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REMODULIN

NDA

TREPROSTINIL | N021272 | UNITED THERAPEUTICS CORP

8 strengths5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)TodayIPRPTAB Challenge

2027

2028

2029

Today

Mar. 29, 2029

Sep. 5, 2028

Sep. 5, 2028

Dec. 15, 2028IPR

Dec. 15, 2028

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
UNITED THERAPEUTICS CORPORATION v. SANDOZ, INC. et al 3:2013cv00316 1 patenttreprostinil	D.N.J.	2013-01-16	Terminated 2014-08-29	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov — 2 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in PH NCT06129240	—	Recruiting	Liquidia Technologies, Inc.	80	2023-12-28 → 2028-02-08
A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD NCT07285655	Phase 3	Recruiting	Liquidia Technologies, Inc.	344	2026-04-23 → 2031-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Remodulin (2023)

Total Spending

$11.8M

Total Claims

1,148

Beneficiaries

Avg Cost/Unit

$384.40

Spending Trend

$5.8M(2019)→$5.2M(2020)→$6.9M(2021)→$10.3M(2022)→$11.8M(2023)

YoY Change:-4.2%

5yr CAGR:-1.9%

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

Medicare Part B Spending

CMS physician-administered drug spending for Remodulin (2023)

Total Spending

$126.5M

Total Claims

12,654

Beneficiaries

931

ASP Price

—

HCPCS: J3285 — Injection, treprostinil, 1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

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

15 letters from Drugs@FDA

Date	Submission	Document
Mar 8, 2023	SUPPL -37	View Letter (PDF)
Sep 13, 2021	SUPPL -32	View Letter (PDF)
Feb 17, 2021	SUPPL -30	View Letter (PDF)
Aug 3, 2018	SUPPL -25	View Letter (PDF)
Jun 14, 2018	SUPPL -26	View Letter (PDF)
Dec 30, 2014	SUPPL -19	View Letter (PDF)
Oct 1, 2013	SUPPL -20	View Letter (PDF)
Sep 26, 2013	SUPPL -20	View Letter (PDF)
Feb 14, 2011	SUPPL -15	View Letter (PDF)
Jan 15, 2010	SUPPL -11	View Letter (PDF)
Sep 16, 2008	SUPPL -8	View Letter (PDF)
Feb 7, 2008	SUPPL -9	View Letter (PDF)
Mar 23, 2006	SUPPL -5	View Letter (PDF)
Jan 30, 2006	SUPPL -3	View Letter (PDF)
May 21, 2002	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (8)

Sort:

#001 — 1MG/ML

RLDAP

5 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Approved: May 21, 2002

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7999007	Mar 29, 2029	—	—	Yes		—
8653137	Sep 5, 2028	—	—	—		—
8658694	Sep 5, 2028	—	—	—		—
9593066	Dec 15, 2028	—	Yes	—	—	—
11723887	Dec 15, 2028	—	Yes	—	—	—

#002 — 2.5MG/ML

RLDAP

5 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Approved: May 21, 2002

#003 — 5MG/ML

RLDAP

5 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Approved: May 21, 2002

#004 — 10MG/ML

RLDAP

5 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Approved: May 21, 2002

#005 — 20MG/ML

RLD

5 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Approved: Jul 30, 2021

#006 — 0.1MG/ML

RLD

5 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Approved: Sep 28, 2023

#007 — 0.2MG/ML

RLD

5 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Approved: Sep 28, 2023

#008 — 0.4MG/ML

RLD

5 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Approved: Sep 28, 2023