You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

FEXOFENADINE HYDROCHLORIDE ALLERGY Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Fexofenadine Hydrochloride Allergy patents expire, and what generic alternatives are available?

Fexofenadine Hydrochloride Allergy is a drug marketed by Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Granules, Hetero Labs Ltd V, Rising, Sciegen Pharms Inc, Sun Pharm Inds, Teva, Unique, and Wockhardt. and is included in ten NDAs.

The generic ingredient in FEXOFENADINE HYDROCHLORIDE 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 Fexofenadine Hydrochloride Allergy

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

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for FEXOFENADINE HYDROCHLORIDE ALLERGY?
  • What are the global sales for FEXOFENADINE HYDROCHLORIDE ALLERGY?
  • What is Average Wholesale Price for FEXOFENADINE HYDROCHLORIDE ALLERGY?
Summary for FEXOFENADINE HYDROCHLORIDE ALLERGY
Drug patent expirations by year for FEXOFENADINE HYDROCHLORIDE ALLERGY
Recent Clinical Trials for FEXOFENADINE HYDROCHLORIDE ALLERGY

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

SponsorPhase
Bristol-Myers SquibbPhase 1
Dhaka Medical CollegePhase 2/Phase 3
Opella Healthcare Group SAS, a Sanofi CompanyPhase 3

See all FEXOFENADINE HYDROCHLORIDE ALLERGY clinical trials

Pharmacology for FEXOFENADINE HYDROCHLORIDE ALLERGY

US Patents and Regulatory Information for FEXOFENADINE HYDROCHLORIDE ALLERGY

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 202039-002 Nov 19, 2014 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wockhardt FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 079112-004 Feb 8, 2012 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hetero Labs Ltd V FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 204097-002 Aug 19, 2016 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys Labs Ltd FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 076502-008 Apr 12, 2011 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sciegen Pharms Inc FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 204507-003 Sep 16, 2015 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hetero Labs Ltd V FEXOFENADINE HYDROCHLORIDE ALLERGY fexofenadine hydrochloride TABLET;ORAL 204097-003 Aug 19, 2016 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

FEXOFENADINE HYDROCHLORIDE ALLERGY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fexofenadine Hydrochloride: A Comprehensive Analysis

Introduction to Fexofenadine Hydrochloride

Fexofenadine hydrochloride is a widely used antihistamine medication, primarily employed in the treatment of various allergic conditions such as hay fever, chronic urticaria, and other allergy-related disorders. This drug has gained significant traction due to its non-drowsy composition and effectiveness in alleviating allergy symptoms.

Market Size and Growth Projections

The global market for fexofenadine hydrochloride is experiencing robust growth. As of 2023, the market size was valued at 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][4].

Key Drivers of Market Growth

Increasing Prevalence of Allergies

The rising incidence of allergy disorders worldwide is a significant driver of the fexofenadine hydrochloride market. Allergies such as seasonal allergic rhinitis, eczema, and food allergies affect a substantial portion of the population, with nearly one-third of American adults and over a quarter of American children suffering from these conditions annually[3].

Non-Drowsy Composition

Fexofenadine hydrochloride's non-drowsy formulation makes it a preferred choice among consumers seeking effective allergy relief without the sedative effects associated with other antihistamines. This preference is a key factor in the market's growth trajectory[1][4].

Advances in Pharmaceutical Formulations

Continuous improvements in pharmaceutical formulations have enhanced the effectiveness and availability of fexofenadine hydrochloride. These advancements include the development of various product forms such as tablets, capsules, oral suspension, and powder, catering to different patient needs[1].

Expanding Healthcare Infrastructure and Over-the-Counter Availability

The growing healthcare infrastructure and the increasing availability of fexofenadine hydrochloride over-the-counter (OTC) have made allergy treatment more accessible and affordable for a wider population. This expanded access is a significant contributor to the market's growth[1][4].

Market Segmentation

By Application

The fexofenadine hydrochloride market is segmented based on various applications, including:

  • Allergy Treatment: This segment dominates the market due to the high demand for antihistamines in treating allergic conditions.
  • Cold & Flu Medications: Fexofenadine hydrochloride is also used in combination with other medications to treat cold and flu symptoms.
  • Nasal Congestion: The drug is effective in alleviating nasal congestion associated with allergies.
  • Dermatological Treatments: It is used in treating skin allergies and conditions like chronic urticaria[1].

By Product

The market is segmented by product forms, including:

  • Tablets
  • Capsules
  • Oral Suspension
  • Powder Each form caters to different patient preferences and needs[1].

By Geography

Geographically, the market is divided into:

  • North America: Dominates the market with a significant share due to the high prevalence of allergies and strong healthcare infrastructure[4].
  • Europe: The fastest-growing region, driven by increasing allergy costs and heightened consumer awareness of antihistamine alternatives[4].
  • Asia-Pacific: Shows promising growth due to the expanding healthcare infrastructure and increasing awareness of allergy management[4].
  • South America and Middle-East & Africa: These regions also contribute to the market growth, albeit at a slower pace compared to North America and Europe[1].

