Launches represent continued expansion of Avenacy’s foundational portfolio of widely-used, critical injectable medications.

Portfolio now includes 20 products launched in less than 14 months since inception in October 2023.

Company continues to make significant progress towards target of 25+ products by year-end 2025.

SCHAUMBURG, Ill.–(BUSINESS WIRE)–Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched a suite of antibiotic products for injection, including:

• Ampicillin for Injection, USP
• Ampicillin and Sulbactam for Injection, USP
• Nafcillin for Injection, USP
• Penicillin G Potassium for Injection, USP
• Piperacillin and Tazobactam for Injection, USP

Combined, these products generated U.S. sales of approximately $175M for the twelve months ended September 30, 2024, representing a meaningful opportunity in the generic injectables market.

“The launch of these five antibiotic products further strengthens Avenacy’s foundational portfolio of high-usage, critical injectable products. I am proud of how swiftly this team has worked to successfully bring 20 important medications to the U.S. market, ”said Jeff Yordon, Co-Founder and CEO of Avenacy. “As we continue to focus on accelerating our growth, these antibiotic products will enable us to deepen our commercial presence in both the hospital and long-term/home health settings. With our growing antibiotic portfolio, we are well-positioned to drive continued market expansion that supports our long-term strategic objectives.”

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

Avenacy will begin shipping all five antibiotics to wholesale partners next week. The Company is supported by a global network of development and contract manufacturing partners that have undergone successful FDA inspections based on cGMP-standards.

The Company will be attending DCAT Week 2025 in New York City from March 17-20^th to showcase its differentiated portfolio, discuss its growth strategy for 2025, and meet with potential partners and customers. To request a meeting with a member of the Avenacy team, please reach out to info@avenacy.com.

Product Information for Launched Antibiotics

Ampicillin for Injection, USP
Ampicillin for Injection, USP is a therapeutic equivalent generic for Omnipen-N® approved by the U.S. Food and Drug Administration. Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions:

• Respiratory Tract Infections caused by Streptococcus pneumoniae, Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic streptococci.
• Bacterial Meningitis caused by E. Coli, Group B streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria.
• Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. Coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis.
• Urinary Tract Infections caused by sensitive strains of E. Coli and Proteus mirabilis.
• Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing.

It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Indicated surgical procedures should be performed.

Ampicillin for Injection, USP had U.S. sales of approximately $3 million for the twelve months ending in September 2024.¹ Avenacy’s Ampicillin for Injection, USP is available as 10 g Pharmacy Bulk Bottles.

Please see link for Full Prescribing Information.

Omnipen-N® is a registered trademark of Bayer AG.

Ampicillin and Sulbactam for Injection, USP
Ampicillin and Sulbactam for Injection, USP is a therapeutic equivalent generic for Unasyn® approved by the U.S. Food and Drug Administration. Ampicillin and Sulbactam for Injection, USP, is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below:

• Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli*, Klebsiella spp.* (including K. pneumoniae*), Proteus mirabilis*, Bacteroides fragilis*, Enterobacter spp.*, and Acinetobacter calcoaceticus*.
  NOTE: For information on use in pediatric patients see PRECAUTIONS-PEDIATRIC USE and CLINICAL STUDIES sections.
• Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*
• Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli*, and Bacteroides spp.* (including B. fragilis*).

*Efficacy for this organism in this organ system was studied in fewer than 10 infections.

While Ampicillin and Sulbactam for Injection, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection, USP should not require the addition of another antibacterial.

Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection, USP.

Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate.

To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection, USP and other antibacterial drugs, Ampicillin and Sulbactam for Injection, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Ampicillin and Sulbactam for Injection, USP had U.S. sales of approximately $44 million for the twelve months ending in September 2024.¹ Avenacy’s Ampicillin and Sulbactam for Injection, USP is available as 1.5 g and 3 g single-dose vials, and 15 g Pharmacy Bulk Package Bottles.

Please see link for Full Prescribing Information.

Unasyn® is a registered trademark of Pfizer.

Nafcillin for Injection, USP
Nafcillin for Injection, USP is a therapeutic equivalent generic for Nallpen® approved by the U.S. Food and Drug Administration. Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see CLINICAL PHARMACOLOGY – SUSCEPTIBILITY TEST METHODS).

Nafcillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to a methicillin-resistant Staphylococcusspp., therapy with Nafcillin for Injection, USP should be discontinued and alternative therapy provided.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin for Injection, USP and other antibacterial drugs, Nafcillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Nafcillin for Injection, USP had U.S. sales of approximately $5 million for the twelve months ending in September 2024.¹ Avenacy’s Nafcillin for Injection, USP is available as 10 g Pharmacy Bulk Bottles.

Please see link for Full Prescribing Information.

Unipen® is a registered trademark of Baxter Healthcare Corporation.

Penicillin G Potassium for Injection, USP
Penicillin G Potassium for Injection, USP is a therapeutic equivalent generic for Pfizerpen-G® approved by the U.S. Food and Drug Administration. Penicillin G Potassium for Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin G.

Therapy with Penicillin G Potassium for Injection, USP may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below; however, once these results become available, appropriate therapy should be continued.

Penicillin G Potassium for Injection, USP had U.S. sales of approximately $13 million for the twelve months ending in September 2024.¹ Avenacy’s Penicillin G Potassium for Injection, USP is available in 5 million units and 20 million units per vial.

Please see link for Full Prescribing Information.

Pfizerpen® is a registered trademark of Pfizer.

Piperacillin and Tazobactam for Injection, USP
Piperacillin and Tazobactam for Injection, USP is a therapeutic equivalent generic for Zosyn® approved by the U.S. Food and Drug Administration. Piperacillin and Tazobactam for Injection, USP is indicated in adults for the prevention of intra-abdominal infections, nosocomial pneumonia, skin and skin structure infections, female pelvic infections, and community-acquired pneumonia.

1.1 Intra-abdominal Infections

Piperacillin and tazobactam for injection, USP is indicated in adults and pediatric patients (2 months of age and older) for the treatment of appendicitis (complicated by rupture or abscess) and peritonitis caused by beta-lactamase producing isolates of Escherichia coli or the following members of the Bacteroides fragilis group: B. fragilis, B. ovatus, B. thetaiotaomicron, or B. vulgatus.

1.2 Nosocomial Pneumonia

Piperacillin and tazobactam for injection, USP is indicated in adults and pediatric patients (2 months of age and older) for the treatment of nosocomial pneumonia (moderate to severe) caused by beta-lactamase producing isolates of Staphylococcus aureus and by piperacillin/tazobactam-susceptible Acinetobacter baumannii, Haemophilus influenzae, Klebsiella pneumoniae, and Pseudomonas aeruginosa (Nosocomial pneumonia caused by P. aeruginosa should be treated in combination with an aminoglycoside) [see Dosage and Administration (2)].

1.3 Skin and Skin Structure Infections

Piperacillin and tazobactam for injection, USP is indicated in adults for the treatment of uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections caused by beta-lactamase producing isolates of Staphylococcus aureus.

1.4 Female Pelvic Infections

Piperacillin and tazobactam for injection, USP is indicated in adults for the treatment of postpartum endometritis or pelvic inflammatory disease caused by beta-lactamase producing isolates of Escherichia coli.

1.5 Community-acquired Pneumonia

Piperacillin and tazobactam for injection, USP is indicated in adults for the treatment of community-acquired pneumonia (moderate severity only) caused by beta-lactamase producing isolates of Haemophilus influenzae.

1.6 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of piperacillin and tazobactam for injection, USP and other antibacterial drugs, piperacillin and tazobactam for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Piperacillin and Tazobactam for Injection, USP had U.S. sales of approximately $110 million for the twelve months ending in September 2024.¹ Avenacy’s Piperacillin and Tazobactam for Injection, USP is available in 3.375 g and 4.5 g single-dose vials.

Please see link for Full Prescribing Information.

Zosyn® is a registered trademark of Baxter Healthcare Corporation.

¹Source: 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 out a pipeline of high-quality FDA approved injectable products in order to ensure a resilient portfolio that can meet the needs of today’s dynamic drug supply chain. With an experienced team, commitment to quality and reliability, and product offerings intended 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  https://www.avenacy.com.

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