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Last Updated: December 22, 2024

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for fexofenadine hydrochloride; pseudoephedrine hydrochloride and what is the scope of freedom to operate?

Fexofenadine hydrochloride; pseudoephedrine hydrochloride is the generic ingredient in three branded drugs marketed by Chattem Sanofi, Aurobindo Pharma, Barr, Dr Reddys, Dr Reddys Labs Ltd, Impax Pharms, and Sun Pharm, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-eight suppliers are listed for this compound. There are four tentative approvals for this compound.

Recent Clinical Trials for FEXOFENADINE HYDROCHLORIDE; 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; PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Subscribe⤷  Subscribe60MG;120MGTABLET, EXTENDED RELEASE;ORAL
⤷  Subscribe⤷  Subscribe60/120MGTABLET, EXTENDED RELEASE; ORAL
⤷  Subscribe⤷  Subscribe60MG; 120MGTABLET, EXTENDED RELEASE; 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; PSEUDOEPHEDRINE HYDROCHLORIDE

US Patents and Regulatory Information for FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Barr FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 076236-001 Apr 14, 2005 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 076667-001 Nov 18, 2014 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys Labs Ltd FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 079043-002 Jun 22, 2011 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

Expired US Patents for FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Introduction to Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Fexofenadine hydrochloride and pseudoephedrine hydrochloride are key components in several over-the-counter (OTC) and prescription medications, primarily used to treat allergic rhinitis, cold and flu symptoms, and other allergy-related conditions. Fexofenadine is a second-generation antihistamine known for its non-drowsy effects, while pseudoephedrine is a decongestant.

Market Size and Growth

The global market for fexofenadine hydrochloride is substantial and growing. 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][5].

Segmentation and Applications

The market is segmented based on various factors, including:

Application

  • Allergy treatment
  • Cold and flu medications
  • Nasal congestion
  • Dermatological treatments

Product Forms

  • Tablets
  • Capsules
  • Oral suspension
  • Powder

Geographical Regions

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

North America dominates the market, accounting for around 40% of the global revenue, driven by the increasing incidence of allergic rhinitis and chronic idiopathic urticaria. Europe is the fastest-growing region due to rising allergy rates and heightened consumer awareness of antihistamine alternatives[5].

Key Drivers of Market Growth

Several factors are driving the growth of the fexofenadine hydrochloride market:

Increasing Allergy Incidence

The rising prevalence of allergies such as hay fever and chronic urticaria globally is a significant driver. As more people seek effective allergy treatments, the demand for non-drowsy antihistamines like fexofenadine hydrochloride increases[1].

Advancements in Pharmaceutical Formulations

Continuous improvements in pharmaceutical formulations enhance the effectiveness and availability of fexofenadine hydrochloride products. This includes the development of extended-release tablets that combine fexofenadine with pseudoephedrine, offering comprehensive relief from allergy symptoms[2].

Expanding Healthcare Infrastructure

The growth in healthcare infrastructure and the increasing availability of OTC drugs make allergy treatments more accessible and affordable for a broader population. This expansion is particularly notable in regions like North America and Europe[1][5].

Consumer Preferences

Consumers increasingly prefer non-drowsy allergy relief solutions, which fexofenadine hydrochloride provides. This preference, combined with growing disposable incomes and increased awareness of allergy management, contributes to the market's growth[1][5].

Pharmacokinetics and Pharmacodynamics

Understanding the pharmacokinetics and pharmacodynamics of fexofenadine hydrochloride and pseudoephedrine hydrochloride is crucial for their effective use.

Absorption and Bioavailability

Fexofenadine hydrochloride is rapidly absorbed, with peak plasma concentrations occurring approximately 2 hours post-dose. The bioavailability of fexofenadine and pseudoephedrine from extended-release tablets is similar to that of separate administration of the components. However, the bioavailability of fexofenadine can be significantly reduced when taken with a high-fat meal[2].

