TYVASO DPI Drug Patent Profile

When do Tyvaso Dpi patents expire, and what generic alternatives are available?

Tyvaso Dpi is a drug marketed by United Therap and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and forty-one patent family members in twenty countries.

The generic ingredient in TYVASO DPI 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 Dpi

A generic version of TYVASO DPI was approved as treprostinil by SANDOZ on November 30^th, 2017.

Summary for TYVASO DPI

International Patents:	141
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	23
Drug Prices:	Drug price information for TYVASO DPI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TYVASO DPI
What excipients (inactive ingredients) are in TYVASO DPI?	TYVASO DPI excipients list
DailyMed Link:	TYVASO DPI at DailyMed

See drug prices for TYVASO DPI

Recent Clinical Trials for TYVASO DPI

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 DPI clinical trials

Pharmacology for TYVASO DPI

Drug Class	Prostacycline Vasodilator
Physiological Effect	Vasodilation

US Patents and Regulatory Information for TYVASO DPI

TYVASO DPI is protected by seven US patents and one FDA Regulatory Exclusivity.

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
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-004	May 23, 2022		RX	Yes	Yes				Y
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-005	Oct 24, 2024		RX	Yes	Yes
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-004	May 23, 2022		RX	Yes	Yes			Y
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-001	May 23, 2022		RX	Yes	Yes

EU/EMA Drug Approvals for TYVASO DPI

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

International Patents for TYVASO DPI

See the table below for patents covering TYVASO DPI around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4135707	TRÉPROSTINIL DESTINÉ À ÊTRE UTILISÉ DANS LE TRAITEMENT D'UNE PNEUMOPATHIE INTERSTITIELLE (TREPROSTINIL FOR USE IN THE TREATMENT OF INTERSITIAL LUNG DISEASE)
South Korea	102584844
South Korea	101390579
South Korea	20200028501	한정된 비표면적을 갖는 디케토피페라진 마이크로입자 (DIKETOPIPERAZINE MICROPARTICLES WITH DEFINED SPECIFIC SURFACE AREAS)
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)

Market Dynamics and Financial Trajectory for TYVASO DPI

Introduction

TYVASO DPI, a dry powder inhaler formulation of treprostinil, has been a significant player in the treatment of pulmonary arterial hypertension (PAH) since its launch in June 2022. Developed by United Therapeutics in collaboration with MannKind Corporation, TYVASO DPI has shown strong market performance and patient demand. Here, we delve into the market dynamics and financial trajectory of this drug.

Launch and Initial Reception

TYVASO DPI was launched in June 2022, marking a significant advancement in the delivery of inhaled treprostinil therapy. The drug offers a more convenient method of administration compared to traditional nebulized Tyvaso therapy, which has been a key factor in its strong patient demand[4].

Revenue Performance

Since its launch, TYVASO DPI has contributed substantially to United Therapeutics' revenue. In the third quarter of 2022, total revenues grew 16% year-over-year to $516 million, with TYVASO DPI playing a crucial role in this growth. By the third quarter of 2023, TYVASO DPI sales reached $326 million, accounting for 53% of the company's quarterly sales[1][3].

Market Share and Competition

TYVASO DPI operates in a competitive landscape dominated by other PAH treatments. Johnson & Johnson's Uptravi, approved in 2015, has quickly gained market share and reported sales exceeding $1.3 billion in 2022. Despite this competition, TYVASO DPI has managed to maintain a strong market position due to its convenience and efficacy[1][3].

Generic Entry and Patent Protection

United Therapeutics has faced challenges from generic entries for some of its products. Remodulin and Adcirca have already seen generic competition, and there are no patents covering Unituxin. However, settlements with generic manufacturers have delayed the generic launches of Tyvaso and Orenitram until 2026 and 2027, respectively. This temporary protection is expected to help TYVASO DPI offset some of the negative effects of generic entry[1][3].

Financial Projections

For 2023, United Therapeutics forecasted total revenue of about $2.2 billion to $2.3 billion, representing growth of 15% to 20% over 2022. However, the company anticipates declining sales later in the 10-year forecast period due to pricing pressure, generic entry, and branded competition[1][3].

Pipeline and Development

United Therapeutics' pipeline is in the early stages of development, which adds to the uncertainty surrounding the company's long-term financial health. The success of TYVASO DPI and other products will be crucial in offsetting potential declines in sales of existing therapies. The company is committed to developing new treatments, including advancements in the delivery of inhaled treprostinil therapy[1][3].

