Gilead Sciences Inc said an unlicensed network of drug distributors and suppliers has sold more than $250 million worth of counterfeit versions of its HIV treatments to pharmacies over the past two years, putting patients at risk.
The drugmaker said it found 85,247 bottles that had been tampered with or tampered with, including versions of its Biktarvy and Descovy treatments.
In a separate statement Wednesday, Gilead said it seized the vials of drugs labeled Gilead at 17 locations in nine states as part of its investigation.
The investigation also uncovered unauthorized pharmaceutical distributors who were selling the drugs to pharmacies, Gilead said.
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Gilead said on Tuesday that counterfeiters used genuine, but often empty or nearly empty, bottles that once contained its HIV medication.
He said the counterfeiters then replaced the fake pills and documentation, and resealed the bottles so they “looked like” genuine unopened bottles.
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The alleged scheme was reported earlier by the Wall Street Journal.
Gilead unveiled its anti-infringement efforts the same day a federal judge in Brooklyn uncovered a related civil lawsuit the Foster City, Calif.-based company filed last July.
Gilead warned the public on HIV counterfeits on August 5, two weeks after filing the complaint under seal.
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The company has charged 22 defendants with violating New York’s federal trademark and consumer protection laws for their role in distributing ‘dangerous’ counterfeits to ‘unsuspecting patients, putting patients’ health and lives in danger”.
Gilead said a common counterfeit was an antipsychotic drug that often causes drowsiness, where the tablets were six times stronger than the US Food and Drug Administration recommended for some patients.
He said a patient who unknowingly took the drug after being given a fake bottle of Biktarvy reported being unable to speak or walk afterwards.
The lawsuit seeks, among other remedies, the seizure of counterfeit drugs, in addition to the court-ordered seizures that have already taken place.
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Global sales of its HIV treatments totaled $4.19 billion in the quarter ending September 30, 2021, including $2.71 billion from Biktarvy and Descovy.
Lori Mayall, head of anti-counterfeiting at Gilead, said the presiding judge in her lawsuit ordered defendant distributors to stop selling Gilead-branded drugs, and the company was not aware of any defendants. violating this order.
“We therefore believe that we have been successful in preventing any further forgery by these defendants from reaching patients,” Mayall said in a statement.
(Reporting by Jonathan Stempel in New York and Manas Mishra and Jahnavi Nidumolu in Bengaluru; Editing by Rosalba O’Brien and Jason Neely)