IP Verse

Tofacitinib Oral Sustained Release Dosage Forms - EP2968155

The patent EP2968155 was granted to Pfizer on Mar 3, 2021. The application was originally filed on Mar 12, 2014 under application number EP14726410A. The patent is currently recorded with a legal status of "Revoked".

EP2968155

PFIZER
Application Number
EP14726410A
Filing Date
Mar 12, 2014
Status
Revoked
Sep 26, 2025
Grant Date
Mar 3, 2021
External Links
Slate, Register, Google Patents

Patent Summary

Patent Family

Patent Family

Patent Oppositions (6)

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GENERICS UKDec 3, 2021ELKINGTON AND FIFEADMISSIBLE
KRAUS & LEDERER PARTGMBBDec 3, 2021KRAUS & LEDERER PARTGMBBADMISSIBLE
STADA ARZNEIMITTELDec 3, 2021HAMM & WITTKOPPADMISSIBLE
TEVA PHARMACEUTICALSDec 3, 2021D YOUNGADMISSIBLE
GREINERDec 2, 2021GREINERADMISSIBLE
AERANov 30, 2021-ADMISSIBLE

Patent Citations (32) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONEP0357369
DESCRIPTIONUS2005181062
DESCRIPTIONUS2005186285
DESCRIPTIONUS2007248671
DESCRIPTIONUS2008199527
DESCRIPTIONUS3247066
DESCRIPTIONUS3952741
DESCRIPTIONUS4519801
DESCRIPTIONUS5358502
DESCRIPTIONUS5612059
DESCRIPTIONUS5698220
DESCRIPTIONWO0142246
DESCRIPTIONWO02096909
DESCRIPTIONWO03048162
DESCRIPTIONWO2005053653
DESCRIPTIONWO2012100949
INTERNATIONAL-SEARCH-REPORTUS2007248671
INTERNATIONAL-SEARCH-REPORTUS5358502
INTERNATIONAL-SEARCH-REPORTUS5698220
INTERNATIONAL-SEARCH-REPORTWO2007057762
INTERNATIONAL-SEARCH-REPORTWO2011039686
INTERNATIONAL-SEARCH-REPORTWO2012100949
INTERNATIONAL-SEARCH-REPORTWO9901121
OPPOSITIONUS2007248671
OPPOSITIONUS5358502
OPPOSITIONUS5698220
OPPOSITIONWO2007057762
OPPOSITIONWO2011039686
OPPOSITIONWO2012009494
OPPOSITIONWO2012100949
OPPOSITIONWO2014147526
OPPOSITIONWO9901121

