Rilpivirine was approved by the United States Food and Drug Administration in 2011. It is not currently included in the WHO guidelines. Rilpivirine is also commonly known as RPV.
Summary
While no quality-assured generic versions of this drug are available yet, market competition for this antiretroviral drug will be possible in countries covered by the voluntary license.
Patent status
The compound patent on rilpivirine is expected to expire in 2022. The patent has been granted in Albania, Argentina, ARIPO member countries, China, EAPO member countries, Egypt, India, Indonesia, Mexico, OAPI member countries, Panama, Philippines, South Africa, Sri Lanka, Turkey and Ukraine, and appears to be pending in Brazil, Jordan, Malaysia, Pakistan, Thailand, Venezuela and Viet Nam.
A patent on the salt form of the drug expires in 2025. The patent has been granted in ARIPO member countries, EAPO member countries, Indonesia, Mexico, Philippines, South Africa, Turkey and Ukraine, and is pending in Brazil, China, Ecuador and Viet Nam.
Licensing status
Voluntary licenses for rilpivirine have been granted to five manufacturers covering 112 countries. The detailed terms and conditions are not publicly available.
Combinations
A combination of rilpivirine with TDF/FTC was developed and obtained regulatory approval in the US in 2011. Clinical trials are ongoing for other combinations containing rilpivirine and for a long-acting formulation.