Preparing a Promising Drug Candidate for ANDA Litigation

Having a promising drug candidate in clinical trials can be an exciting time for a pharmaceutical company. It is also a time when it pays to think ahead on how best to position that drug candidate for patent coverage and how to withstand likely patent challenges. Most new drugs receive about 12 to 16 years of market exclusivity from the time of FDA approval. With patent protection serving an integral role in maintaining market exclusivity against generic competition, you need to understand how your actions may potentially affect patent coverage and enforcement.