Akorn Introduces FDA-approved Generic Cetrorelix Acetate for Injection 0.25 mg at ASRM

Rhea-AI Summary

Akorn Operating Company has launched the first-to-market generic Cetrorelix Acetate for Injection at the ASRM Conference in Anaheim, California. This product serves as a lower-cost alternative for patients undergoing Assisted Reproductive Technology (ART). The FDA granted Akorn a Competitive Generic Therapy designation for Cetrorelix, entitling it to 180 days of market exclusivity. U.S. sales of Cetrorelix are projected at approximately $127 million for 2022, with the drug aimed at preventing premature ovulation during fertility treatments.

Positive

• First-to-market generic Cetrorelix Acetate launched, expanding Akorn's portfolio of generics.
• FDA granted Competitive Generic Therapy designation, enabling 180 days of market exclusivity.
• Projected U.S. sales of Cetrorelix at approximately $127 million for 2022.

Negative

• None.

New generic featured in Booth 1102 at the American Society for Reproductive Medicine Conference (ASRM)

GURNEE, Ill., Oct. 27, 2022 /PRNewswire/ -- Akorn Operating Company LLC, a specialty pharmaceutical company, is launching the first to market generic Cetrorelix Acetate for Injection 0.25 mg (Cetrorelix) at the 2022 American Society for Reproductive Medicine Conference (ASRM) Conference in Anaheim, California. ASRM brings together leading medical professionals to discover the latest in reproductive medicine, treatments, and patient management. Cetrorelix is the first approved, AP–rated and bioequivalent version of EMD Serono's Cetrotide^®.¹

"We are pleased to introduce Cetrorelix to attendees at the ASRM conference," says Akorn President and CEO Douglas Boothe. "As an increasing number of infants are conceived via the use of Assisted Reproductive Technology (ART), 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.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 became eligible for 180 days of market exclusivity, which the Company secured with this week's 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.

Cetrorelix is used to prevent premature ovulation during controlled ovarian stimulation. Learn more and see full prescribing information at MyCetrorelix.com.  

About Cetrorelix

Cetrorelix is used to prevent premature ovulation during controlled ovarian stimulation. 

Cetrorelix blocks the effects of a natural hormone, called gonadotropin–releasing hormone (GnRH). GnRH controls the secretion of another hormone, called luteinizing hormone (LH), which induces ovulation during the menstrual cycle. During hormone treatment for ovarian stimulation, premature ovulation may lead to eggs that are not suitable for fertilization. Cetrorelix Acetate for Injection blocks such undesirable premature ovulation.  

Consult your doctor before taking Cetrorelix if you have had severe allergic reactions.

Do not use Cetrorelix if you:

• have kidney disease;
• are allergic to cetrorelix acetate, mannitol or exogenous peptide hormones (medicines similar to cetrorelix acetate for injection); or
• are pregnant, or think that you might be pregnant, or if you are breast–feeding.

About Akorn

Akorn Operating Company LLC, develops, manufactures and markets specialty pharmaceuticals. Since 1971, as an industry leader in generic products in alternate dosage forms such as ophthalmics, injectables, oral liquids, otics, topicals, inhalants and nasal sprays, we focus each day on our mission to improve lives through the quality, availability and affordability of our products. Additional information is available on Akorn's website at akorn.com. 

¹ The use of the name "EMD Serono" in this press release refers to the healthcare business of Merck KGaA of Darmstadt, Germany. 
² https://www.cdc.gov/art/state–specific–surveillance/ 

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SOURCE Akorn, Inc.

FAQ

What is Akorn's new product launched at the 2022 ASRM Conference?

Akorn launched the first-to-market generic Cetrorelix Acetate for Injection.

What market exclusivity does Cetrorelix Acetate have?

Cetrorelix Acetate has 180 days of market exclusivity following its Competitive Generic Therapy designation.

What are the projected U.S. sales for Cetrorelix in 2022?

Projected U.S. sales for Cetrorelix in 2022 are approximately $127 million.

What does Cetrorelix Acetate do?

Cetrorelix Acetate prevents premature ovulation during controlled ovarian stimulation in fertility treatments.

Where can I learn more about Cetrorelix?

More information on Cetrorelix can be found at MyCetrorelix.com.