San Diego-based ARS Pharmaceuticals, the biotech company behind the FDA-approved epinephrine nasal spray neffy, has filed an antitrust lawsuit against packaging giant AptarGroup Inc., alleging the company has unlawfully monopolized the supply of critical device components. The case, filed in the U.S. District Court for the Southern District of California, could have sweeping implications for both the pharmaceutical device supply chain and the accessibility of needle-free emergency treatments for patients at risk of anaphylaxis.
Background: A New Era in Epinephrine Treatment
ARS gained regulatory approval for neffy in 2024, introducing the first needle-free nasal spray alternative to traditional epinephrine auto-injectors such as Mylan’s EpiPen and Viatris’ generic equivalents. The product was hailed as a breakthrough for patients with severe allergies, offering a quicker, less invasive way to administer life-saving medication in an emergency.
To manufacture neffy, ARS relies on complex nasal spray systems that require specialized parts, including a precision rubber plunger. According to the lawsuit, Aptar controls the production of those essential plungers and has tied their sale to its proprietary intranasal spray systems—forcing ARS to purchase Aptar’s full device package rather than sourcing components competitively.
Allegations Against Aptar
ARS contends that Aptar’s practices violate U.S. antitrust law, particularly provisions designed to prevent monopolistic tying arrangements. By conditioning the sale of the rubber plunger on the purchase of its entire spray system, Aptar allegedly prevented ARS from turning to Silgan Dispensing Systems and other device manufacturers who might offer more cost-effective alternatives.
In its complaint, ARS argues that this arrangement not only inflated its production costs but also suppressed innovation and consumer choice. The biotech firm claims it was compelled to buy far more spray systems than it actually needed, creating an artificial bottleneck in the market and impeding ARS’s ability to scale production of neffy efficiently.
The lawsuit seeks treble damages—a remedy available under U.S. antitrust law to deter unlawful conduct—along with an injunction to stop Aptar from continuing what ARS describes as “exclusionary and coercive” business practices.
A Legal Battle with Broader Stakes
The dispute between the two companies is not new. Earlier this year, Aptar filed its own lawsuit accusing ARS of misappropriating trade secrets related to device technology. ARS has denied those allegations, framing them as an attempt to distract from Aptar’s anti-competitive behavior. The dueling lawsuits suggest that the fight is not merely about contracts and pricing, but about who will control a lucrative new market for epinephrine delivery devices.
Legal experts note that the case could serve as a litmus test for antitrust enforcement in the pharmaceutical supply chain. Device manufacturers like Aptar play a crucial but often under-the-radar role in drug delivery systems, and their market practices can significantly affect both innovation and patient access. A ruling against Aptar could invite closer scrutiny of similar arrangements across the industry.
Potential Impact on Patients and the Market
At the center of this dispute lies a high-stakes issue: ensuring patients have affordable, timely access to life-saving treatments. With millions of Americans at risk of severe allergic reactions, the cost and availability of epinephrine delivery devices are matters of public health.
If ARS succeeds in its antitrust claims, the company could gain more flexibility to negotiate with multiple suppliers, potentially lowering production costs and expanding distribution of neffy. Conversely, if Aptar maintains its grip on the supply chain, ARS argues, the result could be higher prices and restricted competition—outcomes that regulators and courts have long sought to prevent.
Representation and Case Details
ARS is represented in the case by Philip Bowman, David Burns, and W. Chad Shear of Cooley LLP, a law firm known for handling complex antitrust and biotechnology litigation. As of now, Aptar has not yet appeared in court or filed a formal response to the allegations.
The case is captioned ARS Pharmaceuticals Operations Inc. v. AptarGroup Inc., Case No. 3:25-cv-02571-BJC-VET.
Looking Ahead
This legal clash underscores the growing tension between biotechnology innovators and the specialized manufacturers they rely on. As new drug-device combinations reshape the pharmaceutical landscape, courts are likely to see more disputes involving supply chains, intellectual property, and competition law.
For ARS, the outcome of this lawsuit could determine how quickly it can expand neffy’s reach in the United States and abroad. For Aptar, the case could test the limits of how far a device supplier can go in leveraging its control over critical components.
The legal community will be watching closely as the case unfolds, particularly given the Biden administration’s heightened focus on antitrust enforcement and healthcare market competition.
For attorneys and legal professionals following developments in antitrust, biotechnology, and healthcare law, staying ahead of these disputes is critical. To explore more opportunities in the legal field and advance your career, visit LawCrossing—the leading job site dedicated to legal professionals.
