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Developed by 
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Supported by 
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Bictegravir (BIC)
Developer(s)
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Drug structure
Bictegravir chemical structure
MedChemExpress
Drug information
Associated long-acting platforms
Oral solid form
Administration route
Oral
Therapeutic area(s)
HIV
Use case(s)
Treatment
Use of drug
Ease of administration
Self-administered
Frequency of administration
Other/Variable/Unknown : once daily within regimen
User acceptance
Not provided
Dosage
Available dose and strength
various fixed dose combinations
Maximum dose
Not provided
Recommended dosing regimen
Not provided
Additional comments
Not provided
Drug information
Drug's link(s)
Not provided
Generic name
https://go.drugbank.com/drugs/DB11799
Brand name
One of the three compounds of Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide)
Compound type
Small molecule
Drug class/category
Integrase strand transfer inhibitor (INSTI)
Lifecycle status
Not provided
Summary
Bictegravir is an integrase inhibitor used to treat HIV infections.
Alternative names are GS-9883 and GS-9883-01.
Bictegravir is used in combination with tenofovir alafenamide and emtricitabine to treat human immunodeficiency virus-1 (HIV-1) infection.
Approval status
In the US, it may be used in treatment-naive patients weighing at least 14 kg. Alternatively, it may be used to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir.
In Europe, it is approved for use in patients 2 years of age and older with evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.
Regulatory authorities
Approved in many HICs and LMICs
Safety
Not provided
Efficacy
Not provided
Evidence Summary
Not provided
Delivery device(s)
No delivery device
Scale-up and manufacturing prospects
Scale-up prospects
Not provided
Tentative equipment list for manufacturing
Not provided
Manufacturing
Not provided
Specific analytical instrument required for characterization of formulation
Not provided
Clinical trials
Not providedExcipients
Proprietary excipients used
No proprietary excipient used
Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration
No novel excipient or existing excipient used
Residual solvents used
No residual solvent used
Patent info
Compound patent families
Patent informations
| Patent description | Representative patent | Categories | Patent holder | Licence with MPP | Patent source |
|---|---|---|---|---|---|
|
Bictegravir sodium
Expiry date: 2035-06-19 The present Invention relates to sodium (2R,5S,13aR)-7,9-dioxo-10 -((2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2':4,5] pyrazino[2,1-b][1,3]oxazepin-8-olate Form I. |
WO2015196116 | Compound | Gilead Sciences Inc | No |
Patent status
| Patent status/countries | Low, Low- middle and upper-middle | High income |
|---|---|---|
| Granted | World Intellectual Property Organization (WIPO), Argentina, China, Cuba, Dominican Republic, Belarus, Tajikistan, Kazakhstan, Azerbaijan, Kyrgyzstan, Armenia, Türkiye, North Macedonia, Albania, Bosnia and Herzegovina, Montenegro, Serbia, Morocco, Moldova, Republic of, Mexico, Peru, Philippines, El Salvador, India, Benin, Cameroon, Burkina Faso, Chad, Guinea-Bissau, Comoros, Mali, Senegal, Congo, Guinea, Gabon, Niger, Equatorial Guinea, Mauritania, Togo, Côte d'Ivoire, Central African Republic, Botswana, Gambia (the), Ghana, Kenya, Lesotho, Malawi, Mozambique, Namibia, Sierra Leone, Liberia, Rwanda, Sao Tome and Principe, Sudan, Eswatini, Tanzania, United Republic of, Zambia, Zimbabwe, Bolivia (Plurinational State of), Brazil, Colombia, Ecuador, Egypt, Guatemala, Indonesia, Malaysia, Nigeria, Pakistan, Paraguay, South Africa, Venezuela (Bolivarian Republic of), Viet Nam, Turkmenistan, Ukraine, Thailand | Canada, Australia, Israel, Japan, Korea, Republic of, Singapore, Taiwan, Province of China, United States of America, World Intellectual Property Organization (WIPO), Chile, Costa Rica, Russian Federation, Belgium, Germany, France, Luxembourg, Netherlands, Switzerland, United Kingdom, Sweden, Italy, Austria, Liechtenstein, Greece, Spain, Denmark, Monaco, Portugal, Ireland, Finland, Cyprus, Bulgaria, Czechia, Estonia, Slovakia, Hungary, Poland, Iceland, Malta, Norway, San Marino, Croatia, Romania, Latvia, Lithuania, Slovenia, Uruguay, Bahrain, Kuwait, Qatar, Saudi Arabia, Oman, United Arab Emirates, Panama, Trinidad and Tobago, New Zealand, Bahamas, Hong Kong, Macao |
