Biopharmaceutical company Alkermes plc is facing a proposed class-action lawsuit accusing it of illegally blocking the launch of generic versions of Vivitrol, its widely used medication for treating opioid and alcohol dependence. The lawsuit, filed by Value Drug Company in the U.S. District Court for the District of Massachusetts, claims that Alkermes engaged in a long-running scheme to maintain its monopoly on the drug through fraudulent patent tactics and exclusionary settlements with generic manufacturers.
Lawsuit Alleges Fraudulent Patent Strategy and Anticompetitive Deals
According to court filings, Value Drug alleges that Alkermes improperly listed a 2011 patent for Vivitrol in the U.S. Food and Drug Administration’s Orange Book, a publication that tracks drug patents and exclusivity claims. The company allegedly used this listing to trigger automatic regulatory delays for competing generic products.
The complaint accuses Alkermes of manipulating the patent system to keep cheaper alternatives off the market for years, claiming that a generic version of Vivitrol “should have been available as early as 2020.”
The lawsuit further claims that Alkermes negotiated settlements with at least two generic manufacturers — Teva Pharmaceuticals and Amneal Pharmaceuticals — to delay the introduction of competing products. Under the alleged deals:
- Amneal agreed to postpone its generic Vivitrol launch until at least 2028, following a settlement reached before a scheduled trial at the Patent Trial and Appeal Board (PTAB).
- Teva similarly delayed its entry until 2027, under what the complaint describes as a “pay-for-delay” style agreement.
Value Drug claims these agreements illegally extended Alkermes’ market dominance and forced purchasers, including hospitals and wholesalers, to pay inflated prices.
Financial Stakes and Market Impact
The lawsuit estimates that Alkermes’ alleged conduct has cost U.S. purchasers hundreds of millions of dollars in overpayments. Vivitrol, approved by the FDA in 2006, is an injectable form of naltrexone, designed to treat opioid and alcohol dependence by blocking the effects of addictive substances.
Because of its unique administration and patient base, Vivitrol commands a high price compared to oral alternatives. With the generic version delayed, treatment programs, insurers, and public health agencies have continued to pay Alkermes’ monopoly prices.
The company’s patent protection for Vivitrol runs until 2029, but the lawsuit argues that Alkermes’ methods for maintaining exclusivity are not legally justified. Plaintiffs argue that by falsely asserting patent protections and engaging in anticompetitive settlements, Alkermes deprived patients and healthcare providers of affordable treatment options.
Alkermes’ Response
An Alkermes spokesperson said the company is “reviewing the allegations with its legal counsel” and intends to “vigorously defend its intellectual property.” The Dublin-based firm, which has significant U.S. operations in Waltham, Massachusetts, has not yet filed a formal response in court.
This isn’t the first time Alkermes’ Vivitrol business practices have come under scrutiny. In recent years, the company has faced questions over its aggressive marketing tactics, particularly amid the national opioid crisis. However, this latest lawsuit squarely targets antitrust violations, not marketing conduct.
Legal Context: The Intersection of Patent and Antitrust Law
The case highlights an ongoing tension between patent rights and antitrust enforcement in the pharmaceutical industry. While patent laws grant companies temporary monopolies to incentivize innovation, those rights cannot be used to unlawfully restrain competition.
When a drug manufacturer files a patent with the FDA’s Orange Book, it can automatically delay generic approval for up to 30 months while litigation plays out. Critics argue that brand-name drugmakers exploit this system by listing questionable patents or striking settlements to delay competition — a practice often referred to as “pay-for-delay.”
In 2013, the U.S. Supreme Court ruled in FTC v. Actavis that such settlements may violate antitrust laws if they unjustifiably postpone generic entry. The Alkermes lawsuit could become a modern test of how courts interpret this precedent in cases involving injectable drugs and newer licensing strategies.
If the allegations are proven true, Alkermes could face significant financial penalties and be forced to open the market to generic competition sooner than expected.
Broader Implications for Drug Pricing and Access
The lawsuit underscores the growing legal and political pressure on pharmaceutical companies accused of keeping drug prices high. The opioid epidemic has intensified scrutiny of drug manufacturers, especially those producing addiction-treatment medications.
Consumer advocates argue that delaying generics for essential medications like Vivitrol harms vulnerable patients who rely on affordable treatment options. The case could also encourage more wholesalers, insurers, and state agencies to challenge patent-based monopolies in court.
If Value Drug’s claims succeed, the lawsuit could result in substantial damages and potentially set a precedent for similar actions against other companies accused of stifling generic competition.
What’s Next in the Case
Legal analysts expect Alkermes to file a motion to dismiss the lawsuit in the coming weeks. If the court allows the case to proceed, it could move into the discovery phase, where internal communications, patent filings, and licensing agreements will be scrutinized.
Should the class be certified, the case could expand to include a broad group of purchasers nationwide. Alternatively, a settlement could emerge if Alkermes opts to avoid extended litigation and potential reputational damage.
Regardless of the outcome, this case highlights how pharmaceutical patent strategies remain a central focus of both antitrust law enforcement and drug pricing reform efforts in the United States.
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