn Goran, M E Aulton, Pharmaceutics: The Science of Dosage Form Design, Churchill Livingstone, (20020101), pages 397 - 440, ISBN 978-0443055171, XP093109030
OPPOSITION- Ali R. Rajabi-Siahboomi , Thomas P. Farrell, "The Applications of Formulated Systems for the Aqueous Film Coating of Pharmaceutical Oral Solid Dosage Forms", Ali R. Rajabi-Siahboomi , Thomas P. Farrell, James W. McGinity , Linda A. Felton, Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms Third edition, New York, Informa healthcare, (20080101), vol. 176, pages 323 - 341, ISBN 978-0-8493-8789-0, XP093114151
OPPOSITION- Annonymous, "A Novel Method to Evaluate On-Tablet Moisture Barrier Performance of Opadry® Film Coating Systems", (20140101), pages 1 - 4, Colorcon, URL: https://www.colorcon.com/es/markets/pharmaceuticals/download/512/2233/34?method=view, (20231201), XP093107941
OPPOSITION- Annonymous, "Coating Parameters", Colorcon, (20090101), pages 1 - 2, XP093107949
OPPOSITION- Annonymous, "Colorcon adds Opadry amb II to portfolio", (20150310), pages 1 - 5, manufacturingchemist, URL: https://www.manufacturingchemist.com/news/article_page/Colorcon_adds_Opadry_amb_II_to_portfolio/106591, (20231201), XP093107928
OPPOSITION- Annonymous, "our mission", (20140101), pages 1 - 248, Novaris , URL: https://www.novartis.com/sites/novartiscom/files/novartis-annual-report-2014-en.pdf, (20231201), XP093107924
OPPOSITION- Annonymous, "Reducing Coated Tablet Defects from Laboratory through Production Scale: Performance of Hypromellose or Polyvinyl Alcohol-Based Aqueous Film Coating Systems", (20090101), pages 1 - 8, colorcon, URL: https://www.colorcon.com/search/item/83-aaps-2007-reducing-coated-tablet-defects-from-laboratory-through-production-scale-performance-of-hypromellose-based-and-polyvinyl-alcohol-based-aqueous-film-coating-systems, (20231201), XP093107935
OPPOSITION- Annonymous, "Use of Maximum Fluid Delivery Rate Measurements to Assess the Productivity of Moisture Barrier Film Coatings ", (20110101), pages 1 - 5, Colorcon, URL: https://www.colorcon.com/search/item/90-aaps-2009-use-of-maximum-fluid-delivery-rate-measurements-to-assess-the-productivity-of-moisture-barrier-film-coatings, (20231201), XP093107940
OPPOSITION- Anonymous, Anonymous, Wolfgang A. Ritschel , Annette Bauer-Brandl, Die Tablette ; Handbuch der Entwicklung, Herstellung und Qualitatssicherung, Aulendorf, Editio Cantor Verlag, (20020101), pages 1 - 26, ISBN 3-87193-228-0
OPPOSITION- Anonymous, "EUROPEAN PHARMACOPOEIA 5 th Edition", EUROPEAN PHARMACOPOEIA 5 th Edition, (20040615), pages 1521 - 1523, XP093301321
OPPOSITION- Anonymous, "kapitel 1", Anonymous, Wolfgang A Ritschel , Annette Bauer- Brandl, Die Tablette Handbuch der Entwicklung, Herstellung und Qualitatssicherung, Edito Cantor Verlag, (20020101), pages 30 - 31, ISBN 978-3-87193-228-1, XP093113312
OPPOSITION- Anonymous, "Polyvinyl Alcohol", Anonymous, Raymond C Rowe, Paul J Sheskey , Marian E Quinn, Handbook of Pharmaceutical Excipients Sixth edition, Pharmaceutical Press, (20090101), pages 564 - 565, ISBN 978-0-85369-792-3, XP093109062
OPPOSITION- Anonymous, "Polyvinyl Alcohol", Anonymous, Raymond C Rowe; Paul J Sheskey; Marian E Quinn, Handbook of Pharmaceutical Excipients Sixth edition, Pharmaceutical Press, (20090101), pages 564 - 565, XP093109062
OPPOSITION- Anonymous, "Reducing Coated Tablet Defects from Laboratory through Production Scale: Performance of Hypromellose or Polyvinyl Alcohol-Based Aqueous Film Coating Systems", (20090101), pages 1 - 8, Colorcon, URL: https://www.colorcon.com/search/item/83-aaps-2007-reducing-coated-tablet-defects-from-laboratory-through-production-scale-performance-of-hypromellose-based-and-polyvinyl-alcohol-based-aqueous-film-coating-systems, (20231218), XP093113265
