Company Background

Eagle is a specialty pharmaceutical company focused on developing injectable products, primarily in the areas of critical care, orphan diseases, and oncology. Our goal is to provide safer and more convenient solutions for patients and healthcare professionals with optimized formulations. We develop proprietary enhancements to FDA-approved drugs utilizing the 505(b)(2) regulatory pathway. This strategy expedites time for development, FDA review, and approval. We further seek to extend the patent life of our products through orphan drug exclusivity, new intellectual property protection, and/or 3 years of non-patent regulatory exclusivity. These last allowances come by way of the Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch Waxman Act.

Industry Background

Intravenous injection is a preferred drug delivery route for many biopharmaceuticals.2 The reference injectable brands that are the primary focus of the Eagle portfolio have an estimated value of $3.4 billion.1

Furthermore, the United States injectable market is projected to grow at a compound annual rate of 16.3% due to several factors, including1:

  • Label expansion for approved products, which increases the patient pool for such products
  • A pipeline of injectable medications at various stages of clinical development
  • The increasing incidence of certain diseases that may be treated with injectable medications such as cancer and autoimmune disorders

We estimate that the current annual revenue of the overall U.S. market we target is approximately $4 billion.1 In an attempt to capture a larger share of the overall market, we have begun exploring other product opportunities using the 505(b)(2) regulatory pathway in addition to pursuing label expansions of approved Eagle brands.

The Limitations of In-Market Products

We believe that many injectable products used in acute care settings have suboptimal characteristics. These other products may not fully meet the needs of patients and healthcare professionals.

For instance, some existing drugs may be packaged inefficiently while others come in formulations that require reconstitution or dilution, or are otherwise difficult or inconvenient to prepare. Some drugs risk exposing workers to cytotoxic compounds3 and can result in dosing errors.4 These suboptimal characteristics can lead to wasted quantities of drug,5 inefficiencies in staff time and constrained work flow, reduced shelf life,5 and the need for reconstitution of multiple vials in an emergency situation.6,7

At Eagle, we work diligently to create improved formulations that address these issues.

Our Competitive Strengths

Reformulations that Capitalize on Market Opportunities

Our products have the potential to benefit both patients and healthcare professionals. These reformulations of other injectable drugs could provide improvements including:

  • Reduced chance of dosing errors through elimination of drug reconstitution4,8
  • Less drug waste5
  • Improved safety by reduced exposure to cytotoxic vapors3
  • Reduced drug infusion time9,10
  • Less drug volume administered9
  • Fast reconstitution in emergency situations

Compliance

Eagle is committed to conducting business in accordance with the highest ethical standards. We comply with all applicable laws and regulations, and we encourage the reporting of any potential violations.

Eagle maintains several points of contact for reporting violations. All communication channels are available 24 hours a day, 365 days a year:

  • Call the compliance hotline: 855-679-2699 (callers may remain anonymous)
  • Contact us via email
  • Fill out an online form

California Compliance Law
Eagle maintains compliance with the California Health & Safety Code § 119402, as described in this document.