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.
Summary for REMODULIN
| International Patents: | 63 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 86 |
| Clinical Trials: | 30 |
| Patent Applications: | 2,522 |
| Drug Prices: | Drug price information for REMODULIN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for REMODULIN |
| What excipients (inactive ingredients) are in REMODULIN? | REMODULIN excipients list |
| DailyMed Link: | REMODULIN at DailyMed |
Recent Clinical Trials for REMODULIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Lung Biotechnology PBC | Phase 4 |
| Rhode Island Hospital | Phase 1/Phase 2 |
| University of Rhode Island | Phase 1/Phase 2 |
Pharmacology for REMODULIN
| Drug Class | Prostacycline Vasodilator |
| Physiological Effect | Vasodilation |
Anatomical Therapeutic Chemical (ATC) Classes for REMODULIN
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
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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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