| Cysteamine Bitartrate | Horizon Pharma | ||
| 25, 75 mg; Capsule delayed release |
Less Than $1000 mn
|
||
|
Less Than 5
|
Less Than 5
|
||
|
Less Than 5
|
None | ||
| None | None | ||
| PROCYSBI is a cystine-depleting agent indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older. | |||
|
Yes
| |||
| Procysbi | 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 |
|---|---|---|---|---|---|
| ***** | *** \ ********* | *** **, **** | *** ********* / ******* | **** | ** ***** **, **** |
| **** | ** \ ** | **** **, **** | ******* | **** | ***** **** **** |
| Cysteamine Bitartrate | Horizon Pharma | ||
| 75 mg/Packet and 300 mg/Packet ; Delayed-release Granules |
Less Than $1000 mn
|
||
|
Less Than 5
|
Less Than 5
|
||
|
Less Than 5
|
None | ||
| None | None | ||
| PROCYSBI is a cystine-depleting agent indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older. | |||
|
Yes
| |||
| Procysbi | Patent 1 | Patent 2 | Patent 3 | Patent 4 | Patent 5 | Patent 6 | Patent 7 | Patent 8 | Patent 9 | Patent 10 | Patent 11 | Patent 12 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| **** | **** ** ***** **, **** | **** ** ***** **, **** | **** ** ***** **, **** | **** ** ***** **, **** | **** ** ***** **, **** | *** ********* | *** ********* | *** ********* | **** ** ***** **, **** | *** ********* | *** ********* | *** ********* |
| ******* *** ******* ********** ************ *** ******* ******* ** ********* | ******* *** ******* ********** ************ *** ******* ******* ** ********* | ******* *** ******* ********** ************ *** ******* ******* ** ********* | ******* *** ******* ********** ************ *** ******* ******* ** ********* | *********** ****** *********, ********** *** *********** ******* | ******* ******* ********** **** ***********, *** ******* ** ****** *** ***** **** | *********** ****** **********, ********* *** *********** ******* | *********** ****** **********, ********* *** *********** ******* | ******* ******* ********** **** ***********, *** ******* ** ****** *** ***** **** | *********** ****** **********, ********* *** *********** ******* | *********** ****** **********, ********* *** *********** ******* | *********** ****** **********, ********* *** *********** ******* |
| 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 |
|---|