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Supplementary Protection Certificate Details

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Supplementary Protection Certificate (SPC) Summary
SPC No. 2005/021
Date of filing 08/07/2005
Notification of Application Published 10/08/2005
Status Granted
Notification of Grant Published 02/09/2009
Date of Expiry of SPC 23/02/2020
Applicant GILEAD SCIENCES, INC.
333 Lakeside Drive
Foster City
California 94404
UNITED STATES OF AMERICA
Patent Number 0915894
Title of Invention NUCLEOTIDE ANALOGS
Date of Expiry of Patent 24/07/2017
Product Type Medicinal Product
Product Identity Tenofovir disoproxil and salts, hydrates, tautomers and solvates thereof, in particular tenofovir disoproxil fumarate, in combination with emtricitabine
Market AuthorisationIreland European Union 
Authorisation NoEU/1/04/305/001  EU/1/04/305/001 
Authorisation Date21/02/2005 21/02/2005 
Identity of Product AuthorisedTruvada-Emtricitabine/Tenofovir Disoproxil Truvada-Emtricitabine/Tenofovir Disoproxil 
Address for Service TOMKINS & CO.
5 Dartmouth Road
Dublin 6
IRELAND
Renewal Fees
Year Date Renewed
 22  26/07/2018
 21  28/07/2017
18/11/2015 By virtue of Intangible Licence Agreement dated 01/01/2000 as amended as described in Memorandum of Understanding dated 01/01/2012 Gilead Biopharmaceutics Ireland UC, 25/28 North Way Quay, Dublin 1, Ireland, have been registered as exclusive licensee. Certified copy of Licence on File No. 0915894.
16/02/2016 The expiry date of SPC No. 2005/021 has been amended to bring it into line with the decision from the Court of Justice of the European Union in Case C-471/14. New expiry date is 23/02/2020.
25/10/2017 A newly executed Licence Agreement dated 30/06/2017 has been filed in connection with the Licence application. This replaces the original filing of the Intangible Licence Agreement on 18/11/2015.
22/02/2018 Application for an extension of the duration of Supplementary Protection Certificate No. 2005/021 filed on 15/02/2018.