Carbinoxamine maleate - Generic Drug Details

What are the generic drug sources for carbinoxamine maleate and what is the scope of patent protection?

Carbinoxamine maleate is the generic ingredient in three branded drugs marketed by Mcneil, Cypress Pharm, Endo Operations, Genus, Aytu, Invagen Pharms, Mikart, Mission Pharmacal, Strides Pharma, and Ortho Mcneil Pharm, and is included in twelve 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. Eight suppliers are listed for this compound.

Summary for carbinoxamine maleate

International Patents:	21
US Patents:	2
Tradenames:	3
Applicants:	10
NDAs:	12
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	62
Patent Applications:	2,401
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
Genus	CARBINOXAMINE MALEATE	carbinoxamine maleate	SOLUTION;ORAL	040458-001	Apr 25, 2003		RX	No	Yes
Ortho Mcneil Pharm	CLISTIN	carbinoxamine maleate	TABLET;ORAL	008915-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Aytu	KARBINAL ER	carbinoxamine maleate	SUSPENSION, EXTENDED RELEASE;ORAL	022556-001	Mar 28, 2013		RX	Yes	Yes			Y
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	2018160	FORMULATIONS A LIBERATION MODIFIEE CONTENANT DES COMPLEXES MEDICAMENT - RESINE ECHANGEUSE D'IONS (MODIFIED RELEASE FORMULATIONS CONTAINING DRUG-ION EXCHANGE RESIN COMPLEXES)
Denmark	2428205
Brazil	PI0709606	formulações de liberação modificada contendo complexos fármaco-resina de troca iÈnica
Israel	194042	פורמולציות לשחרור שונה המכילות קומפלקסים של תרופה ורזין מחליף יונים (Modified release formulations containing drug-ion exchange resin complexes)
Denmark	2018160

Carbinoxamine maleate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Carbinoxamine Maleate

Introduction to Carbinoxamine Maleate

Carbinoxamine maleate is an antihistamine used primarily for the treatment of seasonal and perennial allergic rhinitis. It is available in various formulations, including immediate-release tablets, oral solutions, and extended-release suspensions.

Market Overview

Global Market Trends

The global market for carbinoxamine maleate is influenced by several factors, including the prevalence of allergic rhinitis, regulatory approvals, and the availability of alternative treatments. The market is expected to grow, driven by increasing demand for antihistamines and advancements in drug formulations[4].

Market Size and Forecast

The carbinoxamine market, while not as large as other pharmaceutical markets, is significant due to the widespread nature of allergic rhinitis. By 2030, the market is anticipated to see steady growth, driven by the increasing incidence of allergies and the development of new formulations such as extended-release products[1].

Product Formulations and Innovations

Immediate-Release Formulations

Immediate-release carbinoxamine maleate products, such as tablets and oral solutions, have been on the market for several decades. These products are well-established and widely used for treating allergic rhinitis[5].

Extended-Release Formulations

The introduction of extended-release formulations, such as Karbinal ER, has marked a significant innovation in the market. These products offer sustained release of the drug, improving patient compliance and reducing the need for frequent dosing. Karbinal ER, for example, is a sustained-release formulation suspended in a drug-polistirex resin complex, ensuring bioequivalence to immediate-release products[5].

Financial Performance of Key Players

Aytu BioPharma

Aytu BioPharma, a company that markets carbinoxamine maleate products, including Karbinal ER, has reported mixed financial results in recent quarters. In the first quarter of fiscal 2025, the company saw a 1% increase in net revenue from its ADHD portfolio, which includes other products, but a decrease in net revenue from its Pediatric Portfolio, which includes Karbinal ER. This decrease was primarily due to changes in payor coverage that affected prescription coverage. Despite this, the Pediatric Portfolio saw a 54% sequential increase in revenue, reflecting positive effects from the company's return-to-growth plan[2].

Revenue Breakdown

• Net Revenue: $16.6 million in Q1 fiscal 2025, down from $17.8 million in the prior year period.
• Pediatric Portfolio: $1.3 million in Q1 fiscal 2025, a 54% increase sequentially.
• Gross Profit: $12.0 million, or 72% of net revenue, in Q1 fiscal 2025[2].

Operational Efficiencies and Cost Reduction

Aytu BioPharma has been focusing on cost reduction and operational efficiencies. Operating expenses, excluding amortization of intangible assets and restructuring costs, decreased from $13.0 million in Q1 fiscal 2024 to $11.2 million in Q1 fiscal 2025. This reduction helped mitigate the impact of lower revenue from the Pediatric Portfolio[2].