Non-Patent Literature (NPL) Citations (32) 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
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OPPOSITION- Anonymous, "Guidance for Industry SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation", US department of Health and Human services, (19970901), pages 1 - 52, US department of Health and Human services, URL: https://www.fda.gov/media/70956/download, (20211217), XP055874184-
OPPOSITION- Anonymous, "POINTS TO CONSIDER ON THE CLINICAL REQUIREMENTS OF MODIFIED RELEASE PRODUCTS SUBMITTED AS A LINE EXTENSION OF AN EXISTING MARKETING AUTHORISATION ", The European Agency for the Evaluation of Medicinal Products, (20031217), pages 1 - 3, The European Agency for the Evaluation of Medicinal Products, URL: https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-clinical-requirements-modified-release-products-submitted-line-extension-existing_en.pdf, (20211217), XP055874176-
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OPPOSITION- AULTON, M. E., Pharmaceutics, The Science of Dosage Form Design, 2nd ed., (20020000), pages 302 - 304, XP055298170-
OPPOSITION- "center for drug evaluation and research 203214 Orig1s000 labeling medical review", FDA Medicial Review for tofacitinib, (20120000), pages 1 - 303-
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OPPOSITION- Linda Felton, "chapter 5 Bioavailability and Bioequivalence Testing", Remington: Essentials of Pharmaceutics, (20130000), pages 51 - 61, XP055911192-
OPPOSITION- Patel Harnish, Et Al, "A REVIEW ON OSMOTIC DRUG DELIVERY SYSTEM", INTERNATIONAL RESEARCH JOURNAL OF PHARMACY, (20120101), pages 88 - 94, INTERNATIONAL RESEARCH JOURNAL OF PHARMACY, URL: https://irjponline.com/admin/php/uploads/978_pdf.pdf, (20211217), XP055874191-
OPPOSITION- "XELJANZ® (tofacitinib) tablets for oral administration", Highlights of Prescribing Information, (20121101), XP055911822-
OPPOSITION- Lamba Manisha, Et Al, "Extended‐Release Once‐Daily Formulation of Tofacitinib: Evaluation of Pharmacokinetics Compared With Immediate‐Release Tofacitinib and Impact of Food", The Journal of clinical pharmacology, LIPPINCOTT CO, HAGERSTOWN, MD, US, US , (20161101), vol. 56, no. 11, doi:10.1002/jcph.734, ISSN 0091-2700, pages 1362 - 1371, XP055874161
OPPOSITION- THOMBRE et al., "Osmotic drug delivery using swellable-core technology", J Control Release, (20040000), vol. 94, no. 1, doi:10.1016/j.jconrel.2003.09.009, pages 75 - 89, XP004480739
OPPOSITION- WATERMAN et al., "Extrudable core system: development of a single-layer osmotic controlled-release tablet", J Control Release, (20090000), vol. 134, no. 3, doi:10.1016/j.jconrel.2008.11.017, pages 201 - 6, XP026049516
OPPOSITION- Waterman et al., "Extrudable core system: Development of a single-layer osmotic controlled-release tablet", Journal of Controlled Release, AMSTERDAM, NL , (20090319), vol. 134, no. 3, doi:10.1016/j.jconrel.2008.11.017, ISSN 0168-3659, pages 201 - 206, XP026049516
OPPOSITION- Waterman, K.C. ; MacDonald, B.C. ; Roy, M.C., "Extrudable core system: Development of a single-layer osmotic controlled-release tablet", Journal of Controlled Release, Elsevier, AMSTERDAM, NL, AMSTERDAM, NL , (20090319), vol. 134, no. 3, doi:10.1016/j.jconrel.2008.11.017, ISSN 0168-3659, pages 201 - 206, XP026003206
OPPOSITION- BURMESTER GERD R et al., "Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trial", LANCET (NORTH AMERICAN EDITION, (20130209), vol. 381, no. 9865, pages 451 - 460, XP002727328
OPPOSITION- BROWN A S et al., "Treating Patients With Documented Atherosclerosis to National Cholesterol Education Program-Recommended Low-Density- Lipoprotein Cholesterol Goals With Atorvastatin, Fluvastatin, Lovastatin and Simvastatin", JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, NEW YORK, NY, US, (19980901), vol. 32, no. 3, ISSN 0735-1097, pages 665 - 672, XP002983358
OPPOSITION- FLANAGAN et al., "Discovery of CP-690,550: A Potent and Selective Janus Kinase (JAK) Inhibitor for the Treatment of Autoimmune Diseases and Organ Transplant Rejection", J. Med. Chem., (20100000), vol. 53, no. 24, doi:10.1021/jm1004286, pages 8468 - 8484, XP055222844
OPPOSITION- Van Gurp et al., "Phase 1 Dose-Escalation Study of CP-690 550 in Stable Renal Allograft Recipients: Preliminary Findings of Safety, Tolerability, Effects on Lymphocyte Subsets and Pharmacokinetics", American journal of transplantation, DK , (20080801), vol. 8, no. 8, doi:10.1111/j.1600-6143.2008.02307.x, ISSN 1600-6135, pages 1711 - 1718, XP055911825
OPPOSITION- Peer, Basic & Clinical Pharmacology & Toxicology, (20090000), vol. 106, pages 146 - 153, XP55874199
OPPOSITION- CAVAGNA L et al., "Atherosclerosis and rheumatoid arthritis: more than a simple association", MEDIATORS OF INFLAMMATION, (20120000), vol. 2012, no. 147354, pages 1 - 8, XP002727193
OPPOSITION- Meyer Debra M et al, "Anti-inflammatory activity and neutrophil reductions mediated by the JAK1/JAK3 inhibitor, CP-690,550, in rat adjuvant-induced arthritis", JOURNAL OF INFLAMMATION, BIOMED CENTRAL, LONDON, GB, GB , (20100811), vol. 7, no. 1, doi:10.1186/1476-9255-7-41, ISSN 1476-9255, page 41, XP021078253
OPPOSITION- Meyer et al., "Anti-inflammatory activity and neutrophil reductions mediated by the JAK1/JAK3 inhibitor, CP-690,550, in rat adjuvant-induced arthritis", JOURNAL OF INFLAMMATION, GB , (20100811), vol. 7, no. 1, doi:10.1186/1476-9255-7-41, ISSN 1476-9255, page 41, XP021078253
OPPOSITION- Chen et al., "Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products: Workshop Summary Report", The AAPS Journal, Boston , (20100504), vol. 12, no. 3, doi:10.1208/s12248-010-9201-5, pages 371 - 377, XP035719119
OPPOSITION- Bannwarth et al., "A pharmacokinetic and clinical assessment of tofacitinib for the treatment of rheumatoid arthritis", Expert Opinion on Drug Metabolism & Toxicology, (20130601), vol. 9, no. 6, doi:10.1517/17425255.2013.789500, pages 753 - 761, XP055911790
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OPPOSITION- Coleman et al., "Dosing Frequency and Medication Adherence in Chronic Disease", JOURNAL OF MANAGED CARE PHARMACY, US , (20120901), vol. 18, no. 7, doi:10.18553/jmcp.2012.18.7.527, ISSN 1083-4087, pages 527 - 539, XP055911815
OPPOSITION- Hsu Denise, Katelaris Constance, "Long-term management of patients taking immunosuppressive drugs", AUSTRALIAN PRESCRIBER, AUSTRALIAN GOVERNMENT - PUBLISHING SERVICE, CANBERRA, AU, AU , (20090601), vol. 32, no. 3, doi:10.18773/austprescr.2009.035, ISSN 0312-8008, pages 68 - 71, XP055874201

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