The FDA has released its most current list of Competitive Generic Therapy (CGT) ANDA approvals (here). CGT-designated products (products for which there is little, if any, generic approvals for NDA products) may be eligible to receive 180-days of market exclusivity from a subsequent ANDA approval for the same strength and product.
After any ANDA approval for a CGT-designated product, in order for them to be eligible to receive the exclusivity period, the ANDA must be marketed within 75 days of approval or the exclusivity is forfeited. There were 7 products reported to have forfeited their CGT exclusivity period. The narrative preceding the table contains clear explanations of the abbreviations and dates. There are a significant number of products for which an exclusivity determination has not yet been made.
