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Last Updated: January 20, 2025

CLARITIN-D Drug Patent Profile


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When do Claritin-d patents expire, and when can generic versions of Claritin-d launch?

Claritin-d is a drug marketed by Bayer Healthcare Llc and is included in two NDAs.

The generic ingredient in CLARITIN-D is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.

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Summary for CLARITIN-D
US Patents:0
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Clinical Trials: 27
Drug Sales Revenues: Drug sales revenues for CLARITIN-D
What excipients (inactive ingredients) are in CLARITIN-D?CLARITIN-D excipients list
DailyMed Link:CLARITIN-D at DailyMed
Drug patent expirations by year for CLARITIN-D
Drug Sales Revenue Trends for CLARITIN-D

See drug sales revenues for CLARITIN-D

Recent Clinical Trials for CLARITIN-D

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

SponsorPhase
Andover Research Eye InstitutePhase 4
National Cancer Institute (NCI)Early Phase 1
Rutgers, The State University of New JerseyEarly Phase 1

See all CLARITIN-D clinical trials

Pharmacology for CLARITIN-D

US Patents and Regulatory Information for CLARITIN-D

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Bayer Healthcare Llc CLARITIN-D loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 019670-002 Nov 27, 2002 OTC Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bayer Healthcare Llc CLARITIN-D 24 HOUR loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 020470-002 Nov 27, 2002 OTC Yes Yes ⤷  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
Showing 1 to 2 of 2 entries

Expired US Patents for CLARITIN-D

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Bayer Healthcare Llc CLARITIN-D loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 019670-002 Nov 27, 2002 4,659,716*PED ⤷  Subscribe
Bayer Healthcare Llc CLARITIN-D loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 019670-002 Nov 27, 2002 4,863,931*PED ⤷  Subscribe
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 2 of 2 entries

International Patents for CLARITIN-D

See the table below for patents covering CLARITIN-D around the world.

CountryPatent NumberTitleEstimated Expiration
Australia 5702690 ⤷  Subscribe
Greece 3022966 ⤷  Subscribe
Ireland 59110 Process for preparing piperidylidene dihydro-dibenzo[a,d]cycloheptenes and aza derivatives thereof, compounds obtained by such process and the use of such compounds for preparing pharmaceutical compositions ⤷  Subscribe
Philippines 23821 AN IMPROVED PROCESS FOR THE PREPARATION OF PIPERIDYLIDENE DIHYDROBENZO(A,D)CYCLOHEPTENES AND AZADERIVATIVES THEREOF ⤷  Subscribe
South Korea 830006218 ⤷  Subscribe
World Intellectual Property Organization (WIPO) 9003375 ⤷  Subscribe
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 6 of 6 entries

Supplementary Protection Certificates for CLARITIN-D

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
1110543 08C0004 France ⤷  Subscribe PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
0152897 2001C/013 Belgium ⤷  Subscribe PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
0152897 C00152897/01 Switzerland ⤷  Subscribe FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0152897 SPC/GB01/012 United Kingdom ⤷  Subscribe PRODUCT NAME: DESLORATADINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/00/157/001-013 20010115; UK EU/1/00/158/001-013 20010115; UK EU/1/00/159/001-013 20010115; UK EU/1/00/160/001-013 20010115; UK EU/1/00/161/001-013 20010115
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 4 of 4 entries

Market Dynamics and Financial Trajectory for Claritin-D

Introduction to Claritin-D

Claritin-D, a combination of loratadine and pseudoephedrine, is a widely used medication for relieving symptoms of allergic rhinitis, including nasal congestion. Understanding the market dynamics and financial trajectory of Claritin-D is crucial for stakeholders in the pharmaceutical industry.

Market Size and Forecast

The global Claritin market, which includes Claritin-D, was valued at USD 0.16 billion in 2023 and is projected to reach USD 0.26 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.67% during the forecast period of 2024-2031[1][3].

Key Drivers of the Market

Several factors drive the growth of the Claritin-D market:

Product Innovation

Continuous research and development lead to novel formulations, such as extended-release variants and combination medicines, which appeal to consumers seeking improved convenience and efficacy[1].

Alterations in Lifestyle Factors

Urbanization and increased exposure to allergens like pollen, dust mites, and pet dander result in higher demand for allergy treatments[1].

Seasonal Demand

Seasonal allergies, particularly in spring and autumn, increase the demand for allergy relief medicines like Claritin-D[1].

Promotions and Marketing

Effective marketing techniques, including commercials and promotions, enhance brand awareness and stimulate sales[1].

Global Expansion

The expansion of Claritin-D into new markets and regions increases its consumer base and potential revenue[1].

Challenges and Constraints

Despite the growth drivers, the Claritin-D market faces several challenges:

Competition from Generic Brands

The presence of generic loratadine products at lower prices can constrain the market share of branded Claritin-D, impacting profitability[1].

Market Saturation

The presence of numerous established antihistamine medicines can lead to market saturation, complicating Claritin-D’s efforts to sustain growth[1].

Adverse Effects and Consumer Reservations

Some consumers may be reluctant to use antihistamines due to potential side effects, although Claritin-D is known for being non-drowsy[1].