OPPOSITION- Ausburger Larry, Albert W Bizeczko , Umang Shah , Huijeong A Hahm , "Superdisintegrants: Characterization and Function", Ausburger Larry, Albert W Bizeczko , Umang Shah , Huijeong A Hahm , James Swarbrick , James C Boylan, Encyclopaedia of Pharmaceutical Technology, New York, Marcel Dekker, Inc , (20010101), pages 269 - 293, ISBN 8-8247-2819-X, XP093109025
OPPOSITION- Daniel To, Jason Teckoe, Ali Rajabi-Siahboomi, "A Novel Method to Evaluate On-Tablet Moisture Barrier Performance of Opadry® Film Coating Systems", (20140101), pages 1 - 4, AAPS Poster Reprint, URL: https://www.colorcon.com/es/products-formulation/all-products/download/512/2233/34?method=view, (20210315), XP055785542
OPPOSITION- Elizabeth Shen, "Cover Up", Innovations in Pharmaceutical Technology, (20150301), no. 52, pages 44 - 47, XP055634329
OPPOSITION- Fang Liu et al., Update on Polymers for Oral Drug Delivery, iSmithers, (20110101), pages 21 - 23, XP093154659
OPPOSITION- Fujii Toshiro, Makoto Noami; Yoshihiro Furuya Keizo; Tomita; ; , "PVA copolymer: the new coating agent", Pharmaceutical Technology, (20081001), Pharmaceutical Technology, URL: https://www.pharmtech.com/view/pva-copolymer-new-coating-agent, XP093173228
OPPOSITION- Gimbel Jeffrey, Daniel To, Brad Prusak, Jason Teckoe , Ali Rajabi-Siahboomi, "Evaluation of a Novel, PEG-free, Immediate Release Opadry® Aqueous Moisture Barrier Film Coating with High Productivity", (20140101), pages 1 - 4, Colorcon, URL: https://www.colorcon.com/jp/markets/pharmaceuticals/download/511/2245/34?method=view, (20231201), XP093107943
OPPOSITION- Hogan John, "Coating of tablets and multiparticulates", Hogan John, M E Aulton, Pharmaceutics: The Science of Dosage Form Design, Churchill Livingstone, (20020101), pages 441 - 448, ISBN 978-0443055171, XP093109032
OPPOSITION- Jeffrey Gimbel, Daniel To, Brad Prusak, Jason Teckoe, Ali Rajabi-Siahboomi, "Evaluation of a Novel, PEG-free Immediate Release Opadry® Aqueous Moisture Barrier Film Coating with High Productivity", (20140101), pages 1 - 4, AAPS Poster Reprint, URL: https://www.colorcon.com/jp/products-formulation/all-products/download/511/2245/34?method=view, (20210315), XP055785541
OPPOSITION- Karuppiah S P, "Analytical method development for dissolution release of finished solid oral dosage forms ", International journal of current pharmaceutical research, IN , (20120101), vol. 4, no. 2, ISSN 0975-7066, pages 48 - 53, XP093107914
OPPOSITION- Leon Lachman , Herbert A Lieberman , Joseph L Kanig, The theory and practice of industrial pharmacy, Varghese Publishing House, (19870101), pages 1 - 19
OPPOSITION- Linda A. Felton, "Film Coating of Oral Solid Dosage Forms", Linda A. Felton, James Swarbrick, Encyclopedia of Pharmaceutical Science and Technology 4th Edition, CRC Press, (2007), pages 1729 - 1747, ISBN 978-1-84184-819-8, XP093114160
OPPOSITION- Rajabi-Siahboomi Ali R, Marina Levina, Sampada B. Upadhye And Jason Teckoe, "Chapter 13 Excipient Selection in Oral Solid Dosage Formulations Containing Moisture Sensitive Drugs", Rajabi-Siahboomi Ali R, Marina Levina, Sampada B. Upadhye And Jason Teckoe, Narang Ajit S, Boddu Sai H S., Excipient Applications in Formulation Design and Drug Delivery, Springer International Publishing, (20150101), pages 385 - 421, ISBN 978-3-319-20206-8, XP093109068
OPPOSITION- Rios Maribel, "A Fresh Coat: Innovation in Excipients", Pharmaceutical Technology, (20081102), Pharmaceutical Technology, URL: https://www.pharmtech.com/view/fresh-coat-innovation-excipients, XP093173226
OPPOSITION- Rudnic Edward M, Joseph D Schwartz, "Oral Solid Dosage Forms", Rudnic Edward M, Joseph D Schwartz, Alfonso R Gennaro, Remington: The Science and Practice of Pharmacy 20th Edition, Lippincott Williams and Wilkins, (20000101), pages 858 - 893, ISBN 978-0683306477, XP093109037