Financial Trajectory

Revenue Projections

The global fexofenadine hydrochloride market is expected to grow from USD 3.5 billion in 2023 to USD 4.5 billion by 2031. This growth is driven by the increasing demand for non-drowsy antihistamines and the expanding healthcare infrastructure[1].

Regional Revenue Contributions

  • North America: Accounts for over 40% of the global revenue, driven by the high prevalence of allergic rhinitis and chronic idiopathic urticaria[4].
  • Europe: Holds around 30% of the global revenue, with a CAGR of 3.3% from 2024 to 2031[4].
  • Asia-Pacific: Contributes around 23% of the global revenue, with a CAGR of 6.8% from 2024 to 2031[4].

Key Players and Market Strategies

The market is dominated by several key players, including:

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

These companies engage in strategic activities such as collaborations, agreements, and the launch of new products to bolster market growth. For instance, Dr. Reddy’s Laboratories launched OTC Fexofenadine HCl 180 mg and Pseudoephedrine HCl 240 mg extended-release tablets in the United States, which is expected to drive segment growth[3].

Regulatory and Funding Aspects

Full Funding Initiatives

In some regions, regulatory bodies have initiated full funding for fexofenadine hydrochloride. For example, in New Zealand, fexofenadine hydrochloride 120 mg and 180 mg tablets will be fully funded from February 1, 2025, making the medication more accessible to patients without any additional cost[2].

Research Funding

Increased research funding for allergic conditions also supports the market growth. For instance, in the United States, research funding for food allergies was USD 77 million in 2022 and is estimated to reach USD 87 million by 2025, which helps in developing new antihistamine therapies[3].

Challenges and Limitations

Despite the growth, the market faces several challenges:

  • Patent Expiry and Generic Drugs: The patent expiry of branded drugs and the introduction of generic drugs can impede market growth.
  • Adverse Effects: The adverse effects associated with antihistamine drugs can also limit market expansion[3].

Consumer Behavior and Awareness

Growing Awareness of Allergy Management

Increased awareness of allergy management among consumers has driven the demand for reliable and practical allergy treatment options. Consumers are more inclined towards non-drowsy antihistamines, which has contributed to the market's expansion[1].

Environmental Factors

Improved environmental allergens and the expanding availability of over-the-counter medications have further fueled the market growth. Consumers are now more aware of preventive care and self-management of mild conditions, which has boosted the demand for fexofenadine hydrochloride[4].

Conclusion

The fexofenadine hydrochloride market is poised for significant growth driven by the increasing prevalence of allergies, advancements in pharmaceutical formulations, and expanding healthcare infrastructure. The market's financial trajectory indicates a steady increase in revenue, with key regions like North America and Europe leading the way. However, the market must navigate challenges such as patent expiry and adverse effects to sustain its growth.

Key Takeaways

  • The global fexofenadine hydrochloride market is expected to grow from USD 3.5 billion in 2023 to USD 4.5 billion by 2031.
  • The market is driven by the increasing prevalence of allergies, non-drowsy composition, and expanding healthcare infrastructure.
  • North America and Europe are the dominant regions, with Asia-Pacific showing promising growth.
  • Key players are engaging in strategic activities to bolster market growth.
  • Regulatory initiatives such as full funding and increased research funding support market expansion.

FAQs

Q: What is the expected CAGR of the fexofenadine hydrochloride market from 2024 to 2031?

A: The fexofenadine hydrochloride market is expected to grow at a CAGR of 3.5% from 2024 to 2031[1].

Q: Which region dominates the fexofenadine hydrochloride market?

A: North America dominates the market, accounting for over 40% of the global revenue[4].

Q: What are the primary drivers of the fexofenadine hydrochloride market growth?

A: The primary drivers include the increasing prevalence of allergies, non-drowsy composition, and expanding healthcare infrastructure[1][4].

Q: Which companies are key players in the fexofenadine hydrochloride market?

A: Key players include Sanofi, GlaxoSmithKline, Bayer, Pfizer, Novartis, Mylan, Dr. Reddy's Laboratories, Teva Pharmaceutical, and Johnson & Johnson[1].

Q: What are the challenges facing the fexofenadine hydrochloride market?

A: The market faces challenges such as patent expiry of branded drugs, introduction of generic drugs, and adverse effects associated with antihistamine drugs[3].

Sources

  1. Market Research Intellect: Fexofenadine Hydrochloride Market Size, Share and Trends [2024].
  2. Pharmac: Decision to fully fund fexofenadine hydrochloride 120 mg and 180 mg tablets.
  3. Mordor Intelligence: Antihistamine Market Size & Share Analysis - Growth Trends.
  4. Cognitive Market Research: Fexofenadine market will grow at a CAGR of 4.80% from 2024 to 2031.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.