| Lumateperone Tosylate | Intra-Cellular | ||
| 10.5 and 21 mg ; Capsule, Oral |
Less Than $1000 mn
|
||
|
More Than 5
|
More Than 5
|
||
|
Less Than 5
|
Less Than 5
|
||
| None | None | ||
| CAPLYTA is an atypical antipsychotic indicated for the treatment of: • Schizophrenia in adults. • Depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate. | |||
|
Yes
| |||
| Caplyta | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ***** | *** ********* | *** ********* | *** ********* | *** ********* | **** ** *** **, **** | *** ********* | *** ********* | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | *** ********* | **** ** *** **, **** | **** ** *** **, **** (***** ******) | **** ** *** **, **** (***** ******) | **** ** *** **, **** (***** ******) | **** ** *** **, **** (***** ******) | **** ** *** **, **** (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) |
| ** *****'* | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | ******* | **** ** *** **, **** | ******* | ******* | **** ** *** **, **** | ******* | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** (***** ******) | **** ** *** **, **** (***** ******) | **** ** *** **, **** (***** ******) | **** ** *** **, **** (***** ******) | **** ** *** **, **** (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) |
| ****** | ******* | *** ********* | *** ********* | *** ********* | ******* | *** ********* | *** ********* | ******* | ******* | ******* | ******* | ******* | ******* | *** ********* | ******* | ******* (***** ******) | ******* (***** ******) | ******* (***** ******) | ******* (***** ******) | ******* (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) |
| Company | FTF Status / 180 days exclusivity | 30-Months stay | Current Litigation Status | Current Approval Status | Likelihood of launch |
|---|---|---|---|---|---|
| ***** | *** \ ********* | *** **, **** | ******* | ********* ******** | *** ****** *** **** |
| ** *****'* | *** \ ********* | *** **, **** | ******* / ********* ******* | **** | *** ****** *** **** |
| ****** | *** \ ********* | *** **, **** | ******* | ********* ******** | ******* *** **** *** *** **** |
| Lumateperone Tosylate | Intra-Cellular | ||
| 42 mg ; Capsule, Oral |
Less Than $1000 mn
|
||
|
More Than 5
|
More Than 5
|
||
|
Less Than 5
|
Less Than 5
|
||
| None | None | ||
| CAPLYTA is an atypical antipsychotic indicated for the treatment of: • Schizophrenia in adults. • Depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate. | |||
|
Yes
| |||
| Caplyta | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ********* | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | **** ** *** **, **** | *** ********* | *** ********* | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | *** ********* | **** ** *** **, **** | **** ** *** **, **** (***** ******) | **** ** *** **, **** (***** ******) | **** ** *** **, **** (***** ******) | **** ** *** **, **** (***** ******) | **** ** *** **, **** (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) |
| ***** | *** ********* | *** ********* | *** ********* | *** ********* | *** ********* | **** ** *** **, **** | *** ********* | *** ********* | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | *** ********* | **** ** *** **, **** | **** ** *** **, **** (***** ******) | **** ** *** **, **** (***** ******) | **** ** *** **, **** (***** ******) | **** ** *** **, **** (***** ******) | **** ** *** **, **** (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) |
| ** *****'* | *** ********* | **** ** *** **, **** | **** ** *** **, **** | *** ********* | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** | ******* | **** ** *** **, **** | **** ** *** **, **** | ******* | **** ** *** **, **** | ******* | **** ** *** **, **** | **** ** *** **, **** | **** ** *** **, **** (***** ******) | **** ** *** **, **** (***** ******) | **** ** *** **, **** (***** ******) | **** ** *** **, **** (***** ******) | **** ** *** **, **** (***** ******) | *** ********* (***** ******) | *** ********* (***** ******) |
| Company | FTF Status / 180 days exclusivity | 30-Months stay | Current Litigation Status | Current Approval Status | Likelihood of launch |
|---|---|---|---|---|---|
| ********* | *** \ ********* | *** **, **** | ******* | ********* ******** | *** ****** *** **** |
| ***** | *** \ ********* | *** **, **** | ******* | ********* ******** | *** ****** *** **** |
| ** *****'* | *** \ ********* | *** **, **** | ******* / ********* ******* | **** | *** ****** *** **** |
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| Drug Name | Generic Name | Dosage | Route of Administration | Probable FTF | Known Para IV Filers | Other ANDA Developers |
|---|