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Last Updated: August 19, 2022

REMODULIN Drug Patent Profile


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When do Remodulin patents expire, and what generic alternatives are available?

Remodulin is a drug marketed by United Therap and is included in two NDAs. There are nine patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-three patent family members in nine countries.

The generic ingredient in REMODULIN is treprostinil. There are nineteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the treprostinil profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Remodulin

A generic version of REMODULIN was approved as treprostinil by SANDOZ INC on November 30th, 2017.

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Drug patent expirations by year for REMODULIN
Drug Prices for REMODULIN

See drug prices for REMODULIN

Recent Clinical Trials for REMODULIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Lung Biotechnology PBCPhase 4
Rhode Island HospitalPhase 1/Phase 2
University of Rhode IslandPhase 1/Phase 2

See all REMODULIN clinical trials

Pharmacology for REMODULIN
Drug ClassProstacycline Vasodilator
Physiological Effect Vasodilation
Paragraph IV (Patent) Challenges for REMODULIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
REMODULIN Injection treprostinil 1 mg/mL, 2.5 mg/mL, and 5 mg/mL, 20 mL vial 021272 1 2012-12-07
REMODULIN Injection treprostinil 10 mg/mL, 20 mL vial 021272 1 2011-12-02

US Patents and Regulatory Information for REMODULIN

REMODULIN is protected by nine US patents.

Patents protecting REMODULIN

Inhalation formulations of Treprostinil
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Inhalation formulations of treprostinil
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION

Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION

Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION

Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION

Compounds and methods for delivery of prostacyclin analogs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE WATER FOR INJECTION OR 0.9% SODIUM CHLORIDEINJECTION PRIOR TO ADMINISTRATION

Process to prepare treprostinil, the active ingredient in remodulin.RTM.
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Parenteral formulations of treprostinil
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-005 Jul 30, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
United Therap REMODULIN treprostinil SOLUTION;INTRAVENOUS, SUBCUTANEOUS 208276-001 Jul 30, 2018 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
United Therap REMODULIN treprostinil SOLUTION;INTRAVENOUS, SUBCUTANEOUS 208276-004 Jul 30, 2018 DISCN No No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-005 Jul 30, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
United Therap REMODULIN treprostinil SOLUTION;INTRAVENOUS, SUBCUTANEOUS 208276-002 Jul 30, 2018 DISCN No No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
United Therap REMODULIN treprostinil SOLUTION;INTRAVENOUS, SUBCUTANEOUS 208276-003 Jul 30, 2018 DISCN No No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for REMODULIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-002 May 21, 2002 See Plans and Pricing See Plans and Pricing
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-001 May 21, 2002 See Plans and Pricing See Plans and Pricing
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-002 May 21, 2002 See Plans and Pricing See Plans and Pricing
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002 See Plans and Pricing See Plans and Pricing
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-003 May 21, 2002 See Plans and Pricing See Plans and Pricing
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-001 May 21, 2002 See Plans and Pricing See Plans and Pricing
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-003 May 21, 2002 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for REMODULIN

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
SciPharm Sàrl Trepulmix treprostinil EMEA/H/C/005207
Treatment of adult patients with WHO Functional Class (FC) III or IV and:inoperable chronic thromboembolic pulmonary hypertension (CTEPH), orpersistent or recurrent CTEPH after surgical treatmentto improve exercise capacity.
Authorised no no yes 2020-04-03
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for REMODULIN

See the table below for patents covering REMODULIN around the world.

Country Patent Number Title Estimated Expiration
Japan 5043433 See Plans and Pricing
China 101780092 Compounds and methods for delivery of prostacyclin analogs See Plans and Pricing
South Korea 0158870 See Plans and Pricing
Japan 3717053 See Plans and Pricing
Canada 2698721 TAMPONS PRESENTANT UNE ACTIVITE BACTERICIDE SELECTIVE CONTRE LES BACTERIES A GRAM NEGATIF ET LEURS PROCEDES D'UTILISATION (BUFFER SOLUTIONS HAVING SELECTIVE BACTERICIDAL ACTIVITY AGAINST GRAM NEGATIVE BACTERIA AND METHODS OF USING SAME) See Plans and Pricing
Spain 2670872 See Plans and Pricing
South Africa 8904614 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Express Scripts
AstraZeneca
McKinsey
Harvard Business School

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