Viewing data from:

TYVASO DPI

NDA

TREPROSTINIL | N214324 | UNITED THERAPEUTICS CORP

5 strengths6 unique patents0 unique exclusivities

Patent Timeline

6 unique patents by expiration date

Expiring < 1yr (1)Active (5)TodayIPRPTAB Challenge

2026

2027

2028

2029

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2031

2032

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2034

2035

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2042

Today

Dec. 15, 2028IPR

Apr. 1, 2035

Jun. 11, 2030

May. 14, 2027

Dec. 15, 2028

Feb. 3, 2042

PTAB Proceedings

2 challenges on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2020-00769	9593066	IPR	Liquidia Technologies, Inc.	Institution Denied	2020-03-30	—
IPR2020-00770	9604901Delisted	IPR	Liquidia Technolgies, Inc.	Final Written Decision	2020-03-30	2024-08-20

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 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	—
LIQUIDIA TECHNOLOGIES, INC. v. UNITED THERAPEUTICS CORPORATION 1:2025cv00299 1 patenttreprostinil	NCMD	2025-04-21	Active	—

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

Medicare Part D Spending

CMS annual spending data for Tyvaso Dpi (2023)

Total Spending

$436.9M

Total Claims

18,556

Beneficiaries

3,017

Avg Cost/Unit

$195.61

Spending Trend

$78.2M(2022)→$436.9M(2023)

YoY Change:+7.5%

5yr CAGR:+7.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain12 active DMFs

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

CHIROGATE INTERNATIONAL INCTREPROSTINIL

DMF 284582014

CHANGZHOU BOHIV PHARMACEUTICAL TECHNOLOGY CO LTDTREPROSTINIL INTERMEDIATE (PG14-15A)

DMF 299152015

MSN LABORATORIES PRIVATE LTDTREPROSTINIL DIETHANOLAMINE [ROUTE CODE TB]

DMF 300002015

DR REDDYS LABORATORIES LTDTREPROSTINIL

DMF 301062016

MSN LABORATORIES PRIVATE LTDTREPROSTINIL DIETHANOLAMINE (CRYSTALLINE) [ROUTE CODE "VM"]

DMF 303142016

TIEN (TIANJIN) PHARMACEUTICAL CO LTDTREPROSTINIL DIETHANOLAMINE

DMF 315242017

MSN LABORATORIES PRIVATE LTDTREPROSTINIL

DMF 315732017

APOTEX INCTREPROSTINIL DIETHANOLAMINE

DMF 320862017

EMCURE PHARMACEUTICALS LTDTREPROSTINIL

DMF 329922018

MANNKIND CORPTREPROSTINIL INHALATION POWDER

DMF 331692018

SHANGHAI FOREFRONT PHARMACEUTICAL CO LTDTREPROSTINIL SODIUM 5.5 HYDRATE

DMF 347862021

TIEN (TIANJIN) PHARMACEUTICAL CO LTDTREPROSTINIL

DMF 424372025

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 24, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 0.016MG/INH

RLD

6 patents0 exclusivities▴

POWDER;INHALATION | Approved: May 23, 2022

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9593066	Dec 15, 2028	—	Yes	—	—	—
10421729	Apr 1, 2035	—	—	Yes	—	—
10772883	Jun 11, 2030	—	—	Yes	—	—
11357782	May 14, 2027	—	—	—		—
11723887	Dec 15, 2028	—	Yes	—	—	—
11826327	Feb 3, 2042	—	—	—		—

#002 — 0.032MG/INH

RLD

6 patents0 exclusivities▾

POWDER;INHALATION | Approved: May 23, 2022

#003 — 0.048MG/INH

RLD

6 patents0 exclusivities▾

POWDER;INHALATION | Approved: May 23, 2022

#004 — 0.064MG/INH

RLD

6 patents0 exclusivities▾

POWDER;INHALATION | Approved: May 23, 2022

#005 — 0.08MG/INH

RLD

6 patents0 exclusivities▾

POWDER;INHALATION | Approved: Oct 24, 2024