Regulatory Challenges

Changes in legislation or constraints on advertising and marketing can influence the promotion and sale of Claritin-D[1].

Economic Factors

Economic recessions or fluctuations can impact consumer spending on healthcare products, including allergy medications[1].

Changes in Consumer Preferences

Increasing trends towards natural and holistic health treatments may prompt customers to seek alternatives to traditional drugs[1].

Geographical Segmentation

The Claritin-D market is segmented geographically into several key regions:

North America

North America, particularly the United States and Canada, has significant market penetration due to strong brand recognition and high prevalence of allergic conditions[1].

Europe

Europe, with countries like Germany and the UK, shows substantial demand driven by rising pollen levels and increased awareness about allergic rhinitis[1].

Asia-Pacific

The Asia-Pacific region is emerging as a significant market due to a growing population, urbanization, and higher disposable income, leading to increased healthcare spending and awareness of allergy-related products[1].

Latin America and Middle East & Africa

Latin America is witnessing a gradual rise in acceptance and demand for allergy medications, while the Middle East and Africa present unique challenges and opportunities due to varying healthcare infrastructure[1].

Distribution Channels

The distribution of Claritin-D is facilitated through various channels:

Online Retail

Online retail has emerged as a dynamic sub-segment, experiencing significant growth due to increasing digital penetration and the convenience of home delivery[1].

Health Stores

Health stores, focusing on natural and over-the-counter remedies, cater to health-conscious consumers seeking specialized products and personalized service[1].

Efficacy and Clinical Trials

Claritin-D has been shown to provide significant relief for patients with allergic rhinitis:

Onset of Action

Claritin-D starts to work in as little as 30 minutes, providing relief from nasal congestion and runny nose more effectively than some other treatments like Flonase[2][5].

Clinical Studies

In clinical trials, Claritin-D provided significantly greater relief of nasal congestion and improved nasal airflow compared to placebo and other treatments like Flonase[2].

Regulatory and Advertising Issues

The advertising claims for Claritin-D have faced regulatory scrutiny:

National Advertising Review Board (NARB) Recommendations

The NARB recommended that Bayer modify or discontinue certain claims, including the assertion that "nothing works faster than Claritin-D," due to insufficient evidence. However, the claim that Claritin-D starts to work in 30 minutes was supported, albeit with the recommendation to qualify it as "in as little as" 30 minutes[5].

Key Players

The major players in the Claritin market include:

Bayer AG

Bayer AG is the primary manufacturer of Claritin-D and plays a significant role in the market.

Other Key Players

Other major players include Sanofi, Pfizer, Johnson & Johnson, and Merck[1].

Impact of External Factors

External factors such as the COVID-19 pandemic have influenced the market:

COVID-19 Impact

The COVID-19 pandemic had a significant impact on the healthcare sector, including the loratadine market. Studies examined the effectiveness of loratadine in COVID-19 treatments, which indirectly affected the market dynamics[4].

Financial Trajectory

The financial trajectory of Claritin-D is positive, driven by the growing demand for allergy treatments:

Revenue Growth

The market is expected to grow from USD 0.16 billion in 2023 to USD 0.26 billion by 2031, with a CAGR of 5.67%[1][3].

Market Penetration

Strong brand recognition, effective marketing, and expansion into new markets contribute to the financial growth of Claritin-D[1].

Key Takeaways

  • The Claritin-D market is projected to grow at a CAGR of 5.67% from 2023 to 2031.
  • Key drivers include product innovation, lifestyle changes, seasonal demand, and effective marketing.
  • Challenges such as competition from generics, market saturation, and regulatory issues must be addressed.
  • Geographical segmentation highlights North America and Europe as significant markets, with Asia-Pacific emerging as a key region.
  • Claritin-D's efficacy is supported by clinical trials, and regulatory compliance is crucial for advertising claims.

Frequently Asked Questions

What is the projected market size of Claritin-D by 2031?

The global Claritin market, including Claritin-D, is expected to reach USD 0.26 billion by 2031[1][3].

What is the CAGR of the Claritin-D market?

The Claritin-D market is expected to exhibit a CAGR of 5.67% during the forecast period[1][3].

What are the main drivers of the Claritin-D market?

The main drivers include product innovation, alterations in lifestyle factors, seasonal demand, promotions and marketing, and global expansion[1].

Which regions are the most significant for the Claritin-D market?

North America, Europe, and the Asia-Pacific region are the most significant markets for Claritin-D[1].

How quickly does Claritin-D start to work?

Claritin-D starts to work in as little as 30 minutes, providing relief from nasal congestion and runny nose[2][5].

Sources:

  1. Verified Market Research: Claritin Market Size, Share, Growth, Trends & Forecast.
  2. Claritin: Claritin-D® Efficacy.
  3. Business Research Insights: Claritin Market Size, Share Growth and Forecast Till 2032.
  4. Mordor Intelligence: Loratadine Market - Size, Analysis, Industry Share & Growth.
  5. BBB Programs: NARB Panel Recommends Bayer Modify, Discontinue Certain Claims for Claritin-D.

More… ↓

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