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Last Updated: December 22, 2024

Cetirizine hydrochloride; pseudoephedrine hydrochloride - Generic Drug Details


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

Cetirizine hydrochloride; pseudoephedrine hydrochloride is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Ivax Sub Teva Pharms, Pld Acquisitions, Ppi-dac, Sun Pharm Inds Ltd, Unichem, and J And J Consumer Inc, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-six suppliers are listed for this compound.

Summary for cetirizine hydrochloride; pseudoephedrine hydrochloride
Recent Clinical Trials for cetirizine hydrochloride; pseudoephedrine hydrochloride

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

SponsorPhase
GlaxoSmithKlineN/A
Fraunhofer-Institute of Toxicology and Experimental MedicineN/A
SandozPhase 1

See all cetirizine hydrochloride; pseudoephedrine hydrochloride clinical trials

Pharmacology for cetirizine hydrochloride; pseudoephedrine hydrochloride
Paragraph IV (Patent) Challenges for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZYRTEC-D 12 HOUR Extended-release Tablets cetirizine hydrochloride; pseudoephedrine hydrochloride 5 mg/120 mg 021150 1 2004-06-02

US Patents and Regulatory Information for cetirizine 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
Ppi-dac CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 210719-001 Nov 16, 2018 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Inds Ltd CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 090922-001 Sep 28, 2012 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma Ltd CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 212409-001 Mar 8, 2023 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
J And J Consumer Inc ZYRTEC-D 12 HOUR cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021150-002 Nov 9, 2007 OTC Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pld Acquisitions CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 077991-001 Mar 5, 2008 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Unichem CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 210507-001 Sep 10, 2024 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ivax Sub Teva Pharms CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 077170-001 Feb 25, 2008 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 cetirizine hydrochloride; pseudoephedrine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc ZYRTEC-D 12 HOUR cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021150-002 Nov 9, 2007 ⤷  Subscribe ⤷  Subscribe
J And J Consumer Inc ZYRTEC-D 12 HOUR cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021150-002 Nov 9, 2007 ⤷  Subscribe ⤷  Subscribe
J And J Consumer Inc ZYRTEC-D 12 HOUR cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021150-002 Nov 9, 2007 ⤷  Subscribe ⤷  Subscribe
J And J Consumer Inc ZYRTEC-D 12 HOUR cetirizine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021150-002 Nov 9, 2007 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Cetirizine hydrochloride; pseudoephedrine hydrochloride Market Analysis and Financial Projection Experimental

Cetirizine Hydrochloride Market Dynamics and Financial Trajectory

Global Market Size and Growth

The global cetirizine hydrochloride market is a significant segment within the pharmaceutical industry, driven by several key factors. As of 2023, the market was valued at approximately USD 6.213 billion. This valuation is expected to grow at a Compounded Annual Growth Rate (CAGR) of 2.2% to reach USD 7.236 billion by 2030. In a more extended forecast, the market is projected to reach USD 8.0 billion by 2034, growing at a CAGR of 2.6% from 2024 to 2034[1][3].

Market Drivers

Increasing Prevalence of Allergic Disorders

One of the primary drivers of the cetirizine hydrochloride market is the rising prevalence of allergic diseases globally. Allergies such as eczema, food allergies, and allergic rhinitis are becoming increasingly common, thereby increasing the demand for effective treatments like cetirizine hydrochloride. For instance, according to the CDC’s National Center for Health Statistics, more than 1 in 4 American children and over 1 in 3 American adults reported having a food allergy, eczema, or seasonal allergy in 2021[1][3].

Advancements in Healthcare Infrastructure

The expansion and improvement of healthcare infrastructure, particularly in regions like North America, Europe, and the Asia Pacific, are contributing significantly to market growth. These regions have robust healthcare systems, increasing awareness about allergy management, and a strong emphasis on innovation, which drives the demand for cetirizine hydrochloride[1].

Generic Versions and Accessibility

The introduction of generic versions of cetirizine hydrochloride has increased competition in the market, leading to lower prices and greater accessibility for people from a broader range of socioeconomic backgrounds. This increased accessibility has further boosted the market's growth potential[1][3].

Financial Trajectory

Revenue and Growth Projections

The financial trajectory of the cetirizine hydrochloride market is promising, with steady growth projected over the coming years. The market is expected to grow from USD 6.213 billion in 2023 to USD 7.236 billion by 2030, with a CAGR of 2.2%. By 2034, the market is projected to reach USD 8.0 billion, growing at a CAGR of 2.6% from 2024 to 2034[1][3].

Budget Impact and Cost Analysis

In the context of emergency department settings, the adoption of intravenous cetirizine hydrochloride has shown a positive budget impact. For example, in one scenario, the adoption of IV cetirizine resulted in a positive net budget impact of $27,876, primarily due to reduced operational costs and increased revenue from treating additional patients[1].

Regional Insights

North America

The North American market is estimated to witness a significantly high revenue share over the forecast period, driven by the high incidence of allergic rhinitis and urticaria (hives) in the region. The growing financial burden of allergic disorders on the affected population also contributes to this growth[3].

