| ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | None | ||
| 100MG,75MG,50MG;150MG, 50MG,37.5MG,25MG;75MG |
Less Than $1000 mn
|
||
| None | None | ||
| None | None | ||
| None | None | ||
| TRIKAFTA is a combination of ivacaftor, a CFTR potentiator, tezacaftor, and elexacaftor indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data. | |||
|
Yes
| |||
| TRIKAFTA (COPACKAGED) | Patent 1 | Patent 2 | Patent 3 | Patent 4 | Patent 5 | Patent 6 | Patent 7 | Patent 8 | Patent 9 | Patent 10 | Patent 11 | Patent 12 | Patent 13 | Patent 14 | Patent 15 | Patent 16 | Patent 17 | Patent 18 | Patent 19 | Patent 20 | Patent 21 | Patent 22 | Patent 23 | Patent 24 | Patent 25 | Patent 26 | Patent 27 | Patent 28 | Patent 29 | Patent 30 | Patent 31 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| *** ********* | |||||||||||||||||||||||||||||||
| ********** ** ***-******* ******** ************ | ****** *********** ** **** ********** | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ************** ************ ** (*)-*-(*,*-*************[*][*,*]******-*-**)-*-(*-(*,*-***************)-*-******-*-(*-*******-*-************-*-**)-**-*****-*-**)*********************** *** ************** ******* | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ***** ***** ** *[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ***** ***** ** (*)-*(*,*-*************[*][*,*]******-*-**)-*-(*-(*,*-***************)-*-******-*-(*-*******-*-************-*-**)-**-*****-*-**)*********************** | ********** ** ***-******* ******** ************ | ************** *********** *** *************** ******* | ********** ** ****** ******** ************* *********** ********* | ********* ** *** ****** ******** ************* *********** *********, ************** ************, ******* ** *********, *** ******* *** ****** *** ********* | ************** ************ *** ******** ****** ******** | ********** ** ****** ******** ************* *********** ********* | ********* ** *** ****** ******** ************* *********** *********, ************** ************, ******* ** *********, *** ******* *** ****** *** ********* | ******* ** ********* *** ****** ******** | ************** *********** *** *************** ******* | ***** ***** ** (*)-*(*,*-*************[*][*,*]******-*-**)-*-(*-(*,*-***************)-*-******-*-(*-*******-*-************-*-**)-**-*****-*-**)*********************** | ********** ** ***-******* ******** ************ | ******* ** ********* *** ****** ******** | ************** *********** *** *************** ******* | ****** *********** ** **** ********** | ********** ** ***-******* ******** ************ |
| ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | None | ||
| ;59.5MG |
Less Than $1000 mn
|
||
| None | None | ||
| None | None | ||
| None | None | ||
| TRIKAFTA is a combination of ivacaftor, a CFTR potentiator, tezacaftor, and elexacaftor indicated for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one F508del mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data. If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one F508del mutation or a mutation that is responsive based on in vitro data. | |||
|
Yes
| |||
| TRIKAFTA (COPACKAGED) | Patent 1 | ||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| *** ********* | |||||||||||||||||||||||||||||||||||
| ********** ** ***-******* ******** ************ | ****** *********** ** **** ********** | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ************** *********** *** *************** ******* | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ***** ***** ** *[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ***** ***** ** (*)-*(*,*-*************[*][*,*]******-*-**)-*-(*-(*,*-***************)-*-******-*-(*-*******-*-************-*-**)-**-*****-*-**)*********************** | ********** ** ***-******* ******** ************ | ************** *********** *** *************** ******* | ************** *********** *** *************** ******* | ********** ** ****** ******** ************* *********** ********* | ********* ** *** ****** ******** ************* *********** *********, ************** ************, ******* ** *********, *** ******* *** ****** *** ********* | ************** *********** *** *************** ******* | ************** ************ *** ******** ****** ******** | ********** ** ****** ******** ************* *********** ********* | ********* ** *** ****** ******** ************* *********** *********, ************** ************, ******* ** *********, *** ******* *** ****** *** ********* | ******* ** ********* *** ****** ******** | ************** *********** *** *************** ******* | ***** ***** ** (*)-*(*,*-*************[*][*,*]******-*-**)-*-(*-(*,*-***************)-*-******-*-(*-*******-*-************-*-**)-**-*****-*-**)*********************** | ********** ** ***-******* ******** ************ | ************** *********** *** *************** ******* | ************** *********** *** *************** ******* | ******* ** ********* *** ****** ******** | ************** *********** *** *************** ******* | ****** *********** ** **** ********** | ********** ** ***-******* ******** ************ |
| ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | None | ||
| ;75MG |
Less Than $1000 mn
|
||
| None | None | ||
| None | None | ||
| None | None | ||
| TRIKAFTA is a combination of ivacaftor, a CFTR potentiator, tezacaftor, and elexacaftor indicated for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one F508del mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data. If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one F508del mutation or a mutation that is responsive based on in vitro data. | |||
|
Yes
| |||
| TRIKAFTA (COPACKAGED) | Patent 1 | ||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| *** ********* | |||||||||||||||||||||||||||||||||||
| ********** ** ***-******* ******** ************ | ****** *********** ** **** ********** | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ************** *********** *** *************** ******* | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ***** ***** ** *[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ***** ***** ** (*)-*(*,*-*************[*][*,*]******-*-**)-*-(*-(*,*-***************)-*-******-*-(*-*******-*-************-*-**)-**-*****-*-**)*********************** | ********** ** ***-******* ******** ************ | ************** *********** *** *************** ******* | ************** *********** *** *************** ******* | ********** ** ****** ******** ************* *********** ********* | ********* ** *** ****** ******** ************* *********** *********, ************** ************, ******* ** *********, *** ******* *** ****** *** ********* | ************** *********** *** *************** ******* | ************** ************ *** ******** ****** ******** | ********** ** ****** ******** ************* *********** ********* | ********* ** *** ****** ******** ************* *********** *********, ************** ************, ******* ** *********, *** ******* *** ****** *** ********* | ******* ** ********* *** ****** ******** | ************** *********** *** *************** ******* | ***** ***** ** (*)-*(*,*-*************[*][*,*]******-*-**)-*-(*-(*,*-***************)-*-******-*-(*-*******-*-************-*-**)-**-*****-*-**)*********************** | ********** ** ***-******* ******** ************ | ************** *********** *** *************** ******* | ************** *********** *** *************** ******* | ******* ** ********* *** ****** ******** | ************** *********** *** *************** ******* | ****** *********** ** **** ********** | ********** ** ***-******* ******** ************ |
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| Drug Name | Generic Name | Dosage | Route of Administration | Probable FTF | Known Para IV Filers | Other ANDA Developers |
|---|