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-nine 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:	193
Clinical Trials:	35
Patent Applications:	4,945
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
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 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

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
Chattem Sanofi	ALLEGRA	fexofenadine hydrochloride	SUSPENSION;ORAL	021963-001	Oct 16, 2006
Chattem Sanofi	ALLEGRA	fexofenadine hydrochloride	SUSPENSION;ORAL	021963-001	Oct 16, 2006
Chattem Sanofi	ALLEGRA	fexofenadine hydrochloride	SUSPENSION;ORAL	021963-001	Oct 16, 2006

International Patents for ALLEGRA

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

Country	Patent Number	Title	Estimated Expiration
Austria	226819
Norway	20065390
Japan	H0132823
Belgium	882704

Market Dynamics and Financial Trajectory for Allegra (Fexofenadine)

Last updated: February 20, 2026

Allegra (fexofenadine) is an antihistamine used primarily to treat allergic rhinitis and chronic idiopathic urticaria. It is marketed by Sanofi and has operated within a mature therapeutic segment. The drug’s market landscape reflects stable revenue, patent expirations, and ongoing competition from generics and other antihistamines.

Market Position and Revenue Trends

Allegra generated approximately $1.15 billion globally in 2022, with North America accounting for about 62% of sales, driven by high prevalence of allergy symptoms. The drug’s revenue has declined marginally from a peak of $1.3 billion in 2018, aligning with the expiration of key patents and increased generic competition.

Revenue Breakdown and Market Share (2022)

Region	Revenue ($ million)	Market Share	Notes
North America	713	62%	Dominant market, high brand loyalty
Europe	200	17%	Generic penetration increasing
Rest of World	240	21%	Growing markets in Asia-Pacific

Patent Timeline and Generic Entry

• Original patent expired in 2011, leading to rapid entry of generics.
• Brand sales remained stable from 2011–2017 due to strong brand loyalty and marketing.
• Post-2017, sales declined as generics gained market share.

Competitive Landscape

The antihistamine class has multiple alternatives:

• Generics and over-the-counter brands: Loratadine and cetirizine are primary competitors.
• Pharmaceutical companies: Teva, Sandoz, Dr. Reddy’s, and others hold significant market share in the generic segment.
• New entrants: Limited innovation; the market predominantly features existing antihistamines.

Market share shifted post-generic entry; Allegra’s brand sales decreased by approximately 35% between 2017–2022 but remain a premium option in specific markets due to perception of higher efficacy.

Regulatory and Patent Challenges

• Allegra’s patent protection expired in 2011, allowing generics to compete.
• In 2020, Sanofi faced patent infringement litigation, which delayed some generic entry in key regions.
• Patent litigation cost and settlement affected revenue stability through 2022.

Future Outlook and Financial Trajectory

The drug's future depends on several factors:

• Market saturation: The antihistamine segment is mature, with limited growth prospects.
• Generic competition: Continues to erode brand revenue; expected to account for over 80% of antihistamine prescriptions by 2025.
• New formulations: Limited pipeline or reformulations for Allegra.
• Potential niche markets: Allergic rhinitis in pediatric populations or underdeveloped regions may sustain demand.

Revenue Forecast (2023–2027)

Year	Projected Revenue ($ million)	Assumptions
2023	950	Stabilization after patent expiration; some recovery from market share regain efforts
2024	900	Continued generic penetration; slight decline in brand dominance
2025	850	Market saturation; competitive pressures persist
2026	800	Further erosion; marginal growth in emerging markets
2027	750	Stable at low levels; potential for biosimilar or alternative therapy impact

Strategic Considerations

Sanofi has limited options to expand Allegra’s market footprint. Focus is on maintaining market share in key regions through marketing rather than innovation. Diversification into newer antihistamine formulations or combination therapies could be future pathways but are not currently in pipeline.

Key Takeaways

• Allegra remains a significant antihistamine, primarily in North America, but faces declining revenues due to patent expiration and generic competition.
• Revenue declined from a peak of $1.3 billion in 2018 to approximately $1.15 billion in 2022.
• Future market potential will depend on niche applications, regional growth, and strategic repositioning within Sanofi’s portfolio.
• Generics dominate the antihistamine segment, with over 80% of prescriptions expected to be generic by 2025.
• Strategic focus should shift toward development of novel formulations or combination therapies to offset declining brand revenue.

FAQs

1. How has Allegra’s market share changed since patent expiry?
Its market share declined sharply after 2011, with brand sales dropping by approximately 35% from 2017 to 2022, due to generic competition.

2. What regions present growth opportunities for Allegra?
Emerging markets in Asia-Pacific and Latin America could offer growth potential, especially in areas with lower generic penetration and limited antihistamine options.

3. Are there any patent protections still protecting Allegra?
No, the primary patent expired in 2011. Litigation related to secondary patents or formulations has delayed some generic entries but no patent protections remain through 2023.

4. What are the main competitors to Allegra?
Loratadine (Claritin), cetirizine (Zyrtec), and generics, primarily from Teva and Sandoz.

5. What strategies can Sanofi pursue to sustain Allegra’s revenues?
Focus on pediatric or niche markets, develop new formulations, or pursue licensing agreements for combination therapies.

References

1. IQVIA (2023). Top 10 Global OTC and Prescription Drug Sales Data.
2. Sanofi (2022). Annual Report.
3. U.S. Food & Drug Administration (2011). Patent expiry notices for Allegra (fexofenadine).
4. MarketWatch (2022). Antihistamines Market Trends and Forecasts.
5. ClinicalTrials.gov (2023). Ongoing studies for antihistamine formulations.

DrugChatter Q&A for ALLEGRA

Can i take allegra with orange juice?
What's better, Allegra or Zyrtec?