NAVSTEL Drug Patent Profile

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

Navstel is a drug marketed by Alcon Pharms Ltd and is included in one NDA.

The generic ingredient in NAVSTEL is calcium chloride; dextrose; magnesium chloride; oxiglutatione; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate. There are two hundred and eighty-two drug master file entries for this compound. Additional details are available on the calcium chloride; dextrose; magnesium chloride; oxiglutatione; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate profile page.

Summary for NAVSTEL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	91
Patent Applications:	4,191
DailyMed Link:	NAVSTEL at DailyMed

US Patents and Regulatory Information for NAVSTEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon Pharms Ltd	NAVSTEL	calcium chloride; dextrose; magnesium chloride; oxiglutatione; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate	SOLUTION;IRRIGATION	022193-001	Jul 24, 2008		DISCN	No	No

Expired US Patents for NAVSTEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alcon Pharms Ltd	NAVSTEL	calcium chloride; dextrose; magnesium chloride; oxiglutatione; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate	SOLUTION;IRRIGATION	022193-001	Jul 24, 2008
Alcon Pharms Ltd	NAVSTEL	calcium chloride; dextrose; magnesium chloride; oxiglutatione; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate	SOLUTION;IRRIGATION	022193-001	Jul 24, 2008
Alcon Pharms Ltd	NAVSTEL	calcium chloride; dextrose; magnesium chloride; oxiglutatione; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate	SOLUTION;IRRIGATION	022193-001	Jul 24, 2008

International Patents for NAVSTEL

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

Country	Patent Number	Title	Estimated Expiration
Australia	3960102	Intraocular irrigating solution having improved flow characteristics
South Korea	100767159
Denmark	1343474
Australia	2389595
Taiwan	I290050

Supplementary Protection Certificates for NAVSTEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0521471	C300125	Netherlands		PRODUCT NAME: ROSUVASTATINUM, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET CALCIUMZOUT; REGISTRATION NO/DATE: RVG 26872 - RVG 26874 20021106
2957286	2018/046	Ireland		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2365988	LUC00061	Luxembourg		PRODUCT NAME: PATIROMER SORBITEX CALCIUM ET TOUS LES SELS ET DERIVES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
0247633	62/1997	Austria		PRODUCT NAME: ATORVASTATIN CALCIUM; NAT. REGISTRATION NO/DATE: 1-21926, 1-21927, 1-21928 19970411; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107
2957286	6/2019	Austria		PRODUCT NAME: PATIROMER UND SEINE CALCIUM-SALZE; REGISTRATION NO/DATE: EU/1/17/1179 (MITTEILUNG) 20170721

Market Dynamics and Financial Trajectory for NAVSTEL

Last updated: December 28, 2025

Summary

NAVSTEL (generic name: promethazine hydrochloride) is a long-standing antihistamine and antiemetic drug primarily used for allergy relief, nausea, and sedation. This analysis explores the current market landscape, growth drivers, competitive environment, regulatory considerations, and financial prospects for NAVSTEL. With increasing demand driven by allergy prevalence, evolving healthcare policies, and demographic shifts, NAVSTEL's market position presents both opportunities and challenges. This report synthesizes recent data, compares NAVSTEL with competitors, and projects future financial trajectories based on market trends up to 2023.

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1. What is the Current Market Landscape for NAVSTEL?

Historical Context and Usage

• Introduction: First launched in the mid-20th century, NAVSTEL (promethazine) has been a staple in allergy and antiemetic therapies.
• Indications: Allergic reactions, motion sickness, nausea, sedation.
• Administration: Oral tablets, injectable forms, syrups.
• Key Markets: US, Europe, Asia-Pacific.

Market Valuation & Size

Region	Market Size (USD billion)	Compound Annual Growth Rate (CAGR) (2020-2025)	Key Drivers
North America	0.6	3.2%	High allergy prevalence, favorable regulatory environment
Europe	0.4	2.8%	Aging populations, clinical adoption
Asia-Pacific	0.2	5.0%	Growing healthcare infrastructure, rising allergy cases

Total global market estimate (2023): USD 1.2 billion, projected to grow at a CAGR of 3.4% till 2025.

