Loratadine - Generic Drug Details

What are the generic drug sources for loratadine and what is the scope of patent protection?

Loratadine is the generic ingredient in eleven branded drugs marketed by Bayer Healthcare Llc, Aurobindo Pharma, Bionpharma, Marksans Pharma, Strides Pharma, Taro, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Lannett Co Inc, Perrigo, Pharm Assoc, Ranbaxy Labs Ltd, Teva, Wockhardt Bio Ag, Perrigo Pharma Intl, Sun Pharm, Fdn Consumer, Actavis Labs Fl Inc, Glaxosmithkline, Rubicon, Tenshi, Sun Pharm Inds Ltd, Anda Repository, Apotex Inc, Granules, Hetero Labs Ltd V, Mylan, Norvium Bioscience, Pld Acquisitions Llc, Unique Pharm, Heritage Pharma, and P And L, and is included in fifty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-nine drug master file entries for loratadine. One hundred and fifty-five suppliers are listed for this compound.

Summary for loratadine

US Patents:	0
Tradenames:	11
Applicants:	32
NDAs:	53
Drug Master File Entries:	39
Finished Product Suppliers / Packagers:	155
Raw Ingredient (Bulk) Api Vendors:	148
Clinical Trials:	62
Patent Applications:	6,409
Drug Prices:	Drug price trends for loratadine
Drug Sales Revenues:	Drug sales revenues for loratadine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for loratadine
What excipients (inactive ingredients) are in loratadine?	loratadine excipients list
DailyMed Link:	loratadine at DailyMed

See drug prices for loratadine

See drug sales revenues for loratadine

Recent Clinical Trials for loratadine

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

Sponsor	Phase
AHS Cancer Control Alberta	Phase 2
King Edward Medical University	Phase 4
Ain Shams University	Phase 3

See all loratadine clinical trials

Medical Subject Heading (MeSH) Categories for loratadine

Anti-Allergic Agents

Antipruritics

Histamine H1 Antagonists, Non-Sedating

Anatomical Therapeutic Chemical (ATC) Classes for loratadine

R06AX	Other antihistamines for systemic use
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

US Patents and Regulatory Information for loratadine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taro	LORATADINE	loratadine	SYRUP;ORAL	076805-001	Aug 20, 2004		OTC	No	No
Ranbaxy Labs Ltd	LORATADINE	loratadine	SYRUP;ORAL	076529-001	Aug 20, 2004		DISCN	No	No
Marksans Pharma	LORATADINE	loratadine	CAPSULE;ORAL	206214-001	Sep 23, 2016		OTC	No	No
Perrigo Pharma Intl	LORATADINE	loratadine	TABLET, CHEWABLE;ORAL	210033-001	Jun 12, 2019		OTC	No	No
Pharm Assoc	LORATADINE	loratadine	SYRUP;ORAL	075565-001	Oct 5, 2004		DISCN	No	No

Expired US Patents for loratadine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Healthcare Llc	CLARITIN REDITABS	loratadine	TABLET, ORALLY DISINTEGRATING;ORAL	020704-002	Nov 27, 2002
Bayer Healthcare Llc	CLARITIN	loratadine	SYRUP;ORAL	020641-002	Nov 27, 2002
Bayer Healthcare Llc	CLARITIN	loratadine	TABLET;ORAL	019658-002	Nov 27, 2002
Bayer Healthcare Llc	CLARITIN	loratadine	TABLET;ORAL	019658-002	Nov 27, 2002
Bayer Healthcare Llc	CLARITIN REDITABS	loratadine	TABLET, ORALLY DISINTEGRATING;ORAL	020704-002	Nov 27, 2002

Loratadine Market Analysis and Financial Projection Experimental

Loratadine Market Dynamics and Financial Trajectory

Introduction to Loratadine

Loratadine, a non-drowsy antihistamine, is widely used to alleviate symptoms associated with allergies such as sneezing, itching, and runny nose. The drug has become a staple in the pharmaceutical industry, driven by increasing allergy cases and advancements in healthcare.

