| Ivacaftor | Vertex pharma | ||
| 150 mg; Tablet, Oral |
Less Than $1000 mn
|
||
|
Less Than 5
|
Less Than 5
|
||
|
More Than 5
|
Less Than 5
|
||
| None | None | ||
| KALYDECO is indicated for the treatment CF in pediatric patients age 2-17 years of age who have one mutation in the CFTR gene that is responsive to ivacaftor potentiation | |||
|
Yes
| |||
| Kalydeco | Patent 1 | Patent 2 | Patent 3 | Patent 4 | Patent 5 | Patent 6 | Patent 7 | Patent 8 | Patent 9 | Patent 10 |
|---|---|---|---|---|---|---|---|---|---|---|
| *** ****** | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | ******* | ******* | *** ********* (***** ******) |
| ***** | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | ******* | ******* | *** ********* (***** ******) |
| ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | ******* | ******* | *** ********* (***** ******) |
| Company | FTF Status / 180 days exclusivity | 30-Months stay | Current Litigation Status | Current Approval Status | Likelihood of launch |
|---|---|---|---|---|---|
| *** ****** | *** \ ********* | *** **, **** | ******* | **** | ******* *** **** (******** ******) *** *** **** |
| ***** | **\ ** | *** **, **** | ******* | ********* ******** | ******* *** **** (******** ******) *** *** **** |
| ********* | ** \ ** | *** **, **** | ******* | ********* ******** | ******* *** **** (******** ******) *** *** **** |
| Ivacaftor | Vertex pharma | ||
| 25, 50, 75 mg/packet ; Oral Granules |
Less Than $1000 mn
|
||
|
Less Than 5
|
Less Than 5
|
||
|
More Than 5
|
Less Than 5
|
||
| None | None | ||
| KALYDECO is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients age 2 years and older who have one of the following mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R and R117H. | |||
|
Yes
| |||
| Kalydeco | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ***** | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | **** ** *** **, **** | *** ********* | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** (***** ******) | **** ** *** **, **** (***** ******) | **** ** *** **, **** (***** ******) |
| ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ********** ** ***-******* ******** ************ | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ********** ** ***-******* ******** ************ | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ************** *********** *** *************** ******* | ***** ***** ** *-[*,*-***(*,*-*************)-*-*************]-*,*-*******-*-************-*-*********** | ************** *********** *** *************** ******* | ************** *********** *** *************** ******* | ************** *********** *** *************** ******* | ************** *********** *** *************** ******* | ********** ******** ******* | ************** *********** *** *************** ******* | ************** *********** *** *************** ******* |
| 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 |
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