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Pharmaceutical Formulations - EP4233846

EP4233846

GILEAD SCIENCES
Application Number
EP23162978A
Filing Date
Jun 29, 2016
Status
Granted And Under Opposition
Nov 1, 2024
Grant Date
Dec 4, 2024
External Links
Slate, Register, Google Patents

Bibliography

The patent EP4233846B1 was granted to Gilead Sciences on Dec 4, 2024 following the initial filing on Jun 29, 2016 under the application number EP23162978A . The current legal status of the patent is Granted And Under Opposition.

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Patent Family

Patent Oppositions (3)

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ELKINGTON AND FIFESep 4, 2025ADMISSIBLE
EIPSep 3, 2025ADMISSIBLE
HAMM & WITTKOPPSep 2, 2025ADMISSIBLE

Patent Citations (14) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONWO0208241
DESCRIPTIONWO03016306
DESCRIPTIONWO2013025788
OPPOSITIONWO2004064846
OPPOSITIONWO2006135932
OPPOSITIONWO2013025788
OPPOSITIONWO2013116720
OTHERWO0208241
OTHERWO2004064846
OTHERWO2006135932
OTHERWO2013025788
SEARCHWO2013116720
SEARCHWO2015022351
SEARCHWO2015196116

Non-Patent Literature (NPL) Citations (24) 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
DESCRIPTION- COSTAGLIOLA D, "Demographics of HIV and aging", Curr. Opin. HIV AIDS, (20140000), vol. 9, no. 4, page 294-
DESCRIPTION- JAMBHEKARBREEN, Basic Pharmacokinetics, (20120000), ISBN 978-0853699804-
DESCRIPTION- Remington: The Science and Practice of Pharmacy, Lippincott, Williams & Wilkins, (20050000), page 732-
DESCRIPTION- ROWLANDTOZER, Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications, (20100000), ISBN 978-0781750097-
DESCRIPTION- S.M. BERGE et al., J. Pharma Sci., (19770000), vol. 66, no. 1, pages 1 - 19-
OPPOSITION- Anonymous, "Approval Package for aplication number 208351Orig1s000 Odefsey", CENTER FOR DRUG EVALUATION AND RESEARCH, (20160301), pages 1 - 10, CENTER FOR DRUG EVALUATION AND RESEARCH, URL: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208351Orig1s000Approv.pdf, (20201102), XP055745977-
OPPOSITION- Anonymous, "Assessment report - Genvoya - Procedure No. EMEA/H/C/004042/0000 ", EMA, (20150924), EMA, URL: https://www.ema.europa.eu/en/documents/assessment-report/genvoya-epar-public-assessment-report_en.pdf, XP093313685-
OPPOSITION- Anonymous, "European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Emtricitabine and Tenofovir Alafenamide for HIV Treatment | Business Wire", bussinesswire, (20150528), pages 1 - 2, bussinesswire, URL: https://www.businesswire.com/news/home/20150528005752/en/European-Medicines-Agency-Validates-Gilead’s-Marketing-Application, (20201102), XP055745982-
OPPOSITION- Anonymous, "Gilead Discontinues Development of GS 9005 and GS 7340; Company Continues Commitment to Research Efforts in HIV", Gilead, (20041021), Gilead, URL: https://www.gilead.com/news/news-details/2004/gilead-discontinues-development-of-gs-9005-and-gs-7340-company-continues-commitment-to-research-efforts-in-hiv, XP093313674-
OPPOSITION- Anonymous, "Truvada 200 mg/245 mg film-coated tablets - Summary of Product Characteristics (SmPC)", EMA, (20200911), XP093313665-
OPPOSITION- Brittain Harry G., "Overview of the Solid Dosage Form Preformulation Program", Preformulation in Solid Dosage Form Development, Informa Healthcare, (20080101), pages 347 - 355, XP093313692-
OPPOSITION- Charles R Cunningham, et al, "Formulation of acetylsalicylic acid tablets for aqueous enteric film coating", Pharmaceutical Technology, (2001), vol. 25, no. 9, pages 38 - 43, XP055671879-