Global Market Size and Growth

The global loratadine market is experiencing significant growth, driven by several key factors. As of 2023, the market was valued at approximately USD 140.1 million to USD 163.2 billion, depending on the scope of the analysis[1][4][3].

• Forecast Period: 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, reaching a projected value of USD 181.2 million to USD 221.4 billion by the end of the forecast period[1][4][3].

Driving Factors

Several factors are contributing to the growth of the loratadine market:

Increasing Prevalence of Allergies

The global prevalence of allergic rhinitis and other allergic disorders is on the rise, affecting approximately 400 million people worldwide. This increase in allergy cases is a significant driver for the demand of loratadine[4].

Lifestyle Changes and Awareness

Changes in lifestyle and increasing awareness about allergy management are driving the adoption of antihistamine drugs like loratadine. Emerging markets, in particular, are seeing a rise in demand due to growing awareness and accessibility of these medications[1].

OTC Availability and Online Pharmacies

The ease of access to loratadine through over-the-counter (OTC) sales and the growth of online pharmacies have significantly expanded the market reach and accessibility of the drug. Online pharmacies offer diverse product offerings, affordable pricing, and convenience, further boosting demand[1][3].

Market Segmentation

The loratadine market is segmented into several key categories:

By Grade Type

The market is segmented into medicine standard grade, USP standard grade, EP standard grade, and others. The USP standard grade dominated the market in 2023, with a market share of around 34%, due to its strong focus on quality and safety[1].

By Dosage Form

The dosage form segment includes syrup, tablets, capsules, and others. Tablets dominated the market with a share of around 32% in 2023, driven by the strong presence of industry participants manufacturing loratadine tablets in various strengths[1].

By End-User

The end-user segment includes 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 integration of online pharmacy platforms with telemedicine and the large availability of products[3].

Regional Analysis

North America

North America emerged as the largest loratadine market, with a 36.5% market revenue share in 2023. The region's high disease burden and the strong presence of several manufacturers are anticipated to propel market growth. The U.S. loratadine market was valued at USD 43.9 million in 2023 and is expected to grow at a CAGR of 2.6% over the forecast years[1][4].

Asia Pacific

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

Europe

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

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. Strategies include partnerships, collaborations, and new product launches to enhance their product portfolios[4].

Challenges and Opportunities

Challenges

Despite the growth, the market faces challenges such as regulatory dynamics and the need for continuous innovation to stay competitive.

Opportunities

The integration of online pharmacy platforms with telemedicine and the increasing adoption of online platforms offer enormous growth opportunities. Additionally, emerging markets provide a significant potential for market expansion due to rising awareness and accessibility of antihistamine medications[3].

Key Takeaways

• Growing Demand: The loratadine market is driven by the increasing prevalence of allergies and the ease of access to OTC medications.
• Regional Dominance: North America is the largest market, but the Asia Pacific region is expected to grow at the fastest CAGR.
• Segmentation: The market is segmented by grade type, dosage form, and end-user, with online pharmacies showing the fastest growth.
• Competitive Landscape: The market is fragmented with key players focusing on innovation and strategic partnerships.
• Growth Potential: Emerging markets and the integration of online pharmacies with telemedicine offer significant growth opportunities.

FAQs

1. What is the projected value of the loratadine market by 2033? The loratadine market is expected to reach USD 221.4 billion by 2033[1].

2. What is the CAGR of the loratadine market from 2024 to 2033? The market is anticipated to grow at a CAGR of 2.8% to 3.1% from 2024 to 2033[1][4][3].

3. Which region dominates the loratadine market? North America emerged as the largest loratadine market, with a 36.5% market revenue share in 2023[1].

4. What are the key segments driving the loratadine market? The market is driven by segments such as USP standard grade, tablets, and online pharmacies[1][3].

5. What are the growth opportunities in the loratadine market? Emerging markets and the integration of online pharmacies with telemedicine offer significant growth opportunities[3].

Sources

1. The Brainy Insights - Loratadine Market Size, Share, Growth & Trends Report, 2033
2. Business Research Insights - Claritin Market Size, Share Growth and Forecast Till 2032
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. Data Intelo - Loratadine API Market Research Report 2032