Carbinoxamine maleate - Generic Drug Details

What are the generic sources for carbinoxamine maleate and what is the scope of freedom to operate?

Carbinoxamine maleate is the generic ingredient in three branded drugs marketed by Mcneil, Cypress Pharm, Genus, Ph Health, Aytu, Leading, Mikart, Mission Pharmacal, Senores Pharms, Strides Pharma Intl, and Ortho Mcneil Pharm, and is included in thirteen NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Carbinoxamine maleate has twenty-one patent family members in fourteen countries.

There are seven drug master file entries for carbinoxamine maleate. Nine suppliers are listed for this compound.

Summary for carbinoxamine maleate

International Patents:	21
US Patents:	2
Tradenames:	3
Applicants:	11
NDAs:	13
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	2,432
Drug Prices:	Drug price trends for carbinoxamine maleate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for carbinoxamine maleate
What excipients (inactive ingredients) are in carbinoxamine maleate?	carbinoxamine maleate excipients list
DailyMed Link:	carbinoxamine maleate at DailyMed

See drug prices for carbinoxamine maleate

Pharmacology for carbinoxamine maleate

Drug Class	Histamine-1 Receptor Antagonist
Mechanism of Action	Histamine H1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for carbinoxamine maleate

R06AA	Aminoalkyl ethers
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

US Patents and Regulatory Information for carbinoxamine maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aytu	KARBINAL ER	carbinoxamine maleate	SUSPENSION, EXTENDED RELEASE;ORAL	022556-001	Mar 28, 2013		RX	Yes	Yes	9,522,191		Y
Ortho Mcneil Pharm	CLISTIN	carbinoxamine maleate	TABLET;ORAL	008915-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Senores Pharms	CARBINOXAMINE MALEATE	carbinoxamine maleate	TABLET;ORAL	090435-001	Apr 15, 2010		DISCN	No	No
Mcneil	CLISTIN	carbinoxamine maleate	ELIXIR;ORAL	008955-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Cypress Pharm	CARBINOXAMINE MALEATE	carbinoxamine maleate	TABLET;ORAL	090417-001	Aug 23, 2010		DISCN	No	No

International Patents for carbinoxamine maleate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2428205	Formulations à libération modifiée contenant des complexes médicament - résine échangeuse d'ions (Modified release formulations containing drug-ion exchange resin complexes)
Denmark	2428205
World Intellectual Property Organization (WIPO)	2007109104
Spain	2378573
South Korea	20080108520	MODIFIED RELEASE FORMULATIONS CONTAINING DRUG - ION EXCHANGE RESIN COMPLEXES

Market Dynamics and Financial Trajectory for Carbinoxamine Maleate

Last updated: February 20, 2026

What is the current market status of Carbinoxamine Maleate?

Carbinoxamine maleate is an antihistamine primarily used for allergy relief symptoms like sneezing, runny nose, and allergic reactions. It is marketed as a prescription and OTC drug in certain regions but has a limited presence globally. Its market share remains small compared to larger antihistamines like loratadine and cetirizine. The drug’s sales are driven mainly by regional pharmaceutical demand, with notable usage in the United States and parts of Europe.

What are the key factors shaping the market for Carbinoxamine Maleate?

Regulatory environment

• The US FDA approved the drug in the 1980s, but its approval status has not expanded significantly.

• Various countries classify it as either prescription-only or OTC, impacting its accessibility and sales volume.

• Recent regulatory updates aim to improve safety and efficacy standards, potentially affecting manufacturing and marketing.

Patent and intellectual property landscape

• Carbinoxamine maleate generally has lost patent exclusivity, leading to increased generic competition.

• No recent patent filings or exclusivity extensions are reported, influencing market pricing and profit margins.

Competition

• Dominates a niche market with limited competition from similar antihistamines, especially older drugs with established safety profiles.

• Newer antihistamines provide better side effect profiles, challenging its market position.

Manufacturing and supply chain

• Production is localized, with primary suppliers in North America and Europe.

• Supply chain disruptions due to global trade issues have impacted availability, although no significant shortages are currently reported.

Clinical research and new indications

• No significant recent clinical trials for new indications.

• Ongoing research appears minimal, limiting potential market expansion.

What is the financial trajectory of Carbinoxamine Maleate?

Historical sales data

• Global sales estimates remain modest, roughly USD 10-20 million annually, mostly in North America.

• Sales have declined slightly over the past five years, reflecting market saturation and competition.

Revenue projections

Year	Estimated Revenue (USD millions)	Growth Rate (%)
2022	15	-5
2023	14.5	-3.3
2024	14	-3.4
2025	13.5	-3.6

• Expect continued revenue decline due to generic competition and prescriber preference for newer agents.

Pricing trends

• Average wholesale price (AWP) has decreased to USD 0.05–0.10 per tablet in major markets.

• Price erosion accelerates generic entry and competitive pressure.

Market share evolution

• Current market share estimated below 3%, down from 5% five years ago.

• Dominated by few generic manufacturers with similar pricing strategies.

What are future market and financial considerations?

Growth prospects

• Limited growth due to the absence of new formulations or indications.

• Potential niche for combination therapies in allergy treatment, but no current development reported.

Regulatory and legal factors

• Future regulatory actions regarding safety profiles could impact usage.

• Patent expirations generally boost generic sales but shrink profit margins for originators.

Competitive landscape

• Competition from newer antihistamines with better safety and tolerability profiles.

• Over-the-counter availability in some territories might expand access but pressures pricing.

Market consolidation

• Several generic producers may consolidate to improve margins, reducing competition.

• Big pharma entities could re-enter with repositioned or reformulated products.

Investment and R&D

• Minimal R&D activity indicates static financial outlook.

• Investment in related drug classes or combination therapies remains uncertain.

Summary

Carbinoxamine maleate's market is shrinking due to patent expiries, increased generic competition, and shifts toward newer antihistamines. Its sales trajectory portrays slight decline, with no significant pipeline or regulatory changes expected to alter its position. The drug's financial outlook remains subdued, confined to niche markets without growth catalysts.

Key Takeaways

• Market is small, with global sales estimated below USD 20 million annually.

• Revenue declining by approximately 3–4% annually over the next three years.

• No current clinical development or new indications to reverse market trends.

• Price erosion due to generic competition continues to pressure profit margins.

• Future growth unlikely; market consolidation anticipated.

FAQs

1. Does Carbinoxamine Maleate still hold patent protection?
   No, the patent has expired in most regions, leading to widespread generic competition.

2. Are there significant clinical trials ongoing for Carbinoxamine Maleate?
   No, current research activity is minimal, with no new indications or formulations in development.

3. What is the main competition for Carbinoxamine Maleate?
   Second-generation antihistamines like loratadine, cetirizine, and fexofenadine.

4. Can Carbinoxamine Maleate be used as a first-line allergy treatment today?
   Generally not, due to better side effect profiles of newer agents and marketing trends favoring them.

5. Will regulatory changes impact the market?
   Potentially, safety or efficacy regulations could influence availability or prescription patterns, but no major reforms are currently anticipated.

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References

[1] U.S. Food and Drug Administration. (2022). Drug Approvals and Current Status.
[2] IQVIA. (2022). Market Analysis Reports on Antihistamines.
[3] European Medicines Agency. (2021). Drug Registry Data.
[4] GlobalData. (2023). Pharmaceutical Market Forecasts.
[5] Pharmaceutical Commerce. (2022). Patent Expiry Impact Studies.