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 one NDA. There are six 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: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 79 |
| Clinical Trials: | 21 |
| Patent Applications: | 2,454 |
| 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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Treprostinil administration by inhalation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
FDA Regulatory Exclusivity protecting TYVASO
INDICATION FOR THE TREATMENT OF PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE TO IMPROVE EXERCISE ABILITY
Exclusivity Expiration: See Plans and Pricing
| 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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| >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 | See Plans and Pricing | See Plans and Pricing |
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | See Plans and Pricing | See Plans and Pricing |
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | See Plans and Pricing | See Plans and Pricing |
| United Therap | TYVASO | treprostinil | SOLUTION;INHALATION | 022387-001 | Jul 30, 2009 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TYVASO
See the table below for patents covering TYVASO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 1264819 | See Plans and Pricing | |
| Canada | 2710205 | PROCEDE AMELIORE DE PREPARATION DE TREPROSTINIL, L'INGREDIENT ACTIF DANS LE REMODULIN (AN IMPROVED PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE INGREDIENT IN REMODULIN) | See Plans and Pricing |
| Germany | 60004181 | See Plans and Pricing | |
| Austria | 245628 | See Plans and Pricing | |
| South Korea | 20090007797 | TREPROSTINIL ADMINISTRATION USING A METERED DOSE INHALER | See Plans and Pricing |
| China | 101495122 | Treprostinil administration using a metered dose inhaler | See Plans and Pricing |
| >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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