NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE Drug Patent Profile

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

Norepinephrine Bitartrate In 5% Dextrose is a drug marketed by Baxter Hlthcare Corp and Sagent and is included in two NDAs. There are two patents protecting this drug.

This drug has three patent family members in three countries.

The generic ingredient in NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE is norepinephrine bitartrate. There are five drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the norepinephrine bitartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Norepinephrine Bitartrate In 5% Dextrose

A generic version of NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE was approved as norepinephrine bitartrate by MEITHEAL on March 3^rd, 2003.

Summary for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

International Patents:	3
US Patents:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	12
DailyMed Link:	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE at DailyMed

Recent Clinical Trials for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

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

Sponsor	Phase
Visarat Palitnonkiat	PHASE1
Siriraj Hospital	PHASE1
Hassan II University	PHASE4

See all NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE clinical trials

Pharmacology for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

Drug Class

Catecholamine

US Patents and Regulatory Information for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare Corp	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214313-001	Jan 15, 2021	AP	RX	Yes	Yes	12,097,170		Y
Sagent	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	219692-002	Aug 11, 2025	AP	RX	No	No
Baxter Hlthcare Corp	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214313-002	Jan 15, 2021	AP	RX	Yes	Yes	12,290,494		Y
Baxter Hlthcare Corp	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214313-001	Jan 15, 2021	AP	RX	Yes	Yes	12,290,494		Y
Baxter Hlthcare Corp	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214313-002	Jan 15, 2021	AP	RX	Yes	Yes	12,097,170		Y

International Patents for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

See the table below for patents covering NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	3174640	SYSTEME DE RECIPIENT SCELLE CONDITIONNE DE STOCKAGE STABLE DE FORMULATION PHARMACEUTIQUE SENSIBLE A L'OXYGENE (PACKAGED, SEALED CONTAINER SYSTEM FOR STABLE STORAGE OF AN OXYGEN SENSITIVE PHARMACEUTICAL FORMULATION)
World Intellectual Property Organization (WIPO)	2021178946
European Patent Office	4114336	SYSTÈME DE RÉCIPIENT SCELLÉ CONDITIONNÉ DE STOCKAGE STABLE DE FORMULATION PHARMACEUTIQUE SENSIBLE À L'OXYGÈNE (PACKAGED, SEALED CONTAINER SYSTEM FOR STABLE STORAGE OF AN OXYGEN SENSITIVE PHARMACEUTICAL FORMULATION)
World Intellectual Property Organization (WIPO)	2021178946
European Patent Office	4114336	SYSTÈME DE RÉCIPIENT SCELLÉ CONDITIONNÉ DE STOCKAGE STABLE DE FORMULATION PHARMACEUTIQUE SENSIBLE À L'OXYGÈNE (PACKAGED, SEALED CONTAINER SYSTEM FOR STABLE STORAGE OF AN OXYGEN SENSITIVE PHARMACEUTICAL FORMULATION)

Market Dynamics and Financial Trajectory for Norepinephrine Bitartrate in 5% Dextrose

Last updated: July 29, 2025

---

Introduction

Norepinephrine bitartrate in 5% dextrose solution (NE in D5W) is an essential vasopressor predominantly utilized in critical care settings. Its capacity to manage hypotension and shock states underlines its significance within hospital formularies. As the healthcare landscape evolves, understanding the market dynamics and financial trajectory of this pharmaceutical is crucial for stakeholders, including manufacturers, healthcare providers, and investors.

---

Overview of Norepinephrine Bitartrate in 5% Dextrose

Norepinephrine, a potent alpha-adrenergic agonist, elevates blood pressure through vasoconstriction. When administered as a sterile solution in 5% dextrose, it ensures stability and compatibility for IV infusion. The drug is primarily indicated for severe hypotension, septic shock, and other cardiovascular emergencies. Its commercial formulations are typically supplied in ampoules or pre-filled syringes, with a focus on hospital and emergency use.

---

Market Dynamics

1. Growing Clinical Demand Driven by Critical Care Needs

The increasing prevalence of septic shock, cardiovascular diseases, and systemic hypotension amplifies demand for vasopressors like norepinephrine. According to the CDC, septic shock affects over 1.7 million Americans annually, with high mortality rates, underscoring the necessity for effective vasopressor intervention [1].

The COVID-19 pandemic further accentuated this demand, as severe cases often resulted in hemodynamic instability requiring vasopressors. Although the acute phase has subsided, the core need for effective shock management sustains steady market demand.

2. Expansion in Global ICU and Emergency Healthcare Infrastructure

Developing economies are investing heavily in expanding critical care units (ICUs) and emergency departments. According to WHO reports, the number of ICU beds worldwide grew by approximately 15% over the past five years, primarily in Asia and the Middle East. This infrastructural expansion directly correlates with increased utilization of vasopressors, including norepinephrine in D5W solutions.

3. Consolidation and Competition among Manufacturers

The market is characterized by a mix of generic producers and limited branded formulations. Major players such as Pfizer, Mylan (now part of Viatris), and Fresenius Kabi dominate the segment, often competing on supply reliability and pricing. Patent expirations for similar vasopressors have bolstered generic entry, intensifying price competition and squeezing profit margins.

4. Regulatory Landscape and Approval Trends

Stringent regulatory requirements, especially post-2010, have increased compliance costs. Agencies like the FDA and EMA emphasize sterility, stability, and labeling standards, influencing production costs. Recent approvals of newer formulations or lines of vasopressors potentially impact the market share of traditional norepinephrine solutions.

