FDA Confirms Paragraph IV Patent Litigation for Bictegravir Sodium, Emtricitabine and Tenofovir Alafenamide Fumarate Tablets
FDA Confirms Para IV Patent Litigation for Bictegravir Sodium, Emtricitabine, Tenofovir Alafenamide Fumarate Tablet
The US Food and Drug Administration (FDA) on Wednesday released its latest batch of product-specific guidance documents to support the development of generic drugs, with 25 new and nine revised draft guidances.
SINGAPORE, Feb. 14, 2019 /PRNewswire/ -- Gilead Sciences, Inc. today announced that the Singapore Health Sciences Authority has approved Biktarvy® (bictegravir 50mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection in adults*.
GlaxoSmithKline had several years to prepare for the U.S. generic assault on its respiratory blockbuster Advair, offering discounts and rolling out new therapies to stay in the game. And now that the day has finally come, while sales are expected to decline, attention has clearly shifted to rebuilding an interest in oncology.
According to the Centers for Disease Control and Prevention data, there were an estimated 39,782 new HIV infections in the United States in 2016, the most recent year for which data is available.
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 25, 2018-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the European Commission has granted Marketing Authorization for Biktarvy® (bictegravir 50mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. BIC/FTC/TAF combines the potency of the novel integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg; FTC/TAF), a guidelines-recommended dual nucleoside reverse transcriptase inhibitor (NRTI) backbone. Today’s decision makes BIC/FTC/TAF Gilead’s third FTC/TAF-based STR approved in the European Union in the past three years.
One of the most intense rivalries in biopharma R&D today centers on the showdown between GlaxoSmithKline and Gilead in HIV.
Three medicines treating HIV, pain and cancer have been recommended for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) at its latest meeting.
The only obstacle standing in the way of Gilead’s new HIV combo drug Biktarvy becoming a blockbuster is competition from a rival that’s so intent on stealing market share away from the longtime HIV leader it filed a patent lawsuit to try to stall the new drug. That rival is GlaxoSmithKline, which also answered Gilead’s FDA approval of Biktarvy in February by launching its eighth phase 3 study of two HIV drugs developed by GSK unit ViiV Healthcare, Tivicay and Epivir.