Astellas Pharma controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
Back to profile7 entries
2023
Employee detention in China
Astellas reported that an employee had been detained by Chinese authorities on alleged espionage grounds. The Japanese government criticized the detention as arbitrary.
2020
Astellas files patent-infringement complaint against pharmaceutical companies
Lawsuit filed
Astellas Pharma Inc. and affiliated plaintiffs filed a complaint in Delaware against 21 pharmaceutical companies. The complaint alleged that the companies' proposed generic versions of Myrbetriq would infringe the '780 patent. The plaintiffs sought relief from the court. These allegations are claims made in the complaint and have not been established as findings.
Source excerpt
At the District Court of Delaware on Tuesday, Astellas Pharma Inc. (API), Astellas Ireland Co. Ltd. (AICL), and Astellas Pharma Global Development (APGD) filed a complaint against 21 pharmaceutical companies alleging patent infringement.
The defendants are as follows: Sandoz Inc., Actavis Elizabeth LLC, Actavis LLC, Teva Pharmaceuticals USA Inc., Apotex Inc., Apotex Corp., Aurobindo Pharma Ltd., Aurobindo Pharma USA Inc., Aurolife Pharma LLC, Sawai Pharmaceutical Co. Ltd., Sawai USA Inc., Prinston Pharmaceutical Inc., Zhejiang Huahai Pharmaceutical Co. Ltd., Huahai US Inc., Solco Healthcare US LLC, Windlas Healthcare Pvt. Ltd., Windlas Biotech Ltd., Zydus Pharmaceuticals (USA) Inc., Cadila Healthcare Ltd. (doing business as Zydus Cadila), Lupin Ltd., and Lupin Pharmaceuticals, Inc.
The patent in question, deemed the ’780 patent, corresponds to APGD’s Myrbetriq extended-release tablets, containing active ingredient mirabegron, which is used to treat overactive bladder.
2019
Medicare copay-foundation settlement
Astellas agreed to pay $100 million to resolve U.S. Department of Justice allegations that it had conspired to provide improper kickbacks through Medicare copay foundations.
2018
Research-funding and clinical-protocol reprimand
The Prescription Medicines Code of Practice Authority reported concerns about research funding awarded to a senior clinician and about Astellas's failure to provide investigators with sufficient and timely information after a hospital protocol was later abandoned.
2017
Suspension extended over oversight and promotional-material findings
The industry suspension was extended after findings concerning nurse oversight and training and incomplete prescribing information. Astellas was also reprimanded over promotional materials for several medicines that lacked required safety information.
2016
United Kingdom industry-code suspension
The Association of the British Pharmaceutical Industry suspended Astellas for a year after findings that the company had not fully disclosed the nature of a meeting described as an advisory board and had misled the relevant medicines-code authority.
2009
Tacrolimus packaging and labeling concerns in Europe
Prograf and Advagraf were reported to be susceptible to dosing errors in Europe, with serious adverse reactions reported among some patients. Packaging and labeling were subsequently corrected following a warning from the United Kingdom medicines regulator.