Collaboration with MannKind Corporation

The development and commercialization of TYVASO DPI are the result of a collaboration between United Therapeutics and MannKind Corporation. MannKind's dry powder formulation technology and Dreamboat inhalation device have been integral to the product's success. Royalties related to TYVASO DPI have been significant, reaching $30.7 million in the first half of 2023 for MannKind[5].

Clinical Trials and Regulatory Approvals

The BREEZE study demonstrated the safety, tolerability, and pharmacokinetic profiles of treprostinil administered as TYVASO DPI. United Therapeutics submitted a New Drug Application (NDA) for TYVASO DPI in April 2021, seeking indications for PAH and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The FDA approval has been a critical milestone in the drug's market trajectory[4].

Patient Demand and Market Impact

The strong patient demand for TYVASO DPI is attributed to its convenience and efficacy. Patients transitioning from traditional nebulized Tyvaso therapy have found the dry powder inhaler to be a significant improvement. This demand has driven the financial performance of United Therapeutics, making TYVASO DPI a key contributor to the company's revenue growth[1][3].

Financial Highlights

• Revenue Growth: TYVASO DPI has driven significant revenue growth for United Therapeutics, with quarterly sales reaching $326 million by the third quarter of 2023.
• Net Income: The company reported net income of $239.3 million in the third quarter of 2022, a 47% increase year-over-year[2].
• Royalties: MannKind Corporation has received substantial royalties from TYVASO DPI, totaling $30.7 million in the first half of 2023[5].

Challenges and Risks

Despite the strong performance, United Therapeutics faces several challenges:

• Generic Competition: The company's reliance on a single active ingredient, treprostinil, and the impending generic entries pose significant risks.
• Branded Competition: J&J’s Uptravi and other branded competitors continue to challenge United Therapeutics’ market share.
• Pricing Pressure: The company anticipates declining sales due to pricing pressure and competition[1][3].

Conclusion

TYVASO DPI has been a game-changer in the treatment of PAH, offering a more convenient and effective method of administration. Its strong market performance and patient demand have driven significant revenue growth for United Therapeutics. However, the company must navigate challenges such as generic entries, branded competition, and pricing pressure to sustain its success in the long term.

Key Takeaways

• Strong Revenue Growth: TYVASO DPI has contributed significantly to United Therapeutics' revenue, with sales reaching $326 million in the third quarter of 2023.
• Convenience and Efficacy: The dry powder inhaler offers a more convenient method of administration compared to traditional nebulized therapy.
• Market Competition: The drug faces competition from J&J’s Uptravi and other branded treatments.
• Generic Entry Risks: United Therapeutics must manage the impact of generic entries on its key products.
• Pipeline Development: The company's pipeline is in the early stages, adding uncertainty to its long-term financial health.

FAQs

Q: What is TYVASO DPI, and how does it differ from traditional Tyvaso therapy? A: TYVASO DPI is a dry powder inhaler formulation of treprostinil, offering a more convenient method of administration compared to traditional nebulized Tyvaso therapy.

Q: How has TYVASO DPI performed in terms of revenue since its launch? A: TYVASO DPI has driven significant revenue growth for United Therapeutics, with quarterly sales reaching $326 million by the third quarter of 2023.

Q: What are the main challenges facing United Therapeutics in the PAH market? A: The company faces challenges from generic entries, branded competition, and pricing pressure.

Q: How does the collaboration with MannKind Corporation impact TYVASO DPI? A: The collaboration has been crucial in developing the dry powder formulation technology and the Dreamboat inhalation device used in TYVASO DPI.

Q: What are the financial projections for United Therapeutics in the coming years? A: The company forecasts total revenue of about $2.2 billion to $2.3 billion for 2023 but anticipates declining sales later in the 10-year forecast period due to various market pressures.

Sources

1. Morningstar: United Therapeutics Earnings: Demand for Tyvaso DPI Drives Strong Sales; Shares Fairly Valued[1].
2. Business Wire: United Therapeutics Corporation Reports Third Quarter 2022 Financial Results[2].
3. Morningstar: Robust Growth Thanks to Strong Tyvaso DPI Sales; Shares Fairly Valued[3].
4. PR Newswire: United Therapeutics Announces BREEZE Study of Investigational Tyvaso DPI Meets Primary Objective[4].
5. MannKind Corporation: MannKind Corporation Reports 2023 Second Quarter Financial Results[5].