Abacavir is recommended by WHO as a component of first and second-line antiretroviral treatment regimens for infants and children. Abacavir is commonly known as ABC.
Summary
The compound patent for abacavir has expired. However, patents on the hemisulfate salt, the pediatric formulation, and the combination of abacavir with lamivudine have been widely granted in many jurisdictions. This could limit market competition for abacavir in certain countries, not covered by voluntary licenses.
Patent status
The compound patent on abacavir expired in 2010 in all jurisdictions for which recent data is available. There are, however, other patents on forms and formulations of abacavir that may affect the market for abacavir and formulations containing abacavir.
A patent on the hemisulfate salt is expected to expire in 2018. According to available information, the patent was granted in Algeria, Argentina, ARIPO member countries, China, EAPO member countries, Ecuador, Egypt, El Salvador, Georgia, Guatemala, Honduras, Indonesia, Jordan, Malaysia, Mexico, Morocco, Nicaragua, Nigeria, OAPI member countries, Pakistan, Panama, Peru, Philippines, South Africa, Sri Lanka, Tunisia, Turkey and Ukraine, and is pending in Brazil and Thailand.
A patent on the pediatric oral solution, version of abacavir, which is expected to expire in 2019, was granted in Algeria, Argentina, ARIPO member countries, Colombia, Dominican Republic, EAPO member countries, Guatemala, Honduras, India, Indonesia, Malaysia, Morocco, Mexico, Nicaragua, Pakistan, Panama, Peru, Philippines, South Africa, Sri Lanka, Thailand, Tunisia and Turkey, and is pending in Egypt.
Licensing status
The patent holder has committed to licensing abacavir to interested antiretroviral drug manufacturers for all low-income countries, least-developed countries and sub-Saharan Africa (at the time of announcement 69 countries). In February 2013, patents on pediatric formulations of abacavir and its combination with lamivudine for pediatric use, have been licensed to the Medicines Patents Pool with a geographical coverage of 118 countries.
In November 2014, the geographical scope was extended to 121 countries by including Peru, Ukraine and Venezuela. The licence also allows sale of abacavir in other countries where there are no patents in force. In addition, a license on abacavir pediatric formulations has been granted by the patent holder directly to at least one manufacturer with a more limited geographical scope.
In the context of the Medicines Patent Pool licence on dolutegravir, licensees benefit from a covenant not to sue for formulations containing abacavir and dolutegravir for countries covered by the dolutegravir licence.
In 2012, Indonesia issued a compulsory licence on abacavir, and Ecuador issued a compulsory licence on a combination patent (see below).
Combinations
Combinations of abacavir have been developed with lamivudine, and with lamivudine and zidovudine, and are sold by several generic manufacturers. Patents on the combination(s) exist in several jurisdictions, including ARIPO member countries, Brazil, China, EAPO member countries , Georgia, Malaysia, Mexico, OAPI member countries, Pakistan, Philippines, South Africa, Thailand, Turkey and Uzbekistan, and are pending in Sri Lanka.
A more recent combination of abacavir with lamivudine and dolutegravir received regulatory approval in the European Union and USA in 2014; patents on this combination are pending or granted in several jurisdictions.