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Modified Release Orally Administered Amino Acid Formulations - EP4129270

The patent EP4129270 was granted to APR Applied Pharma Research on Sep 11, 2024. The application was originally filed on Sep 27, 2016 under application number EP22178328A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP4129270

APR APPLIED PHARMA RESEARCH
Application Number
EP22178328A
Filing Date
Sep 27, 2016
Status
Granted And Under Opposition
Aug 8, 2024
Grant Date
Sep 11, 2024
External Links
Slate, Register, Google Patents

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MAIWALDJun 10, 2025MAIWALDADMISSIBLE

Patent Citations (10) New

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

Citation PhasePublication Number
OPPOSITIONEP1360904
OPPOSITIONEP2468261
OPPOSITIONUS2002004072
OPPOSITIONUS2013251803
OPPOSITIONWO2016112170
SEARCHEP1774858
SEARCHGB1217365
SEARCHWO0067797
SEARCHWO2011043647
SEARCHWO2016112170

Non-Patent Literature (NPL) Citations (40) 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
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EXAMINATION- GIARRATANA NADIA ET AL, "In Vivo Metabolic Responses to Different Formulations of Amino Acid Mixtures for the Treatment of Phenylketonuria (PKU)", INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES, Basel, CH, (20220217), vol. 23, no. 4, doi:10.3390/ijms23042227, ISSN 1422-0067, page 2227, XP093142761
OPPOSITION- Anonymous, "Launch of innovative medical food provides a palatable new option for people diagnosed with rare metabolic disorder in the UK ", Microtabs Galen, (20200213), pages 1 - 2, XP093287089
OPPOSITION- Anonymous, "Microcompresse a lento rilascio. Miscela di aminoacidi priva di fenilalanina, integrata con grassi e carboidrati, indicata per la gestione dietetica della iperfenilalaninemia a partire dal terzo anno di vita inclusa la fenilchetonuria e la fenilchetonuria materna", Iperfenilalaninemia/fenilchetonuria, (20240518), pages 21 - 21, Iperfenilalaninemia/fenilchetonuria, URL: https://www.piamfarmaceutici.com/wp-content/uploads/2018/06/Afenil-micro-3H.pdf, XP093287104
OPPOSITION- Anonymous, "Milupa PKU 2-prima ", product information, (20130401), pages 18 - 19, XP093287073
OPPOSITION- Anonymous, "Milupa PKU 2-secunda", Nutricia Metabolics, (20250101), pages 1 - 2, Nutricia Metabolics , URL: https://www.nutricia-metabolics.de/produkte/produkte-fuer-seltene-stoffwechselstoerungen/phenylketonurie/milupa-pku-2-secunda/, XP093287076
OPPOSITION- Anonymous, "PKU Easy Microtabs Datasheet: A Food for Special Medical Purposes", Easy PKU Microtabs, Orpharma Pty Ltd, Australia, Australia, (20161210), pages 1 - 1, Easy PKU Microtabs , URL: https://www.orpharma.com/cms/content/uploads/2016/12/PKU-Easy-Microtabs-Datasheet_POA-P.pdf, XP093297294
OPPOSITION- Anonymous, "PKU Nutrition Management Guidelines", Nutrition Management Guidelines for PKU, (20150301), pages 1 - 19, Nutrition Management Guidelines for PKU, URL: https://managementguidelines.net/guidelines.php/90/tbls/0/0/PKU%20Nutrition%20Guidelines/Version%201.12/List%20of%20Tables, (20250616), XP093287061
OPPOSITION- D14a - Supplementary Table S2 of D14
OPPOSITION- D21 - Experimental report
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OPPOSITION- Smith Anna , "'Innovative' PKU treatment launched in UK", Pharma Times, (20200217), pages 1 - 3, Pharma Times, URL: https://pharmatimes.com/news/innovative_pku_treatment_launched_in_uk_1326191/#:~:text=PKU%20is%20a%20rare%2C%20inherited,for%20the%20treatment%20of%20phenylketonuria., XP093287093
OPPOSITION- Stuart L Cantor, Augsburger Larry L, Hoag Stephen W, Gerhardt Armin, "Chapter 8: Pharmaceutical Granulation Processes, Mechanism, and the Use of Binders", Pharmaceutical Dosage Forms : Tablets - Unit Operations and Mechanical Properties, CRC Press LLC , (20080603), pages 261 - 302, XP055601290