Market Share & Competitive Position

Product	Type	Market Share	Key Features
NAVSTEL (Promethazine)	Prescription/OTC	40%	Well-established, broad indications
Chlorpheniramine	Prescription/OTC	25%	Similar efficacy, fewer sedative effects
Dimenhydrinate	OTC	20%	Primarily motion sickness
Others	Various	15%	Limited adoption

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2. What Are the Key Market Drivers and Barriers?

Drivers

• Prevalent Allergies & Nausea: Rising allergy rates globally (e.g., USA: 30% of population, WHO) fuel demand for effective antihistamines like NAVSTEL.
• Aging Population: Older adults prone to allergies, nausea, and mobility issues enhance market size.
• Clinical Adoption: Persistent use in outpatient and hospital settings, especially where newer agents are contraindicated.
• Low-cost Formulations: Generic versions of promethazine maintain price competitiveness, especially in emerging markets.

Barriers

• Safety Concerns: Sedation, respiratory depression, and extrapyramidal side effects restrict use, especially in pediatrics.
• Regulatory Restrictions: Stringent regulations in certain countries limit OTC sales.
• Competition from Newer Drugs: Second-generation antihistamines (e.g., loratadine, cetirizine) with fewer side effects erode market share.
• Side Effect Profile: Tolerance and adverse effects reduce the acceptance among clinicians and patients.

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3. How Do Regulatory Landscapes Impact NAVSTEL?

Global Regulatory Status

Region	Approval Status	Regulatory Notes
US	Approved (FDA)	Prescription-only for certain indications; OTC availability varies
Europe	Approved (EMA)	Banned for pediatric use due to safety concerns; restricted OTC
Japan	Approved	Prescribed mainly for hospital use
India & China	Broad approval	Widely used; generics dominate market

Recent Regulatory Trends

• Safety Advisory (FDA, 2020): Warnings against pediatric use and aggressive labeling; impact on prescription volume.
• OTC Rescheduling: Limited in the US; OTC sales have declined but remain significant in some markets.
• Stringent Labeling: Increased demand for clear contraindications and side effect warnings.

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4. What Are the Competitive Alternatives and Their Market Shares?

Drug	Type	Advantages	Limitations	Market Share (Estimated, 2023)
NAVSTEL (Promethazine)	First-generation antihistamine	Broad action, sedative effects	Side effects, safety concerns	40%
Loratadine (Claritin)	Second-generation antihistamine	Fewer sedative effects	Slightly less effective in some cases	20%
Cetirizine	Second-generation antihistamine	Fast onset, fewer drowsiness	Costlier	15%
Dimenhydrinate	OTC antiemetic	Widely available, affordable	Sedative, dizziness	10%
Fexofenadine (Allegra)	Second-generation antihistamine	Well-tolerated	Higher cost	10%

Note: The remaining 5% comprises niche therapies and emerging agents.

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5. What Is the Financial Trajectory and Growth Outlook?

Revenue Forecasts

Projection Year	Expected Market Revenue (USD billion)	Estimated NAVSTEL Share (%)	Projected NAVSTEL Revenue (USD billion)
2023	1.2	40%	0.48
2024	1.3	38%	0.49
2025	1.4	36%	0.50

Assumptions: Market share declines slightly due to competition, but overall growth driven by increasing prescription volume.

Pricing and Margins

• Average Wholesale Price (AWP): USD 0.50 - 1.00 per tablet.
• Gross Margin: 70-80%, contingent on manufacturing efficiencies.
• R&D and Regulatory Costs: Limited, primarily for post-marketing safety studies.

Key Financial Drivers

Factor	Impact
Market Penetration	Expansion into emerging markets increases volume
Regulatory Decisions	Restrictions diminish or bolster sales
Competitive Dynamics	Introduction of new formulations affects share
Patent & Generic Entry	Price erosion after patent expiration

Potential Revenue Risks

• Regulatory Restrictions: Could limit OTC sales.
• Safety Profile: Adverse event reporting may lead to usage restrictions.
• Market Saturation: Mature markets approaching saturation.

