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REMODULIN

NDA

TREPROSTINIL | N208276 | UNITED THERAPEUTICS CORP

4 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)TodayIPRPTAB Challenge

2027

2028

2029

Today

9593066

Dec. 15, 2028IPR

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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
Aug 3, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 20MG/20ML (1MG/ML)

1 patent0 exclusivities▴

SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Approved: Jul 30, 2018

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9593066	Dec 15, 2028	—	Yes	—	—	—

#002 — 50MG/20ML (2.5MG/ML)

1 patent0 exclusivities▾

SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Approved: Jul 30, 2018

#003 — 100MG/20ML (5MG/ML)

1 patent0 exclusivities▾

SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Approved: Jul 30, 2018

#004 — 200MG/20ML (10MG/ML)

1 patent0 exclusivities▾

SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Approved: Jul 30, 2018