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Last Updated: December 22, 2024

CETIRIZINE HYDROCHLORIDE Drug Patent Profile


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

Cetirizine Hydrochloride is a drug marketed by Actavis Mid Atlantic, Amneal Pharms, Apozeal Pharms, Aurobindo Pharma Ltd, Bajaj, Bionpharma, Chartwell Molecular, Lannett Co Inc, Padagis Us, Pharm Assoc, Ranbaxy Labs Ltd, Taro, Teva Pharms, Wockhardt, Indoco, Apotex, Catalent, Strides Pharma, Sun Pharm Inds Inc, Perrigo R And D, Amneal Pharms Ny, Apotex Inc, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Granules, Heritage Pharma, Ipca Labs Ltd, Marksans Pharma, Mylan, Orbion Pharms, Pld Acquisitions, Sun Pharm Inds Ltd, Torrent Pharms Llc, Unichem, Unique, Ivax Sub Teva Pharms, and Ppi-dac. and is included in fifty NDAs.

The generic ingredient in CETIRIZINE HYDROCHLORIDE is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.

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Drug patent expirations by year for CETIRIZINE HYDROCHLORIDE
Recent Clinical Trials for CETIRIZINE HYDROCHLORIDE

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

SponsorPhase
CURE Drug Repurposing Collaboratory (CDRC)Phase 3
Emory UniversityPhase 3
Ruijin HospitalPhase 1/Phase 2

See all CETIRIZINE HYDROCHLORIDE clinical trials

Pharmacology for CETIRIZINE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for CETIRIZINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for CETIRIZINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZYRTEC Syrup cetirizine hydrochloride 5 mg/5 mL 020346 1 2007-03-19
CHILDREN'S ZYRTEC HIVES RELIEF Chewable Tablets cetirizine hydrochloride 5 mg and 10 mg 021621 2005-03-25

US Patents and Regulatory Information for CETIRIZINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
Aurobindo Pharma Ltd CETIRIZINE HYDROCHLORIDE HIVES RELIEF cetirizine hydrochloride TABLET;ORAL 090760-004 Aug 5, 2015 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Heritage Pharma CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 078615-003 Dec 28, 2007 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Cipla Ltd CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 077318-001 Jul 25, 2013 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Inds Inc CETIRIZINE HYDROCHLORIDE HIVES cetirizine hydrochloride TABLET;ORAL 077499-004 Dec 27, 2007 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Orbion Pharms CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 078862-001 Feb 19, 2009 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Taro CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 078072-003 Jul 22, 2009 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

CETIRIZINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cetirizine Hydrochloride

Overview of Cetirizine Hydrochloride

Cetirizine hydrochloride, a second-generation antihistamine, is widely used for treating various allergic conditions, including allergic rhinitis, allergic conjunctivitis, and eczema. It is marketed under brands such as Zyrtec and Aller-Tec, and its popularity stems from its non-sedating properties and minimal side effects[3].

Global Market Size and Growth

As of 2023, the global cetirizine hydrochloride market was valued at approximately USD 6.213 billion. This market is projected to grow at a Compounded Annual Growth Rate (CAGR) of 2.2% to reach USD 7.236 billion by 2030[1].

In a more extended forecast, the market is expected to reach USD 8.0 billion by 2034, growing at a CAGR of 2.6% from 2024 to 2034[3].

Market Drivers

Increasing Prevalence of Allergic Disorders

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. 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[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 to the 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 has further boosted the market's growth potential[3].

Market Segmentation

By Dosage Form

The market is segmented by dosage form into tablets, syrup, and solution. Each form caters to different patient needs and preferences, ensuring a wide range of treatment options[1].

By Age Group

Cetirizine hydrochloride is used across various age groups, including adults and pediatric patients. This broad applicability helps in maintaining a steady demand across different demographics[1].

By Application

The drug is used for treating several allergic conditions, including allergic rhinitis, allergic conjunctivitis, eczema, and others. The versatility of cetirizine hydrochloride in addressing multiple allergy types contributes to its market growth[1].

By Distribution Channel

The market is segmented by distribution channels into hospital pharmacies, retail pharmacies, and online pharmacies. The increasing availability of cetirizine hydrochloride through these channels enhances its accessibility and convenience for patients[1].

Geographical Insights

North America

North America is a prominent market for cetirizine hydrochloride, driven by a high prevalence of allergic conditions, robust healthcare infrastructure, and a strong emphasis on innovation. The region's mature pharmaceutical industry and increasing awareness about allergy management contribute significantly to market growth[1].

Europe

Europe's market is characterized by stringent regulatory standards, sophisticated healthcare systems, and a growing focus on personalized medicine. Increasing investment in research and development makes Europe a key market for pharmaceutical innovations, including cetirizine hydrochloride[1].

Asia Pacific

The Asia Pacific region is experiencing rapid market expansion due to a large population base, rising disposable incomes, and increasing healthcare expenditure. Growing urbanization, changing lifestyles, and a surge in allergic disorders drive the demand for cetirizine hydrochloride in countries like China, India, Japan, and South Korea[1].

Middle East and Africa

The Middle East and Africa region experiences steady growth, propelled by improving healthcare infrastructure, rising awareness about allergy management, and expanding access to pharmaceutical products. Despite challenges related to regulatory frameworks and economic stability, the region presents untapped potential for market expansion[1].

Latin America

Latin America represents a dynamic market, characterized by a diverse population, increasing healthcare expenditure, and a growing prevalence of allergic conditions. Market growth in this region is driven by factors such as urbanization, changing lifestyles, and expanding access to healthcare services[1].

Financial Trajectory

Revenue and Growth Projections

The global cetirizine hydrochloride 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 instance, 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[2].

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[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 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[2].

Sources

  1. Global Cetirizine Hydrochloride Market Growth, Share, Size, Trends and Forecast (2024 - 2030). Reanin.
  2. Budget Impact of Intravenous Cetirizine Hydrochloride for the Treatment of Acute Urticaria in the Emergency Department Setting. AHDB Online.
  3. Cetirizine Hydrochloride Market Size, Trends and Forecast to 2034. Prophecy Market Insights.
  4. Cetirizine Hydrochloride Market Key Players, Sales, Demand, Dynamic Forces and Forecast 2029. BioSpace.

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