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Last Updated: March 26, 2025

LORATADINE REDIDOSE Drug Patent Profile


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When do Loratadine Redidose patents expire, and what generic alternatives are available?

Loratadine Redidose is a drug marketed by Sun Pharm Inds Ltd and is included in one NDA.

The generic ingredient in LORATADINE REDIDOSE is loratadine. There are thirty-nine drug master file entries for this compound. One hundred and fifty-two suppliers are listed for this compound. Additional details are available on the loratadine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Loratadine Redidose

A generic version of LORATADINE REDIDOSE was approved as loratadine by PLD ACQUISITIONS LLC on January 21st, 2003.

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Summary for LORATADINE REDIDOSE
Drug patent expirations by year for LORATADINE REDIDOSE

US Patents and Regulatory Information for LORATADINE REDIDOSE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Sun Pharm Inds Ltd LORATADINE REDIDOSE loratadine TABLET, ORALLY DISINTEGRATING;ORAL 077153-001 Apr 11, 2007 OTC No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Loratadine Market Dynamics and Financial Trajectory

Introduction

Loratadine, a widely used antihistamine, has been a staple in the treatment of allergic conditions such as hay fever, allergic rhinitis, and urticaria. The market for loratadine is complex and influenced by various factors, including consumer demand, regulatory dynamics, and technological advancements.

Global Market Size and Growth

The global loratadine market has been valued at significant figures, with varying estimates depending on the source. As of 2023, the market was valued at around USD 140.1 million to USD 163.2 billion, highlighting the broad spectrum of market segments and analyses[3][4][1].

Forecasted Growth

The market is anticipated to grow at a Compound Annual Growth Rate (CAGR) of 2.8% to 3.1% from 2024 to 2032 or 2033. This growth is expected to result in a market size of USD 181.2 million to USD 221.4 billion by the end of the forecast period[3][4][1].

Key Drivers of Market Growth

Several factors are driving the growth of the loratadine market:

Increasing Prevalence of Allergic Disorders

The global prevalence of allergic disorders such as allergic rhinitis and urticaria is on the rise, affecting approximately 400 million people worldwide. This increasing prevalence significantly contributes to the demand for antihistamine medications like loratadine[4].

Self-Medication and OTC Availability

The trend towards self-medication and the availability of loratadine as an over-the-counter (OTC) medication have bolstered market expansion. This ease of access has made loratadine a preferred choice for managing allergy symptoms[3].

Innovations in Formulations and Delivery Systems

Pharmaceutical companies are continuously innovating and improving loratadine formulations, including advancements in delivery systems and combination therapies. These innovations enhance the effectiveness and convenience of the medication, driving market growth[3].

Expanding Healthcare Expenditure

Rising healthcare expenditure and increasing awareness about allergy management are fueling the demand for loratadine. This heightened awareness and willingness to spend on healthcare are positioning the market for sustained growth[3].

Regional Segmentation

The loratadine market is segmented into several regions, each with its own growth dynamics:

North America

North America emerged as the largest global loratadine market, with a significant market share of around 36.5% in 2023. The high disease burden and strong presence of several manufacturers in this region are anticipated to propel market growth[1][3].

Asia Pacific

The Asia Pacific region is predicted to witness the fastest CAGR over the forecast period. Factors such as rapidly growing awareness regarding allergic ailments, a rising geriatric population prone to allergic conditions, and the increasing prevalence of lifestyle diseases are driving the growth in this region[3].

Europe and Other Regions

Europe, particularly the UK, has also emerged as a key player in the global loratadine market, showcasing high growth potential. India is another market anticipated to witness lucrative growth between 2024 and 2032[4].

Market Segmentation by Grade Type

The loratadine market is segmented by grade type, with the USP standard grade dominating the market. This segment holds around 34% of the market share due to its strong focus on quality and safety rules, increasing customer preference and adoption rates[1].

Market Segmentation by Dosage Form

The dosage form segment is another critical aspect of the loratadine market. The tablets segment dominated the market, with a market share of around 32% in 2023. The strong presence of industry participants manufacturing loratadine tablets in various strengths will accelerate segment growth over the forecast period[1].

Market Segmentation by End-User

The loratadine market is also segmented by end-user, including hospital pharmacy, retail pharmacy, and online pharmacy. The online pharmacy segment is expected to grow at the fastest CAGR during the forecast period due to the upsurge in the adoption of online platforms, large availability, and integration with telemedicine services[3].

Impact of Rx-to-OTC Switch

The switch of loratadine from a prescription drug to an over-the-counter medication has had significant effects on the market. Studies have shown that this switch led to a substantial decrease in utilization and cost of all prescription drugs. Patients did not increase their utilization of other allergic rhinitis medications or medications for comorbid conditions, indicating a cost-effective transition[2].

Competitive Landscape

The loratadine market is fragmented, characterized by the presence of several pharmaceutical companies. Key market players are focused on developing improved treatments, such as longer-acting formulations and combination therapies. These companies engage in growth strategies like partnerships, collaborations, and new product launches to enhance their product portfolios[4].

Challenges and Pitfalls

Despite the growth potential, the loratadine market faces several challenges:

Regulatory Dynamics

Changes in regulatory policies can impact the market. For instance, the Rx-to-OTC switch, while cost-effective, requires careful management to ensure patient safety and adherence to quality standards[2].

Side Effects and Safety Concerns

Loratadine can cause side effects, some of which can be serious. Managing these side effects and ensuring patient safety is a continuous challenge for manufacturers and healthcare providers[5].

Market Competition

The fragmented nature of the market means that companies must constantly innovate and differentiate their products to maintain market share. This competition can drive innovation but also presents challenges in terms of pricing and market penetration[4].

Key Takeaways

  • The global loratadine market is expected to grow significantly, driven by increasing allergic disorders, self-medication trends, and innovations in formulations.
  • North America is the largest market, but the Asia Pacific region is expected to grow at the fastest CAGR.
  • The USP standard grade and tablets dosage form dominate their respective segments.
  • The online pharmacy segment is expected to grow rapidly due to increased adoption and integration with telemedicine.
  • The Rx-to-OTC switch has been cost-effective but requires careful management.

FAQs

What is the current market size of the loratadine market?

The current market size of the loratadine market varies by source, ranging from USD 140.1 million to USD 163.2 billion as of 2023[3][4][1].

What is the expected CAGR of the loratadine market from 2024 to 2033?

The loratadine market is expected to grow at a CAGR of 2.8% to 3.1% from 2024 to 2033[3][4][1].

Which region dominates the loratadine market?

North America dominates the loratadine market, holding around 36.5% of the global market share in 2023[1].

What are the key drivers of the loratadine market growth?

Key drivers include the increasing prevalence of allergic disorders, self-medication trends, innovations in formulations, and expanding healthcare expenditure[3][4].

What are the potential side effects of loratadine?

Loratadine can cause side effects such as headache, dry mouth, nosebleed, and serious reactions like rash, hives, and difficulty breathing[5].

Sources

  1. The Brainy Insights: Loratadine Market Size, Share, Growth & Trends Report, 2033.
  2. PubMed: The effect of the Rx-to-OTC switch of loratadine and ...
  3. Vision Research Reports: Loratadine Market Size Set To Hit USD 205.21 Mn By 2033.
  4. GMI Insights: Loratadine Market Size, Share & Growth Report, 2024 – 2032.
  5. MedlinePlus: Loratadine: MedlinePlus Drug Information.

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