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Pharmaceutical Composition For The Treatment Of Pulmonary Arterial Hypertension - EP3897646

The patent EP3897646 was granted to Actelion Pharmaceuticals on May 22, 2024. The application was originally filed on Dec 20, 2019 under application number EP19832954A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3897646

ACTELION PHARMACEUTICALS
Application Number
EP19832954A
Filing Date
Dec 20, 2019
Status
Granted And Under Opposition
Apr 19, 2024
Grant Date
May 22, 2024
External Links
Slate, Register, Google Patents

Patent Summary

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Patent Family

Patent Oppositions (3)

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GENERICS UKFeb 21, 2025ELKINGTON AND FIFEADMISSIBLE
SANOVEL ILAC SANAYI VE TICARET ANONIM SIRKETIFeb 21, 2025SONNENHAUSERADMISSIBLE
SANDOZFeb 7, 2025ELKINGTON AND FIFEADMISSIBLE

Patent Citations (6) New

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

Citation PhasePublication NumberPublication Link
INTERNATIONAL-SEARCH-REPORTWO2010018549
INTERNATIONAL-SEARCH-REPORTWO2018089804
INTERNATIONAL-SEARCH-REPORTWO2018153513
OPPOSITIONWO2010018549
OPPOSITIONWO2018089804
OPPOSITIONWO2018153513

