A Mount Vernon specialty pharmacy claims that a drugmaker is blocking access to a crucial kidney medicine.
Fleetwood Specialty Pharmacy accused Lupin Pharmaceuticals Inc. of engaging in monopolistic practices to eliminate competition from independent pharmacies, in a complaint filed on April 9 in Westchester Supreme Court.
By “actively blocking qualified independent pharmacies from dispensing the medication,” the complaint states, Lupin is “adversely affecting patient access to a vital drug for adults at risk of rapidly progressing Autosomal Dominant Polycystic Kidney Disease.”
The lawsuit concerns Tolvaptan tablets, a generic version of Jynarque, that treats the disease by slowing down the progression to kidney failure.
Fleetwood Specialty Pharmacy specializes in management of serious chronic illnesses, according to the lawsuit. It was registered as a Westchester County business in 2019 by Marwan Abdullah, of New Rochelle.
Lupin is a transnational pharmaceutical company based in Mumbai, India that makes a multitude of branded and generic drugs.
In 2023, the U.S. Food and Drug Administration granted Lupin tentative approval to market Tolvaptan, and last year formally approved Lupin’s position in the U.S. market. According to a Lupin’s press release, it made about $1.5 billion on Tolvaptan sales in the U.S. in 2024.
The FDA regulates drugs with serious safety issues, such as Tolvaptan, through its Risk Evaluation and Mitigation Strategies program, to ensure that the benefits outweigh the risks. Pharmacies, for example, must be certified to dispense the medicine.
Fleetwood Specialty says it has completed the certification requirements and has the same credentials as large corporate pharmacies. But Lupin, according to the complaint, distributes Tolvaptan only through a closed network of corporate pharmacies, and refuses to stock the drug with major wholesalers that supply independent pharmacies.
When Fleetwood Specialty tried to order Tolvaptan from its wholesaler, Cardinal Health, it was not available, the complaint states. When the pharmacy tried to order directly from Lupin, the request was denied.
Instead, Lupin allegedly instructed Fleetwood Specialty to “surrender its own patients” by referring them to Accredo, CVS, Optum, PantherRx or Walgreens.
Limiting distribution to five large corporate pharmacies, Fleetwood Specialty argues, is meant to limit competition and is “adversely affecting patient access to a vital drug.”
The pharmacy accused Lupin of violating New York’s antitrust law and the state’s general business law on deceptive acts and practices. It is asking the court to compel Lupin to allow Fleetwood Specialty to buy Tolvaptan.
Lupin corporate communications officials did not reply to messages asking for the drugmaker’s side of the story.
The pharmacy is represented by Yonkers attorney Nizar DeWood.
