Generic Drug Product Development Solid Oral Dosage Forms

Since the publication of the first edition of this book, the generic pharmaceutical industry has greatly expanded and has become more competitive. Many generic drug companies have merged, forming large global companies that also manufacture branded drug products. New generic pharmaceutical companies have entered into the marketplace increasing competition. To be successful, generic drug products must be manufactured in a cost-effective manner and on a timely basis. The manufacturer who is first to file a new generic drug product may reap a high financial reward. Even with the successful development of an approvable generic drug product, the manufacturer has financial risks due to possible patent infringement and other legal challenges.