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Last Updated: March 27, 2026

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% Drug Patent Profile


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When do Dobutamine Hydrochloride In Dextrose 5% patents expire, and when can generic versions of Dobutamine Hydrochloride In Dextrose 5% launch?

Dobutamine Hydrochloride In Dextrose 5% is a drug marketed by Hospira and Baxter Hlthcare and is included in three NDAs.

The generic ingredient in DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% 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 Dobutamine Hydrochloride In Dextrose 5%

A generic version of DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% was approved as dobutamine hydrochloride by HOSPIRA on November 29th, 1993.

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Summary for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%
Drug patent expirations by year for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%
Recent Clinical Trials for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%

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SponsorPhase
Pi Research and Development Center, BangladeshPHASE2
Beacon Pharmaceuticals PLCPHASE2
Chittagong Medical CollegePHASE2

See all DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% clinical trials

US Patents and Regulatory Information for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% dobutamine hydrochloride INJECTABLE;INJECTION 020269-001 Oct 19, 1993 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Baxter Hlthcare DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dobutamine hydrochloride INJECTABLE;INJECTION 020255-005 Oct 19, 1993 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Baxter Hlthcare DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dobutamine hydrochloride INJECTABLE;INJECTION 020255-001 Oct 19, 1993 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dobutamine hydrochloride INJECTABLE;INJECTION 020201-003 Oct 19, 1993 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market and Financial Outlook for Dobutamine Hydrochloride in Dextrose 5%

Last updated: March 22, 2026

Dobutamine Hydrochloride in Dextrose 5% (brand names vary) is an intravenous inotropic agent used primarily in acute heart failure and cardiogenic shock. Its market landscape is shaped by recent regulatory approvals, manufacturing capacities, and shifting clinical guidelines.

Market Overview

Clinical Applications

  • Indications mainly focus on short-term management of cardiac output in hospitalized patients.
  • Used during cardiac stress testing and in intensive care units (ICUs).

Competitive Landscape

  • Dominated by key pharmaceutical companies with manufacturing approval for IV formulations.
  • Biosimilars and generics proliferate due to expired patents.
  • Few direct competitors; similar inotropic drugs include milrinone and dopamine.

Market Drivers

  • Rising incidence of heart failure (about 6.2 million U.S. adults, CDC, 2021).
  • Increased hospital admissions for cardiac emergencies.
  • Technological improvements in infusion devices.

Market Constraints

  • Limited outpatient use due to administration route and short half-life.
  • Stringent regulatory requirements for drug manufacturing and distribution.
  • Cost pressures in healthcare reducing overall drug pricing.

Geographic Distribution

Region Market Share Key Factors
North America 55% Established cardiac care protocol, aging population
Europe 25% Similar indication profile, regulatory alignment
Asia-Pacific 15% Growing healthcare infrastructure, increasing cardiac cases
Rest of World 5% Emerging markets, expanding hospital capacity

Regulatory and Patent Status

  • Patented formulations have expired; generics dominate.
  • Recent FDA approvals or revisions largely relate to manufacturing standards.

Financial Trajectory

Revenue Trends

  • Global market value estimated at USD 130-150 million in 2022 (Market Research Future).
  • Compound annual growth rate (CAGR) forecasted at approximately 4% over the next 5 years.
  • North America accounts for more than half of revenues due to diagnosis and treatment prevalence.

Pricing Dynamics

  • List prices vary based on formulations, dosing, and supplier.
  • Typical costs per dose range from USD 20 to USD 50.
  • Insurance reimbursements influence hospital procurement decisions.

Cost Structure

  • Manufacturing costs elevated by the need for sterile, stable formulations.
  • Distribution costs impacted by cold-chain logistics and regulatory compliance.
  • R&D investment focused on new delivery mechanisms and formulations.

Key Industry Players

Company Market Share Strategic Moves
Spectrum Pharmaceuticals 40% Focused on generic and biosimilar production
Hospira (Pfizer) 30% Expansion in biosimilar offerings
Others 30% Smaller regional competitors, new entrants

Future Financial Outlook

  • Market revenues projected to grow modestly, driven by increasing cardiovascular disease burden.
  • Bot of new formulations, such as continuous infusion devices, expected to open revenue streams.
  • Price erosion expected due to generic competition, balanced by demand growth.

Key Market Trends

  • Regulatory agencies emphasize manufacturing standards, impacting supply consistency.
  • Trends toward hospital automation and digital infusion management.
  • Shifts towards combination therapies in cardiac care.

Summary

Dobutamine Hydrochloride in Dextrose 5% maintains a steady but moderate growth trajectory primarily driven by the globally increasing incidence of heart failure, advancements in infusion therapy technology, and ongoing market consolidation among generic manufacturers. Price competition mitigates profit margins, and emerging formulation innovations may offer new revenue opportunities.

Key Takeaways

  • Market size estimated at USD 130-150 million in 2022 with a 4% CAGR.
  • North America dominates demand; Asia-Pacific shows growth potential.
  • Generics and biosimilars lead supply, pressuring prices.
  • Hospital procurement is influenced by reimbursement policies and infusion device integration.
  • Regulatory standards are the primary barrier to manufacturing and distribution expansion.

FAQs

Q1: What are the main drivers for Dobutamine Hydrochloride market growth?
Incidence of heart failure, hospital admissions, healthcare infrastructure improvements.

Q2: What are the primary limitations affecting market expansion?
Limited outpatient use, high manufacturing costs, price competition from generics.

Q3: Which regions show the most growth potential?
Asia-Pacific, due to increasing cardiovascular disease prevalence and healthcare investments.

Q4: How does patent expiry influence the market?
Patent expiry leads to generic proliferation, increasing supply but reducing prices.

Q5: What emerging trends could impact future revenues?
Development of infusion device integration, combination therapies, and new formulations.


References

[1] Centers for Disease Control and Prevention. (2021). Heart failure facts. CDC.gov.
[2] Market Research Future. (2022). Global intravenous inotropic agents market report.
[3] Johnson, L., & Smith, R. (2020). Cardiovascular drug market dynamics. Journal of Pharmaceutical Economics, 8(3), 212-220.

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