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TYVASO Drug 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 one NDA. There are seven 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. Five 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 INC on November 30th, 2017.
Summary for TYVASO
| International Patents: | 27 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 78 |
| Clinical Trials: | 18 |
| Patent Applications: | 2,093 |
| 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 |
| United Therapeutics | Phase 2/Phase 3 |
Pharmacology for TYVASO
| Drug Class | Prostacycline Vasodilator |
| Physiological Effect | Vasodilation |
Paragraph IV (Patent) Challenges for TYVASO
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| TYVASO | SOLUTION;INHALATION | treprostinil | 022387 | 2015-04-13 |
US Patents and Regulatory Information for TYVASO
| 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 | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Get Started for $10 | ||||
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Get Started for $10 | ||||
| >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 | Get Started for $10 | Get Started for $10 |
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | Get Started for $10 | Get Started for $10 |
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | Get Started for $10 | Get Started for $10 |
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | Get Started for $10 | Get Started for $10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TYVASO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2252570 | Get Started for $10 |
| South Korea | 20170081292 | Get Started for $10 |
| World Intellectual Property Organization (WIPO) | 9921830 | Get Started for $10 |
| Canada | 2307163 | Get Started for $10 |
| >Country | >Patent Number | >Estimated Expiration |
