TYVASO Drug Patent Profile

✉ Email this page to a colleague

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 30^th, 2017.

Sign Up

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for TYVASO?
What are the global sales for TYVASO?
What is Average Wholesale Price for TYVASO?

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

Drug patent expirations by year for TYVASO

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

See all TYVASO clinical trials

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

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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

Process to prepare treprostinil, the active ingredient in remodulin.RTM.
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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	214324-004	May 23, 2022		RX	Yes	Yes	⤷ 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				⤷ 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

Expired US Patents for TYVASO

Subscribe to access the full database, or Sign Up
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
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

Subscribe to access the full database, or Sign Up
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.

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Japan	2016006066	定量吸入器を用いたトレプロスチニル投与 (TREPROSTINIL ADMINISTRATION USING METERED DOSE INHALER)	⤷ Sign Up
Hungary	T53524		⤷ Sign Up
Spain	2198760		⤷ Sign Up
Japan	2011506599		⤷ Sign Up
Germany	69816642		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration