Background: Pharmaceutical expenditure grow strongly in most health care systems. Especially high prices of new drugs are perceived to be driver of growth which might threaten the sustainability of financing drugs. Objective: The study aims to analyse a) whether German health policies can...

We study cartels that operated in the US generic drug industry, leveraging quarterly Medicaid data from 2011-2018 and a difference-in-differences approach comparing the evolution of prices of allegedly collusive drugs with a group of competitive control drugs. Our analysis highlights (i) the...

Background: Pharmaceutical expenditure grow strongly in most health care systems. Especially high prices of new drugs are perceived to be driver of growth which might threaten the sustainability of financing drugs. Objective: The study aims to analyse a) whether German health policies can...

We analyze changes in the willingness to substitute from prescribed pharmaceuticals to more affordable generic equivalents in response to the first experience with a substitution. Using Swedish individual-level data of prescribed and dispensed pharmaceuticals, we employ a dynamic event study and...

I use variation in approval time for generic drugs to shed light on the objectives of the federal agency in charge of granting entry permission for these drugs (FDA). Applications belonging to firms later found to have engaged in fraud or corruption were approved nine months faster on average,...

Background: Well-functioning competitive markets are key to controlling generic drug prices. This is important since over 90% of all drugs sold in the US are generics. Recently, there have been examples of large price increases in the generic market. Methods: This paper examines price...

Policy makers use reference pricing to curb pharmaceutical expenditures by reducing coverage of expensive branded drugs. In a theoretical analysis we show that the net effect of reference pricing is generally ambiguous when accounting for entry by generic producers. Reference pricing shifts...

Entry represents a fundamental threat to cartels engaged in price fixing. We study the extent and effect of this behavior in the largest price fixing case in US history, which involves generic drugmakers. To do so, we link information on the cartel’s internal operations to regulatory filings...

One approach that antitrust enforcement authorities use to address potentially anticompetitive mergers is to seek divestitures in specific, competitively problematic overlap markets while allowing the rest of the merger to consummate. We evaluate the efficacy of this approach by studying...

Efforts to reduce inefficient healthcare spending are prevalent across the developed world. Among available policy options, the substitution of brand name for generic drugs is of particular interest because it can deliver large savings without objective quality sacrifices. These policies are...

We study the patent strategy of pharmaceutical firms in reaction to the threat of generic entry. Estimating difference-in-differences saturated with a host of fixed effects, we show that while these firms continue to produce patents after a drug is approved by the US Food and Drug Administration...

We study cartels that operated in the US generic drug industry, leveraging quarterly Medicaid data from 2011-2018 and a difference-in-differences approach comparing the evolution of prices of allegedly collusive drugs with a group of competitive control drugs. Our analysis highlights (i) the...

The debate on whether COVID-19 vaccine patents are slowing down the pace of vaccination and the recovery from the crisis has brought the optimal design of pharmaceutical patent policy to the fore. In this paper we evaluate patent policy in the US pharmaceutical industry. We estimate the effect...

We analyze the effects on consumers of an extreme policy experiment -- Napsterizing' pharmaceuticals -- whereby all patent rights on branded prescription drugs are eliminated for both existing and future prescription drugs without compensation to the patent holders. The question of whether this...

We study the impact of regulation on competition between brand-names and generics and pharmaceutical expenditures using a unique policy experiment in Norway, where reference pricing (RP) replaced price cap regulation in 2003 for a sub-sample of off-patent products. First, we construct a vertical...

Using an extensive longitudinal dataset extracted from the Norwegian Prescription Database (NorPD) containing all prescriptions written in the period January 2004 to June 2007, we selected two particular drugs (chemical substances) used against cholesterol. The two brand-name products on the...

We examine the issue of new goods and price indexes for the important and tractable case of generic and branded drugs. By treating generics as entirely distinct goods and "linking them in" to indexes with fixed weights, the standard price indexes fail to reflect the substantial welfare gains to...

In response to the growing concern on drug safety issues, the U.S. Food and Drug Administration (FDA) has implemented major moves in its inspection regime to ensure that the agency allocates more inspection resources to the low-quality manufacturing facilities. The actions of the government...

The Federal Trade Commission (FTC) frequently files complaints against “pay-for-delay” settlements between brand-name pharmaceutical companies and generic-drug manufacturers, the latter of which challenge the monopoly status of patent-protected drugs. I document than when the top 20 generic...

Generic drug utilization has risen dramatically, from 19% of scrips in 1984 to 47% in 2001, thus bringing significant direct dollar savings. Generic drug use may also yield indirect savings if it lowers the average price of those brand-name drugs that are still purchased. Prior work indicates -...

The generic industry lobby, Association for Accessible Medicines (“AAM”), often represents the public interest. In the pharmaceutical industry, it challenges brand drug companies' anti-competitive conduct. It fights for lower prices for consumers. And it has built up goodwill for its work in...

This Article addresses a paradox in American healthcare technology: a thriving market for generic drugs but a paucity of generic medical devices. Despite the success of generic pharmaceuticals in reducing healthcare costs, no analogous market exists for generic medical devices. This plays a part...

The Affordable Care Act included a provision to eliminate the Medicare prescription drug coverage gap. The policy was phased in by gradually diminishing the gap each year between 2011-2020. This provides a natural experiment to conduct an in-depth study of how the policy affected medication use,...

Do firms increase product lines to deter entry and, if so, when is such a strategy successful? We use data from UK pharmaceuticals to examine how incumbents respond to change in the threat of entry. In line with the entry deterrence motive, originators' product launch rate is higher when the...

Understanding the drivers of market concentration in the generic pharmaceutical industry is essential to guaranteeing the availability of low-cost generics. In this paper, we develop a structural model to capture the multiple determinants governing manufacturers' entry decisions; in particular,...

During patent litigation, pay-for-delay deals involve a payment from a patent holder of a branded drug to a generic drug manufacturer to delay entry and withdraw the patent challenge. In return for staying out of the market, the generic firm receives a payment, and/or an authorized licensed...

Background: Although the association between the price of generic drugs and market competitiveness has been explored in various high-income countries, this association has not been empirically evaluated in South Korea. We aim to determine the association between the prices of generic drugs and...

Healthcare payers try to reduce costs by promoting the use of cheaper generic drugs. We show strong interrelations in drug prescriptions between the inpatient and outpatient sectors by using a large administrative dataset from Austria. Patients with prior hospital visits have a significantly...

Healthcare payers try to reduce costs by promoting the use of cheaper generic drugs. We show that there are strong interrelations in drug prescriptions between the inpatient and the outpatient sector using a large administrative dataset from Austria. Patients with prior hospital visits have a...

Quality regulation attempts to ensure quality and foster competition by reducing vertical differentiation, but it may also have adverse effects on market structure. We study this trade-off in the context of pharmaceutical bioequivalence, which is the primary quality standard for generic drugs....

Settlements of drug patent disputes that involve a potential payment from the brand to the generic signal a possible collusive profit split with a threat to competition, and have undergone intensive scrutiny in the literature on law and economics. A common feature of these brand-generic...

Entry represents a fundamental threat to cartels engaged in price fixing. We study the extent and effect of this behavior in the largest price fixing case in US history, which involves generic drugmakers. To do so, we link information on the cartel's internal operations to regulatory filings and...