Gilead Technology Transfers/Licensing Agreements
Since 2006, Gilead has been licensing its patented HIV and viral hepatitis medicines to generic manufacturers that have proven they can develop and commercialize high-quality, low-cost medicines in low- and middle-income countries. Gilead provides full technology transfers to its licensees and allows generic manufacturers to set their own prices.
The objective of Gilead’s technology transfers is to ensure that generic versions of Gilead medicines – in their intended composition – reach the patients who need them.
The initiative aims to leverage Gilead’s product-specific expertise by equipping local producers who are best prepared to conduct large-scale manufacturing with the technological tools to expand production.
Gilead has been involved in licensing to generic manufacturers since 2006 when it granted its first license to HIV patents. This is part of an effort to allow the development and commercialization of high-quality, low-cost medicines in low- and middle-income countries (LMICs). Gilead’s technology transfers are made in an effort to enable generic versions of Gilead medicines to reach the patients in LMICs who need them.
Gilead works with local producers to enable them to conduct large-scale manufacturing and provides manufacturers with assistance to help them ensure product safety and stability and provides technological tools to expand production. These licensees are able to obtain technology transfers of manufacturing processes not only for finished products, but also for the production of active ingredients. Licensees are then able to sell active pharmaceutical ingredients to other licensees and set their own pricing for finished products. Royalties paid to Gilead by these generic manufacturers are reinvested into Gilead’s support activities to maintain its voluntary licensing program.
Gilead makes it a priority to enable access to medicines based on Gilead innovation for people who can benefit from them, regardless of where they live or their economic status. Dedicated Gilead staff in conjunction with Gilead’s Global Patient Solutions unit oversee these technology transfers, make resources from other parts of the company available to licensees as needed and provide ongoing assistance to licensees after the technology transfer is completed. Gilead has an open line of communication with its licensees, meets with them regularly and is available to provide manufacturing guidance when needed to minimize any manufacturing disruptions.
Gilead’s voluntary licensing program for remdesivir, established in May 2020, has enabled access to the medicine for more than 8 million people in low- and middle income countries. These remdesivir licenses were issued on a royalty free basis.
Gilead was also the first innovator company to join the Medicines Patent Pool, which is a Unitaid-backed organization that works with pharmaceutical companies to expand global access to high-quality, low-cost antiretroviral therapy through the licensing of patents. Today, 18 patent holders have joined the Pool and license their compounds to 57 generic manufacturers.
Results and milestones
Gilead measures the progress of its technology transfers by total patients reached and WHO pre-qualifications and tentative FDA approvals received. To date, 12.6 million people in developing countries are on Gilead-based HIV treatments, 98 percent of whom are receiving licensed generic medicines. 1.7 million people in low- and middle-income countries have been treated with Gilead’s hepatitis C medicines, 1.3 million of whom received generics. Our generic licensees have received more than 30 WHO pre-qualifications and/or FDA tentative approvals for their products.
Since the launch of Gilead’s voluntary generic licensing program, competition among licensees has reduced the lowest price of a Gilead HIV generic therapy, tenofovir disoproxil fumarate, by 89 percent, to as low as $1.80 per patient per month. The lowest price of a Gilead hepatitis C generic therapy, sofosbuvir, is $10.
Today, over 25 generic manufacturers hold licenses to Gilead medicines. Generic versions of our HIV and hepatitis B medicines are available in 116 countries and generic hepatitis C treatments are available in 105 countries.
- Eastern Mediterranean
- South-East Asia
- Western Pacific
- Infectious and Parasitic Disease
- People with low incomes
SGDs the partnership contributes to
- 3.3: Communicable Diseases & NTDs
- 3.8: Achieve universal health coverage
- Burkina Faso
- Cabo Verde
- Central African Republic
- Côte d'Ivoire
- Democratic Republic of the Congo
- Equatorial Guinea
- Sao Tome and Principe
- Sierra Leone
- South Africa
- South Sudan
- United Republic of Tanzania
- Antigua and Barbuda
- Bolivia (Plurinational State of)
- Dominican Republic
- El Salvador
- Saint Kitts and Nevis
- Saint Lucia
- Saint Vincent and the Grenadines
- Trinidad and Tobago
- Syrian Arab Republic
- Republic of Moldova
- Sri Lanka
- Lao People's Democratic Republic
- Papua New Guinea
- Solomon Islands
- Viet Nam
Infectious and Parasitic Disease
- Hepatitis C
- Hepatitis B