Details for New Drug Application (NDA): 208276
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NDA 208276 describes REMODULIN, which is a drug marketed by United Therap and is included in two NDAs. It is available from one supplier. There are nine patents protecting this drug and two Paragraph IV challenges. Additional details are available on the REMODULIN profile page.
The generic ingredient in REMODULIN is treprostinil. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the treprostinil profile page.
The generic ingredient in REMODULIN is treprostinil. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the treprostinil profile page.
Summary for 208276
| Tradename: | REMODULIN |
| Applicant: | United Therap |
| Ingredient: | treprostinil |
| Patents: | 3 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Strength | 20MG/20ML (1MG/ML) | ||||
| Approval Date: | Jul 30, 2018 | TE: | RLD: | No | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Dec 16, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | Dec 15, 2028 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | Dec 16, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER | ||||||||
Expired US Patents for NDA 208276
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| United Therap | REMODULIN | treprostinil | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 208276-003 | Jul 30, 2018 | ⤷ Subscribe | ⤷ Subscribe |
| United Therap | REMODULIN | treprostinil | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 208276-001 | Jul 30, 2018 | ⤷ Subscribe | ⤷ Subscribe |
| United Therap | REMODULIN | treprostinil | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 208276-004 | Jul 30, 2018 | ⤷ Subscribe | ⤷ Subscribe |
| United Therap | REMODULIN | treprostinil | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 208276-004 | Jul 30, 2018 | ⤷ Subscribe | ⤷ Subscribe |
| United Therap | REMODULIN | treprostinil | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 208276-002 | Jul 30, 2018 | ⤷ Subscribe | ⤷ Subscribe |
| United Therap | REMODULIN | treprostinil | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 208276-003 | Jul 30, 2018 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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