Europe

The European market is expanding steadily due to an aging population and the rise in allergy prevalence among senior citizens. The region's well-established healthcare infrastructure further supports market growth[3].

Asia Pacific

The Asia Pacific market is expected to witness the fastest revenue growth due to an aging population, greater disposable income, and rising allergy awareness. Developing nations in this region present considerable market potential for cetirizine hydrochloride[3].

Latin America and Middle East & Africa

Latin America is an emerging region with increased healthcare spending due to a growing middle class, which could propel the market for cetirizine hydrochloride. The Middle East and Africa also experience steady growth, driven by improving healthcare infrastructure, rising awareness about allergy management, and expanding access to pharmaceutical products[3][5].

Challenges and Opportunities

Threat of New Medications

The development of new medications could potentially slow the growth rate of the cetirizine hydrochloride market. However, the established safety profile and effectiveness of cetirizine hydrochloride are likely to maintain its market position[1][3].

Regulatory Frameworks

Stringent regulatory standards, particularly in regions like Europe, can pose challenges for market growth. However, compliance with these regulations can also ensure the quality and safety of the drug, maintaining consumer trust[1].

Emerging Markets

Regions like the Asia Pacific, Latin America, and the Middle East and Africa present significant opportunities for market expansion. Increasing healthcare expenditure, growing awareness about allergy management, and improving healthcare infrastructure in these regions are expected to drive future growth[1][3].

Key Players

The global cetirizine hydrochloride market is substantially consolidated, with key players including UCB Pharma SA, Pfizer Ltd., J & J Industries, Inc., Mylan Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd., Huapont Pharm. Co., Ltd., Hunan Jiudian Pharmaceutical CO., LTD., Sun Pharmaceutical Industries Ltd., and Lunan Pharmaceutical Co., Ltd. These companies are driving market growth through strategic partnerships, research and development activities, and market penetration[3][4].

Market Trends and Forecast

The market is expected to be driven by increasing research and development activities, coupled with strategic partnerships and mergers among key market players. The rising prevalence of allergic conditions and the ongoing pursuit of advanced treatment modalities will ensure a robust demand for cetirizine hydrochloride, promising a steady trajectory for the market in the foreseeable future[5].

"The rising rates of allergic diseases globally are a significant driver for the cetirizine hydrochloride market. Allergies such as eczema, food allergies, and allergic rhinitis are becoming more common, increasing the demand for effective treatments like cetirizine hydrochloride."[1]

Illustrative Statistics

  • Market Value 2023: USD 6.213 billion[1]
  • Projected Market Value 2030: USD 7.236 billion[1]
  • Projected Market Value 2034: USD 8.0 billion[1][3]
  • CAGR 2023-2030: 2.2%[1]
  • CAGR 2024-2034: 2.6%[1][3]
  • Prevalence of Allergies in the US: More than 1 in 4 American children and over 1 in 3 American adults reported having a food allergy, eczema, or seasonal allergy in 2021[1][3].

Quotes from Industry Experts

"Cetirizine hydrochloride's market potential has increased across a range of demographics because of the medication's safety profile and effectiveness," said an industry analyst. "Medical professionals worldwide have come to rely on it for patients ranging in age from children to the elderly."[3]

Key Takeaways

  • The global cetirizine hydrochloride market is valued at USD 6.213 billion in 2023 and is expected to grow to USD 7.236 billion by 2030.
  • The market is driven by the increasing prevalence of allergic disorders, advancements in healthcare infrastructure, and the availability of generic versions.
  • North America, Europe, and the Asia Pacific are key regions driving market growth.
  • The market faces challenges from new medication developments and stringent regulatory frameworks but presents significant opportunities in emerging markets.
  • The adoption of cetirizine hydrochloride in emergency department settings has shown a positive budget impact.

FAQs

What is the current market size of cetirizine hydrochloride?

The global cetirizine hydrochloride market was valued at approximately USD 6.213 billion in 2023[1].

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

The market is expected to grow at a CAGR of 2.2% from 2023 to 2030 and at a CAGR of 2.6% from 2024 to 2034[1][3].

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

North America, Europe, and the Asia Pacific are the key regions driving market growth due to their high incidence of allergic conditions and robust healthcare infrastructure[1].

What are the main drivers of the cetirizine hydrochloride market?

The main drivers include the increasing prevalence of allergic disorders, advancements in healthcare infrastructure, and the availability of generic versions of the drug[1][3].

How does the adoption of intravenous cetirizine hydrochloride impact the budget in emergency department settings?

The adoption of IV cetirizine has shown a positive budget impact, primarily due to reduced operational costs and increased revenue from treating additional patients[1].

Sources

  1. DrugPatentWatch - Cetirizine hydrochloride - Generic Drug Details[1]
  2. FDA - Cetirizine Hydrochloride; Pseudoephedrine Hydrochloride[2]
  3. Prophecy Market Insights - Global Cetirizine Hydrochloride Market[3]
  4. BioSpace - Cetirizine Hydrochloride Market Key Players, Sales, Demand[4]
  5. Reanin - Cetirizine Hydrochloride Market | Growth | Size | Trends and Forecast[5]

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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.