Fig 1.
Classification of FDC at First Approval
Fig 2.
FDC Potential Patent and Exclusivity Protection
Table 1.
FDA-Approved NMEs and BLAs and NNE-FDC drugs by Therapeutic Category, 1980–2012.
Table 2.
FDA-Approved Non-NNE-FDC drugs by Therapeutic Category, 1980–2012.
Table 3.
Time Lag between Approval of Single Active Ingredient NME and FDC.
Table 4.
Time lag between FDC Drug Approval and Single Drug Generic Market Entry.
Table 5.
Effective Patent and Exclusivity Life: FDCs Compared to Single Active Ingredient Included in Combination.