ALLEGRA Drug Patent Profile

When do Allegra patents expire, and when can generic versions of Allegra launch?

Allegra is a drug marketed by Chattem Sanofi and is included in five NDAs.

The generic ingredient in ALLEGRA 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

A generic version of ALLEGRA was approved as fexofenadine hydrochloride; pseudoephedrine hydrochloride by DR REDDYS LABS LTD on June 22^nd, 2011.

Summary for ALLEGRA

US Patents:	0
Applicants:	1
NDAs:	5
Raw Ingredient (Bulk) Api Vendors:	224
Clinical Trials:	35
Patent Applications:	4,489
Drug Sales Revenues:	Drug sales revenues for ALLEGRA
DailyMed Link:	ALLEGRA at DailyMed

Recent Clinical Trials for ALLEGRA

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

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

See all ALLEGRA clinical trials

US Patents and Regulatory Information for ALLEGRA

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	fexofenadine hydrochloride	CAPSULE;ORAL	020625-001	Jul 25, 1996		DISCN	No	No
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011		OTC	Yes	Yes
Chattem Sanofi	ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	020872-010	Jan 24, 2011		OTC	Yes	Yes
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
Chattem Sanofi	ALLEGRA	fexofenadine hydrochloride	SUSPENSION;ORAL	021963-001	Oct 16, 2006		DISCN	Yes	No
Chattem Sanofi	ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	020872-007	Jan 24, 2011		OTC	Yes	No

Expired US Patents for ALLEGRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	ALLEGRA	fexofenadine hydrochloride	CAPSULE;ORAL	020625-001	Jul 25, 1996	7,135,571*PED
Chattem Sanofi	ALLEGRA	fexofenadine hydrochloride	SUSPENSION;ORAL	021963-001	Oct 16, 2006	6,187,791
Chattem Sanofi	ALLEGRA	fexofenadine hydrochloride	CAPSULE;ORAL	020625-001	Jul 25, 1996	5,932,247*PED
Chattem Sanofi	ALLEGRA	fexofenadine hydrochloride	CAPSULE;ORAL	020625-001	Jul 25, 1996	6,399,632*PED
Chattem Sanofi	ALLEGRA	fexofenadine hydrochloride	CAPSULE;ORAL	020625-001	Jul 25, 1996	4,254,129
Chattem Sanofi	ALLEGRA	fexofenadine hydrochloride	SUSPENSION;ORAL	021963-001	Oct 16, 2006	6,399,632

International Patents for ALLEGRA

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

Country	Patent Number	Title	Estimated Expiration
Hungary	9603167
Germany	69527429
Portugal	812195
Germany	3005948
China	1090935
Chile	2004000304

ALLEGRA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Allegra

Introduction

Allegra, known generically as fexofenadine hydrochloride, is a second-generation antihistamine used to treat seasonal allergic rhinitis (hay fever) and uncomplicated hives. The drug's transition from a prescription-only medication to an over-the-counter (OTC) product has significantly impacted its market dynamics and financial trajectory.

Historical Prescription Sales

Before its transition to OTC, Allegra maintained lucrative prescription sales. The drug, available in 180 mg and 60 mg formulations, had combined sales of $1.5 billion. Additionally, Allegra D-12, another variant, had annual sales of $600 million in 2009[1].

Impact of Generic Versions

The introduction of generic versions of Allegra in 2010 led to a substantial decline in its prescription sales. Net sales in the United States plummeted by 53.6% to approximately $200 million, highlighting the significant impact of generic competition on brand sales[1].

Transition to OTC

Sanofi-Aventis, the manufacturer, made a strategic decision to transition Allegra to an OTC medication. This move was part of the company's growth strategy and followed the acquisition of Chattem, a consumer health care company, for $1.9 billion in 2009. The FDA approved Allegra for OTC sale in January 2011, and the product was launched in March of the same year[1].

Speed to Market and Retail Strategy

The transition was executed swiftly, with Sanofi-Aventis and its partners focusing on rapid market penetration. Retailers, particularly supermarkets and mass-market channels, played a crucial role in this process. They ensured quick product availability, maintained supply levels, and supported the launch with off-shelf displays and promotions. This strategy helped in recapturing the customer base that had previously relied on prescription Allegra[1].

