Ritonavir (Protease Inhibitor for Treatment of HIV)

Drug Information

• Ritonavir is used with other medications to treat human immunodeficiency virus (HIV) infection. Ritonavir is in a class of antiviral medications called protease inhibitors. It works by slowing the spread of HIV infection in the body.1
• Ritonavir was approved by the FDA on March 1, 1996, for use with other antiretroviral agents in the treatment of HIV infection in adults and children 2 years of age or older. Ritonavir is now approved with other anti-HIV drugs in the treatment of HIV-1 infection in individuals over 1 month in age. Studies have shown that ritonavir works as a booster for some other protease inhibitors. Taking ritonavir makes it possible to take a lower dose of the other protease inhibitors.2
• Norvir is Abbott Laboratories’ brand name for ritonavir. Kaletra or Aluvia are Abbott’s brand name for the HIV treatment that combines lopinavir and ritonavir.3
• Ritonavir is a key component of HIV/AIDS treatment regimens worldwide.

Exclusive commercialization

• In spite of the publicly-funded research that directly contributed to the development of ritonavir, Abbott still maintains the exclusive rights to commercialize ritonavir and lopinavir+ritonavir (LPV/r) in the United States and many low- and middle-income countries.4
• Abbott prolongs its monopoly on Kaletra through its “patent-evergreening” strategy. Abbott has applied for new patents for slight modifications to the drug despite the fact that these alterations rarely change the drug’s therapeutic efficacy.

Generics

• In countries which are members of the Clinton Health Access Initiative (CHAI) Procurement Consortium, WHO-prequalified generic LPV/r heat-stable is offered at a maximum price of 399 USD per person per year.5
•  There are multiple generic versions of ritonavir available, including versions prequalified by the World Health Organization – but only where patent barriers can be overcome.
• Prices for generic LPV/r, including but not limited to heat-stable tablets, are significantly lower than Kaletra prices – up to 90% lower.
• Peru has perhaps the global low price for LPV/r. By facilitating consistent competitive bidding between firms, Peru has obtained a price of $396 per person per year from Eske Group, a Cipla affiliate. Kaletra prices in middle income countries still often approach $4,000.6

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1 Quoted from U.S. National Library of Medicine, available at: http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000986/.
2 Quoted from AIDSinfo, National Institutes of Health, available at: http://www.aidsinfo.nih.gov/drugsnew/DrugDetailNT.aspx?int_id=244&ClassI….
3 “Kaletra.” Abbott Laboratories. 2010. http://www.kaletra.com/consumer_kaletra_difference.cfm?s_mcid=google. 6 July 2011.
4 See e.g., Medicines Patent Pool Patent Status Database for Selected HIV Medicines, available at: http://www.medicinespatentpool.org/LICENSING/Patent-Status-of-ARVs.
5 http://www.clintonfoundation.org/files/chai_arv_ceilingPriceList_201105_…
6 Maybarduk, Peter. “Colombia Sets Price Ceiling on Important HIV/AIDS Drug.” Essential Action. 11 May 2009. http://www.essentialaction.org/access/index.php?/archives/182-Colombia-S… 25 July 2011. Abbott offers an

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