IP Verse

Methods For Ensuring Resuspension Of Paliperidone Palmitate Formulations - EP4005555

EP4005555

JANSSEN PHARMACEUTICA
Application Number
EP21210307A
Filing Date
Nov 24, 2021
Status
Granted And Under Opposition
Apr 12, 2024
Grant Date
May 15, 2024
External Links
Slate, Register, Google Patents

Bibliography

The patent EP4005555B1 was granted to Janssen Pharmaceutica on May 15, 2024 following the initial filing on Nov 24, 2021 under the application number EP21210307A . The current legal status of the patent is Granted And Under Opposition.

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Patent Oppositions (2)

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HAMM & WITTKOPPFeb 17, 2025ADMISSIBLE
ELKINGTON AND FIFEFeb 14, 2025ADMISSIBLE

Patent Citations (11) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONUS10143693
DESCRIPTIONUS5254556
DESCRIPTIONUS6077843
DESCRIPTIONUS6555544
DESCRIPTIONUS9439906
OPPOSITIONEP3311374
OPPOSITIONUS10143693
OPPOSITIONWO2016199170
SEARCHEP3311374
SEARCHUS10143693
SEARCHWO2016199170

Non-Patent Literature (NPL) Citations (13) 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- Anonymous, "Assessment report - BYANNLI - International non-proprietary name: paliperidone", European Medicines Agency (EMA); EMA/502561/2021 Committee for Medicinal Products for Human Use (CHMP); Procedure No. EMEA/H/C/005486/X/0002/G, (20210101), XP093262433-
OPPOSITION- Anonymous, "Highlights of prescribing information Invega Sustenna ", FDA, pages 1 - 56, FDA , URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022264s023lbl.pdf, XP093231831-
OPPOSITION- Anonymous, "Highlights of prescribing information Invega Trinza", FDA, pages 1 - 55, FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207946s003lbl.pdf, XP093231532-
OPPOSITION- Anonymous, "Janssen Submits Paliperidone Palmitate 6-Month (PP6M) Supplemental New Drug Application to U.S. FDA for Treatment of Schizophrenia in Adults", PR Newswire, pages 1 - 10, PR Newswire, URL: https://www.prnewswire.com/news-releases/janssen-submits-paliperidone-palmitate-6-month-pp6m-supplemental-new-drug-application-to-us-fda-for-treatment-of-schizophrenia-in-adults-301164580.html, XP093231533-
OPPOSITION- D9 - Packaging for Invega Hafyera® - sourced from drugs.com, https://www.drugs.com/pro/invega-hafyera.html (accessed 21 January 2025)-
OPPOSITION- Christian Isalomboto Nkanga, "Clinically established biodegradable long acting injectables: An industry perspective", Advanced Drug Delivery Reviews, (20201114), vol. 167, doi:10.1016/j.addr.2020.11.008, XP086399228
OPPOSITION- Guo Jianxin, Lewis Lavinia M., Billones Hilbert, Torres Ekaterina, Kolhe Parag, "The Effect of Shipping Stresses on Vaccine Re-dispersion Time", Journal of pharmaceutical sciences, Elsevier Inc, Hoboken, Hoboken, (20160601), vol. 105, no. 6, doi:10.1016/j.xphs.2016.03.023, ISSN 0022-3549, pages 2009 - 2013, XP009560201
OPPOSITION- Srihari Gopal, An Vermeulen, Partha Nandy, Paulien Ravenstijn, Isaac Nuamah, José Antonio Buron Vidal, Joris Berwaerts, Adam Savitz, David Hough, Mahesh N. Samtani, "Practical guidance for dosing and switching from paliperidone palmitate 1 monthly to 3 monthly formulation in schizophrenia", Current Medical Research and Opinion, HANTS, GB, GB , (20151102), vol. 31, no. 11, doi:10.1185/03007995.2015.1085849, ISSN 0300-7995, pages 2043 - 2054, XP055627208
OPPOSITION- Anonymous, "Designation: D4169-16 - Standard Practice for Performance Testing of Shipping Containers and Systems", ASTM International, ASTM International, (20160101), doi:10.1520/D4169-16, XP093262448
OPPOSITION- Wuxin Zhu, Lien Vermeir, Ruxandra Govoreanu, Katrien Verbruggen, Tina Ariën, Arne Verliefde, Paul Van der Meeren, "In situ nondestructive sediment characterization and resuspendability evaluation of concentrated aqueous paliperidone palmitate suspensions in prefilled syringes by low-field one-dimensional pulsed-field gradient NMR profilometry", PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY, NEW YORK, NY, US, US , (20120301), vol. 17, no. 3, doi:10.3109/10837450.2012.672990, ISSN 1083-7450, pages 259 - 267, XP009560200
SEARCH- Anonymous, "INVEGA SUSTENNA (paliperidone palmitate) extended-release injectable suspension, for intramuscular use", (20170601), URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022264s023lbl.pdf, (20190129), XP055548926 [X] 30-42 * the whole document * [I] 1-29-
SEARCH- Janssen Pharmaceuticals ET AL, "INVEGA TRINZA®", (20160315), pages 1 - 16, URL: https://web.archive.org/web/20160315102845if_/https://www.janssenmd.com/pdf/invega-trinza/INVEGA-TRINZA_PI.pdf, (20210927), XP055845012 [X] 30-42 * the whole document * [I] 1-29-
SEARCH- SRIHARI GOPAL ET AL, "Practical guidance for dosing and switching from paliperidone palmitate 1 monthly to 3 monthly formulation in schizophrenia", CURRENT MEDICAL RESEARCH AND OPINION, GB, (20151002), vol. 31, no. 11, doi:10.1185/03007995.2015.1085849, ISSN 0300-7995, pages 2043 - 2054, XP055627208 [X] 30-42 * the whole document * [I] 1-29

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