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 five patents protecting this drug and two Paragraph IV challenges.
This drug has thirty-one patent family members in seven 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 on November 30th, 2017.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for REMODULIN?
- What are the global sales for REMODULIN?
- What is Average Wholesale Price for REMODULIN?
Summary for REMODULIN
International Patents: | 31 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 100 |
Clinical Trials: | 30 |
Patent Applications: | 1,779 |
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 |
University of Rhode Island | Phase 1/Phase 2 |
United Therapeutics | Phase 1/Phase 2 |
Pharmacology for REMODULIN
Drug Class | Prostacycline 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 five US patents.
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 | 9,593,066 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
United Therap | REMODULIN | treprostinil | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021272-004 | May 21, 2002 | AP | RX | Yes | Yes | 8,658,694 | ⤷ Try for Free | ⤷ Try for Free | |||
United Therap | REMODULIN | treprostinil | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021272-003 | May 21, 2002 | AP | RX | Yes | Yes | 8,658,694 | ⤷ Try for Free | ⤷ Try for Free | |||
United Therap | REMODULIN | treprostinil | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021272-004 | May 21, 2002 | AP | RX | Yes | Yes | 7,999,007 | ⤷ Try for Free | Y | ⤷ Try for Free | ||
United Therap | REMODULIN | treprostinil | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021272-003 | May 21, 2002 | AP | RX | Yes | Yes | 9,593,066 | ⤷ Try for Free | Y | ⤷ Try for Free | ||
United Therap | REMODULIN | treprostinil | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021272-006 | Sep 28, 2023 | RX | Yes | Yes | 8,658,694 | ⤷ Try for Free | ⤷ Try for Free | ||||
United Therap | REMODULIN | treprostinil | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021272-001 | May 21, 2002 | AP | RX | Yes | Yes | 7,999,007 | ⤷ Try for Free | Y | ⤷ Try for Free | ||
>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 | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 208276-002 | Jul 30, 2018 | 9,713,599 | ⤷ Try for Free |
United Therap | REMODULIN | treprostinil | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021272-001 | May 21, 2002 | 10,695,308 | ⤷ Try for Free |
United Therap | REMODULIN | treprostinil | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021272-004 | May 21, 2002 | 9,199,908 | ⤷ Try for Free |
United Therap | REMODULIN | treprostinil | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021272-007 | Sep 28, 2023 | 9,199,908 | ⤷ Try for Free |
United Therap | REMODULIN | treprostinil | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021272-002 | May 21, 2002 | 10,695,308 | ⤷ Try for Free |
United Therap | REMODULIN | treprostinil | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021272-006 | Sep 28, 2023 | 9,199,908 | ⤷ Try for Free |
United Therap | REMODULIN | treprostinil | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 208276-004 | Jul 30, 2018 | 10,076,505 | ⤷ Try for Free |
>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 |
---|---|---|---|
China | 1283184 | ⤷ Try for Free | |
Germany | 602004028155 | ⤷ Try for Free | |
South Korea | 20100074169 | BUFFER SOLUTIONS HAVING SELECTIVE BACTERICIDAL ACTIVITY AGANIST GRAM NEGATIVE BACTERIA AND METHODS OF USING SAME | ⤷ Try for Free |
Spain | 2045437 | ⤷ Try for Free | |
Canada | 2959852 | COMPOSES ET METHODES DE DISTRIBUTION D'ANALOGUES DE PROSTACYCLINE (COMPOUNDS AND METHODS FOR DELIVERY OF PROSTACYCLIN ANALOGS) | ⤷ Try for Free |
China | 103181893 | Buffer solutionsha ving selective bactericidal activity against gramnegative bacteria and methods of using same | ⤷ Try for Free |
Japan | 5851691 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for Remodulin
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