| Roflumilast | Arcutis | ||
| 0.3% ; Cream |
Less Than $1000 mn
|
||
|
Less Than 5
|
Less Than 5
|
||
|
More Than 5
|
None | ||
| None | None | ||
| ZORYVE is a phosphodiesterase 4 inhibitor indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. | |||
|
Yes
| |||
| Zoryve | Patent 1 | Patent 2 | Patent 3 | Patent 4 | Patent 5 | Patent 6 |
|---|---|---|---|---|---|---|
| ******* | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** |
| ********** ** ******* ****** ** *********** | ******* *********** *********** ****** ******** ******** *** ****** **** **** | ********** ** ******* ****** ** *********** | ******* *********** *********** ****** ******** ******** *** ****** ****-**** | ********** ** ******* ****** ** *********** | ********** ** ******* ****** ** *********** |
| Company | FTF Status / 180 days exclusivity | 30-Months stay | Current Litigation Status | Current Approval Status | Likelihood of launch |
|---|---|---|---|---|---|
| ******* | *** \ ********* | *** **, **** | ******* | **** | *** ****** *** **** |
| Roflumilast | None | ||
|
Less Than $1000 mn
|
|||
| None | None | ||
| None | None | ||
| None | None | ||
| ZORYVE foam, 0.3%, is a phosphodiesterase 4 inhibitor indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older. | |||
|
Yes
| |||
| Zoryve | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| *** ********* | ||||||||||||||||||||
| ********** ** ******* ****** ** *********** | ********** ** ******* ****** ** *********** | ********** ** ******* ****** ** *********** | ******* *********** *********** ****** ******** ******** *** ****** **** **** | ******* *********** *********** ****** ********** ********** | ********** ** ******* ****** ** *********** | ******* *********** *********** ****** ******** ******** *** ****** ****-**** | ****** *** ******** **** ******* **** ************** ** *****************-* ********** | ******* *********** *********** ****** ******** ******** *** ****** **** **** | ******* *********** *********** ****** ******** ******** *** ****** ****-**** | *********** ************ **** ** ******** *************** ******* | *********** ************ **** ** ******** *************** ******* | ****** *** ******** **** ******* **** ************** ** *****************-* ********** | *********** ************ **** ** ******** *************** ******* | ********** ** ******* ****** ** *********** | ******* *********** *********** ****** ******** ******** *** ****** ****-**** | ******* *********** *********** ****** ********** ********** | ********** ** ******* ****** ** *********** | ****** *** ******** **** ******* **** ************** ** *****************-* ********** | ******* *********** ******* ***** |
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| Drug Name | Generic Name | Dosage | Route of Administration | Probable FTF | Known Para IV Filers | Other ANDA Developers |
|---|