| Treprostinil | United Therapeutic Corporation | ||
| 2.5 mg; Tablet, Extended Release |
Less Than $1000 mn
|
||
|
Less Than 5
|
Less Than 5
|
||
|
Less Than 5
|
Less Than 5
|
||
| None | None | ||
| Indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. | |||
|
Yes
| |||
| Orenitram | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* |
| *** ****** | ******* | ******* | ******* | ******* | ******* | *** ********* | ******* | ******* | ******* | ******* | ******* | ******* | ******* |
| Company | FTF Status / 180 days exclusivity | 30-Months stay | Current Litigation Status | Current Approval Status | Likelihood of launch |
|---|---|---|---|---|---|
| ******* | *** \ ** | *** *, **** | ******* | ********* ******** | ** *** **, **** |
| *** ****** | ** \ ** | *** **, **** | ******* | **** | ** ** **** |
| Treprostinil | United Therapeutic Corporation | ||
| 0.25, 1 mg; Tablet ER |
Less Than $1000 mn
|
||
|
Less Than 5
|
Less Than 5
|
||
| None |
Less Than 5
|
||
| None | None | ||
| None | |||
|
No
| |||
| Orenitram | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* |
| Company | FTF Status / 180 days exclusivity | 30-Months stay | Current Litigation Status | Current Approval Status | Likelihood of launch |
|---|---|---|---|---|---|
| ******* | *** \ ** | *** **, **** | ******* | ********* ******** | ** *** **, **** |
| Treprostinil | United Therapeutic Corporation | ||
| 0.125, 5 mg; Tablet ER |
Less Than $1000 mn
|
||
|
Less Than 5
|
Less Than 5
|
||
|
Less Than 5
|
Less Than 5
|
||
| None | None | ||
| None | |||
|
No
| |||
| Orenitram | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ** ******* |
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| Drug Name | Generic Name | Dosage | Route of Administration | Probable FTF | Known Para IV Filers | Other ANDA Developers |
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