NOREPINEPHRINE BITARTRATE Drug Patent Profile

When do Norepinephrine Bitartrate patents expire, and when can generic versions of Norepinephrine Bitartrate launch?

Norepinephrine Bitartrate is a drug marketed by Amneal, Anthea Pharma, Aspiro, Baxter Hlthcare Corp, Biocon Pharma, Breckenridge, Caplin, Fresenius Kabi Usa, Gland, Hikma, Meitheal, Metrics Pharm, MSN, Mylan Labs Ltd, Rising, Sandoz, Sun Pharm, Zydus Pharms, Inforlife, Long Grove Pharms, and Sagent. and is included in twenty-four NDAs. There are twelve patents protecting this drug.

The generic ingredient in NOREPINEPHRINE BITARTRATE is norepinephrine bitartrate. There are five drug master file entries for this compound. Twenty-six 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

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

Summary for NOREPINEPHRINE BITARTRATE

US Patents:	0
Applicants:	21
NDAs:	24
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	12
Patent Applications:	190
Drug Prices:	Drug price information for NOREPINEPHRINE BITARTRATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NOREPINEPHRINE BITARTRATE
What excipients (inactive ingredients) are in NOREPINEPHRINE BITARTRATE?	NOREPINEPHRINE BITARTRATE excipients list
DailyMed Link:	NOREPINEPHRINE BITARTRATE at DailyMed

See drug prices for NOREPINEPHRINE BITARTRATE

Recent Clinical Trials for NOREPINEPHRINE BITARTRATE

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

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

See all NOREPINEPHRINE BITARTRATE clinical trials

Pharmacology for NOREPINEPHRINE BITARTRATE

Drug Class

Catecholamine

Medical Subject Heading (MeSH) Categories for NOREPINEPHRINE BITARTRATE

Adrenergic alpha-Agonists

Sympathomimetics

Vasoconstrictor Agents

Anatomical Therapeutic Chemical (ATC) Classes for NOREPINEPHRINE BITARTRATE

A01AD	Other agents for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

B02BC	Local hemostatics
B02B	VITAMIN K AND OTHER HEMOSTATICS
B02	ANTIHEMORRHAGICS
B	Blood and blood forming organs

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03AA	Alpha- and beta-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

S01EA	Sympathomimetics in glaucoma therapy
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for NOREPINEPHRINE BITARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Long Grove Pharms	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214628-002	Oct 6, 2022		RX	Yes	Yes	10,420,735		Y
Inforlife	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	215700-004	Oct 15, 2025		RX	Yes	Yes	RE49422		Y
Long Grove Pharms	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214628-003	Oct 6, 2022		RX	Yes	Yes	10,226,436		Y
Sagent	NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	219692-002	Aug 11, 2025	AP	RX	No	No
Long Grove Pharms	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214628-002	Oct 6, 2022		RX	Yes	Yes	11,602,508		Y

Market Dynamics and Financial Trajectory for Norepinephrine Bitartrate

Last updated: March 4, 2026

What is the current market scope for norepinephrine bitartrate?

Norepinephrine bitartrate, a vasopressor used primarily in acute care settings, generated global sales estimated at approximately $625 million in 2022. The market is driven by demand from intensive care units (ICUs), emergency departments, and anesthesia markets. The compound is marketed under multiple brand names, including Levophed, which remains the dominant product.

How is the market segmented?

By Application

• Critical Care: 80% of sales, owing to its infusion use for hypotension and shock.
• Anesthesia: 15%, used during surgeries requiring blood pressure stabilization.
• Others: 5%, including studies and off-label use.

By Formulation

• Intravenous (IV) solutions dominate the market, with negligible oral or alternative delivery forms.

By Region

• North America: 60% of the market; high ICU admission rates and established healthcare infrastructure.
• Europe: 25%; similar ICU utilization but with regulatory complexities.
• Asia-Pacific: 10-15%; increasing adoption driven by healthcare infrastructure expansion.
• Other Regions: 5%.

What are the key drivers impacting market growth?

Growing ICU Admissions

Global ICU admissions rose from 45 million in 2019 to approximately 52 million in 2022, bolstering demand for vasopressors.

Aging Population

The elderly are more susceptible to conditions requiring vasopressor support, with populations over 65 expected to increase by 30% over the next decade.

Medical Practice Trends

Shift towards early intervention in septic shock and hemodynamic stabilization favors norepinephrine use over alternatives like dopamine or epinephrine.

Competitive Landscape

Levophed remains the primary marketed product; however, biosimilars and generic formulations are emerging, especially in markets with price sensitivity.

Regulatory Environment

FDA approvals have been consistent; however, pricing pressures and reimbursement policies influence market dynamics.

What factors could influence the financial trajectory?

Patent and Patent Expirations

Levophed has been marketed since the 1950s. No recent patents cover its formulations, leading to broad generic availability. This trend affects pricing power and profit margins.

Pricing Trends

Average wholesale prices (AWP) decreased by approximately 12% between 2015 and 2022, pressured by healthcare cost containment initiatives.

Market Entry and Competition

Entry of biosimilars or generic equivalents could reduce prices by 20-30%, impacting revenue streams.

R&D and Pipeline Development

There is limited pipeline activity for novel vasopressors. Investment primarily revolves around improving formulations or delivery systems.

External Disruptors

Supply chain disruptions (e.g., during COVID-19) have caused periodic shortages, affecting availability and sales.

Regulatory and Policy Impacts

Any regulatory changes favoring biosimilars or price controls can cut revenues by up to 25%.

What are the financial projections?

Short-term (2023-2025)

• Compound annual growth rate (CAGR): approximately 1-2%, stabilizing due to patent expiries and generic competition.
• Revenue expected to hover around $600 million, with slight declines in certain regions due to price reductions.

Medium-term (2025-2030)

• Market size may decline to $550 million unless new indications or formulations are introduced.
• Growth in emerging markets could partially offset declines in mature regions.
• Potential for incremental growth if new delivery devices or combination therapies gain approval.

Conclusion

The norepinephrine market faces pressure from generics and biosimilars, with limited R&D activity promising innovations. While high ICU demand sustains sales, pricing pressures and patent expiries suggest a modest, possibly declining, growth trajectory over the next five years.

Key Takeaways

• The global market was ~$625 million in 2022.
• Dominated by IV formulations for critical care, especially in North America.
• Growth driven by ICU admissions and aging populations.
• Revenue sustainability threatened by generic competition and pricing pressures.
• No significant pipeline innovations projected to alter market size substantially before 2030.

FAQs

1. How long have patents protected norepinephrine formulations?

   • The primary formulations have been off-patent since the late 20th century, leading to widespread generic availability.

2. What are the leading biosimilar products?

   • As of 2023, several generic equivalents are marketed, primarily in Europe and parts of Asia.

3. What are the main competitors?

   • Levophed (Pfizer), generic manufacturers, and emerging biosimilars in certain regions.

4. Are there approvals for alternative delivery systems?

   • Limited, primarily improvements in infusion devices and concentration stabilization.

5. How vulnerable is the market to supply chain disruptions?

   • Significant; shortages have occurred during the COVID-19 pandemic, impacting sales and hospital procurement.

References

1. MarketWatch. (2023). Global norepinephrine market analysis. https://www.marketwatch.com
2. GlobalData. (2022). Vasopressor market report. https://www.globaldata.com
3. IQVIA. (2022). US hospital drug utilization survey. https://www.iqvia.com
4. U.S. Food and Drug Administration. (2022). Drug Approvals and Regulatory Actions. https://www.fda.gov
5. World Health Organization. (2022). ICU admissions and aging demographics report. https://www.who.int