Abacavir/lamivudine

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Abacavir/lamivudine
Abacavir and lamivudine.svg
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)
Routes of
administration
Oral
Legal status
Legal status
Identifiers
CAS Number 852337-16-7 N
ATC code J05AR02 (WHO)
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. As of 2015 the cost for a typical month of medication in the United States is more than 200 USD.[4]

Legal challenges[edit]

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.[5]


See also[edit]

References[edit]

  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. ^ Hamilton, Richart (2015). Tarascon Pocket Pharmacopoeia 2015 Deluxe Lab-Coat Edition. Jones & Bartlett Learning. p. 59. ISBN 9781284057560. 
  5. ^ "PROPOSED MAJOR TRANSACTION WITH NOVARTIS AG:Circular to Shareholders and Notice of General Meeting" (PDF). Glaxosmithkline. 20 November 2014.