Abacavir/lamivudine

Abacavir/lamivudine
Combination of
Abacavir Nucleotide analogue reverse transcriptase inhibitor
Lamivudine Nucleotide analogue reverse transcriptase inhibitor
Clinical data
Trade names Kivexa, Epzicom
MedlinePlus a696011
Pregnancy
category
  • US: C (Risk not ruled out)
Legal status
Routes of
administration		 Oral
Identifiers
CAS Number 852337-16-7 N
ATC code J05AR02
PubChem CID 5273759
NIAID ChemDB 225604
 NYesY (what is this?)  (verify)

Abacavir/lamivudine (INNs) is a combination drug for the treatment of HIV infection.[1][2] It is marketed as Kivexa in most countries except for the United States, where it is branded as Epzicom.[3] It is a fixed dose combination of a certain crystal form of lamivudine (3TC, Epivir) and the hemisulphate salt of abacavir (ABC, Ziagen).

Lamivudine and abacavir are both nucleoside reverse transcriptase inhibitors (NRTI).

It was approved by the FDA on August 2, 2004. It is marketed by ViiV Healthcare.

Legal challenges

Teva Pharmaceuticals and Lupin Ltd both filed abbreviated new drug applications (ANDAs) relating to the treatments of HIV using various combinations of abacavir, lamivudine and AZT, and challenging various patents. In 2013 the US District Court for the District of Delaware upheld the validity of a patent covering Epzicom and Tizivir. Other matters were subject to appeal or litigation as of 20 November 2014.[4]


See Also

References

  1. ↑ Smith, Kimberly Y; Patel, Parul; Fine, Derek; Bellos, Nicholaos; Sloan, Louis; Lackey, Philip; Kumar, Princy N; Sutherland-Phillips, Denise H; Vavro, Cindy; Yau, Linda; Wannamaker, Paul; Shaefer, Mark S (July 2009). "Randomized, double-blind, placebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/emtricitabine with lopinavir/ritonavir for initial HIV treatment". AIDS 23 (12): 1547–1556. doi:10.1097/QAD.0b013e32832cbcc2.
  2. ↑ Post, Frank A; Moyle, Graeme J; Stellbrink, Hans Jürgen; Domingo, Pere; Podzamczer, Daniel; Fisher, Martin; Norden, Anthony G; Cavassini, Matthias; Rieger, Armin; Khuong-Josses, Marie-Aude; Branco, Teresa; Pearce, Helen C; Givens, Naomi; Vavro, Cindy; Lim, Michael L (September 2010). "Randomized Comparison of Renal Effects, Efficacy, and Safety With Once-Daily Abacavir/Lamivudine Versus Tenofovir/Emtricitabine, Administered With Efavirenz, in Antiretroviral-Naive, HIV-1–Infected Adults: 48-Week Results From the ASSERT Study". JAIDS Journal of Acquired Immune Deficiency Syndromes 55 (1): 49–57. doi:10.1097/QAI.0b013e3181dd911e.
  3. ↑ ViiV Healthcare: Kivexa
  4. ↑ "PROPOSED MAJOR TRANSACTION WITH NOVARTIS AG:Circular to Shareholders and Notice of General Meeting" (PDF). Glaxosmithkline. 20 November 2014.


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