ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION Drug Patent Profile

When do Allegra-d 24 Hour Allergy And Congestion patents expire, and what generic alternatives are available?

Allegra-d 24 Hour Allergy And Congestion is a drug marketed by Chattem Sanofi and is included in one NDA.

The generic ingredient in ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Allegra-d 24 Hour Allergy And Congestion

A generic version of ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION was approved as fexofenadine hydrochloride; pseudoephedrine hydrochloride by DR REDDYS LABS LTD on June 22^nd, 2011.

Summary for ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	69
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
DailyMed Link:	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION at DailyMed

Pharmacology for ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION

Drug Class	Histamine-1 Receptor Antagonist alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Histamine H1 Receptor Antagonists

US Patents and Regulatory Information for ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chattem Sanofi	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021704-002	Jan 24, 2011		OTC	Yes	Yes

Expired US Patents for ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021704-002	Jan 24, 2011	6,613,357
Chattem Sanofi	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021704-002	Jan 24, 2011	5,578,610*PED
Chattem Sanofi	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021704-002	Jan 24, 2011	RE39069
Chattem Sanofi	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021704-002	Jan 24, 2011	7,138,524*PED
Chattem Sanofi	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021704-002	Jan 24, 2011	6,399,632*PED
Chattem Sanofi	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021704-002	Jan 24, 2011	6,187,791*PED

International Patents for ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION

See the table below for patents covering ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	766668
China	101337922
Norway	944287
Germany	69320952
Germany	69818607
Brazil	9802144

ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Allegra-D 24 Hour Allergy and Congestion

Introduction

Allegra-D 24 Hour, a combination of fexofenadine HCl and pseudoephedrine HCl, is a widely used over-the-counter (OTC) medication for the relief of seasonal allergy symptoms and nasal congestion. This article delves into the market dynamics and financial trajectory of Allegra-D 24 Hour, highlighting its market presence, consumer demand, and financial performance.

Market Presence and Consumer Demand

Seasonal Allergy Market

The market for seasonal allergy medications is substantial, with over 40 million adults and children in the United States suffering from seasonal allergies. Allegra-D 24 Hour is a key player in this market, offering 24-hour relief from symptoms such as nasal congestion, sneezing, runny nose, itchy eyes, and itchy throat[2][4].

Competitive Landscape

The allergy and congestion relief market is competitive, with several brands and generics available. However, Allegra-D 24 Hour stands out due to its non-drowsy formulation and the inclusion of pseudoephedrine, a clinically proven decongestant. This has made it the #1 allergist-recommended non-drowsy allergy brand[4].

Product Variants and Availability

Allegra-D 24 Hour and 12 Hour Formulations

Allegra-D is available in both 24-hour and 12-hour formulations. The 24-hour tablets provide extended relief, making them a convenient option for consumers. The product is sold behind the pharmacy counter in most U.S. states, although prescriptions are required in Mississippi and Oregon[4].

Store-Brand Equivalents

Dr. Reddy’s Laboratories has launched store-brand equivalents of Allegra-D 24 Hour and 12 Hour, which are approved by the U.S. Food and Drug Administration (USFDA). These generics offer consumers affordable alternatives without compromising on quality[1][3].

Financial Performance

Sales Figures

As of May 2022, Allegra-D 24 Hour had U.S. retail sales of approximately $45 million. Similarly, the Allegra-D 12 Hour brand and generic had U.S. sales of around $44 million for the twelve months ending in May 2019[1][3].

Market Share

The financial success of Allegra-D 24 Hour can be attributed to its strong market share in the allergy and congestion relief segment. The product's effectiveness and convenience have helped it maintain a significant presence in the market.

Consumer Preferences and Symptoms Relief

Symptom Relief

Allegra-D 24 Hour is designed to relieve eight allergy symptoms with one tablet, including nasal congestion, sinus pressure, sneezing, itchy, watery eyes, itchy nose, and itchy throat. The inclusion of pseudoephedrine as a decongestant makes it particularly effective for nasal congestion, which is often cited as the most frustrating symptom by allergy patients[2][4].

