| Bictegravir Sodium, Emtricitabine and Tenofovir Alafenamide Fumarate | Gilead | ||
| 50 mg/200 mg/ 25 mg ; Tablets |
More Than $1000 mn
|
||
|
Less Than 5
|
Less Than 5
|
||
|
More Than 5
|
Less Than 5
|
||
| None | None | ||
| BIKTARVY is a three-drug combination of bictegravir (BIC), a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or 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 for at least 3 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of BIKTARVY. | |||
|
Yes
| |||
| Biktarvy | Patent 1 | Patent 2 | Patent 3 | Patent 4 | Patent 5 | Patent 6 | Patent 7 | Patent 8 | Patent 9 | Patent 10 | Patent 11 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| ***** | ******* **** *** | *** ********* | ******* **** *** | ******* **** *** | ******* **** *** | ******* | ******* **** *** | ******* | ******* | ******* | ******* (***** ******) |
| ****** **** | ******* **** *** | *** ********* | ******* **** *** | ******* **** *** | ******* **** *** | ******* | ******* **** *** | ******* | ******* | ******* | ******* (***** ******) |
| ***** | **** *** | *** ********* | **** *** | **** *** | **** *** | ******* | **** *** | ******* | ******* | ******* | ******* (***** ******) |
| Company | FTF Status / 180 days exclusivity | 30-Months stay | Current Litigation Status | Current Approval Status | Likelihood of launch |
|---|---|---|---|---|---|
| ***** | *** / ********* | *** **, **** | ******* | ********* ******** | ** *** **, **** |
| ****** **** | *** / ********* | *** **, **** | ******* | ********* ******** | ** *** **, **** |
| ***** | *** / ********* | *** **, **** | ******* | **** | ** *** **, **** |
| Bictegravir Sodium, Emtricitabine and Tenofovir Alafenamide Fumarate | Gilead | ||
| 30 mg / 120 mg / 15 mg ; Tablet |
More Than $1000 mn
|
||
| None | None | ||
|
More Than 5
|
Less Than 5
|
||
| None | None | ||
| BIKTARVY is a three-drug combination of bictegravir (BIC), a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or 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 history of treatment failure and no known substitutions associated with resistance to the individual components of BIKTARVY. | |||
|
Yes
| |||
| Biktarvy | Patent 1 | Patent 2 | Patent 3 | Patent 4 | Patent 5 | Patent 6 | Patent 7 |
|---|---|---|---|---|---|---|---|
| ***** | ******* *** ********* | ******* *** ********* | ******* *** ********* | ******* *** ********* | ******* *** ********* | ******* *** ********* | ******* *** ********* |
| ****** (**,**,****)-*,*-*****-**-((*,*,*-***************)*********)-*,*,*,*,*,*,**,***-*********-*,*-*************[*′,*′:*,*]********[*,*-*][*,*]********-*-***** | ******** ** *********** ********** ********* | ********* *********** ************ | *********** *,*,*,*,*,*,**,***-***************[*′,*′:*,*]********[*,*-*][*,*]********** *** ******* *** ******** ***** ********** | ********* *********** ************ | ****** (**,**,****)-*,*-*****-**-((*,*,*-***************)*********)-*,*,*,*,*,*,**,***-*********-*,*-*************[*′,*′:*,*]********[*, *-*][*, *]********-*-***** | *********** *,*,*,*,*,*,**,***-***************[*′,*′:*,*]********[*,*-*][*,*]********** *** ******* *** ******** ***** ********** |
| Company | FTF Status / 180 days exclusivity | 30-Months stay | Current Litigation Status | Current Approval Status | Likelihood of launch |
|---|---|---|---|---|---|
| ***** | *** \ ********* | ** | ******* *** ********* | ********* ******** | ** *** **, **** |
Download ParaIV Report
| Drug Name | Generic Name | Dosage | Route of Administration | Probable FTF | Known Para IV Filers | Other ANDA Developers |
|---|