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Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.
Sanofi filed an antitrust lawsuit with a district court in New Jersey alleging Mylan took steps to restrict access to a competing epinephrine autoinjector.
Mylan received a great deal of backlash in 2016 after the company raised the price of its EpiPen autoinjector, a popular anaphylaxis treatment, nearly 400%. Now the company is back in the news, facing an anti-trust lawsuit from competitor Sanofi.
The complaint was filed by Sanofi in a District Court in NJ on April 24, 2017. The focus of the complaint is Auvi-Q, a competing autoinjector and anaphylaxis treatment, previously owned by Sanofi. According to the 68-page filing, Sanofi claims when Auvi-Q launched in 2013, Mylan became concerned that the new autoinjector represented a “competitive threat” to EpiPen’s market share. Sanofi alleges that Mylan “erected artificial barriers” to United States consumers, restricting access to the competing treatment.
“Mylan offered new and unprecedented rebates to commercial insurance companies, pharmaceutical benefit managers, and state-based Medicaid agencies (collectively ‘third-party payors’) conditioned exclusively on Auvi-Q not being an [epinephrine autoinjector] drug device that those payors would reimburse for use by US consumers,” court documents state.
Sanofi is alleging that this action resulted in the blocking of Auvi-Q from approximately 50% of the US epinephrine autoinjector market. Although Sanofi no longer manufacturers Auvi-Q, the company is seeking “treble the amount of damages Sanofi has suffered as a result of Mylan’s illegal conduct.”
Auvi-Q has not been without its own manufacturing issues. The auto-injector was recalled in 2015 due to inaccurate dosage delivery. In February 2016, Sanofi returned the rights of Auvi-Q to Kaléo. The company reintroduced Auvi-Q to the US market in early 2017, but encountered issues when a member of Congress questioned its $4500 listing price.
Source: United States District Court for the District of New Jersey