Lopinavir – LPV

Lopinavir, boosted with ritonavir, is recommended by WHO as a component of second-line antiretroviral treatment regimens for adults and children, and as a component of the first-line treatment regimen for children under three. Lopinavir is commonly known as LPV. When boosted with ritonavir it is known as LPV/r.

Summary

Patents on lopinavir, ritonavir and on the capsules and tablets of LPV/r have been granted or are pending in many jurisdictions. There are currently four quality-assured generic suppliers of LPV/r adult formulations and two suppliers of pediatric formulations. Competition among manufacturers for adult formulations may be limited to countries where there are no patents or where a compulsory license has been issued. As for pediatric formulations, market competition (or market entry by generics with new formulations) is likely to take place in countries covered by the Medicines Patent Pool license, or in countries where there are no patents in force.

Patent status

The compound patent for lopinavir is expected to expire in 2016 and has been granted in Argentina, Brazil, China, Colombia, Mexico, Pakistan, Philippines, South Africa and Thailand. Since lopinavir is available only in combination with ritonavir, patents on formulations of LPV/r are also very important, and are outlined below.

Licensing

In December 2014, certain pediatric formulations of LPV/r and ritonavir were licensed to the Medicines Patent Pool. The license includes 102 countries and allows for the sale of generic versions of LPV/r outside the licensed territory, to countries where there are no patents in force. The license is primarily on pediatric formulations suitable for children under three years of age.

Some countries (e.g. Ecuador) have issued compulsory licenses on ritonavir or on the combination of LPV/r (e.g. Indonesia and Thailand).

Combinations

A patent on the LPV/r soft gel capsules, expiring in 2017, was granted in Argentina, Brazil, China, Malaysia, Mexico, Philippines, South Africa and Turkey, and is pending in Pakistan and Thailand.
Two patents on LPV/r tablet formulations, which expire in 2024 and 2026 respectively, have been granted in Albania, Bosnia, China, EAPO member countries, Georgia, Guatemala, Indonesia, Malaysia, Mexico, Montenegro, Panama, Peru, Philippines, South Africa, Sri Lanka, Turkey, Ukraine and Viet Nam, and are pending in Brazil, Dominican Republic, Ecuador, El Salvador, Nicaragua and Thailand.

LPV/r is also available as an oral solution and as pellets (small pills or granules), both of which are for pediatric use.

The image above is of the drug LPV/r.

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