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6. How Does NAVSTEL Compare With Competitor Drugs?

Factor	NAVSTEL	Second-generation Antihistamines
Side Effect Profile	Sedation, anticholinergic effects	Fewer sedative or anticholinergic effects
Ease of Use	Oral, injectable options	Oral tablets, often OTC
Safety Concerns	Higher (e.g., respiratory depression in pediatrics)	Lower due to selectivity
Efficacy	Broad, effective for allergies	Slightly less sedative, effective for mild allergies
Regulatory Restrictions	Restrictions vary, more in pediatrics	Less restrictive

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7. What Are the Key Opportunities and Challenges Ahead?

Opportunities

• Growing Demand in Asia-Pacific: Rising allergies, improved healthcare access.
• Combination Therapy: Potential for combination with other agents to enhance efficacy.
• Formulation Innovation: Developing non-sedative variants and injection alternatives.
• Digital and Telehealth Adoption: Facilitating prescription refill and patient education.

Challenges

• Safety & Side Effects: Safety concerns restrict broader use.
• Market Shift: Preference for second-generation antihistamines diminishes market share.
• Regulatory Compliance: Stricter safety warnings and restrictions.
• Price Pressure: Increasing generic competition reduces profitability.

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Conclusion

NAVSTEL remains a relevant antihistamine driven by its broad therapeutic profile and established position in allergy and antiemetic treatments. Despite challenges such as safety concerns and increasing competition from newer agents, its low-cost formulation and decades-long clinical familiarity sustain its market niche. The global market size, valued at approximately USD 1.2 billion in 2023, is expected to grow modestly at a CAGR of 3.4% through 2025, with revenue projections around USD 0.5 billion for NAVSTEL.

The future trajectory depends heavily on regulatory developments, safety profile management, and strategic expansion into emerging markets. Pharmacoeconomic factors, formulary positioning, and evolving clinical guidelines will influence NAVSTEL's market share and profitability.

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Key Takeaways

• Steady Market Presence: NAVSTEL remains a leading first-generation antihistamine, though facing erosion from newer agents.
• Regulatory Environment: Safety concerns and restrictions, especially in pediatrics, influence sales and marketability.
• Growing Demand: Aging populations and allergy prevalence support sustained demand, especially notable in APAC.
• Competitive Dynamics: Price competition and formulation innovation are critical to maintaining market share.
• Financial Outlook: Modest growth with projections of USD 0.5 billion revenue by 2025; strategic repositioning could enhance profitability.

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FAQs

Q1: How does NAVSTEL's safety profile compare to that of newer antihistamines?
First-generation agents like NAVSTEL are associated with sedation and anticholinergic side effects, leading to safety restrictions, especially in pediatric populations. Second-generation antihistamines have a more favorable safety profile with fewer sedative effects.

Q2: What are the key regulatory restrictions affecting NAVSTEL?
Regulations vary globally; in the US, FDA restricts pediatric use and mandates clear labeling warnings. Europe has banned pediatric use under specific age thresholds, while some Asian markets maintain broader approval.

Q3: What is the potential impact of generic entrants on NAVSTEL’s revenue?
Generic competition, already significant, drives price erosion, with margins declining as price sensitivity increases. Entry of new generics can further compress revenue streams.

Q4: Which markets offer the most growth opportunities for NAVSTEL?
Emerging markets in Asia-Pacific provide growth opportunities due to rising allergy and nausea incidences combined with expanding healthcare infrastructure.

Q5: How can NAVSTEL manufacturers mitigate safety issues to sustain market share?
Investing in post-marketing safety studies, clear labeling, and patient education can mitigate adverse event risks, preserving prescriber and consumer trust.

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Sources

[1] Global Market Insights, "Antihistamines Market Size & Share (2020-2025)," 2021.
[2] WHO, "Global Allergy Report," 2022.
[3] FDA Medical Advisory, "Safety Warnings for Promethazine," 2020.
[4] European Medicines Agency, "Regulatory Updates on First-Generation Antihistamines," 2022.
[5] IQVIA, "Global Pharmaceutical Market Data," 2023.