X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
https://www.fiercepharma.com/pharma/mercks-key-pah-approval-tap-johnson-johnson-wins-nod-pah-combo-tablet
https://www.prnewswire.com/news-releases/us-fda-approves-opsynvi-macitentan-and-tadalafil-as-the-first-and-only-once-daily-single-tablet-combination-therapy-for-patients-with-pulmonary-arterial-hypertension-pah-302097530.html
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211195
https://www.globenewswire.com/news-release/2023/06/26/2694136/0/en/Janssen-Submits-Marketing-Authorisation-Application-to-the-European-Medicines-Agency-EMA-Seeking-Approval-of-Single-Tablet-Combination-Therapy-STCT-of-Macitentan-and-Tadalafil-for-.html
https://www.prnewswire.com/news-releases/janssen-submits-new-drug-application-to-us-fda-seeking-approval-of-investigational-single-tablet-combination-therapy-of-macitentan-and-tadalafil-for-treatment-of-patients-with-pulmonary-arterial-hypertension-pah-301834852.html
https://www.fiercepharma.com/pharma/acc23-jjs-combo-pill-opsumit-plus-tadalafil-improves-blood-flow-pah-patients
https://www.prnewswire.com/news-releases/late-breaking-phase-3-a-due-data-show-investigational-single-tablet-combination-therapy-of-macitentan-and-tadalafil-significantly-improves-pulmonary-hemodynamics-versus-monotherapy-in-patients-with-pulmonary-arterial-hypertension--301762855.html
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214112
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211224
https://www.businesswire.com/news/home/20200829005001/en/TRITON-Phase-3b-Study-Results-Presented-European#:~:text=In%20the%20TRITON%20trial%2C%20both,difference%20observed%20between%20both%20groups.
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211026
https://www.prnewswire.com/news-releases/new-opsumit-macitentan-data-show-initial-combination-therapy-with-tadalafil-improved-hemodynamic-clinical-and-functional-parameters-in-patients-with-pulmonary-arterial-hypertension-300941648.html
https://www.reuters.com/article/us-johnson-johnson-settlement/jj-unit-to-pay-360-million-to-u-s-to-resolve-charity-kickback-probe-idUSKBN1O51XB
https://www.ema.europa.eu/documents/procedural-steps-after/opsumit-epar-procedural-steps-taken-scientific-information-after-authorisation_en.pdf
https://www.businesswire.com/news/home/20180927005080/en/Nautic-Partners-Announces-Acquisition-of-Mikart-Inc.-Michael-Kallelis-Appointed-as-CEO
http://www.pharmatimes.com/news/actelions_opsumit_shows_promise_in_portopulmonary_hypertension_1252780
https://www.businesswire.com/news/home/20180916005006/en/Randomized-Controlled-Trial-Portopulmonary-Hypertension-Shows-OPSUMIT%C2%AE
https://www.fiercepharma.com/pharma/fda-posts-lists-drugmakers-it-says-may-be-gaming-rules-to-thwart-generic-competition
http://www.pmlive.com/pharma_news/fda_names_and_shames_generic-blocking_pharma_companies_1235934
https://www.prnewswire.com/news-releases/actelion-submits-supplemental-new-drug-application-to-us-fda-seeking-approval-of-opsumit-macitentan-for-the-treatment-of-chronic-thromboembolic-pulmonary-hypertension-cteph-300638648.html
https://www.pharmacompass.com/pdf/news/opsumit-macitentan-actelion-pharmaceuticals-v-zydus-pharmaceuticals-usa-1517811262.pdf
https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-challenge-of-opsumitmacitentantablets-1512710808.pdf
http://www.fool.com/investing/2017/01/27/johnson-johnson-may-never-recoup-its-costs-to-buy.aspx
http://www.fiercepharma.com/pharma/j-j-disappoints-q4-launches-review-strategic-options-for-diabetes-biz
http://www.fiercepharma.com/pharma/actelion-fails-key-phase-3-but-investors-brush-it-off-as-j-j-mega-deal-draws-near
http://www.reuters.com/article/us-actelion-m-a-johnson-johnson-exclusiv-idUSKBN14I1HX
http://www.fiercepharma.com/pharma/sanofi-to-slash-20-diabetes-salesforce-as-struggling-unit-faces-brand-new-biosim
http://www.reuters.com/article/us-actelion-johnson-johnson-m-a-idUSKBN13N179
http://www.reuters.com/article/us-actelion-results-idUSKCN1010G4
http://www.reuters.com/article/us-actelion-results-idUSKCN0VI0BF
http://www.fiercepharma.com/story/fda-nod-actelion-adds-blockbuster-hopeful-uptravi-pah-portfolio/2015-12-22
http://www.reuters.com/article/us-actelion-fda-idUSKBN0U50HO20151222
http://www.pmlive.com/pharma_news/gsk_earns_expanded_approval_for_volibris_in_europe_874366
http://www.pmlive.com/pharma_news/gilead_and_gsk_pulmonary_hypertension_drugs_work_in_tandem_807320?utm_content=buffer11e7f&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer
http://contractservices.pharmaceutical-business-review.com/news/dksh-signs-agreement-with-actelion-to-drive-growth-in-asia-120815-4645377?utm_term=Pharma&utm_source=PBR&utm_medium=twitter
http://www.fiercepharma.com/story/actelions-opsumit-growth-heralds-smooth-switch-aging-tracleer/2015-07-21
Market Place
Share 