OPPOSITION- Wen Hong, Park Kinam , "Oral Controlled Release Formulation Design and Drug Delivery: Theory to Practice - Index ", Wen Hong, Park Kinam , Wen Hong, Park Kinam, Oral controlled release formulation design and drug delivery: Theory to practice, Hoboken, NJ , John Wiley & Sons, Inc. , (20101001), pages 1 - 24, ISBN 978-0-470-25317-5, XP093287114
OPPOSITION- Melegari Cecilia; Bertoni Serena; Genovesi Alberto; Hughes Kevin; Rajabi-Siahboomi Ali R.; Passerini Nadia; Albertini Beatrice, "Ethylcellulose film coating of guaifenesin-loaded pellets: A comprehensive evaluation of the manufacturing process to prevent drug migration", European journal of pharmaceutics and biopharmaceutics, NL , (20151211), vol. 100, doi:10.1016/j.ejpb.2015.12.001, ISSN 0939-6411, pages 15 - 26, XP029395636
OPPOSITION- Marucci Mariagrazia; Andersson Helene; Hjärtstam Johan; Stevenson Gary; Baderstedt Julia; Stading Mats; Larsson Anette; von Corswant Christian , "New insights on how to adjust the release profile from coated pellets by varying the molecular weight of ethyl cellulose in the coating film", International Journal of Pharmaceutics, AMSTERDAM, NL, (20130925), vol. 458, no. 1, doi:10.1016/j.ijpharm.2013.09.016, ISSN 0378-5173, pages 218 - 223, XP028774678
OPPOSITION- Giovannini Marcello; Riva Enrica; Salvatici Elisabetta; Cefalo Graziella; Radaelli Giovanni, "Randomized Controlled Trial of a Protein Substitute with Prolonged Release on the Protein Status of Children with Phenylketonuria", Journal of the American College of Nutrition, US , (20140101), vol. 33, no. 2, doi:10.1080/07315724.2013.857281, ISSN 0731-5724, pages 103 - 110, XP008182551
OPPOSITION- Giarratana Nadia, Gallina Guglielmo, Panzeri Valentina, Frangi Alessandra, Canobbio Andrea, Reiner Giorgio, "A New Phe-Free Protein Substitute Engineered to Allow a Physiological Absorption of Free Amino Acids for Phenylketonuria", Journal of Inborn Errors of Metabolism and Screening, (20180101), vol. 6, doi:10.1177/2326409818783780, ISSN 2326-4098, pages 1 - 9, XP093287125
OPPOSITION- M. Efentakis, H. Naseef, M. Vlachou, "Two- and three-layer tablet drug delivery systems for oral sustained release of soluble and poorly soluble drugs", Journal Drug Development and Industrial Pharmacy, US , (20100801), vol. 36, no. 8, doi:10.3109/03639040903585119, ISSN 0363-9045, pages 903 - 916, XP055534677
OPPOSITION- Giarratana Nadia, Giardino Luciana, Bighinati Andrea, Reiner Giorgio, Rocha Júlio César, "In Vivo Metabolic Responses to Different Formulations of Amino Acid Mixtures for the Treatment of Phenylketonuria (PKU)", International journal of molecular sciences, Basel, CH , vol. 23, no. 4, doi:10.3390/ijms23042227, ISSN 1422-0067, pages 1 - 12, XP093142761
OPPOSITION- Scheinin Mika, Barassi Anna, Junnila Jouni, Lovró Zsófia, Reiner Giorgio, Sarkkinen Essi, Macdonald Anita, "Amino Acid Plasma Profiles from a Prolonged-Release Protein Substitute for Phenylketonuria: A Randomized, Single-Dose, Four-Way Crossover Trial in Healthy Volunteers", Nutrients, CH , (20200101), vol. 12, no. 6, doi:10.3390/nu12061653, ISSN 2072-6643, pages 1 - 16, XP093287127
SEARCH- Anonymous, "Afenil Micro 3H", Internet citation, (2014), URL: http://www.piamfarmaceutici.com/Internet/medifood/Prodotti.aspx?P=100&C=12, (20161209), XP002765113 [A] 1-15 * the whole document *
SEARCH- GIOVANNINI MARCELLO ET AL, "Randomized Controlled Trial of a Protein Substitute with Prolonged Release on the Protein Status of Children with Phenylketonuria", JOURNAL OF THE AMERICAN COLLEGE OF NUTRIT, vol. 33, no. 2, doi:10.1080/07315724.2013.857281, ISSN 0731-5724, (2014), pages 103 - 110, (20140414), XP008182551 [A] 1-15 * the whole document * * page 104, column r, paragraph l - page 105, column l, paragraph l *

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