ALLEGRA ALLERGY Drug Patent Profile

Which patents cover Allegra Allergy, and when can generic versions of Allegra Allergy launch?

Allegra Allergy is a drug marketed by Chattem Sanofi and is included in one NDA.

The generic ingredient in ALLEGRA ALLERGY is fexofenadine hydrochloride. There are twenty-three drug master file entries for this compound. One hundred and three suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Allegra Allergy

A generic version of ALLEGRA ALLERGY was approved as fexofenadine hydrochloride by TEVA on September 1^st, 2005.

Summary for ALLEGRA ALLERGY

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	35
Patent Applications:	1,782
What excipients (inactive ingredients) are in ALLEGRA ALLERGY?	ALLEGRA ALLERGY excipients list
DailyMed Link:	ALLEGRA ALLERGY at DailyMed

Recent Clinical Trials for ALLEGRA ALLERGY

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Food and Drug Administration (FDA)	Early Phase 1
University of California, San Francisco	Early Phase 1
University of Alabama at Birmingham	Phase 2

See all ALLEGRA ALLERGY clinical trials

Pharmacology for ALLEGRA ALLERGY

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

US Patents and Regulatory Information for ALLEGRA ALLERGY

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 ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	020872-007	Jan 24, 2011		OTC	Yes	No
Chattem Sanofi	ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	020872-010	Jan 24, 2011		OTC	Yes	Yes

Expired US Patents for ALLEGRA ALLERGY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	020872-010	Jan 24, 2011
Chattem Sanofi	ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	020872-010	Jan 24, 2011
Chattem Sanofi	ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	020872-010	Jan 24, 2011
Chattem Sanofi	ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	020872-007	Jan 24, 2011

International Patents for ALLEGRA ALLERGY

See the table below for patents covering ALLEGRA ALLERGY around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	812195
Germany	3005948
China	1090935
Germany	69527429

ALLEGRA ALLERGY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Allegra Allergy Medication

Introduction

Allegra, known generically as fexofenadine hydrochloride, is a second-generation antihistamine widely used for treating allergic conditions such as hay fever and chronic urticaria. This article delves into the market dynamics and financial trajectory of Allegra, highlighting key factors driving its market performance.

Market Size and Growth

The market for fexofenadine hydrochloride, the active ingredient in Allegra, is projected to grow significantly. By 2031, the market is expected to reach USD 4.5 billion, up from USD 3.5 billion in 2023, growing at a Compound Annual Growth Rate (CAGR) of 3.5% from 2024 to 2031[1].

Driving Factors

Several factors contribute to the growth of the Allegra market:

Increasing Prevalence of Allergies

The rising incidence of allergy disorders globally is a major driver. As more people suffer from conditions like hay fever and chronic urticaria, the demand for effective antihistamines like Allegra increases[1].

Non-Drowsy Composition

Allegra's non-drowsy composition makes it a preferred choice for consumers seeking symptom relief without sedation. This feature enhances its market appeal and contributes to its growth[1].

Advancements in Pharmaceutical Formulations

Continuous improvements in pharmaceutical science and formulations have enhanced the effectiveness and availability of fexofenadine hydrochloride. These advancements have made the drug more accessible and reliable for consumers[1].

Expanding Healthcare Infrastructure

The growth of healthcare infrastructure and the increasing availability of over-the-counter (OTC) drugs have made allergy treatment more affordable and accessible to a broader population. This expansion has significantly boosted the market for Allegra[1].

Consumer Awareness and Disposable Income

Growing awareness about allergy management and increasing disposable incomes have led more people to seek reliable and practical allergy treatment options, further driving the market growth[1].

Transition from Prescription to OTC

A pivotal moment in Allegra's market trajectory was its transition from a prescription drug to an OTC medication. This switch, facilitated by Sanofi-Aventis, was a strategic move to leverage the equity in Allegra's prescription franchise and build a consumer products platform.

Impact on Sales

When Allegra transitioned to OTC in 2010, it faced significant challenges, including a 53.6% drop in net sales in the United States due to the impact of prescription generics. However, Sanofi's investment in marketing and distribution, particularly through the acquisition of Chattem, helped mitigate these losses and establish a strong OTC presence[4].