OPPOSITION- Rudnic Edward M, Joseph D Schwartz, "Oral Solid Dosage Forms ", Rudnic Edward M, Joseph D Schwartz, Alfonso R Gennaro, Remington: The Science and Practice of Pharmacy, Baltimore Maryland , USA, Lippincott Williams & Wilkins , (20000101), pages 858 - 893, ISBN 978-0-683-30647-7, XP093113276
OPPOSITION- Shen Elizabeth, "Protection Beyond the Packaging", Drug Quality Assurance, (20160101), pages 1 - 4, XP093108979
OPPOSITION- Vidula Neelima, "Regaining Control of the Cell Cycle With CDK 4/6 Inhibitors: A Promising Targeted Therapy for Breast Cancer", (20140922), pages 1 - 18, Targeted Oncology, URL: https://www.targetedonc.com/view/regaining-control-of-the-cell-cycle-with-cdk-46-inhibitors-a-promising-targeted-therapy-for-breast-cancer, (20231201), XP093107908
OPPOSITION- W A Ritschel , A Bauer-Brandl, Die Tablette ; Handbuch der Entwicklung , Herstellung und Qualitatssicherung, Editio Cantor Verlag, (20020101), pages 1 - 26, ISBN 978-3-87193-228-1
OPPOSITION- Ando M. , Ito, R. , Ozeki Y. , Nakayama Y., Nabeshima T., "Evaluation of a novel sugar coating method for moisture protective tablets", International Journal of Pharmaceutics, NL , (20070504), vol. 336, no. 2, doi:10.1016/j.ijpharm.2006.12.015, ISSN 0378-5173, pages 319 - 328, XP022060323
OPPOSITION- Joshi S. , Petereit H.U, "Film coatings for taste masking and moisture protection", International Journal of Pharmaceutics, NL , (20131020), vol. 457, no. 2, doi:10.1016/j.ijpharm.2013.10.021, ISSN 0378-5173, pages 395 - 406, XP028779506
OPPOSITION- Giron D, "Characterisation of salts of drug substances", Journal of thermal analysis and calorimetry, NL , (20030101), vol. 73, no. 2, doi:10.1023/A:1025461625782, ISSN 1388-6150, pages 441 - 457, XP093107946
OPPOSITION- R. C. Rowe, "The effect of polymer molecular weight on the incidence of film cracking and splitting on film coated tablets", Journal of Pharmacy and Pharmacology, (19800901), vol. 32, no. 1, doi:10.1111/j.2042-7158.1980.tb13003.x, pages 583 - 584, XP093154661
OPPOSITION- Olanich Mary E., Sun Wenyue, Hewitt Stephen M., Abdullaev Zied, Pack Svetlana D., Barr Frederic G., "CDK4 Amplification Reduces Sensitivity to CDK4/6 Inhibition in Fusion-Positive Rhabdomyosarcoma", Clinical Cancer Research, US, (20151101), vol. 21, no. 21, doi:10.1158/1078-0432.CCR-14-2955, ISSN 1078-0432, pages 4947 - 4959, XP093107910
OPPOSITION- Otilia M. Y. Koo; John D. Fiske; Haitao Yang; Faranak Nikfar; Ajit Thakur; Barry Scheer; Monica L. Adams, "Investigation into Stability of Poly(Vinyl Alcohol)-Based Opadry® II Films", AAPS Pharmscitech, US , (20110607), vol. 12, no. 2, doi:10.1208/s12249-011-9630-1, ISSN 1530-9932, pages 746 - 754, XP019925570
OPPOSITION- Avbunudiogba John A., Cash-Torunarigha Omonyemen E, Onah Ikechukwu, "Effect of Humidity on the Physical Properties of Aspirin Tablets Produced By Melt Granulation and Slugging Methods", IOSR Journal of Pharmacy and Biological Sciences, (20130101), vol. 7, no. 5, doi:10.9790/3008-0752025, ISSN 2319-7676, pages 20 - 25, XP093301315
OTHER- Daniel To et al, "A Novel Method to Evaluate On-Tablet Moisture Barrier Performance of Opadry® Film Coating Systems", AAPS Poster Reprint, (2014), pages 1 - 4, URL: https://www.colorcon.com/es/products-formulation/all-products/download/512/2233/34?method=view, XP055785542
OTHER- D. GIRON, "Characterisation of Salts of Drug Substances", Journal of Thermal Analysis and Calorimetry, (20030000), vol. 73, pages 441 - 457, XP019254693
OTHER- J. GIMBEL et al, "Evaluation of a Novel, PEG-free Immediate Release Opadry® Aqueous Moisture Barrier Film Coating with High Productivity", AAPS Poster Reprint, (20140000), pages 1 - 4, URL: https://www.colorcon.com/jp/products-formulation/all-products/download/511/2245/34?method=view, XP055785541

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