abacavir (ABC)

Nucleoside & Nucleotide Reverse Transcriptase Inhibitors (NRTI & NtRTI)

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Price information:Developing country prices in US$ per patient per year, as quoted by companies. The price in brackets corresponds to the unit price of one capsule/tablet/ml of oral solution.
Daily Dose ViiV Aspen Aurobindo Cipla Hetero Matrix (Mylan) Ranbaxy Strides
ABC 20mg/ml oral solution
(paediatrics)		 12ml 415 (0.095/ml) 183 (0.042/ml) 256(0.058/ml) 210 (0.048/ml) 160 (0.036/ml)
ABC 60mg tablet
(paediatrics)		 4 134 (0.092) 170 (0.117) 122 (0.083)
ABC 300mg tablet 2 380 (0.520) 183 (0.250) 243 (0.333) 169 (0.232) 170(0.233) 237 (0.325) 256 (0.350)
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Please refer to Annex 2 for the conditions of eligibility set by individual companies, and for the incoterms associated with these prices.

Products quality assured by US FDA and WHO prequalification (as of June 2012) are in bold.

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Evolution of the lowest price quoted for eligible developing countries since 2001:

As of June 2012, there are six generic sources of ABC 300mg tablet which are quality-assured by US FDA or WHO prequalification. The lowest price is shown here.

Since 2001, the originator price has decreased by 73% while the generic price has dropped by 94%.

Also found in the following Fixed-Dose Combinations (FDCs):

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General Information

• Therapeutic class: Nucleoside reverse transcriptase inhibitor (NRTI).

• 2010 WHO Guidelines: Indicated for treatment for adults and adolescents. For infants and children, it is an alternate NRTI in first-line treatment.13, 29

• Originator company, and product brand name: GlaxoSmithKline (GSK), Ziagen. In April 2009, Pfizer and GSK jointly announced the creation of ViiV, a new joint venture focusing solely on the R&D and commercialisation of HIV medicines.

• First approved by US Food and Drug Administration (FDA): December 1998.30

• WHO Model List of Essential Medicines (EML): Included in the 17th edition for adults and the
3rd edition for children.31,32

• World sales of originator product for 2011: Sales not reported; 2010: Sales not reported; 2009: US$160 million; 2008: $175 million; 2007: $215 million; 2006: $230 million; 2005: $268 million; 2004: $290 million.33, 34, 35, 36, 37, 38

• Patents: GSK applied for the basic patents on ABC in 198938 and 1990,39 and these expired in 2009 and 2010 respectively. To extend its patent monopoly, GSK subsequently applied for additional secondary patents related to new intermediates in 1995,40 to the hemisulfate salt of ABC in 1998,41 and to compositions of ABC particularly relevant for paediatric use in 1999,42 which are due to expire in 2015, 2018 and 2019 respectively.

How to read Price Information

This table provides information on developing country prices, as quoted by companies. All prices are quoted in United States Dollars (US$). Currency conversions were made on the day the price information was received using the currency converter site www.oanda.com.

For Additional Details, see How To Read the Drug Profiles

How to read Price Discounts

Each originator company applies different eligibility criteria for discounted prices on ARVs. Even if a country is eligible for a price discount from one company, it may be excluded from the list of eligible countries by another company. Category 1 describes countries that are eligible for the most discounted price. Category 2 describes countries that are offered a discount, usually considerably smaller than the discount offered to category 1 countries.

To know whether a country is eligible for a discounted price offered by a given company, or to find out the category of a given country by different companies, please refer to the annexes.

For Additional Details, see How To Read the Drug Profiles

How to read Price Changes Over Time

This chart shows the price evolution over time, for both originator and generic products, as quoted to MSF for the purpose of this document since 2001.

If a WHO prequalified generic product is available, the lowest price quoted is shown in the graph. If no generic product is WHO prequalified, the lowest possible price quoted is considered in the graph, regardless of quality status.

For Additional Details, see How To Read the Drug Profiles

How to read General Information

Drug profiles include general information, product history, and relevant WHO Guidance for each of the antiretrovirals (ARVs).15, 16 Single ARVs and fixed-dose combinations (FDCs) containing two or three ARVs have separate profiles.

For Additional Details, see How To Read the Drug Profiles

How to read Access Issues

The most salient issues related to access to each product is summarised here. The focus is on the availability of products, their affordability and their adaptability for the developing world.

A special comment has been included when appropriate with regard to paediatrics.

For Additional Details, see How To Read the Drug Profiles

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Spotlight on access issues

Affordability remains an issue with abacavir (ABC), despite the 94% decrease in price of the generic version since 2001. The current lowest generic price per patient per year for abacavir 300mg tablet is still more than double the lowest generic ppy of tenofovir (TDF) 300mg and zidovudine (AZT) 300mg.

Patents

GSK could not apply for the basic patents on ABC in countries which did not grant patents on pharmaceuticals before the full implementation of the TRIPS agreement. The basic patents on ABC have now expired in China.43

In addition, GSK applied for patents on the hemisulfate salt of ABC in India but withdrew this application in October 2007 after it was opposed by civil society groups in a pre-grant opposition procedure.44 However the same application on the hemisulfate salt of ABC was also filed by GSK in China in May 1998. It was granted in 2008 and will effectively block generic versions until 2018.

GSK also applied for a patent on the oral solution of ABC particularly relevant for paediatric use, which was granted in December 2007.46 This patent raised concerns over the continued generic availability of the ABC paediatric formulation. However, the paediatric composition patent has not been used by GSK to block the development of the ABC/3TC FDC for children.

Two patents of ABC on the composition for paediatric use and the hemisulfate salt were granted in ARIPO countries, while a patent on the hemisulfate salt was granted in OAPI countries.47

Paediatrics

ABC is approved for use in children. In its 2010 guidelines for antiretroviral therapy for HIV in infants and children, WHO recommends ABC as one of the possible NRTIs to be given with lamivudine (3TC) and either an NNRTI or a PI in the first line. WHO guidelines recommend a preferential order of NRTIs to be used in first-line regimens, with AZT preferred over ABC and ABC preferred over stavudine (d4T).29

ABC can also be part of a second-line regimen, depending on what has been used as first line.

There are currently three prequalified generic sources of the ABC 60mg tablet. However, the price of this formulation is still high despite the fact that the lowest generic price has decreased from US$134 ppy in 2011 to $122 ppy in 2012. ABC 60mg is also combined in a paediatric FDC with 3TC 30mg tablet, the 2012 reported price for which is $140 ppy. Please refer to the ABC/3TC drug profile.

Despite there being three qualified generic sources of the ABC 20mg/ml solution, price is still an issue. Currently, the lowest generic ppy for the abacavir solution is about double the lowest prequalified generic price ppy of the AZT 10mg/ml solution.