Akorn rolls out generic Cetrorelix
Akorn is launching cetrorelix acetate for injection 0.25 mg, the first Food and Drug Administration-approved generic of EMD Serono’s Cetrotide.
Cetrorelix is used to prevent premature ovulation during controlled ovarian stimulation.
[Read more: Akorn receives FDA OK for generic Cetrotide]
“We are pleased to introduce cetrorelix to attendees at the ASRM conference,” said Akorn president and CEO Douglas Boothe. “As an increasing number of infants are conceived via the use of Assisted Reproductive Technology, Akorn is pleased to offer a lower-cost alternative to support patients who undergo this series of treatments. This is a welcome addition to Akorn's portfolio of over 200 specialty and injectable generics.”
ART is defined as fertility treatments where eggs or embryos are handled for the purpose of establishing a pregnancy.
The FDA granted Akorn a Competitive Generic Therapy designation for cetrorelix. As the first approved applicant with the CGT designation, Akorn became eligible for 180 days of market exclusivity.
[Read more: Akorn obtains FDA green light for loteprednol etabonate ophthalmic gel]
Cetrorelix had a market value of approximately $63 million through June 2022, with a full-year U.S. sales projection of roughly $127 million, according to IQVIA.