| Filed | ||
| Not in force |
Patent informations
| Patent description | Representative patent | Categories | Patent holder | Licence with MPP | Patent source |
|---|---|---|---|---|---|
|
Bictegravir synthesis
Expiry date: 2035-06-16 Methods of making compounds of Formula (I) are disclosed. |
WO2015195656 | Process | Gilead Sciences, Inc | No |
Patent status
| Patent status/countries | Low, Low- middle and upper-middle | High income |
|---|---|---|
| Granted | World Intellectual Property Organization (WIPO), Argentina, China, Belarus, Tajikistan, Kazakhstan, Azerbaijan, Kyrgyzstan, Armenia, Türkiye, North Macedonia, Albania, Bosnia and Herzegovina, Montenegro, Serbia, Morocco, Mexico, Brazil, Turkmenistan, India | Canada, Australia, Israel, Japan, Korea, Republic of, Singapore, Taiwan, Province of China, United States of America, World Intellectual Property Organization (WIPO), Russian Federation, Belgium, Germany, France, Luxembourg, Netherlands, Switzerland, United Kingdom, Sweden, Italy, Austria, Liechtenstein, Greece, Spain, Denmark, Monaco, Portugal, Ireland, Finland, Cyprus, Bulgaria, Czechia, Estonia, Slovakia, Hungary, Poland, Iceland, Malta, Norway, San Marino, Croatia, Romania, Latvia, Lithuania, Slovenia, New Zealand, Bahamas, Hong Kong, Macao |
| Filed | ||
| Not in force |
Patent informations
| Patent description | Representative patent | Categories | Patent holder | Licence with MPP | Patent source |
|---|---|---|---|---|---|
|
Bictegravir compounds
Expiry date: 2033-12-19 Compounds for use in the treatment of human immunodeficiency virus (HIV) infection are disclosed. The compounds have the following Formula (I): including stereoisomers and pharmaceutically acceptable salts thereof, wherein R1, X, W, Y1, Y2, &Zgr;1 and Z4 are as defined herein. Methods associated with preparation and use of such compounds, as well as pharmaceutical compositions comprising such compounds, are also disclosed. |
WO2014100323 | Compound | Gilead Sciences, Inc | No |
Patent status
| Patent status/countries | Low, Low- middle and upper-middle | High income |
|---|---|---|
| Granted | World Intellectual Property Organization (WIPO), Argentina, Brazil, China, Belarus, Tajikistan, Kazakhstan, Azerbaijan, Kyrgyzstan, Armenia, Türkiye, North Macedonia, Albania, Bosnia and Herzegovina, Montenegro, Serbia, Moldova, Republic of, Mexico, Peru, Philippines, Gambia (the), Kenya, Malawi, Sierra Leone, Liberia, Zimbabwe, Bolivia (Plurinational State of), Ecuador, El Salvador, Ethiopia, Fiji, India, Colombia, Congo, democratic Republic of the, Egypt, Grenada, Indonesia, Jamaica, Kiribati, Nepal, Pakistan, Paraguay, Solomon Islands, South Africa, Thailand, Tuvalu, Ukraine, Venezuela (Bolivarian Republic of), Viet Nam, Malaysia, Turkmenistan, Botswana, Ghana, Lesotho, Mozambique, Namibia, Rwanda, Sudan, Eswatini, Tanzania, United Republic of, Uganda, Zambia, Saint Lucia | Canada, Australia, Hong Kong, Israel, Japan, Korea, Republic of, New Zealand, Singapore, Taiwan, Province of China, United States of America, World Intellectual Property Organization (WIPO), Chile, Costa Rica, Russian Federation, Belgium, Germany, France, Luxembourg, Netherlands, Switzerland, United Kingdom, Sweden, Italy, Austria, Liechtenstein, Greece, Spain, Denmark, Monaco, Portugal, Ireland, Finland, Cyprus, Bulgaria, Czechia, Estonia, Slovakia, Hungary, Poland, Iceland, Malta, Norway, San Marino, Croatia, Romania, Latvia, Lithuania, Slovenia, Uruguay, Anguilla, Bermuda, Falkland Islands (Malvinas), Bahrain, Kuwait, Qatar, Saudi Arabia, Oman, United Arab Emirates, Montserrat, Panama, Seychelles, Turks and Caicos Islands, Bahamas, Guyana, Gibraltar, Jersey, Macao, Guernsey |
| Filed | ||
| Not in force |
Supporting material
Publications
There are no publication
Additional documents
No documents were uploaded
Useful links
There are no additional links
Additional information
Not provided