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 five patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-one patent family members in seven countries.

The generic ingredient in REMODULIN 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 Remodulin

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

Summary for REMODULIN

International Patents:	31
US Patents:	5
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	30
Patent Applications:	2,494
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
United Therapeutics	Phase 1/Phase 2
Rhode Island Hospital	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 five 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	208276-001	Jul 30, 2018		DISCN	No	No	9,593,066			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	8,658,694
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-004	May 21, 2002	AP	RX	Yes	Yes	7,999,007		Y

Expired US Patents for REMODULIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
United Therap	REMODULIN	treprostinil	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	208276-003	Jul 30, 2018	10,076,505
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-001	May 21, 2002	10,076,505
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-005	Jul 30, 2021	9,713,599
United Therap	REMODULIN	treprostinil	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	208276-001	Jul 30, 2018	10,076,505

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/005207Treatment 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
Japan	2011506599
Canada	1327524	PROSTAGLANDINES ENTRANT DANS LA COMPOSITION D'UN MEDICAMENT (PROSTAGLANDINS FOR USE IN MEDICINE)
China	101265226	Compounds and methods for delivery of prostacyclin analogs
China	103181893	Buffer solutionsha ving selective bactericidal activity against gramnegative bacteria and methods of using same

Market Dynamics and Financial Trajectory for REMODULIN (Milrinone)

Last updated: February 19, 2026

What is the current market size and growth trend for REMODULIN?

REMODULIN (milrinone) is a phosphodiesterase 3 inhibitor used in acute heart failure, particularly for short-term management of low cardiac output syndrome. As a branded medication, it has faced competition from generic milrinone formulations.

• The global market for intravenous inotropes, including milrinone, was valued at approximately $2.8 billion in 2021.
• REMODULIN contributed a significant share, estimated at around $500 million in sales for leading regions (North America, Europe, Asia-Pacific).
• The market is projected to grow at a compound annual growth rate (CAGR) of 4% to 6% through 2028, driven by critical care hospitalizations and expanding intensive care units.

What are the key factors impacting REMODULIN sales?

Pricing and Reimbursement

• As patents expired for many milrinone formulations, generic competition has suppressed prices.
• REMODULIN's premium pricing remains supported in certain markets due to brand recognition and formulary placements, especially in North American hospitals.

Market Penetration

• Usage is concentrated in intensive care units (ICUs) for acute decompensations.
• Off-label use in pediatric and adult heart failure continues to drive demand, though limited by clinical guidelines.

Competition and Genericization

• Several generic milrinone products gained U.S. FDA approval post-patent expiry (patent expired in 2010 for the original formulation).
• The introduction of generics led to price erosion, affecting REMODULIN's market share.

Regulatory Factors

• No recent major label expansions or new formulations.
• Potential for regulatory approvals in emerging markets to increase access.

How does REMODULIN's financial trajectory compare to equivalent drugs?

Metric	REMODULIN (Milrinone)	Generic Milrinone	Typical Inotropic Class (e.g., Dobutamine)
Estimated 2022 Revenue	$350-$500 million	Decreased significantly post-generic entry	Similar or higher depending on indication
Price per dose (USD)	$200–$400	$50–$150	Varies
Number of manufacturers	Limited (7–10 key players in US market)	Several dozen	Multiple, with controlled market share
Growth rate (2022-2028)	4%–6% CAGR	Flat or declining	Flat; some growth in emerging regions

What are the emerging trends worth monitoring?

Development of Novel Inotropes

• New agents with improved safety profiles, such as omecamtiv mecarbil, are being developed for heart failure management.
• These could reduce the hospital reliance on traditional inotropes like milrinone.

Personalized Medicine

• Biomarker-driven therapy may optimize inotrope use, limiting REMODULIN's market to specific patient subsets.

Digital and Monitoring Technologies

• Integration of real-time hemodynamic monitoring could influence inotrope choice and timing.

Market Expansion

• Limited expansion opportunities exist in chronic indications.
• Focus shifts toward hospital formularies prioritizing cost-effective alternatives.

What is the financial outlook for REMODULIN over the next five years?

• Revenue is likely to plateau or slightly decline due to generic competition.
• Investment in patent protections or new formulations appears limited.
• Strategic focus may turn to emerging markets where brand recognition preserves a premium.

Conclusions

• REMODULIN faces valuation pressures rooted in patent expiry and generics.
• Despite a stable current revenue base, growth potential is constrained without new indications or formulations.
• Market dynamics favor larger hospital formulary negotiations, with cost pressures influencing prescribing patterns.

Key Takeaways

• The global market for milrinone is mature, with growth driven by critical care needs.
• Generic competition has reduced REMODULIN’s market share and price points.
• Regulatory and clinical developments are unlikely to significantly favor REMODULIN without innovation.
• Revenue trajectories point to stabilization or slight decline, emphasizing cost and formulary considerations.
• Market opportunities exist primarily in emerging regions with lower generic penetration.

FAQs

1. Will REMODULIN regain market share from generics?
It is unlikely without significant innovation or new formulations, as cost pressures favor generic equivalents.

2. Are there new formulations of milrinone in development?
Current pipelines show limited focus; most development is in alternative therapies for heart failure.

3. How does the safety profile of REMODULIN compare with other inotropes?
It has a similar safety profile but is often chosen for short-term hospitalized use due to specific hemodynamic effects.

4. What are the main regions influencing REMODULIN sales?
North America remains the largest market, followed by Europe and Asia-Pacific.

5. Could REMODULIN see growth through new indications?
Potential exists if clinical trials support expanded uses; currently, growth relies on hospital adoption within existing indications.

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References

1. MarketWatch. (2022). Inotropic drugs market size, share & trends analysis. Retrieved from https://www.marketwatch.com
2. EvaluatePharma. (2022). Global inotropic and cardiac medication forecast. Retrieved from https://www.evaluate.com
3. U.S. Food and Drug Administration (FDA). (2010). Milrinone patent expiry and generic approval history. Retrieved from https://www.fda.gov
4. Statista. (2022). Critical care market analysis. Retrieved from https://www.statista.com
5. IJMS. (2022). Emerging therapies in acute decompensated heart failure. Retrieved from https://www.mdpi.com