There’s Nothing Generic About a Generic Launch: How Shifting Market Dynamics and Stakeholder Strategies Are Disrupting Standard Assumptions for Forecasting the Impact of Generic Entrants
Over the past several years, the pharmaceutical industry has shifted away from traditional small-molecule drugs to focus more on complex formulations and specialty agents. The additional market complexities that are accompanying this shift have impacted stakeholder strategies for all drugs facing loss of exclusivity.
Stakeholders can no longer rely on assumptions that have been considered standard for predicting pricing and erosion after a generic launch. Instead, identifying noteworthy market conditions and understanding the outcomes they trigger provides more accurate insight for stakeholders who are forecasting the market and financial impact of a generic launch.
IPD Analytics has identified four market factors as representative elements that can cause deviations from traditionally standard generic launch patterns, including: copay coupons, brand-over-generic strategies, supply channel strategies, and shifts in manufacturer pricing strategies.
This insight brief describes key elements of an expanded model versus a traditional model of a generic launch that are essential to understanding the shifting generic landscape.
November 5, 2019
Authorized to Compete: Shifting Competitive Strategies Require a Fresh Look at Authorized Generics
Authorized generic (AG) drugs have existed for more than 40 years and have long been utilized as a life-cycle management strategy by manufacturers to compete with generics.
More recently, however, brand manufacturers are increasingly using AGs to compete with other brands as well. Shifts in contracting and rebate dynamics have made AGs a cornerstone of a “dual strategy” by which manufacturers attempt to capture and retain market share.
This new trend creates the need for complementary strategies on the part of payers and PBMs to preemptively manage AGs. Likewise, manufacturers should fully understand the factors impacting payer management of AGs in order to maximize their success.
June 5, 2019
Losing by Winning at the Patent Office: Zytiga Case Illustrates How IPR Estoppel Could Reshape Patent Challenges and Delay Generic Launches
What does a recent case decided by the Federal Circuit Court mean for brand and generic manufacturer strategy in the future? Our Insight Brief reveals a subplot with potentially high stakes for payers, providers, and patients alike. Check out this brief to learn about loss-of-exclusivity-analysis.
February 7, 2020
Recent Trends in ANDA Submissions One Year Prior to NCE Exclusivity Expirations
In this report, IPD explores recent trends in ANDA submissions one year prior to the expiration of New Chemical Entity (“NCE”) exclusivity associated with a referenced branded drug, referred to as the “NCE-1 date.”
The NCE-1 date is often the first opportunity for a generic drug manufacturer to submit an ANDA referencing a branded drug with NCE exclusivity and is therefore critical for pursuing 180-day marketing exclusivity granted to a first-filed ANDA.
Whether to pursue an ANDA submission at an NCE-1 date is a complex decision for a generic drug manufacturer. Thus, IPD examines trends in ANDA submissions at the NCE-1 date to provide useful insights into the changing dynamics in the generic drug landscape.