IQV - ANI Pharma gains as FDA clears generics for Celontin and Fosamax
2023-05-15 07:15:14 ET
Shares of ANI Pharmaceuticals ( NASDAQ: ANIP ) spiked in the pre-market Monday after announcing that the FDA approved the market entry of the company’s generics for seizure therapy Celontin and osteoporosis drug RLD Fosamax Oral Solution.
In approving the two Abbreviated New Drug Applications (ANDAs), the agency has also issued Competitive Generic Therapy (CGT) Exclusivity for the treatments.
Accordingly, Methsuximide Capsules, the generic for Celontin, comes with a 180-day exclusivity, and Alendronate Sodium Oral Solution, the off-patent version of RLD Fosamax, is eligible for CGT Exclusivity upon market entry.
According to drug analytics firm IQVIA ( IQV ), the current U.S. market for Methsuximide Capsules and Alendronate Sodium Oral Solution is valued at $6.3M annually.
“Our R&D team continues to build strong momentum, and with these launches, we expect to share the top spot in CGT approvals,” CEO of ANI Pharmaceuticals ( ANIP ) Nikhil Lalwani remarked.
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ANI Pharma gains as FDA clears generics for Celontin and Fosamax