Details for New Drug Application (NDA): 213005
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NDA 213005 describes YUTREPIA, which is a drug marketed by Liquidia Tech and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the YUTREPIA profile page.
The generic ingredient in YUTREPIA is treprostinil sodium. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the treprostinil sodium profile page.
The generic ingredient in YUTREPIA is treprostinil sodium. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the treprostinil sodium profile page.
Summary for 213005
| Tradename: | YUTREPIA |
| Applicant: | Liquidia Tech |
| Ingredient: | treprostinil sodium |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213005
Generic Entry Date for 213005*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT Dosage:
POWDER;INHALATION |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 213005
| Physiological Effect | Vasodilation |
Suppliers and Packaging for NDA: 213005
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| YUTREPIA | treprostinil sodium | POWDER;INHALATION | 213005 | NDA | Liquidia Technologies, Inc. | 72964-011 | 72964-011-01 | 7 BLISTER PACK in 1 CARTON (72964-011-01) / 4 CAPSULE in 1 BLISTER PACK / 1 CAPSULE in 1 CAPSULE |
| YUTREPIA | treprostinil sodium | POWDER;INHALATION | 213005 | NDA | Liquidia Technologies, Inc. | 72964-012 | 72964-012-01 | 7 BLISTER PACK in 1 CARTON (72964-012-01) / 4 CAPSULE in 1 BLISTER PACK / 1 CAPSULE in 1 CAPSULE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | EQ 0.0265MG BASE/INH | ||||
| Approval Date: | May 23, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 23, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | May 5, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION OR PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY USING AN INHALATION DEVICE | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | May 5, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION OR PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY USING AN INHALATION DEVICE | ||||||||
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