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Amherst, NH, United States, 2013/12/10 - Greystone research associates examines market, competitive and regulatory factors influencing the injectable drug sector - GreystoneAssociates.org.
As generics continue to encroach upon branded drug markets, their share as a percentage of all marketed drugs continues to increase. To date, this phenomenon has been focused on oral solid dosage forms a segment that lowers formulation risks for generics companies seeking to minimize costs, reduce regulatory oversight and eliminate potential supply chain complexities that could foster launch delays and consume a portion of the coveted 180-day FDA first-filer exclusivity marketing window.
As competition among generics suppliers for new products accelerates and would-be ANDA filers become increasingly aggressive in attempting to identify future opportunities, their ANDA filing strategies have come to reflect this. It’s is no longer uncommon for the owners of brand drug NDAs to find a list of tentative ANDA approvals in the FDA queue as their patent and/or exclusivity protection comes to an end. So-called P (iv) filings are now routine for most brand drugs, requiring NDA holders to decide on a legal strategy to protect the brand often many years before existing patents for their products are due to expire.
The end result is a generic drug segment that is rapidly evolving and highly unpredictable an environment that lacks a true data compass to assist decision makers in mapping strategies for success in this segment. Attempting to determine the optimal time to file an ANDA application is a process that can be worth hundreds of millions in profits for first-to-filers. But it is a process that is fraught with risk and potential consequences.
As the market continues to mature, the action among generics companies will move increasingly in the direction of injectables. The level of activity will be tempered by two factors: (1) compared to oral drugs, the list of approved injectables is quite small, providing generics suppliers with fewer opportunities to pursue new products; (2) the generics segment as it is currently defined by the provisions of the Hatch-Waxman Act effectively exclude the market for biosimilars, and by association the truly attractive and potentially lucrative biologicals such as Humira, Enbrel, and Neulasta. But as the pendulum swings toward injectables, owners of injectable NDAs will face a new set of challenges. For injectable drug companies on either side of the market, understanding the essential dynamics of generic injectables is a key to meeting operational targets.
Greystone has just completed a new and comprehensive study that analyzes the market for generic injectables supplied in prefilled devices through 2019. The report Prefilled Generic Injectables to 2019: Products, Devices, Therapeutics, Markets and Forecasts - includes analysis and assessments of products and markets, analysis of market factors, and profiles of market participants.
Greystone Research Associates (greystoneassociates.org) is a medical technology consulting firm focused on the areas of medical market strategy, product commercialization, venture development, and market research. We assist medical and healthcare market participants in achieving their business objectives through the creation of detailed development strategies, product commercialization programs, and comprehensive market and technology research and analysis. Our market research publications are designed, researched and written to provide timely and insightful information and data on focused market segments, with the aim of providing market participants with the essential knowledge to refine and execute their marketing plans and financial targets.