Remodulin is a drug owned by United Therapeutics Corp. It is protected by 13 US drug patents filed from 2013 to 2023. Out of these, 10 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 29, 2029. Details of Remodulin's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8497393 | Process to prepare treprostinil, the active ingredient in Remodulin® |
Dec, 2028
(4 years from now) | Active |
| US9593066 | Process to prepare treprostinil, the active ingredient in remodulin® |
Dec, 2028
(4 years from now) | Active |
| US11723887 | Process to prepare treprostinil, the active ingredient in Remodulin® |
Dec, 2028
(4 years from now) | Active |
| US9604901 | Process to prepare treprostinil, the active ingredient in Remodulin® |
Dec, 2028
(4 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7999007 | Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same |
Mar, 2029
(4 years from now) | Active |
| US8653137 | Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same |
Sep, 2028
(3 years from now) | Active |
| US8658694 | Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same |
Sep, 2028
(3 years from now) | Active |
| US9713599 | Parenteral formulations of treprostinil |
Dec, 2024
(23 days from now) | Active |
| US10695308 | Inhalation formulations of treprostinil |
Dec, 2024
(23 days from now) | Active |
| US10076505 | Inhalation formulations of Treprostinil |
Dec, 2024
(23 days from now) | Active |
| US9199908 | Compounds and methods for delivery of prostacyclin analogs |
May, 2024
(5 months ago) |
Expired
|
| US6765117 | Process for stereoselective synthesis of prostacyclin derivatives |
Oct, 2017
(7 years ago) |
Expired
|
| US5153222 | Method of treating pulmonary hypertension with benzidine prostaglandins |
Oct, 2014
(10 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Remodulin's patents.
Latest Legal Activities on Remodulin's Patents
Given below is the list of recent legal activities going on the following patents of Remodulin.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Dec, 2023 | US10695308 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 May, 2023 | US9199908 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 01 Feb, 2023 | US7999007 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 02 Mar, 2022 | US10076505 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Jan, 2021 | US9713599 |
| Patent Issue Date Used in PTA Calculation Critical | 30 Jun, 2020 | US10695308 |
| Recordation of Patent Grant Mailed Critical | 30 Jun, 2020 | US10695308 |
| Email Notification Critical | 11 Jun, 2020 | US10695308 |
| Issue Notification Mailed Critical | 10 Jun, 2020 | US10695308 |
| Dispatch to FDC | 21 May, 2020 | US10695308 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Remodulin and ongoing litigations to help you estimate the early arrival of Remodulin generic.
Remodulin's Litigations
Remodulin been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 02, 2015, against patent number US8497393. The petitioner SteadyMed Ltd., challenged the validity of this patent, with United Therapeutics Corporation as the respondent. Click below to track the latest information on how companies are challenging Remodulin's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9604901 | March, 2020 |
FWD Entered
(08 Oct, 2021) | United Therapeutics Corp. | Liquidia Technolgies, Inc. |
| US9593066 | March, 2020 |
Terminated-Denied
(13 Oct, 2020) | United Therapeutics Corp. | Liquidia Technologies, Inc. |
| US8497393 | October, 2015 |
FWD Entered
(31 Mar, 2017) | United Therapeutics Corporation | SteadyMed Ltd. |
Several oppositions have been filed on Remodulin's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Remodulin's generic, the next section provides detailed information on ongoing and past EP oppositions related to Remodulin patents.
Remodulin's Oppositions Filed in EPO
Remodulin has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 30, 2016, by Teva Pharmaceutical Industries Ltd. This opposition was filed on patent number EP08829225A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP13188882A | Dec, 2019 | Generics [UK] Ltd | Revoked |
| EP13188882A | Nov, 2019 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP04776104A | Oct, 2017 | Teva Pharmaceutical Industries Ltd | Patent maintained as amended |
| EP08829225A | Oct, 2016 | Generics (U.K.) Limited | Revoked |
| EP08829225A | Sep, 2016 | Teva Pharmaceutical Industries Ltd | Revoked |
US patents provide insights into the exclusivity only within the United States, but Remodulin is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Remodulin's family patents as well as insights into ongoing legal events on those patents.
Remodulin's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Remodulin's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 29, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Remodulin Generic API suppliers:
Treprostinil is the generic name for the brand Remodulin. 5 different companies have already filed for the generic of Remodulin, with Alembic Global having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Remodulin's generic
How can I launch a generic of Remodulin before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Remodulin's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Remodulin's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Remodulin -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg/mL, 20 mL vial | 02 Dec, 2011 | 1 | 30 Nov, 2017 | 29 Mar, 2029 | Eligible |
| 1 mg/mL, 2.5 mg/mL, and 5 mg/mL, 20 mL vial | 07 Dec, 2012 | 1 | 30 Nov, 2017 | 29 Mar, 2029 | Eligible |
Alternative Brands for Remodulin
Remodulin which is used for treating pulmonary hypertension., has several other brand drugs using the same active ingredient (Treprostinil). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |||
|---|---|---|---|---|
| United Therap |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Treprostinil, Remodulin's active ingredient. Check the complete list of approved generic manufacturers for Remodulin
About Remodulin
Remodulin is a drug owned by United Therapeutics Corp. It is used for treating pulmonary hypertension. Remodulin uses Treprostinil as an active ingredient. Remodulin was launched by United Therap in 2023.
Approval Date:
Remodulin was approved by FDA for market use on 28 September, 2023.
Active Ingredient:
Remodulin uses Treprostinil as the active ingredient. Check out other Drugs and Companies using Treprostinil ingredient
Treatment:
Remodulin is used for treating pulmonary hypertension.
Dosage:
Remodulin is available in the following dosage forms - solution form for intravenous, subcutaneous use, injectable form for intravenous, subcutaneous use, injectable form for iv (infusion), subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.1MG/ML | INJECTABLE | Prescription | IV (INFUSION), SUBCUTANEOUS |
| 10MG/ML | INJECTABLE | Prescription | INTRAVENOUS, SUBCUTANEOUS |
| 2.5MG/ML | INJECTABLE | Prescription | INTRAVENOUS, SUBCUTANEOUS |
| 5MG/ML | INJECTABLE | Prescription | INTRAVENOUS, SUBCUTANEOUS |
| 20MG/ML | INJECTABLE | Prescription | IV (INFUSION), SUBCUTANEOUS |
| 0.4MG/ML | INJECTABLE | Prescription | INTRAVENOUS, SUBCUTANEOUS |
| 0.2MG/ML | INJECTABLE | Prescription | INTRAVENOUS, SUBCUTANEOUS |
| 1MG/ML | INJECTABLE | Prescription | INTRAVENOUS, SUBCUTANEOUS |
| 100MG/20ML (5MG/ML) | SOLUTION | Discontinued | INTRAVENOUS, SUBCUTANEOUS |
| 200MG/20ML (10MG/ML) | SOLUTION | Discontinued | INTRAVENOUS, SUBCUTANEOUS |
| 50MG/20ML (2.5MG/ML) | SOLUTION | Discontinued | INTRAVENOUS, SUBCUTANEOUS |
| 20MG/20ML (1MG/ML) | SOLUTION | Discontinued | INTRAVENOUS, SUBCUTANEOUS |