President Jason Shandell on Tuesday announced the launch reshuffle, which will see the firm’s prefilled syringe version of Pfizer’s contraceptive injection launch in Q1, 2018.
According to Shandell, Teva Pharmaceutical Industries’ generic Depo-Provera in vials is the only alternative version on the market.
“There is possibility of others, but we are confident that this is a complicated product, with limited competition,” he added.
Shandell told investors there have been no approvals to date for a generic, prefilled syringe version.
“So we are prioritizing that due to the great revenue potential and profit, and we’ll push nitroprusside to the second quarter,” he explained.
Amphastar’s nitroprusside product – a generic version of Valeant Pharmaceuticals’ Nitropress – is indicated to control bleeding during surgery, and treat acute congestive heart failure.
The US Food and Drug Administration (FDA) approved Amphastar Pharmaceuticals’ abbreviated new drug application (ANDA) for its sodium nitroprusside injection 25mg/mL, 2mL single dose vial in December last year.
“We originally had planned [the launch] for the first quarter,” Shandell said, adding that strong competition in that sector changed his mind.
“That one is a highly competitive landscape. I believe we are the seventh entrant into that market, and that’s why we are putting less priority on it.”