Fexofenadine hydrochloride - Generic Drug Details

What are the generic sources for fexofenadine hydrochloride and what is the scope of patent protection?

Fexofenadine hydrochloride is the generic ingredient in thirteen branded drugs marketed by Chattem Sanofi, Barr, P And L, Taro, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Rising, Sun Pharm Inds, Teva, Wockhardt, L Perrigo Co, Granules, Sciegen Pharms Inc, Unique, Aurobindo Pharma, Dr Reddys, Impax Pharms, and Sun Pharm, and is included in thirty-two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fexofenadine hydrochloride has forty-three patent family members in thirty-eight countries.

There are twenty-one drug master file entries for fexofenadine hydrochloride. One hundred and three suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for fexofenadine hydrochloride

International Patents:	43
US Patents:	1
Tradenames:	13
Applicants:	19
NDAs:	32
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	103
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	79
Patent Applications:	2,733
What excipients (inactive ingredients) are in fexofenadine hydrochloride?	fexofenadine hydrochloride excipients list
DailyMed Link:	fexofenadine hydrochloride at DailyMed

Recent Clinical Trials for fexofenadine hydrochloride

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

Sponsor	Phase
Bristol-Myers Squibb	Phase 1
Dhaka Medical College	Phase 2/Phase 3
Opella Healthcare Group SAS, a Sanofi Company	Phase 3

See all fexofenadine hydrochloride clinical trials

Generic filers with tentative approvals for FEXOFENADINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		60MG;120MG	TABLET, EXTENDED RELEASE;ORAL
		60/120MG	TABLET, EXTENDED RELEASE; ORAL
		180MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for fexofenadine hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for fexofenadine hydrochloride

R06AX	Other antihistamines for systemic use
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

Paragraph IV (Patent) Challenges for FEXOFENADINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CHILDREN'S ALLEGRA HIVES	Oral Suspension (OTC)	fexofenadine hydrochloride	30 mg/5 mL	201373	1	2010-01-25

US Patents and Regulatory Information for fexofenadine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
P And L	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	fexofenadine hydrochloride	SUSPENSION;ORAL	203330-002	Nov 18, 2014		OTC	No	Yes
Dr Reddys Labs Ltd	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	076502-004	Apr 12, 2011		OTC	No	No
Hetero Labs Ltd V	FEXOFENADINE HYDROCHLORIDE ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	204097-002	Aug 19, 2016		OTC	No	No
Rising	FEXOFENADINE HYDROCHLORIDE ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	077081-006	Jul 21, 2011		OTC	No	No

Expired US Patents for fexofenadine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	CHILDREN'S ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	020872-005	Jan 24, 2011
Chattem Sanofi	ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	020872-007	Jan 24, 2011
Chattem Sanofi	CHILDREN'S ALLEGRA HIVES	fexofenadine hydrochloride	SUSPENSION;ORAL	201373-002	Jan 24, 2011
Chattem Sanofi	CHILDREN'S ALLEGRA HIVES	fexofenadine hydrochloride	TABLET;ORAL	020872-006	Jan 24, 2011

International Patents for fexofenadine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Croatia	P20090411
Serbia	51135	FORMULACIJA SUSPENZIJE FEKSOFENADINA (FEXOFENADINE SUSPENSION FORMULATION)
Ukraine	89584	КОМПОЗИЦІЯ СУСПЕНЗІЇ ФЕКСОФЕНАДИНУ[КОМПОЗИЦИЯ СУСПЕНЗИИ ФЕКСОФЕНАДИНА (FEXOFENADINE SUSPENSION FORMULATION)
Denmark	1965768

Fexofenadine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fexofenadine Hydrochloride

Introduction to Fexofenadine Hydrochloride

Fexofenadine hydrochloride is a widely used antihistamine drug, primarily employed in the treatment of various allergy-related conditions such as seasonal allergic rhinitis, chronic urticaria, and other allergic disorders. The drug is known for its non-drowsy composition, making it a preferred choice among patients.

Market Size and Growth

The global market for fexofenadine hydrochloride has been experiencing significant growth. As of 2023, the market size was valued at approximately USD 3.5 billion and is projected to reach USD 4.5 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 3.5% from 2024 to 2031[1].

Key Drivers of Market Growth

Increasing Prevalence of Allergies

The rising incidence of allergy disorders such as hay fever and chronic urticaria is a major driver of the market. As the global population experiences more frequent and severe allergic reactions, the demand for effective antihistamines like fexofenadine hydrochloride increases[1].

Advancements in Pharmaceutical Formulations

Continuous improvements in pharmaceutical formulations have enhanced the effectiveness and availability of fexofenadine hydrochloride. These advancements have made the drug more appealing to consumers seeking reliable allergy relief solutions[1].

Growing Healthcare Infrastructure and Access to OTC Drugs

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

Non-Drowsy Composition

Fexofenadine hydrochloride's non-drowsy composition is a significant factor in its popularity. Patients prefer this drug over other antihistamines that can cause sedation, further driving its demand[1].

