REMODULIN Drug Patent Profile

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

Remodulin is a drug marketed by United Therap and is included in two NDAs. There are nine patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-four patent family members in nine countries.

The generic ingredient in REMODULIN 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 Remodulin

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

Summary for REMODULIN

International Patents:	64
US Patents:	9
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	100
Clinical Trials:	30
Patent Applications:	1,943
Drug Prices:	Drug price information for REMODULIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for REMODULIN
What excipients (inactive ingredients) are in REMODULIN?	REMODULIN excipients list
DailyMed Link:	REMODULIN at DailyMed

See drug prices for REMODULIN

Recent Clinical Trials for REMODULIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Lung Biotechnology PBC	Phase 4
University of Rhode Island	Phase 1/Phase 2
United Therapeutics	Phase 1/Phase 2

See all REMODULIN clinical trials

Pharmacology for REMODULIN

Drug Class	Prostacycline Vasodilator
Physiological Effect	Vasodilation

Paragraph IV (Patent) Challenges for REMODULIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
REMODULIN	Injection	treprostinil	1 mg/mL, 2.5 mg/mL, and 5 mg/mL, 20 mL vial	021272	1	2012-12-07
REMODULIN	Injection	treprostinil	10 mg/mL, 20 mL vial	021272	1	2011-12-02

US Patents and Regulatory Information for REMODULIN

REMODULIN is protected by nine US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
United Therap	REMODULIN	treprostinil	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	208276-003	Jul 30, 2018		DISCN	No	No	10,076,505		Y
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-004	May 21, 2002	AP	RX	Yes	Yes	8,658,694
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-003	May 21, 2002	AP	RX	Yes	Yes	9,199,908
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-006	Sep 28, 2023		RX	Yes	Yes	9,199,908
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-005	Jul 30, 2021		RX	Yes	Yes	8,658,694

Expired US Patents for REMODULIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-001	May 21, 2002	9,199,908
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-004	May 21, 2002	9,199,908
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-004	May 21, 2002	10,076,505
United Therap	REMODULIN	treprostinil	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	208276-002	Jul 30, 2018	10,076,505
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-002	May 21, 2002	9,199,908

EU/EMA Drug Approvals for REMODULIN

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 REMODULIN

See the table below for patents covering REMODULIN around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	101161889
Spain	2562669
South Korea	100447022
Japan	H0240325	PHARMACEUTICAL COMPOUND
Spain	2045437

REMODULIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Remodulin

Introduction to Remodulin

Remodulin, a treprostinil-based drug, is a key player in the treatment of pulmonary arterial hypertension (PAH) and other related conditions. Developed and marketed by United Therapeutics Corporation, Remodulin has been a significant contributor to the company's revenue and growth.

Market Position and Competitors

Remodulin operates in a competitive landscape dominated by several classes of drugs, including endothelin receptor antagonists (ERAs), phosphodiesterase type 5 inhibitors (PDE5is), prostacyclins, and guanylyl cyclase stimulators (GCS)[1].

• Competitors: The market includes competitors such as Pfizer, Inc., Bayer HealthCare Pharmaceuticals, GlaxoSmithKline Plc, and others. However, United Therapeutics Corporation has managed to maintain a strong market position with its treprostinil-based products[4].

Revenue Performance

Recent Financial Results

United Therapeutics Corporation has reported robust financial results, with significant contributions from Remodulin and other treprostinil-based products.

• 2023 Financials: The company achieved record revenues of $2.33 billion, a 20% increase over 2022. While Remodulin itself did not see the same level of growth as Tyvaso, it remains a crucial part of the company's product portfolio[3].

Historical Revenue Trends

• Net Product Sales: In the first quarter of 2021, net product sales from treprostinil-based products, including Remodulin, Tyvaso, and Orenitram, grew by $8.4 million compared to the same period in 2020[5].

