The Generic Injectables Market
|出版商||Greystone Research Associates||商品編碼||358326|
法律規章上的課題 訴訟上的課題 ANDA申請策略的發展 CMO所扮演的角色 醫療的經濟學
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.