TYVASO DPI Drug Patent Profile
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When do Tyvaso Dpi patents expire, and what generic alternatives are available?
Tyvaso Dpi is a drug marketed by United Therap and is included in one NDA. There are eight patents protecting this drug.
This drug has one hundred and thirty-nine patent family members in twenty countries.
The generic ingredient in TYVASO DPI is treprostinil. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the treprostinil profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tyvaso Dpi
A generic version of TYVASO DPI was approved as treprostinil by SANDOZ on November 30th, 2017.
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Summary for TYVASO DPI
International Patents: | 139 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 23 |
Drug Prices: | Drug price information for TYVASO DPI |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TYVASO DPI |
What excipients (inactive ingredients) are in TYVASO DPI? | TYVASO DPI excipients list |
DailyMed Link: | TYVASO DPI at DailyMed |
![TYVASO DPI drug patent expirations Drug patent expirations by year for TYVASO DPI](/p/graph/s/t/TYVASO_DPI-patent-expirations.png)
![Drug Prices for TYVASO DPI](/p/graph/drug-price/TYVASO+DPI.png)
Recent Clinical Trials for TYVASO DPI
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
United Therapeutics | Phase 1 |
Bastiaan Driehuys | Phase 2 |
Children's Hospital Medical Center, Cincinnati | Phase 2 |
Pharmacology for TYVASO DPI
Drug Class | Prostacycline Vasodilator |
Physiological Effect | Vasodilation |
US Patents and Regulatory Information for TYVASO DPI
TYVASO DPI is protected by eight US patents.
Patents protecting TYVASO DPI
Diketopiperazine salts for drug delivery and related methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Microcrystalline diketopiperazine compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Treprostinil administration by inhalation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
Diketopiperazine microparticles with defined specific surface areas
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
Process to prepare treprostinil, the active ingredient in remodulin.RTM.
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
United Therap | TYVASO DPI | treprostinil | POWDER;INHALATION | 214324-004 | May 23, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
United Therap | TYVASO DPI | treprostinil | POWDER;INHALATION | 214324-004 | May 23, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
United Therap | TYVASO DPI | treprostinil | POWDER;INHALATION | 214324-004 | May 23, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
United Therap | TYVASO DPI | treprostinil | POWDER;INHALATION | 214324-001 | May 23, 2022 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
United Therap | TYVASO DPI | treprostinil | POWDER;INHALATION | 214324-003 | May 23, 2022 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
United Therap | TYVASO DPI | treprostinil | POWDER;INHALATION | 214324-003 | May 23, 2022 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for TYVASO DPI
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 TYVASO DPI
See the table below for patents covering TYVASO DPI around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 104721825 | Diketopiperazine Microparticles With Defined Specific Surface Areas | ⤷ Sign Up |
Japan | 4990142 | ⤷ Sign Up | |
Japan | 2012530064 | ⤷ Sign Up | |
Japan | 2021054850 | 微結晶性ジケトピペラジン粒子の製造方法 (METHODS OF MAKING MICROCRYSTALLINE DIKETOPIPERAZINE PARTICLES) | ⤷ Sign Up |
Japan | 2008510824 | ⤷ Sign Up | |
South Korea | 20090007797 | TREPROSTINIL ADMINISTRATION USING A METERED DOSE INHALER | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |