| IVACAFTOR; LUMACAFTOR | None | ||
| 125MG;200MG, 125MG;100MG |
Less Than $1000 mn
|
||
| None | None | ||
| None | None | ||
| None | None | ||
| ORKAMBI is a combination of lumacaftor and ivacaftor, a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator, indicated for the treatment of cystic fibrosis (CF) in patients age 2 years and older who are homozygous for the F508del mutation in the CFTR gene. If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene. | |||
|
Yes
| |||
| ORKAMBI | 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| *** ********* | ||||||||||||||||||||||||||||||||||||||||||||||
| ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**) ***********************)-*-*************-*-**)******* **** | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**) ***********************)-*-*************-*-**)******* **** | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**) ***********************)-*-*************-*-**)******* **** | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**) ***********************)-*-*************-*-**)******* **** | ****** ***** ** *-(*-(*-(*,*-*************[*] [*,*] ******-*-**) ***********************)-*-*************-*-**)******* **** | ****** ***** ** *-(*-(*-(*,*-*************[*] [*,*] ******-*-**) ***********************)-*-*************-*-**)******* **** | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**) ***********************)-*-*************-*-**) ******* **** | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**) ***********************)-*-*************-*-**) ******* **** | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**)***********************)-*-*************-*-**) ******* **** | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**)***********************)-*-*************-*-**) ******* **** | ****** ***** ** *-(*-(*-(*,*-*************[*] [*,*] ******-*-**) ***********************)-*-*************-*-**)******* **** | ****** ***** ** *-(*-(*-(*,*-*************[*] [*,*] ******-*-**) ***********************)-*-*************-*-**)******* **** | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ***** ***** ** *[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ***** ***** ** *[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ************** ************ ** *-(*-(*-(*,*-*************[*][*,*]******-*-**) ***********************)-*-*************-*-**) ******* **** *** ************** ******* | ************** ************ ** *-(*-(*-(*,*-*************[*][*,*]******-*-**) ***********************)-*-*************-*-**) ******* **** *** ************** ******* | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**)***********************)-*-*************-*-**) ******* **** | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**)***********************)-*-*************-*-**) ******* **** | ************** *********** *** *************** ******* | ************** *********** *** *************** ******* | ************** ************ ** *-(*-(*-(*,*-*************[*][*,*]******-*-**) ***********************)-*-*************-*-**) ******* **** *** ************** ******* | ************** ************ ** *-(*-(*-(*,*-*************[*][*,*]******-*-**) ***********************)-*-*************-*-**) ******* **** *** ************** ******* | ************** *********** *** *************** ******* | ************** *********** *** *************** ******* | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**)***********************)-*-*************-*-**) ******* **** | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**)***********************)-*-*************-*-**) ******* **** | ************** *********** *** *************** ******* | ************** *********** *** *************** ******* |
| IVACAFTOR; LUMACAFTOR | None | ||
| 125MG;100MG, 188MG;150MG, 94MG;75MG |
Less Than $1000 mn
|
||
| None | None | ||
| None | None | ||
| None | None | ||
| ORKAMBI is a combination of lumacaftor and ivacaftor, a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator, indicated for the treatment of cystic fibrosis (CF) in patients age 2 years and older who are homozygous for the F508del mutation in the CFTR gene. If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene. | |||
|
Yes
| |||
| ORKAMBI | 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 | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| *** ********* | ||||||||||||||||||||||||||||||||||||||||||
| ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**) ***********************)-*-*************-*-**)******* **** | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**) ***********************)-*-*************-*-**)******* **** | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**) ***********************)-*-*************-*-**)******* **** | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**) ***********************)-*-*************-*-**)******* **** | ****** ***** ** *-(*-(*-(*,*-*************[*] [*,*] ******-*-**) ***********************)-*-*************-*-**)******* **** | ****** ***** ** *-(*-(*-(*,*-*************[*] [*,*] ******-*-**) ***********************)-*-*************-*-**)******* **** | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**) ***********************)-*-*************-*-**) ******* **** | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**) ***********************)-*-*************-*-**) ******* **** | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**)***********************)-*-*************-*-**) ******* **** | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**)***********************)-*-*************-*-**) ******* **** | ****** ***** ** *-(*-(*-(*,*-*************[*] [*,*] ******-*-**) ***********************)-*-*************-*-**)******* **** | ****** ***** ** *-(*-(*-(*,*-*************[*] [*,*] ******-*-**) ***********************)-*-*************-*-**)******* **** | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ***** ***** ** *[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ***** ***** ** *[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**)***********************)-*-*************-*-**) ******* **** | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**)***********************)-*-*************-*-**) ******* **** | ************** *********** *** *************** ******* | ************** *********** *** *************** ******* | ************** *********** *** *************** ******* | ************** *********** *** *************** ******* | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**)***********************)-*-*************-*-**) ******* **** | ***** ***** ** *-(*-(*-(*,*-*************[*][*,*]******-*-**)***********************)-*-*************-*-**) ******* **** | ************** *********** *** *************** ******* | ************** *********** *** *************** ******* |
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| Drug Name | Generic Name | Dosage | Route of Administration | Probable FTF | Known Para IV Filers | Other ANDA Developers |
|---|