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YUTREPIA

NDA

TREPROSTINIL SODIUM | N213005 | LIQUIDIA TECHNOLOGIES INC

4 strengths6 unique patents1 unique exclusivity

Patent Timeline

6 unique patents, 1 exclusivity by expiration date

Active (6)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

Today

May. 5, 2037

May. 5, 2037

May. 5, 2037

May. 5, 2037

May. 5, 2037

May. 5, 2037

May. 23, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

3 cases on OB patents (2 active) from PACER

Case	Court	Filed	Status	Judge
UNITED THERAPEUTICS CORPORATION v. LIQUIDIA TECHNOLOGIES, INC. 1:2025cv00368 1 patenttreprostinil	NCMD	2025-05-09	Active	—
United Therapeutics Corporation v. Liquidia Technologies, Inc. 1:2023cv00975 1 patenttreprostinil	D. Del.	2023-09-05	Active	—
United Therapeutics Corporation v. Liquidia Technologies, Inc. 1:2020cv00755 2 patentstreprostinil	D. Del.	2020-06-04	Terminated 2022-09-09	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain6 active DMFs

6 active API suppliers hold Drug Master Files for this ingredient.

EUROFINS CDMO ALPHORA INCTREPROSTINIL SODIUM

DMF 255482011

YS LIFE SCIENCE CO LTDTREPROSTINIL SODIUM

DMF 276802013

CHIROGATE INTERNATIONAL INCTREPROSTINIL SODIUM

DMF 283402016

SS PHARMA LLCTREPROSTINIL SODIUM

DMF 308612016

EUROAPI HUNGARY LTDTREPROSTINIL SODIUM

DMF 311452016

MSN LABORATORIES PRIVATE LTDTREPROSTINIL SODIUM

DMF 314502017

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 28, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 0.0265MG BASE/INH

RLD

6 patents1 exclusivity▴

POWDER;INHALATION | Approved: May 23, 2025

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10898494	May 5, 2037	—	—	—		—
11660304	May 5, 2037	—	—	—		—
11712442	May 5, 2037	—	—	—		—
11744835	May 5, 2037	—	—	Yes	—	—
11744836	May 5, 2037	—	—	Yes	—	—
12390475	May 5, 2037	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
NP	May 23, 2028	Active

#002 — EQ 0.053MG BASE/INH

RLD

6 patents1 exclusivity▾

POWDER;INHALATION | Approved: May 23, 2025

#003 — EQ 0.0795MG BASE/INH

RLD

6 patents1 exclusivity▾

POWDER;INHALATION | Approved: May 23, 2025

#004 — EQ 0.106MG BASE/INH

RLD

6 patents1 exclusivity▾

POWDER;INHALATION | Approved: May 23, 2025