Non-Patent Literature (NPL) Citations (38) 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
EXAMINATION- Anonymous, "Center for Drug Evaluation and Research. Clinical Pharmacology and Biopharmaceutics Review, application number. 204410Origls000", Fda.gov, (20130101), URL: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204410Orig1s000ClinPharmR.pdf, (20230322), XP093034000-
EXAMINATION- PATRICIA N SIDHARTA ET AL, "Macitentan: entry-into-humans study with a new endothelin receptor antagonist", EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY, SPRINGER, BERLIN, DE, (20110504), vol. 67, no. 10, doi:10.1007/S00228-011-1043-2, ISSN 1432-1041, pages 977 - 984, XP019949637
EXAMINATION- TROW T K ET AL, "Endothelin receptor blockade in the management of pulmonary arterial hypertension: Selective and dual antagonism", RESPIRATORY MEDICINE, ELSEVIER, AMSTERDAM, NL, vol. 103, no. 7, doi:10.1016/J.RMED.2009.02.016, ISSN 0954-6111, (20090701), pages 951 - 962, (20090321), XP026168629
EXAMINATION- Pulido Tom�s ET AL, "Macitentan and Morbidity and Mortality in Pulmonary Arterial Hypertension", The New England journal of medicine, US, (20130829), vol. 369, no. 9, doi:10.1056/NEJMoa1213917, ISSN 0028-4793, pages 809 - 818, XP055970060
EXAMINATION- Kunita-Takanezawa Mutsumi ET AL, "Novel Dual Endothelin Receptor Antagonist Macitentan Reverses Severe Pulmonary Arterial Hypertension in Rats", JOURNAL OF CARDIOVASCULAR PHARMACOLOGY, US, (20141101), vol. 64, no. 5, doi:10.1097/FJC.0000000000000141, ISSN 0160-2446, pages 473 - 480, XP093033664
OPPOSITION- Anonymous, "Australian Public Assessment Report for macitentan - Proprietary Product Name: Opsumit", Australian Government, Australian Government, URL: https://www.tga.gov.au/sites/default/files/auspar-macitentan-140428.pdf, XP093261700-
OPPOSITION- Anonymous, "CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 204410Orig1s000 - OPSUMIT ® macitentan", FDA, (20130101), XP093261681-
OPPOSITION- Anonymous, "CENTER FOR DRUG EVALUATION AND RESEARCH - APPLICATION NUMBER: 204410Orig1s000 - Opsumit Macitentan", FDA, vol. 62, no. Suppl 1, doi:10.1039/C6TB01730D, pages S358 - 6864, FDA, URL: https://www.browserstack.com/guide/login-automation-using-selenium-webdriver, XP093261736-
OPPOSITION- Anonymous, "Clinical Study on Macitentan, RT and TMZ Concurrent Therapy Followed by Maintenance Macitentan and TMZ in Newly Diagnosed Glioblastoma - NCT02254954", Clinical Trials, ClinicalTrials.gov, Clinical Trials, URL: https://clinicaltrials.gov/study/NCT02254954?term=NCT02254954&rank=1&tab=history&a=1#version-content-panel, XP093261729-
OPPOSITION- Anonymous, "Clinical Study on the Safety and Tolerability of Macitentan in Combination With Dose-dense Temozolomide in Patients With Recurrent Glioblastoma - NCT01499251", Clinical Trials, ClinicalTrials.gov, Clinical Trials, URL: https://clinicaltrials.gov/study/NCT01499251?term=NCT01499251%20&rank=1&tab=history&a=1#version-content-panel, XP093261724-
OPPOSITION- Anonymous, "HIGHLIGHTS OF PRESCRIBING INFORMATION - OPSUMIT® (macitentan) tablets, for oral use", (20131001), XP093261687-
OPPOSITION- Anonymous, "Opsumit 10 mg film-coated tablets", EMA, Package leaflet: information for the user, pages 1 - 6, EMA, Package leaflet: information for the user, URL: https://www.actelion.com/documents/en-rebranded/our-products/opsumit-pil.pdf, (20200324), XP055679353-
OPPOSITION- Anonymous, "Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension (UNISUS) - NCT04273945", Clinical Trials, ClinicalTrials.gov, Clinical Trials, URL: https://clinicaltrials.gov/study/NCT04273945?term=NCT04273945%20&rank=1&tab=history&a=1#version-content-panel, XP093261739-
OPPOSITION- Armstrong N.A., "Tablet manufacture", Encyclopedia of Pharmaceutical Technology, (20070101), pages 3653 - 3672, XP055449024-
OPPOSITION- D11 - Data report filed by then-applicant on 21 February 2023-
OPPOSITION- D16 - Data report filed by then-applicant on 18 October 2023-
OPPOSITION- D17 - Data report filed by then-applicant on 18 October 2023-
OPPOSITION- D27 - T 1592/12-
OPPOSITION- D30 - Submission of 18th October 2023-
OPPOSITION- D31 - Annex to the Summons to attend oral proceedings of 11 April 2023-
OPPOSITION- Fujian Song, "What is indirect comparison? ", Hayward Medical Communications, pages 1 - 6, Hayward Medical Communications,, URL: http://www.bandolier.org.uk/painres/download/whatis/What_is_ind_comp.pdf, (20200608), XP055701986-
OPPOSITION- Popovtzer Baruch , Jason N. Salamon, Jeremy Mazurek, Muhammad Sardar, Ronald Zolty, "Mortality in Primary Pulmonary Arterial Hypertension Stratified by Hemoglobin Levels", Journal of Cardiac Failure, (20110801), vol. 17, no. 8S, pages S96 - S96, XP093296589-
OPPOSITION- Tozer Thomas N., Malcolm Rowland, "Chapter 12 - Initiating and Managing Therapy", Introduction to Pharmacokinetics and Pharmacodynamics - The Quantitative Basis of Drug Therapy, (20060101), pages 249 - 265, XP093122437-
OPPOSITION- Zolty R, H. Brink, K. Dhar, B. Lowes, "Endothelin-1 Levels in Exercise-Induced Pulmonary Hypertension", The Journal of Heart and Lung Transplantation, (20240101), vol. 43, pages S409 - S409, XP093296601-
