The generic injectable drug segment is a rapidly evolving and highly competitive market 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 significant profits for first-to-filers. But it is a process that is marked by little in the way of analytical decision support and in which litigation has become a staple defensive mechanism for both the filer and the branded drug owner.
There are 235 distinct APIs for which there is at least one approved generic injectable ANDA. These 235 APIs account for 1,182 approved ANDAs. Including all approved doses, the current universe of generic injectables consists of 1,726 unique injectable products. These products are currently marketed and supplied by slightly less than one hundred companies. Competition among the various drug and therapeutic classes is uneven, with the top ten segments accounting for a disproportionate level of activity and revenue. Understanding the underlying factors affecting business performance is key to attaining financial targets.
The Generic Injectables Market - What You Will Learn
- Provides detailed analysis of generic drugs supplied as injectables and assesses key market segments, market dynamics and potential product opportunities - Presents the competitive picture for generic injectables in two dozen drug classes - Evaluates the importance of ANDA filing strategies and indirect ANDA acquisition on participant growth prospects - Analyzes the impact of patents, exclusivity and litigation on participant market sector prospects - Assesses the market presence and product position of the top twenty-four generic injectables suppliers - Evaluates the impact of economic, technology, and regulatory factors
Key Topics Covered:
1. Executive Summary
2. The Market Opportunity
- The Economics of Injectable Drugs - Growth in Injectables - Demand Drivers - Competitive Landscape
3. Generic Injectables - Growth Factors
- Patents and Exclusivity - Litigation and First-to-File ANDA Strategies - Buying and Selling ANDAs