Details for New Drug Application (NDA): 021272
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NDA 021272 describes REMODULIN, which is a drug marketed by United Therap and is included in two NDAs. It is available from one supplier. There are five 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. Five 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. Five suppliers are listed for this compound. Additional details are available on the treprostinil profile page.
Summary for 021272
| Tradename: | REMODULIN |
| Applicant: | United Therap |
| Ingredient: | treprostinil |
| Patents: | 5 |
Pharmacology for NDA: 021272
| Physiological Effect | Vasodilation |
Suppliers and Packaging for NDA: 021272
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| REMODULIN | treprostinil | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021272 | NDA | United Therapeutics Corporation | 66302-101 | 66302-101-01 | 1 VIAL in 1 BOX (66302-101-01) / 20 mL in 1 VIAL |
| REMODULIN | treprostinil | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021272 | NDA | United Therapeutics Corporation | 66302-102 | 66302-102-01 | 1 VIAL in 1 BOX (66302-102-01) / 20 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Strength | 1MG/ML | ||||
| Approval Date: | May 21, 2002 | TE: | AP | RLD: | Yes | ||||
| Patent: | 11,723,887 | Patent Expiration: | Dec 15, 2028 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | 7,999,007 | Patent Expiration: | Mar 29, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION | ||||||||
| Patent: | 8,653,137 | Patent Expiration: | Sep 5, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION | ||||||||
Expired US Patents for NDA 021272
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| United Therap | REMODULIN | treprostinil | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021272-001 | May 21, 2002 | 10,076,505 | ⤷ Start Trial |
| United Therap | REMODULIN | treprostinil | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021272-005 | Jul 30, 2021 | 9,713,599 | ⤷ Start Trial |
| United Therap | REMODULIN | treprostinil | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021272-004 | May 21, 2002 | 9,713,599 | ⤷ Start Trial |
| United Therap | REMODULIN | treprostinil | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021272-002 | May 21, 2002 | 5,153,222 | ⤷ Start Trial |
| United Therap | REMODULIN | treprostinil | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021272-006 | Sep 28, 2023 | 9,199,908 | ⤷ Start Trial |
| United Therap | REMODULIN | treprostinil | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021272-004 | May 21, 2002 | 6,765,117 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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