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Last Updated: December 22, 2024

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE Drug Patent Profile


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Which patents cover Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride, and what generic alternatives are available?

Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride is a drug marketed by Aurobindo Pharma, Barr, Dr Reddys, Dr Reddys Labs Ltd, Impax Pharms, and Sun Pharm. and is included in seven NDAs.

The generic ingredient in FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 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.

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Summary for FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Drug patent expirations by year for FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Recent Clinical Trials for FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

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

SponsorPhase
SanofiPhase 4
SanofiPhase 3
Dr. Reddy's Laboratories LimitedPhase 1

See all FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials

Pharmacology for FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

US Patents and Regulatory Information for FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209116-001 Oct 30, 2017 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 090818-001 Jan 29, 2015 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 215434-001 May 31, 2022 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 AND PSEUDOEPHEDRINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Market Overview

The market for fexofenadine hydrochloride, often combined with pseudoephedrine hydrochloride, is experiencing significant growth driven by several key factors.

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 becomes more aware of effective allergy treatments, the demand for antihistamines like fexofenadine hydrochloride is on the rise[1][4].

Non-Drowsy Composition

Fexofenadine hydrochloride's non-drowsy composition makes it a preferred choice for consumers seeking symptom relief without sedation. This characteristic enhances its market appeal, particularly in regions where active lifestyles demand alertness throughout the day[1][4].

Pharmaceutical Advancements

Continuous improvements in pharmaceutical formulations have enhanced the effectiveness and availability of fexofenadine hydrochloride. These advancements contribute to the market's growth by offering better treatment options for allergy sufferers[1].

Expanding Healthcare Infrastructure

The expansion of healthcare infrastructure and the increasing availability of over-the-counter (OTC) drugs are making allergy treatments more accessible and affordable. This broader reach is a significant factor in the market's growth trajectory[1][4].

Market Size and Growth Projections

Current Market Size

As of 2023, the fexofenadine hydrochloride market was valued at USD 3.5 billion. This figure is expected to grow substantially in the coming years[1].

Growth Projections

The market 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. Another report suggests a slightly higher CAGR of 4.80% from 2024 to 2031, indicating robust growth in the sector[1][4].

Geographical Trends

North America

North America dominates the market, accounting for around 40% of the global revenue in 2024. The region's growth is driven by the increasing occurrence of allergic rhinitis and chronic idiopathic urticaria, along with improved access to healthcare and OTC availability[4].

Europe

Europe is the fastest-growing region, driven by growing allergy costs and heightened consumer awareness of antihistamine alternatives. The increasing availability of OTC fexofenadine products and the emphasis on preventive care in European healthcare systems are key contributors to this growth[4].

Asia-Pacific, Latin America, and Middle East & Africa

The Asia-Pacific region is expected to grow at a CAGR of 6.8% from 2024 to 2031, while Latin America and the Middle East & Africa are projected to grow at CAGRs of 4.2% and 4.5%, respectively. These regions are also seeing increased demand due to expanding healthcare access and rising allergy prevalence[4].

Product and Application Segments

Product Forms

The market is segmented into various product forms, including tablets, capsules, oral suspension, and powder. Each form caters to different consumer preferences and needs, contributing to the overall market growth[1].

Application Areas

Fexofenadine hydrochloride is used in several application areas, including allergy treatment, cold & flu medications, nasal congestion, and dermatological treatments. The treatment of chronic idiopathic urticaria (hives) is a particularly fast-growing category due to fexofenadine's proven efficacy in this area[1][4].

Combination Therapy with Pseudoephedrine

Efficacy and Safety

Combination therapy with pseudoephedrine hydrochloride is more effective than using either drug alone in relieving the full spectrum of seasonal allergic rhinitis (SAR) symptoms. This combination provides comprehensive relief from both histamine-related and nasal congestion components of SAR[5].

Pharmacokinetics

The coadministration of fexofenadine and pseudoephedrine does not significantly affect the bioavailability of either component. However, it is recommended to take these medications on an empty stomach to avoid reduced bioavailability of fexofenadine when taken with a high-fat meal[2].

Market Interventions and Strategies

Mandatory vs. Voluntary Switches

Studies have shown that mandatory switches from other antihistamines to fexofenadine can significantly increase its market share and reduce prescription costs. Voluntary switch programs have a more modest impact but still contribute to market growth[3].

Financial Impact

Cost Savings

Mandatory switches to fexofenadine have been shown to reduce the average cost per antihistamine prescription by as much as 22.3%. This cost savings is a significant financial benefit for healthcare systems and consumers alike[3].

Revenue Growth

The growing demand for fexofenadine hydrochloride, driven by its efficacy and non-drowsy composition, is expected to continue driving revenue growth. The market's expansion into new regions and the increasing availability of OTC products further contribute to this financial trajectory[1][4].

Key Takeaways

  • The fexofenadine hydrochloride market is expected to grow from USD 3.5 billion in 2023 to USD 4.5 billion by 2031.
  • North America and Europe are key regions driving market growth.
  • The non-drowsy composition and combination therapy with pseudoephedrine are significant market drivers.
  • Expanding healthcare infrastructure and OTC availability are crucial factors.
  • The market is segmented by product forms and application areas, with urticaria treatment being a fast-growing category.

FAQs

What is the current market size of fexofenadine hydrochloride?

The current market size of fexofenadine hydrochloride was valued at USD 3.5 billion in 2023[1].

What is the projected growth rate of the fexofenadine hydrochloride market?

The market is projected to grow at a CAGR of 3.5% from 2024 to 2031, reaching USD 4.5 billion by 2031[1].

Which regions are driving the growth of the fexofenadine hydrochloride market?

North America and Europe are the primary regions driving the market growth, with Asia-Pacific also showing significant growth potential[4].

What are the key application areas for fexofenadine hydrochloride?

Key application areas include allergy treatment, cold & flu medications, nasal congestion, and dermatological treatments, with urticaria treatment being a particularly fast-growing category[1][4].

How does the combination of fexofenadine and pseudoephedrine affect their bioavailability?

The combination does not significantly affect the bioavailability of either component, but it is recommended to take these medications on an empty stomach to avoid reduced bioavailability of fexofenadine[2].

Sources

  1. Market Research Intellect: Fexofenadine Hydrochloride Market Size, Share and Trends [2024-2031][1]
  2. FDA: ALLEGRA-D 24 HOUR (fexofenadine HCl 180 mg and pseudoephedrine HCl 240 mg) Extended-Release Tablets[2]
  3. PubMed: Impact of interventions designed to increase market share of fexofenadine[3]
  4. Cognitive Market Research: Fexofenadine Market Report 2024[4]
  5. PubMed: The Efficacy and Safety of Fexofenadine HCl and Pseudoephedrine HCl Combination Therapy[5]

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