Avenacy Announces Launch of Leuprolide Acetate Injection in the U.S. Market

Represents the Company’s 23^rd product launch since inception in October 2023

Expands Avenacy’s commercial reach into the mail order and retail pharmacy channels

Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Leuprolide Acetate Injection in the United States. The product is a therapeutic generic equivalent to LUPRON^®, as approved by the U.S. Food and Drug Administration, and is indicated for the palliative treatment of advanced prostate cancer. Avenacy’s Leuprolide Acetate Injection is available as a 14-Day Patient Administration Kit, which includes one multi-dose vial containing 14 mg per 2.8 mL (1 mg per 0.2 mL), 14 disposable syringes, and 28 alcohol wipes.

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“The launch of Leuprolide Acetate Injection marks an important milestone for Avenacy as our first product available through mail order and retail pharmacies,” said Jeff Yordon, Co-Founder and CEO of Avenacy. “As we continue to expand our commercial presence across more settings of care, this launch reflects our broader commitment to increasing access to high-quality injectable therapies, and we look forward to introducing additional products into these channels in the near future.”

In line with Avenacy’s mission to champion patient safety and streamline patient care, Leuprolide Acetate Injection will feature the Company’s highly differentiated packaging and labeling to support accurate medication selection.

The company will begin shipping Leuprolide Acetate Injection to wholesale partners this week. Avenacy is supported by a global network of development and contract manufacturing partners that have undergone successful FDA inspections based on cGMP standards.

U.S. sales of Leuprolide Acetate Injection were approximately $49 million for the twelve months ending in March 2025.¹

Indication:

Leuprolide Acetate Injection is indicated in the palliative treatment of advanced prostatic cancer.

Important Safety Information:

Leuprolide acetate is contraindicated in patients with known hypersensitivity to GnRH, GnRH agonist analogs, or any of the excipients. It may cause a transient increase in serum testosterone levels, which can lead to worsening symptoms during the first few weeks of treatment. Serious risks include spinal cord compression, ureteral obstruction, hyperglycemia, diabetes, and cardiovascular events. Periodic monitoring of testosterone and PSA levels is recommended. Leuprolide Acetate Injection is not indicated for use in women and may cause fetal harm if administered during pregnancy. Please refer to the Full Prescribing Information for additional warnings and precautions.

¹ Source: IQVIA

About Avenacy

Avenacy is a U.S.-based specialty pharmaceutical company focused on supplying critical injectable medications used to treat patients in various medically supervised settings, from acute care hospitals to outpatient clinics and physician offices. Through a rigorous and optimized selection process, the company is building a pipeline of high-quality, FDA-approved injectable products to ensure a resilient portfolio that can meet the needs of today’s dynamic drug supply chain. With an experienced team, a commitment to quality and reliability, and product offerings designed to facilitate safe and efficient patient care, Avenacy strives to be a trusted partner for essential medications.

Avenacy was launched in 2023 and is headquartered in Schaumburg, IL. For more information, please visit www.avenacy.com.

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