Regulatory Environment

FDA Approvals and Withdrawals

The regulatory environment for carbinoxamine maleate has been complex. The FDA has previously withdrawn marketing approvals for certain formulations due to lack of bioavailability studies. However, the approval of Karbinal ER, which provided the necessary bioavailability data, has been a significant milestone. The FDA's review process ensures that any new formulations meet current scientific and regulatory standards[5].

Safety and Efficacy

Clinical reviews have found no new safety concerns for carbinoxamine maleate beyond those already known and labeled. The side effects reported are consistent with the labeling for immediate-release products, with the addition of borderline elevations in uric acid noted in some studies[5].

Market Competition

Alternative Treatments

The market for antihistamines is competitive, with second-generation antihistamines often preferred due to fewer side effects such as sedation and anti-cholinergic effects. However, carbinoxamine maleate remains a viable option, especially for patients who require extended-release formulations[5].

Generic and Branded Products

The presence of both generic and branded products in the market affects pricing and market share. Generic immediate-release carbinoxamine maleate products are widely available, but branded extended-release products like Karbinal ER offer unique benefits that can justify higher pricing[5].

Financial Metrics and Performance Indicators

Net Income and Adjusted EBITDA

Aytu BioPharma reported a net income of $1.5 million in Q1 fiscal 2025, a significant improvement from the net loss of $8.1 million in the prior year period. Adjusted EBITDA was $1.9 million, down from $2.4 million in Q1 fiscal 2024, primarily due to the decrease in Pediatric Portfolio revenue[2].

Cash and Cash Equivalents

The company's cash and cash equivalents stood at $20.1 million at the end of Q1 fiscal 2025, slightly up from $20.0 million at the end of Q4 fiscal 2024[2].

Future Outlook

Growth Prospects

The market for carbinoxamine maleate is expected to grow, driven by increasing demand for antihistamines and the introduction of new formulations. Companies like Aytu BioPharma are likely to benefit from these trends, especially if they continue to implement effective return-to-growth strategies[1].

Challenges and Opportunities

Despite the positive outlook, the market faces challenges such as changes in payor coverage and competition from second-generation antihistamines. However, the unique benefits of extended-release formulations and ongoing cost reduction efforts provide opportunities for growth and improved financial performance[2].

Key Takeaways

• Market Growth: The carbinoxamine maleate market is expected to grow driven by increasing demand and new formulations.
• Financial Performance: Aytu BioPharma's financial results reflect mixed performance, with decreases in some revenue segments but improvements in operational efficiencies.
• Regulatory Environment: FDA approvals and withdrawals have shaped the market, with a focus on ensuring bioavailability and safety.
• Market Competition: The market is competitive, with both generic and branded products influencing pricing and market share.
• Future Outlook: Growth prospects are positive, but challenges such as payor coverage changes and competition need to be addressed.

FAQs

What is carbinoxamine maleate used for?

Carbinoxamine maleate is primarily used for the treatment of seasonal and perennial allergic rhinitis.

What are the different formulations of carbinoxamine maleate?

Carbinoxamine maleate is available in immediate-release tablets, oral solutions, and extended-release suspensions like Karbinal ER.

How has Aytu BioPharma's financial performance been in recent quarters?

Aytu BioPharma reported a net income of $1.5 million in Q1 fiscal 2025, with a decrease in net revenue from the Pediatric Portfolio but an increase in sequential revenue.

What are the key challenges facing the carbinoxamine maleate market?

Challenges include changes in payor coverage, competition from second-generation antihistamines, and regulatory hurdles.

What is the future outlook for the carbinoxamine maleate market?

The market is expected to grow, driven by increasing demand and the introduction of new formulations, but companies must address challenges such as payor coverage changes and competition.

Sources

1. Allied Market Research: Carbinoxamine Market Share, Trend & Industry Forecast 2030.
2. Biospace: Aytu BioPharma Reports Fiscal 2025 First Quarter Operational and Financial Results.
3. Avadel Pharmaceuticals PLC: Unaudited Consolidated Balance Sheets.
4. Market Research Intellect: Global Carbinoxamine Maleate API Market Size, Scope And Forecast Report.
5. FDA: Clinical Review of Carbinoxamine Extended-Release Oral Suspension.