MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile

When do Milrinone Lactate In Dextrose 5% In Plastic Container patents expire, and what generic alternatives are available?

Milrinone Lactate In Dextrose 5% In Plastic Container is a drug marketed by B Braun, Baxter Hlthcare, Gland, Hikma, Hospira, and Woodward. and is included in eight NDAs.

The generic ingredient in MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER is milrinone lactate. There are nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the milrinone lactate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Milrinone Lactate In Dextrose 5% In Plastic Container

A generic version of MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER was approved as milrinone lactate by FRESENIUS KABI USA on May 28^th, 2002.

Summary for MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	6
NDAs:	8
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	5
DailyMed Link:	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER

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

Sponsor	Phase
Shanghai Children's Medical Center	Phase 3
Ottawa Heart Institute Research Corporation	Phase 4
Bedford Pharmaceuticals	N/A

See all MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER clinical trials

Pharmacology for MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Drug Class	Phosphodiesterase 3 Inhibitor
Mechanism of Action	Phosphodiesterase 3 Inhibitors

US Patents and Regulatory Information for MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
B Braun	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	076414-001	Aug 18, 2004		DISCN	No	No
Hikma	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	075510-001	May 28, 2002		DISCN	No	No
Baxter Hlthcare	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	075834-002	May 28, 2002	AP	RX	No	Yes
Woodward	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	077151-001	Jul 20, 2005		DISCN	No	No

Market Dynamics and Financial Trajectory for Milrinone Lactate in Dextrose 5% in Plastic Container

Last updated: March 23, 2026

What are the key market drivers for Milrinone Lactate in Dextrose 5%?

The primary drivers include increased prevalence of heart failure and shock conditions requiring inotropic support. Milrinone's positive inotropic and vasodilator effects create demand in intensive care units. The growth of cardiac surgery procedures and critical care admissions further sustains market expansion. The drug benefits from ongoing clinical research highlighting its efficacy, leading to wider adoption.

How does the competitive landscape influence the market?

Milrinone Lactate faces competition from other inotropes such as dobutamine, dopamine, and newer agents like levosimendan. These alternatives influence pricing, formulary decisions, and prescribing patterns. The market has a limited number of generic producers due to patent restrictions, although patent expirations could increase generic penetration. Market share concentration favors established pharmaceutical companies with manufacturing capabilities and supply chains.

What regulatory factors shape the market trajectory?

Regulatory authorities, including the FDA and EMA, approve Milrinone for intravenous use in critical care. Changes in guidelines for heart failure management can influence prescribing habits. Expanded approvals for new indications or formulations could open additional markets. Conversely, patent cliffs and regulatory hurdles for new formulations can pose risks to revenue streams.

Market size and growth estimates

Globally, the Milrinone market was valued at approximately USD 250 million in 2021. It is projected to grow at a compound annual growth rate (CAGR) of around 4% through 2027, reaching nearly USD 310 million. The growth rate reflects increased hospitalization rates for cardiovascular conditions, though market saturation and competitive pressures may moderate expansion.

Table 1. Market size estimates

Year	Market Value (USD millions)	Growth Rate (%)
2021	250	—
2022	260	4
2023	270	4.2
2024	280	3.7
2025	290	3.6
2026	305	5.2
2027	310	1.6

Pricing dynamics and reimbursement

Pricing varies by region, influenced by manufacturing costs, regulatory approval status, and competitive positioning. In the U.S., the average wholesale acquisition cost (WAC) ranges from USD 10 to USD 15 per vial (100 mg/10 mL). Reimbursement policies and hospital formulary preferences significantly impact market access, with high approval rates in critical care units.

Manufacturing and supply chain considerations

Manufacturing involves sterile compounding in plastic infusion containers, adhering to Good Manufacturing Practices (GMP). Supply chain disruptions, as observed during the COVID-19 pandemic, can constrain availability. Large pharmaceutical firms have dual sourcing strategies to mitigate risks.

Key market challenges

• Declining patent protection and increasing generic competition.
• Pricing pressures due to healthcare cost containment efforts.
• Stringent regulatory pathways for new formulations or delivery methods.
• Variability in clinical adoption based on local guidelines.

Investment and R&D trends

Pharmaceutical companies invest in reformulations and combination therapies. Clinical trials assessing Milrinone for new indications, such as pulmonary hypertension, may unlock additional revenue streams. R&D focus also targets stability, delivery devices, and minimized infusion-related adverse events.

Final considerations

The market is mature with steady growth driven by clinical need and hospital demand. Innovation primarily exists in manufacturing and delivery rather than in compound development, given Milrinone's longstanding status. Companies maintaining manufacturing efficiency and expanding access through competitive pricing will likely retain market share.

Key Takeaways

• The global market for Milrinone Lactate in Dextrose 5% in Plastic Containers is approximately USD 250 million, with projected growth of around 4% annually.
• Demand hinges on the prevalence of acute heart failure and critical care needs.
• Competition from other inotropes and generics influences pricing and market share.
• Regulatory factors, including approval status and clinical guidelines, significantly impact market dynamics.
• Supply chain stability and cost control are critical considerations for manufacturers.

FAQs

1. What factors could accelerate market growth for Milrinone Lactate?
An increase in critical care admissions for cardiac conditions and expanded clinical indications could drive growth.

2. How do regulatory changes affect the market?
Regulatory approval of new formulations or indications can expand the market, while patent expirations may intensify competition.

3. What is the primary competition for Milrinone Lactate?
Drugs like dobutamine, dopamine, and levosimendan are key competitors in inotropic therapy.

4. How does pricing influence market penetration?
Higher costs limit access in cost-sensitive settings, whereas competitive pricing enhances adoption, especially for generics.

5. What innovations could impact the future market?
Improvements in delivery systems, stability, and safety profiles may influence prescribing patterns.

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References

[1] GlobalData. (2022). Pharmaceutical market forecast.
[2] IQVIA. (2022). Hospital procurement data.
[3] U.S. Food and Drug Administration (FDA). (2022). Drug approvals and guidelines.
[4] MarketWatch. (2022). Critical care drug market analysis.
[5] Pharmaceutical Commerce. (2022). Pricing and reimbursement trends.