Janssen announced that it has filed a lawsuit in the United States District Court for the Eastern District of New York seeking seizure of counterfeit HIV medications from unauthorized distributors.
The legal action follows an investigation that identified counterfeit products being sold by distributors not authorized to sell Janssen’s medicines. In December 2020, the Company issued a statement alerting the medical community of counterfeit Symtuza® (darunavir, cobicistat, emtricitabine, tenofovir alafenamide) being discovered in 3 pharmacies in the US.
“Counterfeiting of life-saving medicines is a criminal act that puts patient lives at risk,” said Dave Anderson MD, Vice President, US Medical Affairs, Janssen Infectious Diseases & Vaccines, Janssen Scientific Affairs, LLC. “In addition to the anticounterfeiting measures and legal action we have taken, we want to remind all stakeholders about the situation and provide specific guidance on how to identify authentic HIV medicines.”
Symtuza is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40kg who have no prior antiretroviral treatment history, or who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least 6 months, and have no known substitutions associated with resistance to darunavir or tenofovir.
The authentic product is supplied as yellow to yellowish-brown, capsule-shaped, film-coated tablets debossed with “8121” on one side and “JG” on the other side. If the product does not match this description, it should be reported to the FDA’s Office of Criminal Investigations (800-551-3989) or Janssen Medical Information (800-526-7736).
According to Janssen, product obtained from authorized distributors should be considered safe for use. The Company has also created a resource for clinicians and patients to help identify authentic HIV medications. Other HIV medications that have been impacted by counterfeiting in recent years include Edurant (rilpivirine), Intelence (etravirine), Prezcobix (darunavir/cobicistat) and Prezista (darunavir).
Janssen takes further legal action to help end the distribution of counterfeit HIV medicines in the United States. News release. April 26, 2022. https://www.janssen.com/us/sites/www_janssen_com_usa/files/janssen_takes_further_legal_action_to_help_end_the_distribution_of_counterfeit_hiv_medicines_in_the_united_states.pdf