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 nine patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-seven patent family members in seven 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.
Summary for TYVASO
| International Patents: | 27 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 60 |
| Clinical Trials: | 21 |
| Patent Applications: | 1,594 |
| 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 |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for TYVASO
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 six US patents and one FDA Regulatory Exclusivity.
Patents protecting TYVASO
Treprostinil administration by inhalation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Treprostinil administration by inhalation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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.
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting TYVASO
INDICATION FOR THE TREATMENT OF PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE TO IMPROVE EXERCISE ABILITY
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| United Therap | TYVASO DPI | treprostinil | POWDER;INHALATION | 214324-004 | May 23, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| United Therap | TYVASO DPI | treprostinil | POWDER;INHALATION | 214324-002 | May 23, 2022 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| United Therap | TYVASO DPI | treprostinil | POWDER;INHALATION | 214324-003 | May 23, 2022 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >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 | ⤷ Try a Trial | ⤷ Try a Trial |
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| European Patent Office | 0347243 | PROSTAGLANDIN ANALOGUES FOR USE IN MEDICINE | ⤷ Try a Trial |
| United Kingdom | 8824187 | ⤷ Try a Trial | |
| Austria | 245628 | ⤷ Try a Trial | |
| Denmark | 1025083 | ⤷ Try a Trial | |
| Hungary | T53524 | ⤷ Try a Trial | |
| >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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