Drugs

Consider Antitrust in Apokyn Generic Case: FTC

The Federal Trade Commission (FTC) says the Delaware federal court should consider the antitrust implications in deciding whether to grant a Supurnus Pharmaceuticals motion to dismiss a generic Apokyn (apomorphine) case brought by Sage Chemical and its marketing partner TruPharma. An FTC statement says that Sage and TruPharma allege that multiple defendants, including Supurnus, have engaged in numerous unlawful strategies to delay or block entry of a generic version of Apokyn, an injectable drug used to treat patients with advanced symptoms of Parkinson’s disease. The statement says the cost of Apokyn per Medicare Part D patient in 2020 was close to $100,000.

Many of Supurnus’ alleged strategies, FTC says, leverage their control over the Apokyn pen injector that FDA requires to be used with both branded and generic apomorphine cartridges. Sage says that without access to the pen injectors, consumers can’t use its FDA-approved generic version of Apokyn.

“This case may have significant implications for patients who rely on apomorphine to treat debilitating symptoms of advanced Parkinson’s disease,” FTC says in an amicus brief. “Moreover, because the strategies alleged here are similar to strategies used by other branded pharmaceutical companies to block generic competition, there is a broader public interest in the legal issues this case presents.”

FTC asks the court to consider four antitrust issues when making its decision:

exclusion of a generic competitor not only harms the competitor but also competition and consumers more generally;
Sage and TruPharma’s development of a generic apomorphine cartridge is not improper “free riding” within the meaning of antitrust law;
exclusive agreements like the one between Supurnus and the injectable pen manufacturer can be unlawful when they foreclose a competitor’s access to a key input, even if the competitor could theoretically develop an alternative version; and
defining a relevant antitrust market requires assessing which products are available to consumers if prices are raised about a competitive level and single-brand or single-manufacturer markets may be appropriate when there are no adequate substitutes.

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