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Last Updated: March 19, 2024

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 ten patents protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in REMODULIN is treprostinil. There are nineteen drug master file entries for this compound. Six 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 on November 30th, 2017.

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Drug patent expirations by year for REMODULIN
Drug Prices for REMODULIN

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Recent Clinical Trials for REMODULIN

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

SponsorPhase
Lung Biotechnology PBCPhase 4
University of Rhode IslandPhase 1/Phase 2
United TherapeuticsPhase 1/Phase 2

See all REMODULIN clinical trials

Pharmacology for REMODULIN
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation
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 ten US patents.

Patents protecting REMODULIN

Inhalation formulations of Treprostinil
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Inhalation formulations of treprostinil
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Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION


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Patent Expiration: ⤷  Try a Trial

Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same
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Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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
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Patent Expiration: ⤷  Try a Trial
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.
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Patent Expiration: ⤷  Try a Trial

Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
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Patent Expiration: ⤷  Try a Trial

Parenteral formulations of treprostinil
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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 SOLUTION;INTRAVENOUS, SUBCUTANEOUS 208276-001 Jul 30, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-002 May 21, 2002 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-002 May 21, 2002 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
United Therap REMODULIN treprostinil SOLUTION;INTRAVENOUS, SUBCUTANEOUS 208276-004 Jul 30, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-003 May 21, 2002 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-003 May 21, 2002 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 021272-003 May 21, 2002 ⤷  Try a Trial ⤷  Try a Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-001 May 21, 2002 ⤷  Try a Trial ⤷  Try a Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002 ⤷  Try a Trial ⤷  Try a Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-002 May 21, 2002 ⤷  Try a Trial ⤷  Try a Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-002 May 21, 2002 ⤷  Try a Trial ⤷  Try a Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-001 May 21, 2002 ⤷  Try a Trial ⤷  Try a Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-003 May 21, 2002 ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial
European Patent Office 2200650 TAMPONS PRÉSENTANT UNE ACTIVITÉ BACTÉRICIDE SÉLECTIVE CONTRE LES BACTÉRIES À GRAM NÉGATIF ET LEURS PROCÉDÉS D'UTILISATION (BUFFER SOLUTIONS HAVING SELECTIVE BACTERICIDAL ACTIVITY AGAINST GRAM NEGATIVE BACTERIA AND METHODS OF USING SAME) ⤷  Try a Trial
Austria 473736 ⤷  Try a Trial
Japan 2016047850 グラム陰性菌に対して選択的殺菌活性を有するバッファー溶液およびそれを使用する方法 (BUFFER SOLUTIONS HAVING SELECTIVE BACTERICIDAL ACTIVITY AGAINST GRAMNEGATIVE BACTERIA AND METHODS OF USING SAME) ⤷  Try a Trial
European Patent Office 1025083 PROCEDE DE SYNTHESE STEREOSELECTIVE DE DERIVES DE LA PROSTACYCLINE (PROCESS FOR STEREOSELECTIVE SYNTHESIS OF PROSTACYCLIN DERIVATIVES) ⤷  Try a Trial
China 101827612 Buffer solutionsha ving selective bactericidal activity against gramnegative bacteria and methods of using same ⤷  Try a Trial
South Korea 101614465 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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