Market Segments and Geographical Split

Global Market Analysis

The global Remodulin market is segmented into major regions such as North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America.

• Regional Performance: The market analysis indicates that Remodulin has a strong presence in North America and Europe, with growing demand in the Asia-Pacific region[4].

Product Lifecycle and Innovations

Product Evolution

Remodulin has undergone significant product lifecycle management, including the development of new delivery systems.

• Delivery Systems: The transition from traditional infusion systems to more convenient delivery methods, such as the Tyvaso DPI (Dry Powder Inhaler), has enhanced patient compliance and convenience. Although Tyvaso DPI has seen a 362% increase in sales, Remodulin's traditional delivery methods continue to be relevant[3].

Clinical Trials and Label Expansions

Ongoing Research

Clinical trials are crucial for expanding the label and indications of Remodulin.

• Clinical Trials: While Remodulin itself is not currently under investigation for label expansions like Opsumit and Uptravi, the overall trend in PAH treatment involves early implementation of polytherapy, which could indirectly benefit Remodulin by increasing the use of prostacyclins in combination therapies[1].

Challenges and Opportunities

Generic Competition

The PAH market faces significant generic competition, particularly affecting the PDE5i class.

• Generic Erosion: The PDE5i class, which includes drugs like Adcirca and Revatio, has seen substantial generic erosion since 2018, leading to a loss of market share. However, Remodulin, being a prostacyclin, has been less affected by this trend[1].

International Market Expansion

United Therapeutics is expanding its reach into international markets.

• International Expansion: The expansion of nebulized Tyvaso in Japan, for example, represents a strategic initiative to capture market share in international markets, which could also benefit Remodulin in the long run[3].

Financial Health and R&D Investments

Operational Efficiency

United Therapeutics has demonstrated operational efficiency and a strong market position.

• Net Income and R&D: The company reported a net income of $984.8 million in 2023, with a significant increase in R&D expenses, indicating substantial investment in future growth areas. This investment is crucial for maintaining a competitive edge and developing novel therapies[3].

Key Takeaways

• Revenue Growth: Remodulin contributes significantly to United Therapeutics' revenue, although the recent growth has been more pronounced in other treprostinil-based products like Tyvaso.
• Market Position: Remodulin operates in a competitive PAH market but maintains a strong position due to its efficacy and the company's strategic product lifecycle management.
• Innovations: The development of new delivery systems and ongoing R&D efforts are key to sustaining long-term revenue growth.
• Global Expansion: International market expansion is a critical strategy for diversifying revenue sources and capturing new market share.

FAQs

Q: What is Remodulin used for? A: Remodulin is used for the treatment of pulmonary arterial hypertension (PAH) and other related conditions.

Q: Who is the primary manufacturer of Remodulin? A: United Therapeutics Corporation is the primary manufacturer of Remodulin.

Q: How has Remodulin performed financially in recent years? A: While Remodulin has not seen the same level of growth as Tyvaso, it remains a crucial part of United Therapeutics' product portfolio and contributes significantly to the company's revenue.

Q: What are the main competitors of Remodulin in the PAH market? A: The main competitors include other PAH drugs from companies like Pfizer, Bayer HealthCare Pharmaceuticals, and GlaxoSmithKline Plc.

Q: What are the future growth prospects for Remodulin? A: The future growth prospects for Remodulin are tied to the company's innovative pipeline, international market expansion, and the development of new delivery systems.

Sources

1. Global Pulmonary Arterial Hypertension Market Report 2021 - GlobeNewswire
2. United Therapeutics Corporation Reports Fourth Quarter and Full Year 2022 Financial Results - BusinessWire
3. United Therapeutics Corporation Reports Fourth Quarter and Full Year 2023 Financial Results - StockTitan
4. Remodulin Market Report 2024 (Global Edition) - Cognitive Market Research
5. United Therapeutics Corporation Reports First Quarter 2021 Financial Results - PR Newswire