OPPOSITION- Patricia N. Sidharta, Van Giersbergen Paul L. M., Dingemanse Jasper, "Safety, tolerability, pharmacokinetics, and pharmacodynamics of macitentan, an endothelin receptor antagonist, in an ascending multiple-dose study in healthy subjects : The Journal of Clinical Pharmacology", The Journal of clinical pharmacology, LIPPINCOTT CO, HAGERSTOWN, MD, US, US , (20130801), vol. 53, no. 11, doi:10.1002/jcph.152, ISSN 0091-2700, pages 1131 - 1138, XP055678913
OPPOSITION- Patricia N. Sidharta; Paul L. M. van Giersbergen; Atef Halabi; Jasper Dingemanse, "Macitentan: entry-into-humans study with a new endothelin receptor antagonist", European Journal of Clinical Pharmacology, Springer, Berlin, DE, Berlin, DE , (20110504), vol. 67, no. 10, doi:10.1007/s00228-011-1043-2, ISSN 1432-1041, pages 977 - 984, XP019949637
OPPOSITION- Li Young Ahn, Kim Sung Eun, Yi Sojeong, Dingemanse Jasper, Lim Kyoung Soo, Jang In-Jin, Yu Kyung-Sang, "Pharmacokinetic-Pharmacodynamic Relationships of Macitentan, a New Endothelin Receptor Antagonist, After Multiple Dosing in Healthy Korean Subjects", AMERICAN JOURNAL OF CARDIOVASCULAR DRUGS, ADIS INTERNATIONAL,, NZ, NZ , (20141001), vol. 14, no. 5, doi:10.1007/s40256-014-0081-4, ISSN 1175-3277, pages 377 - 385, XP055678918
OPPOSITION- Lowe Elizabeth S, Juan J.L. Lertora, "Dose-Effect and Concentration-Effect Analysis", Lowe Elizabeth S, Juan J.L. Lertora, Shiew-Mei Huang, Juan J.L. Lertora, Arthur J. Atkinson , Principles of Clinical Pharmacology - 3rd Edition, Elsevier , (20120101), pages 343 - 356, doi:10.1016/B978-0-12-385471-1.00020-9, ISBN 978-0-12-385471-1, XP093296592
OPPOSITION- Ramani G.; Lam D.; Park M., "The Impact of Anemia on Survival in Pulmonary Arterial Hypertension", Journal of Heart and Lung Transplantation, AMSTERDAM, NL , (20140401), vol. 33, no. 4, doi:10.1016/j.healun.2014.01.597, ISSN 1053-2498, XP028635098
OPPOSITION- Southwood Mark; MacKenzie Ross Robert V.; Kuc Rhoda E.; Hagan Guy; Sheares Karen K.; Jenkins David P.; Goddard Martin; Davenport Anthony P.; Pepke-Zaba Joanna, "Endothelin ETAreceptors predominate in chronic thromboembolic pulmonary hypertension", Life Science, GB , (20160210), vol. 159, doi:10.1016/j.lfs.2016.02.036, ISSN 0024-3205, pages 104 - 110, XP029688347
OPPOSITION- Trow, T.K. ; Taichman, D.B., "Endothelin receptor blockade in the management of pulmonary arterial hypertension: Selective and dual antagonism", Respiratory Medicine, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20090701), vol. 103, no. 7, doi:10.1016/j.rmed.2009.02.016, ISSN 0954-6111, pages 951 - 962, XP026168629
OPPOSITION- Pulido Tomás, Adzerikho Igor, Channick Richard N., Delcroix Marion, Galiè Nazzareno, Ghofrani Hossein-Ardeschir, Jansa Pavel, Jing Zhi-Cheng, Le Brun Franck-Olivier, Mehta Sanjay, Mittelholzer Camilla M., Perchenet Loïc, Sastry B.K.S., Sitbon Olivier, Souza Rogério, Torbicki Adam, Zeng Xiaofeng, Rubin Lewis J., Simonneau Gérald, "Macitentan and Morbidity and Mortality in Pulmonary Arterial Hypertension", The New England journal of medicine, Massachusetts Medical Society, US, US , (20130829), vol. 369, no. 9, doi:10.1056/NEJMoa1213917, ISSN 0028-4793, pages 809 - 818, XP055970060
OPPOSITION- Kunita-Takanezawa Mutsumi, Abe Kohtaro, Hirooka Yoshitaka, Kuwabara Yukimitsu, Hirano Katsuya, Oka Masahiko, Sunagawa Kenji, "Novel Dual Endothelin Receptor Antagonist Macitentan Reverses Severe Pulmonary Arterial Hypertension in Rats", JOURNAL OF CARDIOVASCULAR PHARMACOLOGY, RAVEN PRESS, NEW YORK, NY, US, US , (20141101), vol. 64, no. 5, doi:10.1097/FJC.0000000000000141, ISSN 0160-2446, pages 473 - 480, XP093033664
OPPOSITION- Martin Bedan, Daniela Grimm, Markus Wehland, Ulf Simonsen, Manfred Infanger, Marcus Krüger, "A Focus on Macitentan in the Treatment of Pulmonary Arterial Hypertension", BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY, NORDIC PHARMACOLOGICAL SOCIETY, COPENHAGEN, DK, COPENHAGEN, DK , (20180801), vol. 123, no. 2, doi:10.1111/bcpt.13033, ISSN 1742-7835, pages 103 - 113, XP055679362
OPPOSITION- Toba Michie, Alzoubi Abdallah, O'neill Kealan D., Gairhe Salina, Matsumoto Yuri, Oshima Kaori, Abe Kohtaro, Oka Masahiko, Mcmurtry Ivan F., "Temporal hemodynamic and histological progression in Sugen5416/hypoxia/normoxia-exposed pulmonary arterial hypertensive rats", American Journal of Physiology Heart and Circulatory Physiology, American Physiological Society, US, US , (20140115), vol. 306, no. 2, doi:10.1152/ajpheart.00728.2013, ISSN 0363-6135, pages H243 - H250, XP093261649
OPPOSITION- Hoeper M. M., "Liver toxicity: the Achilles' heel of endothelin receptor antagonist therapy?", European Respiratory Journal, European Respiratory Society, Leeds, Leeds, (20090901), vol. 34, no. 3, doi:10.1183/09031936.00094409, ISSN 0903-1936, pages 529 - 530, XP093261653
OPPOSITION- Cyrus A Kholdani, Fares Wh, Trow Tk, "Macitentan for the treatment of pulmonary arterial hypertension", Vascular Health and Risk Management, vol. 10, doi:10.2147/VHRM.S33904, pages 665 - 673, XP055678823
OPPOSITION- Yokoyama Yoshinari, Dingemanse Jasper, Hatta Motonori, Fukase Hiroyuki, "Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of Macitentan, a New Endothelin Receptor Antagonist, in Healthy Japanese Male Subjects ", Japanese Journal ofClinical Pharmacology and Therapeutics, NIHON RINSHO YAKURI GAKKAI, TOKYO, JP, JP , (20160101), vol. 47, no. 4, doi:10.3999/jscpt.47.143, ISSN 0388-1601, pages 143 - 150, XP093261660

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