tyvaso Drug Patent Profile
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Which patents cover Tyvaso, and what generic alternatives are available?
Tyvaso is a drug marketed by United Therap and is included in two NDAs. There are eleven patents protecting this drug and one Paragraph IV challenge.
This drug has thirty-five patent family members in nine countries.
The generic ingredient in TYVASO 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
A generic version of tyvaso was approved as treprostinil by SANDOZ on November 30th, 2017.
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Summary for tyvaso
International Patents: | 35 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 60 |
Clinical Trials: | 23 |
Patent Applications: | 1,360 |
Drug Prices: | Drug price information for tyvaso |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for tyvaso |
What excipients (inactive ingredients) are in tyvaso? | tyvaso excipients list |
DailyMed Link: | tyvaso at DailyMed |
![tyvaso drug patent expirations Drug patent expirations by year for tyvaso](/p/graph/s/t/tyvaso-patent-expirations.png)
![Drug Prices for tyvaso](/p/graph/drug-price/tyvaso.png)
Recent Clinical Trials for tyvaso
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
Drug Class | Prostacycline Vasodilator |
Physiological Effect | Vasodilation |
Paragraph IV (Patent) Challenges for TYVASO
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TYVASO | Inhalation Solution | treprostinil | 0.6 mg/mL, 2.9 mL ampules | 022387 | 1 | 2015-04-13 |
US Patents and Regulatory Information for tyvaso
tyvaso is protected by eight US patents and one FDA Regulatory Exclusivity.
Patents protecting tyvaso
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
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
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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
Treprostinil administration by inhalation
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
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
INDICATION FOR THE TREATMENT OF PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE TO IMPROVE EXERCISE ABILITY
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 | 214324-003 | May 23, 2022 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 |
Expired US Patents for tyvaso
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | ⤷ Sign Up | ⤷ Sign Up |
United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | ⤷ Sign Up | ⤷ Sign Up |
United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for tyvaso
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
See the table below for patents covering tyvaso around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 1161234 | ⤷ Sign Up | |
Spain | 2707548 | ⤷ Sign Up | |
Japan | 5797376 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |