DACLATASVIR (DAC)
In November 2015, the Medicines Patent Pool (MPP) announced a licensing agreement with Bristol Myers Squibb (BMS) covering the direct-acting antiviral (DAA) drug daclatasvir (DAC), and its combinations. The agreement allows generic manufacture of the hepatitis C treatment for sale in at least 112 countries that together are home to 65.4% of people living with HCV in low- and middle-income countries. In addition to the countries in the Territory, DAC can be supplied into these additional countries:Albania, Argentina, Armenia, Belarus, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, China, Colombia, Egypt, Jordan, Kazakhstan, Kosovo, Kyrgyzstan, Lebanon, Malaysia, Mexico, Moldova, Montenegro, North Macedonia, Peru, Romania, Serbia, Tajikistan, Thailand, Turkey, Ukraine, United Arab Emirates, Uruguay, and Venezuela. As of December 2021, generic daclatasvir can be supplied to at least 143 countries.
| Eligibility for sublicences | Sublicences can be issued to qualified entities worldwide. |
| Manufacturing | Allows for the manufacturing of generic active pharmaceutical ingredient and finished formulations of DCV anywhere in the world. |
| Geographical scope for sale | Allows for sale in at least 112 countries where 65.4% of people living with HCV in low- and middle-income countries live. |
| Sales outside the licensed territory | Enables manufacturers that do not rely on BMS technology to sell outside the 112 countries if no granted patent is being infringed. This includes cases in which a compulsory licence is issued. |
| Royalties | The license is royalty free. |
| Quality assurance | Licensees must obtain approval from WHO Pre-qualification, or a Stringent Regulatory Authority. Where such approval is not yet available, temporary approval from a WHO Expert Review Panel may be obtained. |
| Combinations | Sublicensees have the right to combine DCV with other drugs and to develop new fixed-dose combinations. |
| Data exclusivity | Data exclusivity is waived in countries with such form of protection, thus facilitating regulatory approval of generics. |
| Patent disclosure | The licence discloses the list of pending and granted patents worldwide at the time of licence signing. |
| Technology transfer |
A technology transfer package is provided to all the sublicensees, but there is no obligation to use the technology. Information necessary for registration is also provided. |
Six sublicensees, namely Cipla, Hetero, Laurus, Mylan, Natco and Zydus Cadila have taken the technical decision not to rely on the licensed technology transfer package.
Quality assured formulations from MPP generic partners:
- DAC 30mg
- DAC 60mg
- DAC/SOF 60/400 mg
GENERIC PARTNERS AND PRODUCT DEVELOPERS
Click the logos to access the sublicensing agreements:
