| Treprostinil Sodium | United Therapeutic Corporation | ||
| 1, 2.5, 5, 10 mg/ml INJECTABLE;IV (INFUSION), SUBC |
Less Than $1000 mn
|
||
|
Less Than 5
|
Less Than 5
|
||
|
More Than 5
|
None | ||
|
Less Than 5
|
Less Than 5
|
||
| indicated for the treatment of pulmonary arterial hypertension | |||
|
Yes
| |||
| Remodulin | Patent 1 | Patent 2 | Patent 3 | Patent 4 | Patent 5 | Patent 6 | Patent 7 | Patent 8 | Patent 9 | Patent 10 | Patent 11 |
|---|---|---|---|---|---|---|---|---|---|---|---|
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| Company | FTF Status / 180 days exclusivity | 30-Months stay | Current Litigation Status | Current Approval Status | Likelihood of launch |
|---|---|---|---|---|---|
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| Treprostinil Sodium | None | ||
| 20MG/20ML, 50MG/20ML, 100MG/20ML, 200MG/20ML |
Less Than $1000 mn
|
||
| None | None | ||
| None | None | ||
| None | None | ||
| Remodulin is a prostacyclin vasodilator indicated for: • Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). • Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. | |||
|
Yes
| |||
| Remodulin | Patent 1 | Patent 2 | Patent 3 | Patent 4 |
|---|---|---|---|---|
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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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