tyvaso dpi Drug Patent Profile
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Which patents cover Tyvaso Dpi, 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 forty 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: | 140 |
| 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 |
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 and one FDA Regulatory Exclusivity.
Patents protecting tyvaso dpi
Diketopiperazine salts for drug delivery and related methods
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Microcrystalline diketopiperazine compositions and methods
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Treprostinil administration by inhalation
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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
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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.
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Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
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FDA Regulatory Exclusivity protecting tyvaso dpi
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Exclusivity 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 | ⤷ 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 | ⤷ 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 | 214324-002 | 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 | 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 |
|---|---|---|---|
| Spain | 2543007 | ⤷ Sign Up | |
| Taiwan | 201113260 | Diketopiperazine microparticles with defined specific surface areas | ⤷ Sign Up |
| Hong Kong | 1156551 | 用於藥物傳遞的包含哌嗪二酮鹽的微粒子 (MICROPARTICLES COMPRISING DIKETOPIPERAZINE SALTS FOR DRUG DELIVERY) | ⤷ Sign Up |
| Israel | 216911 | חלקיקים מיקרונים של דיקטופיפרזינים בעלי שטח פנים 60-40 מ" ר/גרם ותכשירים המכילים חלקיקים אלה (Diketopiperazine microparticles with defined specific surface areas of from 40 to 67 m2/gram and compositions containing same) | ⤷ Sign Up |
| Canada | 3172665 | TREPROSTINIL DESTINE A ETRE UTILISE DANS LE TRAITEMENT D'UNE PNEUMOPATHIE INTERSTITIELLE (TREPROSTINIL FOR USE IN THE TREATMENT OF INTERSITIAL LUNG DISEASE) | ⤷ Sign Up |
| European Patent Office | 2026816 | ADMINISTRATION DE TREPROSTINIL UTILISANT UN INHALATEUR À DOSE MESURÉE (TREPROSTINIL ADMINISTRATION USING A METERED DOSE INHALER) | ⤷ Sign Up |
| South Korea | 20170081292 | 레모둘린?의 활성 성분인 트레프로스티닐의 개선된 제조 방법 (? AN IMPROVED PROCESS TO PREPARE TREPROSTINIL THE ACTIVE INGREDIENT IN REMODULIN?) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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