Tyvaso is a drug owned by United Therapeutics Corp. It is protected by 13 US drug patents filed from 2013 to 2023. Out of these, 9 drug patents are active and 4 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 03, 2042. Details of Tyvaso'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. | |||
| US9604901 | Process to prepare treprostinil, the active ingredient in Remodulin® |
Dec, 2028
(3 years from now) | Active |
| US9593066 | Process to prepare treprostinil, the active ingredient in remodulin® |
Dec, 2028
(3 years from now) | Active |
| US11723887 | Process to prepare treprostinil, the active ingredient in Remodulin® |
Dec, 2028
(3 years from now) | Active |
| US8497393 | Process to prepare treprostinil, the active ingredient in Remodulin® |
Dec, 2028
(3 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). | |||
| US11826327 | Treatment for interstitial lung disease |
Feb, 2042
(17 years from now) | Active |
| US9358240 | Treprostinil administration by inhalation |
May, 2028
(3 years from now) | Active |
| US9339507 | Treprostinil administration by inhalation |
Mar, 2028
(3 years from now) | Active |
| US10376525 | Treprostinil administration by inhalation |
May, 2027
(2 years from now) | Active |
| US10716793 | Treprostinil administration by inhalation |
May, 2027
(2 years from now) | Active |
| US6756033 | Method for delivering benzindene prostaglandins by inhalation |
Nov, 2018
(6 years ago) |
Expired
|
| US6521212 | Method for treating peripheral vascular disease by administering benzindene prostaglandins by inhalation |
Nov, 2018
(6 years 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 Tyvaso's patents.
Latest Legal Activities on Tyvaso's Patents
Given below is the list of recent legal activities going on the following patents of Tyvaso.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification Critical | 09 Mar, 2024 | US11826327 |
| Mail Pet Dec Routed to Certificate of Corrections Branch | 08 Mar, 2024 | US11826327 |
| Mail-Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 08 Mar, 2024 | US11826327 |
| Adjustment of PTA Calculation by PTO | 07 Mar, 2024 | US11826327 |
| Pet Dec Routed to Certificate of Corrections Branch | 07 Mar, 2024 | US11826327 |
| Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 07 Mar, 2024 | US11826327 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 03 Jan, 2024 | US10716793 |
| Petition Entered | 30 Nov, 2023 | US11826327 |
| Email Notification Critical | 29 Nov, 2023 | US11826327 |
| Mail Patent eGrant Notification | 28 Nov, 2023 | US11826327 |
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 Tyvaso and ongoing litigations to help you estimate the early arrival of Tyvaso generic.
Tyvaso's Litigations
Tyvaso 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 Tyvaso's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10716793 | January, 2021 |
Final Written Decision - Appealed
(02 Feb, 2023) | United Therapeutics Corporation | Liquidia Technologies, Inc. |
| 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. |
| US9339507 | June, 2017 |
Terminated-Settled
(27 Aug, 2018) | United Therapeutics Corp. | Watson Laboratories, Inc. |
| US9358240 | June, 2017 |
Terminated-Settled
(27 Aug, 2018) | United Therapeutics Corp. | Watson Laboratories, Inc. |
| US8497393 | October, 2015 |
FWD Entered
(31 Mar, 2017) | United Therapeutics Corporation | SteadyMed Ltd. |
FDA has granted some exclusivities to Tyvaso. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tyvaso, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Tyvaso.
Exclusivity Information
Tyvaso holds 4 exclusivities. All of its exclusivities have expired in 2024. Details of Tyvaso's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Jul 30, 2012 |
| Orphan Drug Exclusivity(ODE) | Jul 30, 2016 |
| M(M-145) | May 20, 2017 |
| New Indication(I-856) | Mar 31, 2024 |
US patents provide insights into the exclusivity only within the United States, but Tyvaso 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 Tyvaso's family patents as well as insights into ongoing legal events on those patents.
Tyvaso's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tyvaso's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 03, 2042 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tyvaso Generic API suppliers:
Treprostinil is the generic name for the brand Tyvaso. 5 different companies have already filed for the generic of Tyvaso, with Alembic Global having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Tyvaso's generic
How can I launch a generic of Tyvaso before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tyvaso's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tyvaso'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 Tyvaso -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.6 mg/mL, 2.9 mL ampules | 13 Apr, 2015 | 1 | 15 Dec, 2028 | Extinguished |
Alternative Brands for Tyvaso
Tyvaso which is used for treating pulmonary hypertension, specifically associated with interstitial lung disease, by administering treprostinil or a salt thereof through inhalation., has several other brand drugs in the same treatment category and 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 | Treatment Area | ||
|---|---|---|---|---|
| United Therap |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Treprostinil. Given below is the list of those drugs and companies owning them.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Treprostinil, Tyvaso's active ingredient. Check the complete list of approved generic manufacturers for Tyvaso
About Tyvaso
Tyvaso is a drug owned by United Therapeutics Corp. It is used for treating pulmonary hypertension, specifically associated with interstitial lung disease, by administering treprostinil or a salt thereof through inhalation. Tyvaso uses Treprostinil as an active ingredient. Tyvaso was launched by United Therap in 2009.
Approval Date:
Tyvaso was approved by FDA for market use on 30 July, 2009.
Active Ingredient:
Tyvaso uses Treprostinil as the active ingredient. Check out other Drugs and Companies using Treprostinil ingredient
Treatment:
Tyvaso is used for treating pulmonary hypertension, specifically associated with interstitial lung disease, by administering treprostinil or a salt thereof through inhalation.
Dosage:
Tyvaso is available in solution form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.6MG/ML | SOLUTION | Prescription | INHALATION |