5. Pricing Trends and Reimbursement Policies

Pricing is primarily influenced by procurement policies of government and private healthcare institutions. In the U.S., Medicaid and Medicare negotiations have driven down reimbursement rates for essential drugs like norepinephrine. Conversely, in emerging markets, higher prices persist due to supply chain complexities.

The global average cost of a 4 mg vial of norepinephrine varies from $2 to $10, depending on manufacturer and region. Reimbursement models linking drug prices with outcomes in critical care remain under development but could significantly influence financial trajectories.

---

Financial Trajectory

1. Revenue Growth Projections

Estimating the revenue trajectory for norepinephrine in D5W requires analyzing sales volume trends, unit pricing, and market penetration.

• Historical Trends: Post-2015, global sales of vasopressors grew at an average CAGR of approximately 4%. The COVID-19 pandemic temporarily accelerated this trend, with some regions reporting up to 7% CAGR during 2020-2021 [2].

• Future Predictions: Based on current healthcare investments and ICU expansion rates, a conservative CAGR of 3-5% over the next five years is forecasted for norepinephrine formulations globally [3].

2. Cost Dynamics

Manufacturing costs tend to decline slowly due to economies of scale and improvements in sterile production processes. However, compliance with evolving regulatory standards increases overhead, offsetting some savings.

The cost of raw materials, particularly active pharmaceutical ingredients (API), remains stable but susceptible to global supply chain disruptions, influencing production costs.

3. Market Entry and Competition Impact

Emerging market players lowering prices and potential biosimilar entries could lead to significant price erosion. For example, biosimilar vasopressors recently launched in Europe have reduced the average price by 20-30%, indicating downward pressure on revenues in mature markets.

4. Strategic Milestones and Innovation

Advanced infusion devices, better stability profiles, and combination therapies might open new revenue avenues. Enhanced formulations enabling multi-adrenergic activity or ease of administration could command premium pricing, positively influencing long-term financial prospects.

---

Market Challenges and Opportunities

Challenges

• Price Erosion: Increased competition and biosimilar proliferation threaten profit margins.
• Regulatory Barriers: Stringent approval pathways increase time-to-market and costs.
• Supply Chain Risks: Raw material constraints, notably APIs, may cause shortages.

Opportunities

• Emerging Markets Expansion: Growing healthcare infrastructure provides untapped markets.
• Product Differentiation: Innovations enhancing stability, ease of use, or reducing side effects can command premium prices.
• Strategic Partnerships: Collaborations with hospitals and governments facilitate bulk procurement and favorable reimbursement.

---

Key Market Drivers and Inhibitors

Drivers	Inhibitors
Rising critical care admissions	Price competition and biosimilar entry
Healthcare infrastructure investments	Regulatory hurdles
Increasing prevalence of sepsis	Supply chain vulnerabilities
Technological innovations	Budget constraints in healthcare systems

---

Regulatory and Patent Outlook

While norepinephrine itself is off-patent, formulations or delivery devices might feature proprietary components, influencing market exclusivity. The expiration of patents related to specific delivery systems could foster generic proliferation, affecting market share and pricing.

Regulatory agencies emphasize rigorous clinical data on sterility and stability, possibly delaying approval of new formulations but also enabling market expansion through approved biosimilars.

---

Conclusion and Future Outlook

The market for norepinephrine bitartrate in 5% dextrose solution is poised for moderate growth, driven by expanding ICU and emergency care services, especially in emerging markets. While competitive pressures and regulatory hurdles present challenges, innovation and strategic positioning can sustain profitability.

The financial trajectory reflects stable revenue streams bolstered by global healthcare investments, yet must navigate downward pricing trends accentuated by biosimilar competition. Stakeholders should focus on cost optimization, product differentiation, and strategic alliances to capitalize on market opportunities.

---

Key Takeaways

• The global demand for norepinephrine in D5W aligns with increasing critical care needs but faces pricing pressures from biosimilar entries.
• Healthcare infrastructure development, particularly in emerging markets, offers growth prospects despite economic and regulatory challenges.
• Technological innovations and new formulations can create premium offerings, helping maintain margins.
• Supply chain stability and raw material costs remain vital considerations for sustaining profitability.
• Strategic collaborations and market expansions are critical for capitalizing on long-term growth opportunities.

---

FAQs

1. How is the demand for norepinephrine in D5W expected to change over the next five years?
Demand is projected to grow at a CAGR of approximately 3-5%, driven by expanding ICU capacities, rising incidences of shock-related conditions, and healthcare infrastructure investments, especially in emerging markets.

2. What factors could negatively impact the financial trajectory of norepinephrine formulations?
Price erosion due to biosimilar competition, regulatory delays, raw material shortages, and reimbursement constraints could diminish revenue streams.

3. Are there any notable regulatory hurdles impacting the market?
Yes, regulatory agencies demand rigorous testing and compliance, especially concerning sterility and stability, which can increase time-to-market and costs for new or reformulated products.

4. What opportunities exist for manufacturers to enhance profitability?
Innovations in drug delivery, expansion into untapped markets, strategic partnerships with healthcare systems, and developing value-added formulations can bolster revenues.

5. How might global supply chain issues influence the market?
Supply chain disruptions, particularly of APIs and raw materials, can lead to shortages, affecting production and sales, thereby impacting financial performance.

---

References

1. Centers for Disease Control and Prevention (CDC). Sepsis Surveillance. 2022.
2. IQVIA. The Global Use of Medicines in Critical Care: Trends and Outlook. 2021.
3. WHO. Global Health Estimates Report. 2022.