Details for New Drug Application (NDA): 214324
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NDA 214324 describes TYVASO DPI, which is a drug marketed by United Therap and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the TYVASO DPI profile page.
The generic ingredient in TYVASO DPI 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 TYVASO DPI 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 214324
| Tradename: | TYVASO DPI |
| Applicant: | United Therap |
| Ingredient: | treprostinil |
| Patents: | 7 |
Pharmacology for NDA: 214324
| Physiological Effect | Vasodilation |
Suppliers and Packaging for NDA: 214324
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TYVASO DPI | treprostinil | POWDER;INHALATION | 214324 | NDA | United Therapeutics Corporation | 66302-610 | 66302-610-02 | 1 KIT in 1 PACKAGE (66302-610-02) * 4 INHALANT in 1 BLISTER PACK * 4 INHALANT in 1 BLISTER PACK * 4 INHALANT in 1 BLISTER PACK |
| TYVASO DPI | treprostinil | POWDER;INHALATION | 214324 | NDA | United Therapeutics Corporation | 66302-616 | 66302-616-03 | 4 BLISTER PACK in 1 KIT (66302-616-03) / 7 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 0.016MG/INH | ||||
| Approval Date: | May 23, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 23, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 10,130,685 | Patent Expiration: | Aug 23, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 10,421,729 | Patent Expiration: | Apr 1, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 214324
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| United Therap | TYVASO DPI | treprostinil | POWDER;INHALATION | 214324-003 | May 23, 2022 | 10,130,685 | ⤷ Get Started Free |
| United Therap | TYVASO DPI | treprostinil | POWDER;INHALATION | 214324-005 | Oct 24, 2024 | 10,130,685 | ⤷ Get Started Free |
| United Therap | TYVASO DPI | treprostinil | POWDER;INHALATION | 214324-004 | May 23, 2022 | 10,130,685 | ⤷ Get Started Free |
| United Therap | TYVASO DPI | treprostinil | POWDER;INHALATION | 214324-002 | May 23, 2022 | 10,130,685 | ⤷ Get Started Free |
| United Therap | TYVASO DPI | treprostinil | POWDER;INHALATION | 214324-001 | May 23, 2022 | 10,130,685 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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