Retail and Marketing Strategies

The successful launch of Allegra OTC was marked by effective premarketing, rapid shelf placement, and robust display availability. Retailers like Giant Eagle played a crucial role in supporting the launch with in-store promotions and off-shelf displays, which helped retain prescription users and attract new customers[4].

Competitive Landscape

The human antihistamine drug market, where Allegra operates, is highly competitive. Key players include Sanofi, Allegra, GlaxoSmithKline, Bayer, Pfizer, Novartis, Mylan, Dr. Reddy's Laboratories, Teva Pharmaceutical, and Johnson & Johnson. These companies are constantly innovating and introducing new formulations to enhance treatment efficacy and market share[1].

Market Share and Dominance

Second-generation antihistamines, such as Allegra, hold a significant market share due to their improved safety profiles and reduced sedative effects. In 2023, second-generation antihistamines accounted for over 62.7% of the market share in the human antihistamine drug market[3].

Regional Analysis

North America is a key region for the human antihistamine drug market, including Allegra. In 2023, North America secured a leading position with a substantial 37.2% market share, driven by high awareness about allergy management, a high incidence of allergic conditions, and a proactive approach to healthcare[3].

Financial Performance

Sanofi, the company behind Allegra, has reported solid financial performance in recent years. For instance, in the fourth quarter of 2023, Sanofi's sales grew by 9.3% at constant exchange rates (CER), with business EPS increasing by 8.2% at CER. The company's consumer healthcare segment, which includes Allegra, saw an 8.5% growth, benefiting from the acquisition of Qunol and the performance of Digestive Wellness and Physical and Mental Wellness products[2].

Challenges and Opportunities

Despite the growth, the market faces several challenges:

Generic Competition

The introduction of generic versions of antihistamines can significantly impact sales, as seen in the case of Allegra's transition to OTC. However, strategic marketing and distribution can help mitigate these effects[4].

Regulatory Environment

Changes in regulatory environments and approval processes can affect the market. For example, the FDA approval for Allegra's OTC switch was a critical milestone in its market expansion[4].

Innovations and R&D

Continuous investments in research and development are crucial for maintaining market competitiveness. Innovations in drug formulations and delivery methods can enhance the effectiveness and appeal of antihistamines like Allegra[3].

Key Takeaways

• The fexofenadine hydrochloride market, including Allegra, is expected to grow to USD 4.5 billion by 2031.
• The non-drowsy composition and expanding healthcare infrastructure are key drivers of this growth.
• The transition from prescription to OTC was a significant strategic move that impacted sales but was managed effectively through robust marketing and distribution strategies.
• North America is a leading region for the human antihistamine drug market.
• Continuous innovation and R&D are essential for maintaining market competitiveness.

FAQs

What is the projected market size for fexofenadine hydrochloride by 2031?

The market for fexofenadine hydrochloride is expected to reach USD 4.5 billion by 2031, growing at a CAGR of 3.5% from 2024 to 2031[1].

Why is Allegra preferred over other antihistamines?

Allegra is preferred due to its non-drowsy composition, which makes it a better option for consumers seeking symptom relief without sedation[1].

How did the transition to OTC affect Allegra's sales?

The transition to OTC resulted in a significant drop in sales initially due to generic competition, but strategic marketing and distribution helped stabilize and grow the market[4].

Which region dominates the human antihistamine drug market?

North America is the leading region, with a substantial 37.2% market share in 2023, driven by high awareness and incidence of allergic conditions[3].

What are the key challenges facing the Allegra market?

Key challenges include generic competition, regulatory changes, and the need for continuous innovation in drug formulations and delivery methods[3][4].

Sources

1. Market Research Intellect: Fexofenadine Hydrochloride Market Size, Share and Trends [2024-2031][1].
2. Sanofi: Press Release Q4 2023 English[2].
3. Market.US: Human Antihistamine Drug Market Size | CAGR OF 9.9%[3].
4. Supermarket News: Rx to OTC: A Case Study[4].