Tyvaso Dpi is a drug owned by United Therapeutics Corp. It is protected by 8 US drug patents filed from 2022 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 03, 2042. Details of Tyvaso Dpi'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 |
| 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 |
| US10421729 | Microcrystalline diketopiperazine compositions and methods |
Apr, 2035
(10 years from now) | Active |
| US10772883 | Diketopiperazine microparticles with defined specific surface areas |
Jun, 2030
(5 years from now) | Active |
| US10716793 | Treprostinil administration by inhalation |
May, 2027
(2 years from now) | Active |
| US10130685 | Diketopiperazine salts for drug delivery and related methods |
Aug, 2025
(8 months from now) | Active |
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 Dpi's patents.
Latest Legal Activities on Tyvaso Dpi's Patents
Given below is the list of recent legal activities going on the following patents of Tyvaso Dpi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Mar, 2024 | US10772883 |
| Email Notification Critical | 09 Mar, 2024 | US11826327 |
| Mail-Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 08 Mar, 2024 | US11826327 |
| Mail Pet Dec Routed to Certificate of Corrections Branch | 08 Mar, 2024 | US11826327 |
| Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 07 Mar, 2024 | US11826327 |
| Pet Dec Routed to Certificate of Corrections Branch | 07 Mar, 2024 | US11826327 |
| Adjustment of PTA Calculation by PTO | 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 |
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 Dpi and ongoing litigations to help you estimate the early arrival of Tyvaso Dpi generic.
Tyvaso Dpi's Litigations
Tyvaso Dpi been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Mar 30, 2020, against patent number US9593066. The petitioner Liquidia Technologies, Inc., challenged the validity of this patent, with United Therapeutics Corp. as the respondent. Click below to track the latest information on how companies are challenging Tyvaso Dpi'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. |
FDA has granted some exclusivities to Tyvaso Dpi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tyvaso Dpi, 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 Dpi.
Exclusivity Information
Tyvaso Dpi holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Tyvaso Dpi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 23, 2025 |
US patents provide insights into the exclusivity only within the United States, but Tyvaso Dpi 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 Dpi's family patents as well as insights into ongoing legal events on those patents.
Tyvaso Dpi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tyvaso Dpi'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 Dpi Generic API suppliers:
Treprostinil is the generic name for the brand Tyvaso Dpi. 5 different companies have already filed for the generic of Tyvaso Dpi, with Alembic Global having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Tyvaso Dpi's generic
Alternative Brands for Tyvaso Dpi
Tyvaso Dpi which is used for treating pulmonary hypertension associated with interstitial lung disease by inhaling treprostinil., 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 Dpi's active ingredient. Check the complete list of approved generic manufacturers for Tyvaso Dpi
About Tyvaso Dpi
Tyvaso Dpi is a drug owned by United Therapeutics Corp. It is used for treating pulmonary hypertension associated with interstitial lung disease by inhaling treprostinil. Tyvaso Dpi uses Treprostinil as an active ingredient. Tyvaso Dpi was launched by United Therap in 2022.
Approval Date:
Tyvaso Dpi was approved by FDA for market use on 23 May, 2022.
Active Ingredient:
Tyvaso Dpi uses Treprostinil as the active ingredient. Check out other Drugs and Companies using Treprostinil ingredient
Treatment:
Tyvaso Dpi is used for treating pulmonary hypertension associated with interstitial lung disease by inhaling treprostinil.
Dosage:
Tyvaso Dpi is available in powder form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.032MG/INH | POWDER | Prescription | INHALATION |
| 0.016MG/INH | POWDER | Prescription | INHALATION |
| 0.048MG/INH | POWDER | Prescription | INHALATION |
| 0.064MG/INH | POWDER | Prescription | INHALATION |