Consumer Satisfaction

Consumer satisfaction is high due to the product's non-drowsy formulation and 24-hour relief. This makes it a preferred choice for individuals who need all-day relief from allergy symptoms without the sedative effects associated with some other antihistamines.

Regulatory and Safety Considerations

FDA Approval

Allegra-D 24 Hour has been approved by the USFDA, ensuring that it meets stringent safety and efficacy standards. The product is subject to various regulatory requirements, including contraindications for patients with certain medical conditions such as narrow-angle glaucoma, urinary retention, and severe hypertension[5].

Side Effects and Contraindications

While generally well-tolerated, Allegra-D 24 Hour can have side effects such as headache, cold, back pain, and nervousness due to the pseudoephedrine component. It is contraindicated in patients taking MAO inhibitors or those with specific health conditions[2][5].

Market Expansion and Generic Competition

Generic Launches

The launch of store-brand equivalents by Dr. Reddy’s Laboratories has expanded the market reach of Allegra-D 24 Hour, making it more accessible to a broader consumer base. These generics are available in various pack sizes, further increasing their appeal[1][3].

Competitive Strategies

To maintain market share, the original brand and generic manufacturers must focus on competitive pricing, marketing strategies, and ensuring high-quality products. Collaborations with retailers and pharmacies are also crucial for maintaining a strong distribution network.

Future Outlook

Seasonal Demand

The demand for Allegra-D 24 Hour is seasonal, peaking during the spring and fall when allergen levels are high. Manufacturers must be prepared to meet this seasonal demand to capitalize on market opportunities.

Innovation and Product Development

Continued innovation in the allergy and congestion relief segment is essential. Manufacturers may explore new formulations or delivery methods to enhance consumer convenience and satisfaction.

Key Takeaways

• Strong Market Presence: Allegra-D 24 Hour is a leading brand in the allergy and congestion relief market.
• Consumer Demand: The product addresses a significant consumer need, providing 24-hour relief from seasonal allergy symptoms.
• Financial Performance: The product has substantial retail sales, indicating its financial success.
• Regulatory Compliance: It is approved by the USFDA and subject to strict safety and efficacy standards.
• Generic Competition: Store-brand equivalents have expanded market access and competition.

FAQs

Q: What are the active ingredients in Allegra-D 24 Hour?

A: The active ingredients are fexofenadine HCl 180 mg and pseudoephedrine HCl 240 mg.

Q: Who is the target audience for Allegra-D 24 Hour?

A: The target audience includes adults and children 12 years of age and older suffering from seasonal allergies.

Q: Are there any contraindications for using Allegra-D 24 Hour?

A: Yes, it is contraindicated in patients with narrow-angle glaucoma, urinary retention, severe hypertension, and those taking MAO inhibitors.

Q: How is Allegra-D 24 Hour available in the market?

A: It is available behind the pharmacy counter in most U.S. states, although prescriptions are required in Mississippi and Oregon.

Q: What are the common side effects of Allegra-D 24 Hour?

A: Common side effects include headache, cold, back pain, and nervousness due to the pseudoephedrine component.

Sources

1. Dr. Reddy's Announces the First-to-Market Launch of Over-the-Counter Store-Brand Equivalent of Allegra-D® 24 HR - Biospace
2. ALLEGRA-D® 24 HOUR (fexofenadine HCl 180 mg/pseudoephedrine HCl 240 mg) Extended-Release Tablets - Sanofi
3. Dr. Reddy's announces the launch of over-the-counter, store-brand equivalent of Allegra-D® 12 HR Allergy and Congestion Extended-Release Tablets - Biospace
4. 24 Hour Tablets | Allegra-D® Allergy & Congestion Relief Medicine - Allegra
5. ALLEGRA-D 24 HOUR- fexofenadine hydrochloride and pseudoephedrine hydrochloride - DailyMed