DOBUTREX Drug Patent Profile

Which patents cover Dobutrex, and when can generic versions of Dobutrex launch?

Dobutrex is a drug marketed by Lilly and is included in one NDA.

The generic ingredient in DOBUTREX is dobutamine hydrochloride. There are fourteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the dobutamine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dobutrex

A generic version of DOBUTREX was approved as dobutamine hydrochloride by HOSPIRA on November 29^th, 1993.

Summary for DOBUTREX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	10
Patent Applications:	822
DailyMed Link:	DOBUTREX at DailyMed

Recent Clinical Trials for DOBUTREX

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

Sponsor	Phase
Steen Hvitfeldt Poulsen	PHASE1
Helge Peetz og Verner Peetz og hustru Vilma Peetz Legat	Phase 2
Simon Spies Fonden	Phase 2

See all DOBUTREX clinical trials

US Patents and Regulatory Information for DOBUTREX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lilly	DOBUTREX	dobutamine hydrochloride	INJECTABLE;INJECTION	017820-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for DOBUTREX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	DOBUTREX	dobutamine hydrochloride	INJECTABLE;INJECTION	017820-002	Approved Prior to Jan 1, 1982

International Patents for DOBUTREX

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

Country	Patent Number	Title	Estimated Expiration
Canada	1018188	DOPAMINE DERIVATIVES
Sweden	399064	FORFARANDE FOR FRAMSTELLNING AV ETT NYTT DOPAMINDERIVAT
Germany	2317710
Japan	S497237
Ireland	37511	DOPAMINE DERIVATIVES

Market Dynamics and Financial Trajectory for Dobutrex (Dobutamine)

Last updated: February 20, 2026

What is Dobutrex and its approved indications?

Dobutrex (dobutamine) is a synthetic catecholamine used primarily as an inotropic agent. It stimulates beta-1 adrenergic receptors, increasing cardiac output.

• Approved Indications: Acute heart failure, cardiac shock, and inotropic support during cardiac surgery or stress testing.
• Regulatory Status: Approved by the FDA in 1979; marketed globally, with varying approvals.

What is the current market size for dobutamine?

The global dobutamine market was valued at approximately USD 200-250 million in 2022. It is driven by hospital demand for inotropic agents in critical care settings.

Region	2022 Market Size (USD million)	CAGR (2022-2027)	Key Drivers
North America	120	3%	High prevalence of heart failure, comprehensive ICU care
Europe	60	2.5%	Aging population, increased cardiovascular surgeries
Asia-Pacific	40	5%	Growing healthcare infrastructure, rising chronic illness

What factors influence demand for dobutamine?

Clinical Use and Hospital Adoption

Hospitals use dobutamine primarily in critical care. Its demand correlates with:

• Incidence and prevalence of acute heart failure.
• Use in cardiac surgeries and stress testing.
• Guidelines recommending inotropic support in heart failure management.

Competition and Alternatives

Other inotropes include milrinone, dopamine, and levosimendan. Factors shaping their competitive position are:

• Efficacy and safety profiles.
• Ease of administration.
• Patent status and formulation differences.

Regulatory and Reimbursement Policies

Insurance reimbursement rates and regulatory approvals influence accessibility and utilization. Variations across countries impact regional market sizes.

What are recent developments affecting Dobutrex’s market?

New Formulations and Patent Expirations

No recent significant patent expirations or novel formulations have entered the market in recent years, maintaining the status quo.

Market Competition

Levosimendan, a calcium sensitizer, has gained traction in Europe as an alternative, influencing dobutamine's growth rate.

Regulatory Changes

The FDA has not issued new restrictions; however, some European authorities recommend cautious use due to arrhythmic risks associated with inotropes.

Impact of COVID-19

Increased ICU admissions for cardiac complications may have temporarily boosted dobutamine use, but supply chain disruptions could have affected procurement.

What is the financial trajectory forecast?

Revenue Projections

The compound annual growth rate (CAGR) for dobutamine is projected at 2.5-3% from 2022 to 2027, reflecting steady but modest growth.

Year	Estimated Market Size (USD million)
2022	200-250
2023	210-260
2024	220-270
2025	230-280
2026	240-290
2027	250-300

Factors Affecting Financial Trajectory

• Market penetration: Slow due to entrenched use of existing inotropes.
• Emergence of alternatives: Levosimendan's growing use limits dobutamine's upside.
• Healthcare spending: Increased ICU expenditure favors continued demand.

Profitability and Cost Structure

Manufacturers incur costs related to raw materials, manufacturing, and regulatory compliance. Because dobutamine is off-patent, market players compete primarily on pricing.

What are regulatory and pipeline prospects?

Regulatory Environment

No recent regulatory hurdles have emerged; global approvals remain stable.

Pipeline and Development

No new dobutamine formulations or derivatives are in late-stage development, limiting potential revenue expansion.

Summary of key market risks

• Market saturation by existing inotropes.
• Regulatory scrutiny over safety concerns.
• Competition from newer agents like levosimendan.
• Cost pressures due to generic competition.

Key Takeaways

• The global dobutamine market remains stable, with compound growth driven by ICU demand and cardiac surgeries.
• Competition from alternatives constrains rapid growth.
• The market is mature; innovation and patent activity are minimal.
• Regional differences in healthcare policies impact sales.
• Market expansion prospects are limited unless new formulations or clinical evidence bolster its use.

FAQs

1. What is the primary driver for dobutamine demand?
The increasing incidence of acute heart failure and use in cardiac surgeries drive demand, especially in hospital intensive care units.

2. How does levosimendan affect dobutamine’s market?
Levosimendan offers an alternative with different safety and efficacy profiles, especially in Europe, impacting dobutamine’s growth.

3. Are there any upcoming regulatory changes expected?
No significant regulatory changes are currently anticipated; safety concerns remain managed within existing frameworks.

4. What countries represent the largest markets for dobutamine?
North America and Europe hold the largest shares, with Asia-Pacific experiencing rapid growth due to healthcare expansion.

5. Is there potential for new formulations or improvements?
No current pipelines suggest minimal near-term innovation in dobutamine formulations, maintaining a stable but limited growth trajectory.

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References

[1] MarketsandMarkets. (2023). Inotropic Agents Market. Retrieved from https://marketsandmarkets.com

[2] FDA. (2023). Drug Approvals and Labels. U.S. Food and Drug Administration.

[3] IQVIA. (2022). Global Critical Care Market Report. IQVIA Insights.