OPPOSITION- Gilead, "Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide for HIV Treatment", Press Release, (20150407), pages 1 - 2, Press Release, (20201207), XP055757389-
OPPOSITION- Prasad Telaprolu, M Venkata Anjaneyulu, Y Nagarjuna Reddy, "A REVIEW ON PHARMACEUTICAL EXCIPIENTS", International Journal of Research in Pharmaceutical and Nano Sciences, (20130101), pages 423 - 431, International Journal of Research in Pharmaceutical and Nano Sciences, URL: http://ijrpns.com/article/A%20REVIEW%20ON%20PHARMACEUTICAL%20EXCIPIENTS.pdf, XP055719927-
OPPOSITION- "SCIENTIFIC PRINCIPLES OF DOSAGE FORM DESIGN", M.E. Aulton, PHARMACEUTICS: THE SCIENCE OF DOSAGE FORM DESIGN, 2ND EDITION, Churchill Livingstone, (2002), page 128-131-
OPPOSITION- Wolfgand A. Ritschel, Ritschel Wolfgang A, Bauer Annette, "Die Tablette", Der Pharmazeutische betrieb, (20020101), pages 64 - 65, XP055371911-
OPPOSITION- Ajit S. Narang; Divyakant Desai; Sherif Badawy, "Impact of Excipient Interactions on Solid Dosage Form Stability", Pharmaceutical Research, Kluwer Academic Publishers-Plenum Publishers, NL, NL , (20120616), vol. 29, no. 10, doi:10.1007/s11095-012-0782-9, ISSN 1573-904X, pages 2660 - 2683, XP035111460
OPPOSITION- Albert Mihranyan et al, "Moisture sorption by cellulose powders of varying crystallinity", International Journey of Pharmaceutics, (2004), vol. 269, doi:10.1016/j.ijpharm.2003.09.030, pages 433 - 442, XP055182458
OPPOSITION- DU J, HOAG S W, "THE INFLUENCE OF EXCIPIENTS ON THE STABILITY OF THE MOISTURE SENSITIVE DRUGS ASPIRIN AND NIACINAMIDE: COMPARISON OF TABLETS CONTAINING LACTOSE MONOHYDRATE WITH TABLETS CONTAINING ANHYDROUS LACTOSE", Pharmaceutical Development and Technology, NEW YORK, NY, US, US , (20010101), vol. 06, no. 02, doi:10.1081/PDT-100000742, ISSN 1083-7450, pages 159 - 166, XP009049485
OPPOSITION- Ruane Peter J., Dejesus Edwin, Berger Daniel, Markowitz Martin, Bredeek U. Fritz, Callebaut Christian, Zhong Lijie, Ramanathan Srini, S. Rhee Martin, Fordyce Marshall W., Yale Kitty, "Antiviral Activity, Safety, and Pharmacokinetics/Pharmacodynamics of Tenofovir Alafenamide as 10-Day Monotherapy in HIV-1-Positive Adults", JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES, LIPPINCOTT WILLIAMS AND WILKINS,PHILADELPHIA, PA, US, US , (20130801), vol. 63, no. 4, doi:10.1097/QAI.0b013e3182965d45, ISSN 1525-4135, pages 449 - 455, XP093107466
OTHER- Kasper Dennis L., "Harrisons Principles of Internal Medicine: Passage", Harrisons Principles of Internal Medicine 19th Edition, (20150901), page 1278, XP093215518-
OTHER- Qiu Y., "Developing Solid Oral Dosage forms Pharmaceutical Theory and Practice ", Developing Solid Oral Dosage forms Pharmaceutical Theory and Practice second edition, (20170101), pages 566 - 568, XP093215528-
OTHER- YUAN L C, ET AL., "DEGRADATION KINETICS OF OXYCARBONYLOCYMETHYL PRODRUGS OF PHOSPHONATES IN SOLUTION", Environmental Science and Pollution Research, Berlin/Heidelberg, (20010201), vol. 18, no. 02, doi:10.1023/A:1011044804823, ISSN 0724-8741, pages 234 - 237, XP009035540
SEARCH- Gilead, "Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide for HIV Treatment", Press Release, (20150407), pages 1 - 2, URL: https://www.gilead.com/news-and-press/press-room/press-releases/2015/4/gilead-submits-new-drug-application-to-us-food-and-drug-administration-for-fixeddose-combination-of-emtricitabinetenofovir-alafenamide-for-hiv-tre, (20201207), XP055757389 [A] 1-12 * the whole document *-

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