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Authorized Generics: Look Before you Leap
Decision Resources, Inc., Nov 2006, Pages: 20
Introduction
When faced with a paragraph IV challenge, research-based pharmaceutical companies sometimes use “authorized generics” as a way to slow market share losses. When making these decisions, firms should consider the rate of generic erosion over the 180-day exclusivity period, payer dynamics related to the adoption of generic products during this period, and the terms of any deals forged with generics company partners.
Get the Answers You Need to Shape Your Strategy
The 1984 Hatch-Waxman amendments to the Food, Drug, and Cosmetic Act encourage early generic entry by providing an incentive of a 180-day exclusivity period for generics companies that successfully challenge brand-name drug patents. How successful has this strategy been for generics companies, and how have brand-name pharmaceutical companies responded to this challenge?
The rate of generic erosion of a brand during the 180-day exclusivity period depends on the dynamics of the generic market. What are three key scenarios that illustrate generic erosion during the 180-day exclusivity period?
When an exclusive generic is priced lower than the brand by only a small amount, managed care organizations save little. Factor in the loss of rebates provided by the brand and the lower copay, and exclusive generics can actually increase payers’ expenditures. However, some payers have begun to consider such factors when making reimbursement decisions. How can payer behavior influence the rate at which erosion of brand sales occurs during the 180-day exclusivity period?
When deciding whether to issue an authorized generic, pharmaceutical companies should consider three possible scenarios. What are those scenarios, and how would each affect the research pharmaceutical company’s sales?
Scope
Pharmaceutical companies’ response to paragraph IV challenges: authorized generics.
Authorized generics: the two sides of the debate. Generic erosion: the key factors that affect it.
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