Generic Solid Dosage Forms


The generic solid dosage form drug segment is a rapidly evolving and highly unpredictable environment that has been a challenge to decision makers attempting to map strategies for success in this segment. There are 611 distinct APIs for which there is at least one approved generic solid dosage form ANDA. These 611 APIs account for 4,314 approved ANDAs. Including all approved doses, the current universe of generic solid dosage forms consists of 9,895 unique tablet and capsule products. These products are marketed and supplied by more than 800 companies. This report analyzes generic tablet and capsule products and the indications and therapeutic classes for which they compete. We have also included analysis of competitive factors, ANDA filing strategies, market growth trends and strategic and economic factors, and provides assessments of the market presence of sector participants.



Because of the relatively low barriers to entry, generic solid dosage forms – better known as tablets and capsules – are outstripping all other drug categories in terms of market authorization approvals. 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. The report includes analysis and assessments that assist market sector participants in strategic planning and market tactics.