3TC

Inventors: Choi, W; Liotta, D: Schinazi, R

Lamivudine (3TC) is a widely prescribed anti-HIV drug (70-80% of patients) and is sold singly as Epivir®, in fixed-dose combination with zidovudine as Combivir®, in fixed-dose combination with zidovudine and abacivir sulfate as Trizivir® and, as approved by the FDA in 2004, in fixed-dose combination with abacavir sulfate as Epzicom™. In 2002, Emory University, GlaxoSmithKline and Shire Pharmaceuticals settled global disputes over certain patent rights relating to lamivudine and Emory licensed its patent estate relating to lamivudine to GlaxoSmithKline and Shire. In November 2009, GlaxoSmithKline and Pfizer combined their HIV businesses under the umbrella of ViiV Healthcare, which began selling the Lamivudine-contianing products. In Mau 2011, TEVA Pharmaceuticals obtained approval of the first lamivudine/zidovudine generic equivalent in the US, and in May 2012, two further generics were approved. Lamivudine is also approved for the treatment of HBV (Epivir-HBV®). Lamivudine was approved in November 1995 in combination with AZT and again in 2002 as a once daily dosing form.

  • Combivir® is a fixed dose combination of lamivudine and zidovudine (AZT) that was approved in the US in September, 1997.
  • Trizivir® is a triple combination of abacavir, zidovudine (AZT) and lamivudine, Trizivir was approved in November, 2000 as the first triple combination therapy for HIV.
  • Epzicom® (maked as Kivexa outside of the US) is a fixed dose combination of abacavir and lamivudine. It was approved in the US in August, 2004 and is marketed by ViiV Healthcare.
  • Epivir-HBV® was approved in the US in December, 1998 as a tablet and oral solution. The dosage in Epivir-HBV (100mg tablets and 5mg/ml solutions) is lower than the dosage used in the Epivir® for HIV tablets and oral solutions (300 or 150 mg and 10 mg/ml, respectively).