| DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM | None | ||
| 50MG;20MG;4MG, 125MG;50MG;10MG |
Less Than $1000 mn
|
||
| None | None | ||
| None | None | ||
| None | None | ||
| ALYFTREK is a combination of deutivacaftor, a CFTR potentiator, tezacaftor, and vanzacaftor indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation or another responsive mutation in the CFTR gene. If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one indicated mutation. | |||
|
Yes
| |||
| ALYFTREK | 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 | Patent 32 | Patent 33 | Patent 34 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| *** ********* | ||||||||||||||||||||||||||||||||||
| ********** ** ***-******* ******** ************ | ****** *********** ** **** ********** | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ********** **** ************ | ************** ************ ** (*)-*-(*,*-*************[*][*,*]******-*-**)-*-(*-(*,*-***************)-*-******-*-(*-*******-*-************-*-**)-**-*****-*-**)*********************** *** ************** ******* | ********** **** ************ | ********** **** ************ | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ***** ***** ** *[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ********** **** ************ | ************** ************ ** (*)-*-(*,*-*************[*][*,*]******-*-**)-*-(*-(*,*-***************)-*-******-*-(*-*******-*-************-*-**)-**-*****-*-**) ******************-***** *** ************** ******* | ***** ***** ** (*)-*(*,*-*************[*][*,*]******-*-**)-*-(*-(*,*-***************)-*-******-*-(*-*******-*-************-*-**)-**-*****-*-**)*********************** | ************** ************ *** *** ********* ** ****** ******** ************* *********** ********* ******** ******** | ********** ** ***-******* ******** ************ | ************** *********** *** *************** ******* | ********** ** ****** ******** ************* *********** *********, ************** ************, ******* ** *********, *** ******* *** ****** *** ********** | ************** *********** *** *************** ******* | ***** ***** ** (*)-*(*,*-*************[*][*,*]******-*-**)-*-(*-(*,*-***************)-*-******-*-(*-*******-*-************-*-**)-**-*****-*-**)*********************** | ********** ** ***-******* ******** ************ | ********** ** ****** ******** ************* *********** *********, ************** ************, ******* ** *********, *** ******* *** ****** *** ********** | *********** ***** ** **** ********** | ************** ************ *** *** ********* ** ****** ******** ************* *********** ********* ******** ******** | ******* ** ********* *** ****** ******** | ****** *********** ** **** ********** | ********** ** ***-******* ******** ************ |
Download ParaIV Report
| Drug Name | Generic Name | Dosage | Route of Administration | Probable FTF | Known Para IV Filers | Other ANDA Developers |
|---|