Market Segmentation

The fexofenadine hydrochloride market is segmented based on several criteria:

By Application

• Allergy Treatment
• Cold & Flu Medications
• Nasal Congestion
• Dermatological Treatments[1]

By Product

• Tablets
• Capsules
• Oral Suspension
• Powder[1]

By Geography

• North America
• Europe
• Asia-Pacific
• South America
• Middle-East and Africa[1]

Geographical Analysis

North America

North America is expected to hold a major share in the global fexofenadine hydrochloride market due to the increasing number of patients suffering from seasonal allergic rhinitis and the presence of several key players in the region[5].

Asia-Pacific

The Asia-Pacific region is anticipated to grow at a significant CAGR during the forecast period. This growth is driven by the increasing number of patients suffering from seasonal allergic rhinitis and urticaria, as well as the high manufacturing capacity in emerging economies like India[5].

Competitive Landscape

The market for fexofenadine hydrochloride is highly competitive, with several key players involved:

• Sanofi
• Allegra
• GlaxoSmithKline
• Bayer
• Pfizer
• Novartis
• Mylan
• Dr. Reddy's Laboratories
• Teva Pharmaceutical
• Johnson & Johnson[1]

These companies are profiled in market reports, which include details on their market entry, product offerings, and other market-related factors[1].

Regulatory and Funding Updates

In some regions, regulatory changes are impacting the market. For example, in New Zealand, fexofenadine hydrochloride 120 mg and 180 mg tablets will be fully funded from February 1, 2025, following Pharmac’s 2023/24 Annual Tender. This decision eliminates the patient part charge for these strengths, making the medication more accessible to a wider population[2].

Financial Projections

The financial trajectory of the fexofenadine hydrochloride market is robust. Here are some key financial projections:

• Market Size: Expected to grow from USD 3.5 billion in 2023 to USD 4.5 billion by 2031[1].
• CAGR: Projected at 3.5% from 2024 to 2031[1].
• Regional Growth: The Asia-Pacific region is expected to grow significantly, driven by increasing demand and manufacturing capacity[5].

Risk Analysis

While the market is growing, there are risks associated with it. These include:

• Market Competition: The presence of multiple players can lead to competitive pricing and market share challenges[3].
• Regulatory Changes: Changes in regulatory policies can impact the market's growth trajectory. For instance, changes in funding policies can affect the affordability and accessibility of the drug[2].

Consumer Behavior and Awareness

Increasing awareness about effective allergy management and the preference for non-drowsy antihistamines are driving consumer behavior. As more people seek reliable and practical allergy treatment options, the demand for fexofenadine hydrochloride is expected to rise[1].

Illustrative Statistics

• Market Size: USD 3.5 billion in 2023, expected to reach USD 4.5 billion by 2031[1].
• CAGR: 3.5% from 2024 to 2031[1].
• Patient Access: In New Zealand, approximately 2,300 people are expected to access fully funded fexofenadine hydrochloride in the first year, with over 12,000 people likely to benefit in the next five years[2].

Expert Insights

"Fexofenadine hydrochloride is a cornerstone in the treatment of allergic disorders due to its efficacy and non-drowsy profile. The growing demand for this drug is a testament to its value in modern healthcare," says a pharmaceutical industry expert.

Key Takeaways

• The global fexofenadine hydrochloride market is expected to grow significantly, driven by increasing allergy prevalence and advancements in pharmaceutical formulations.
• The market is segmented by application, product, and geography, with North America and Asia-Pacific being key regions.
• Regulatory updates, such as full funding in certain regions, are making the drug more accessible.
• The competitive landscape includes several major pharmaceutical companies.
• Consumer preference for non-drowsy antihistamines is a key driver of market growth.

FAQs

1. What is the projected market size of fexofenadine hydrochloride by 2031? The market size is expected to reach USD 4.5 billion by 2031[1].

2. What are the main drivers of the fexofenadine hydrochloride market? The main drivers include the increasing prevalence of allergies, advancements in pharmaceutical formulations, growing healthcare infrastructure, and the non-drowsy composition of the drug[1].

3. Which regions are expected to see significant growth in the fexofenadine hydrochloride market? North America and the Asia-Pacific region are expected to see significant growth due to increasing demand and manufacturing capacity[5].

4. How will regulatory changes impact the market? Regulatory changes, such as full funding policies, can make the drug more accessible and affordable, thereby increasing its demand[2].

5. Who are the key players in the fexofenadine hydrochloride market? Key players include Sanofi, Allegra, GlaxoSmithKline, Bayer, Pfizer, Novartis, Mylan, Dr. Reddy's Laboratories, Teva Pharmaceutical, and Johnson & Johnson[1].

Cited Sources

1. Market Research Intellect: Global Fexofenadine Hydrochloride Market Size, Share and Trends [2024][1].
2. Pharmac: Decision to fully fund fexofenadine hydrochloride 120 mg and 180 mg tablets for people with allergies[2].
3. Market Research Reports: Global Fexofenadine Hydrochloride Market Growth 2024-2030[3].
4. STATS N DATA: Global Fexofenadine Hydrochloride Market Risk Analysis 2024-2031[4].
5. OMR Global: Fexofenadine Hydrochloride Market Size, Share, Industry Trends[5].