Elimination

The mean elimination half-life of fexofenadine is approximately 14.4 hours, with most of the dose recovered in the feces. Pseudoephedrine has a shorter half-life of 4-6 hours, which can be influenced by urine pH. In patients with renal impairment, the peak plasma levels and half-life of both drugs can be significantly affected[2][3].

Clinical Studies and Efficacy

Clinical studies have demonstrated the efficacy of fexofenadine hydrochloride and pseudoephedrine hydrochloride combination tablets in reducing symptoms of seasonal allergic rhinitis. A 2-week, multicenter, randomized trial showed significant reductions in sneezing, rhinorrhea, itchy nose/palate/throat, and nasal congestion[2].

Regional Market Analysis

North America

North America is the largest market, driven by the high incidence of allergic rhinitis and chronic idiopathic urticaria. The region's well-developed healthcare infrastructure and consumer preference for non-drowsy allergy treatments further fuel the market's growth[5].

Europe

Europe is the fastest-growing region, with increasing allergy rates and heightened consumer awareness of antihistamine alternatives. The availability of OTC fexofenadine products across European countries has made it more accessible to consumers[5].

Asia-Pacific

The Asia-Pacific region is also experiencing significant growth, driven by the increasing awareness of allergy management and the expanding healthcare infrastructure. This region is expected to grow at a CAGR of 6.8% from 2024 to 2031[5].

Market Trends and Challenges

Increasing Competition

The market faces competition from other antihistamines and allergy treatments. However, fexofenadine hydrochloride's non-drowsy properties and the combination with pseudoephedrine give it a competitive edge[1].

Regulatory Policies

Regulatory policies and changes in healthcare regulations can impact the market. For instance, the availability of OTC vs. prescription-only status can significantly affect market dynamics[5].

Key Takeaways

  • The global fexofenadine hydrochloride market is projected to grow from USD 3.5 billion in 2023 to USD 4.5 billion by 2031.
  • North America dominates the market, with Europe being the fastest-growing region.
  • Increasing allergy incidence, advancements in pharmaceutical formulations, and expanding healthcare infrastructure are key drivers.
  • Consumer preference for non-drowsy allergy relief solutions is a significant factor.
  • The combination of fexofenadine hydrochloride and pseudoephedrine hydrochloride offers comprehensive relief from allergy symptoms.

Frequently Asked Questions (FAQs)

Q: What is the projected growth rate of the fexofenadine hydrochloride market from 2024 to 2031? A: The 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 around 40% of the global revenue[5].

Q: What are the key drivers of the fexofenadine hydrochloride market growth? A: Key drivers include increasing allergy incidence, advancements in pharmaceutical formulations, expanding healthcare infrastructure, and consumer preference for non-drowsy allergy relief solutions[1][5].

Q: How does the combination of fexofenadine hydrochloride and pseudoephedrine hydrochloride affect bioavailability? A: The bioavailability of fexofenadine and pseudoephedrine from extended-release tablets is similar to that of separate administration of the components. However, bioavailability can be reduced when taken with a high-fat meal[2].

Q: What is the impact of renal impairment on the pharmacokinetics of fexofenadine hydrochloride and pseudoephedrine hydrochloride? A: Renal impairment can significantly increase peak plasma levels and half-life of both drugs, necessitating dose adjustments[2][3].

Cited Sources:

  1. Market Research Intellect: Fexofenadine Hydrochloride Market Size, Share and Trends [2024-2031][1].
  2. Drugs.com: Fexofenadine and Pseudoephedrine: Package Insert / Prescribing Info[2].
  3. FDA: ALLEGRA-D 24 HOUR (fexofenadine HCl 180 mg and pseudoephedrine HCl 240 mg) Extended-Release Tablets[3].
  4. Cognitive Market Research: Fexofenadine Hydrochloride Market Report 2024 (Global Edition)[4].
  5. Cognitive Market Research: Fexofenadine market will grow at a CAGR of 4.80% from 2024 to 2031[5].

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