Retailer and Supplier Dynamics

The switch from prescription to OTC posed challenges for both retailers and suppliers. Retailers needed to recapture the revenue lost when the drug was no longer covered by insurance. Suppliers had to ensure that the product was widely available and that the brand loyalty was retained. The successful launch of Allegra OTC was attributed to effective premarketing, distribution, and retail support[1].

Market Expansion and Competition

The OTC transition opened up new market opportunities, especially for food and mass-market channels without in-store pharmacies. These retailers could now compete for a share of the Allegra business, which had previously been dominated by drug stores. The supermarket channel, in particular, benefited significantly from this transition, as they could offer Allegra alongside other health and wellness products[1].

Pediatric and Adult Market

Allegra's approval for pediatric use has also been a significant factor in its market dynamics. The FDA approved Allegra Oral Suspension for children as young as 2 years old, providing a safe and effective treatment option for seasonal allergies and chronic idiopathic urticaria in pediatric patients. This expansion into the pediatric market has further broadened the drug's consumer base[2].

Global Market Trends

The global allergy treatment market, of which Allegra is a part, is projected to grow significantly. By 2034, the market is expected to reach a valuation of $34.9 billion, driven by a CAGR of 5.8%. Factors such as increasing allergic conditions due to lifestyle changes, poor air quality, and pollution are driving this growth. Improved allergy management techniques and the demand for non-drowsy treatments also contribute to the market's expansion[3].

Fexofenadine Market Growth

The global fexofenadine market, specifically, is anticipated to grow at a CAGR of 4.80% from 2024 to 2031. North America dominates this market, driven by the growing occurrence of allergic rhinitis and chronic idiopathic urticaria, as well as increased OTC availability and healthcare access[4].

Financial Projections

The transition to OTC has stabilized Allegra's financial trajectory after the initial decline due to generic competition. The drug's widespread availability and strong retail support have helped maintain its market share. Sanofi's investment in the consumer health care segment, including the acquisition of Chattem, has provided a solid platform for Allegra's continued success in the OTC market.

Key Financial Metrics

• Pre-Transition Sales: $1.5 billion (combined sales of Allegra 180 mg and 60 mg) and $600 million (Allegra D-12)[1].
• Post-Transition Sales: While exact figures are not provided, the successful launch and continued market presence indicate a stable financial performance.
• Market Growth: The allergy treatment market is projected to reach $34.9 billion by 2034, with the fexofenadine market growing at a CAGR of 4.80% from 2024 to 2031[3][4].

Conclusion

The transition of Allegra from a prescription to an OTC medication has been a pivotal moment in its market dynamics and financial trajectory. Despite initial challenges posed by generic competition, Sanofi's strategic move and effective retail execution have ensured the drug's continued success. The growing allergy treatment market and the specific growth projections for fexofenadine underscore the potential for sustained financial performance.

Key Takeaways

• Allegra's transition to OTC was a strategic move to leverage its prescription franchise and build a consumer products platform.
• The transition was executed swiftly with strong retail support, ensuring quick market penetration.
• The drug's approval for pediatric use has expanded its consumer base.
• The global allergy treatment market and fexofenadine market are projected to grow significantly.
• Sanofi's investment in the consumer health care segment has provided a solid platform for Allegra's continued success.

FAQs

Q: What was the impact of generic versions on Allegra's prescription sales? A: The introduction of generic versions led to a 53.6% decline in Allegra's net sales in the United States, from $600 million to approximately $200 million[1].

Q: Why did Sanofi transition Allegra to an OTC medication? A: The transition was part of Sanofi's growth strategy to leverage the equity in Allegra’s prescription franchise and build a consumer products platform[1].

Q: How did retailers support the launch of Allegra OTC? A: Retailers ensured quick product availability, maintained supply levels, and supported the launch with off-shelf displays and promotions[1].

Q: What is the projected growth of the global allergy treatment market? A: The market is expected to reach $34.9 billion by 2034, driven by a CAGR of 5.8%[3].

Q: How is the fexofenadine market expected to grow? A: The global fexofenadine market is anticipated to grow at a CAGR of 4.80% from 2024 to 2031[4].

Sources

1. Supermarket News - Rx to OTC: A Case Study
2. Sanofi US - FDA approves ALLEGRA® (fexofenadine hydrochloride) oral suspension
3. GlobeNewswire - Allergy Treatment Market Size and Share Projected to Surpass USD 34.9 Billion by 2034
4. Cognitive Market Research - Fexofenadine market will grow at a CAGR of 4.80% from 2024 to 2031