Costly Gadgets: Barriers to Market Entry and Price Competition for Generic Drug-Device Combinations in the United States
Year: 2022
Type: article
Abstract: Prescription drug prices continue to rise unabated in the United States, largely due to a system that allows brand-name drug makers to charge whatever the market will bear.Some of the costliest pharmaceuticals in the United States-both by price and by total expenditure-are drugs that require a drug delivery device for proper use.Examples include respiratory inhalers, immunologic drugs, opioid overdose reversal drugs, patches for chronic pain, emergent anaphylaxis treatments, and insulin products.One of the ways manufacturers have successfully extended market exclusivity on such combination products is by pursuing tertiary patents on the device component of the product.Once all patents have expired on a drug-device combination, generic entry has been further complicated by the FDA's strict standards for approving "complex generic" products via the Abbreviated New Drug Application (ANDA) pathway.These additional requirements have proven particularly onerous for some generic firms, and given such obstacles to complex generic approval via the ANDA pathway, many companies have turned to an arguably more straightforward path to compete with drug-
Author: Michael S. Sinha
Institutions: Harvard University, Harvard-MIT Center for Regulatory Science
Language: English
Subfield: Economics and Econometrics
Domain: Social Sciences
Open Access status: bronze
OpenAlex ID: W3204958574