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Akorn Announces FDA-approved Generic Cetrorelix Acetate for Injection 0.25 mg

Wednesday, August 17, 2022

Akorn Operating Company LLC, a specialty pharmaceutical company, announces that it received FDA approval for a generic version of Cetrorelix Acetate for Injection, 0.25 mg (Cetrorelix). This is the first approved AP-Rated bioequivalent version of Merck Serono's Cetrotide®.

"We are pleased to announce the first approved AP-rated generic option for women receiving fertility treatments," says Akorn President and CEO Douglas Boothe.   "As an increasing number of infants are being conceived via the use of ART, Akorn is excited to be able to offer a competitively priced option to support women who undergo this series of treatments.  This is a welcome addition to our portfolio of more than 200 specialty and injectable generics."

Assisted Reproductive Technology (ART) is defined as fertility treatments where eggs or embryos are handled for the purpose of establishing a pregnancy. 2

The FDA granted Akorn a Competitive Generic Therapy (CGT) designation for Cetrorelix, a designation intended to incentivize effective development, efficient review, and timely market entry of drugs for which there is inadequate generic competition.  As the first approved applicant with the CGT designation, Akorn's Cetrorelix is eligible for 180 days of CGT market exclusivity, which will begin to run from the commercial launch of Cetrorelix.

According to IQVIA, U.S. sales of Cetrorelix through June of 2022 were approximately $63 million with full year U.S. sales projection of approximately $127 million.

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