Competitive Generic Therapy – A Boon for Complex Pharmaceutical Drugs
Often drugs which are difficult to mass produce and have limited market potential as well as less profit margin, do not find sufficient generic competition in the market. This leads to a sharp spike in drug prices and a potential for drug paucity. In 2017, the Competitive Generic Therapy (CGT) pathway was formulated under the U.S. Food & Drug Administration Reauthorization Act (FDARA) to put in place a mechanism by which such sole-source drugs with “inadequate generic competition” can be identified and designated as a CGT1. This new approval pathway helped generic manufacturers to get the process of development and review of their generics for CGT-designated drugs expedited.
The additional benefit was the 180-day marketing exclusivity for such drug products. Since only one exclusivity period is available for each CGT, an Abbreviated New Drug Application (ANDA) would not be eligible for CGT exclusivity if it also qualifies for 180-day patent challenge exclusivity. An additional criterion is that a drug product in an ANDA that receives a CGT designation becomes eligible for CGT exclusivity only if the patents or exclusivities listed in the Orange Book at the time of the ANDA submission for the CGT-designated drug product have already expired2.
U.S. FDA has hitherto approved 221 ANDAs for generic drugs with a CGT designation, out of which 118 ANDAs were eligible for 180-day CGT exclusivity3. With commercial marketing in place for more than 80 generic drugs within 75 days of the date of approval of the ANDA, the success of this U.S. FDA program is evident.
Majority of the ANDAs with 180-day CGT exclusivity include active ingredients and formulations for therapy areas such as cardiovascular disorders, opioid overdose, infectious diseases, central nervous system disorders, and anti-inflammatories.
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