KARBINAL ER Drug Patent Profile

When do Karbinal Er patents expire, and what generic alternatives are available?

Karbinal Er is a drug marketed by Aytu and is included in one NDA. There are two patents protecting this drug.

This drug has twenty-one patent family members in fourteen countries.

The generic ingredient in KARBINAL ER is carbinoxamine maleate. There are seven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the carbinoxamine maleate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Karbinal Er

A generic version of KARBINAL ER was approved as carbinoxamine maleate by GENUS on March 19^th, 2003.

Summary for KARBINAL ER

International Patents:	21
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	62
Patent Applications:	1,314
Drug Prices:	Drug price information for KARBINAL ER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KARBINAL ER
DailyMed Link:	KARBINAL ER at DailyMed

See drug prices for KARBINAL ER

See drug sales revenues for KARBINAL ER

Pharmacology for KARBINAL ER

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

US Patents and Regulatory Information for KARBINAL ER

KARBINAL ER 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
Aytu	KARBINAL ER	carbinoxamine maleate	SUSPENSION, EXTENDED RELEASE;ORAL	022556-001	Mar 28, 2013		RX	Yes	Yes			Y
Aytu	KARBINAL ER	carbinoxamine maleate	SUSPENSION, EXTENDED RELEASE;ORAL	022556-001	Mar 28, 2013		RX	Yes	Yes			Y

International Patents for KARBINAL ER

See the table below for patents covering KARBINAL ER around the world.

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

KARBINAL ER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Karbinal ER

Introduction

Karbinal ER (carbinoxamine maleate) is an extended-release oral suspension approved by the FDA in 2013 for the treatment of various allergic conditions, including seasonal and perennial allergic rhinitis, vasomotor rhinitis, and allergic conjunctivitis. Here, we will delve into the market dynamics and financial trajectory of this drug.

Regulatory History and Approval

Karbinal ER was approved on March 28, 2013, by the FDA, based on pharmacokinetic studies in adults that established bioequivalence to an approved immediate-release carbinoxamine product. This approval was significant as it marked the introduction of an extended-release formulation for carbinoxamine, which had previously been available in immediate-release forms[1][4].

Market Position and Competition

Karbinal ER is part of Aytu BioPharma's pediatric portfolio, which also includes Poly-Vi-Flor and Tri-Vi-Flor. The market for antihistamines is competitive, with various products available, both prescription and over-the-counter. However, Karbinal ER's extended-release formulation provides a unique selling point, offering patients a more convenient dosing regimen compared to traditional immediate-release products[2].

Revenue Performance

In recent years, the revenue performance of Karbinal ER has shown mixed trends. In the first quarter of fiscal 2025, the pediatric portfolio, which includes Karbinal ER, saw a 54% sequential increase in net revenue to $1.3 million. This growth was attributed to initiatives aimed at improving coverage and repositioning the product in the marketplace. However, this increase followed a period where net revenue from the Pediatric Portfolio had decreased due to changes in payor coverage[2].

Financial Impact on Aytu BioPharma

Aytu BioPharma's overall financial performance is influenced by the success of its product portfolios, including the pediatric segment. Despite the challenges posed by payor coverage changes, the company has reported positive adjusted EBITDA for six consecutive quarters. The net revenue from the pediatric portfolio, although smaller compared to the ADHD portfolio, contributes significantly to the company's overall revenue and profitability[2].

Operational and Strategic Initiatives

Aytu BioPharma has implemented several strategic initiatives to enhance the commercial performance of Karbinal ER and its other pediatric products. These include improving coverage, increasing promotional efforts, and optimizing operational processes. The company's commercial platform, Aytu RxConnect, has also played a crucial role in driving prescriptions and revenue growth[2].

Safety and Regulatory Surveillance

The safety of Karbinal ER has been under continuous surveillance by the FDA, particularly in pediatric patients. The drug is contraindicated in children younger than 2 years of age and in nursing mothers due to the risk of mortality and other adverse effects. Since its approval, no new safety signals have been identified, and the FDA recommends continued ongoing safety monitoring[1][4].

Market Trends and Growth Prospects

The market for pediatric antihistamines is influenced by several factors, including changes in payor coverage, prescribing trends, and the availability of alternative treatments. Despite the challenges, Aytu BioPharma's efforts to reposition and promote Karbinal ER have shown positive results. The company's focus on improving coverage and enhancing its commercial platform is expected to drive further growth in the pediatric portfolio[2].

Competitive Landscape

The competitive landscape for antihistamines includes a range of products from various manufacturers. Karbinal ER's unique extended-release formulation and the company's strategic marketing efforts help it stand out in a crowded market. However, competition from both branded and generic products remains a significant factor in the market dynamics[1][4].

Future Outlook

The future outlook for Karbinal ER is tied to Aytu BioPharma's overall strategy and market conditions. With continued optimization of operational processes and a focus on driving revenue growth, the company is well-positioned to leverage the unique benefits of Karbinal ER. The positive impact of recent initiatives and the company's commitment to reducing operating expenses suggest a promising financial trajectory for the product[2].

Key Takeaways

• Approval and Regulatory History: Karbinal ER was approved in 2013 based on bioequivalence studies.
• Revenue Performance: Recent sequential revenue growth of 54% in the pediatric portfolio.
• Financial Impact: Contributes to Aytu BioPharma's overall revenue and profitability.
• Operational Initiatives: Focus on improving coverage, promotional efforts, and operational optimization.
• Safety Surveillance: Continuous monitoring by the FDA with no new safety signals identified.
• Market Trends: Influenced by payor coverage, prescribing trends, and competitive landscape.
• Future Outlook: Positive growth prospects with ongoing strategic initiatives.

FAQs

What is Karbinal ER used for?

Karbinal ER is used for the treatment of seasonal and perennial allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis, and other mild allergic skin manifestations[4].

When was Karbinal ER approved by the FDA?

Karbinal ER was approved by the FDA on March 28, 2013[1][4].

What is the unique feature of Karbinal ER?

Karbinal ER is an extended-release oral suspension, providing a more convenient dosing regimen compared to traditional immediate-release products[1][4].

What are the contraindications for Karbinal ER?

Karbinal ER is contraindicated in children younger than 2 years of age and in nursing mothers due to the risk of mortality and other adverse effects[1][4].

How has the revenue from Karbinal ER performed recently?

The revenue from the pediatric portfolio, which includes Karbinal ER, increased by 54% sequentially in the first quarter of fiscal 2025, following a period of decline due to payor coverage changes[2].

Cited Sources

1. FDA: Karbinal ER DPARP Backgrounder for PAC - FDA[1].
2. Biospace: Aytu BioPharma Reports Fiscal 2025 First Quarter Operational and Financial Results[2].
3. Annual Reports: AVADEL PHARMACEUTICALS PLC - Annual Reports[3].
4. FDA: Summary of Safety Review karbinal ER (carbinoxamine maleate)[4].
5. Annual Reports: Form 10-K for Aytu Biopharma INC filed 09/26/2022 - Annual Reports[5].