CLINICAL TRIALS PROFILE FOR LORATADINE; PSEUDOEPHEDRINE SULFATE

All Clinical Trials for Loratadine; Pseudoephedrine Sulfate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00837915 ↗	Bioequivalnce Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fasting Conditions	Completed	Ranbaxy Laboratories Limited	N/A	2002-06-01	The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Schering (Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets, in a fully replicated design, under fasting conditions.
NCT00845546 ↗	Bioequivalence Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fed Conditions	Completed	Ranbaxy Laboratories Limited	N/A	2002-06-01	The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Schering (Claritin-D® 24 hour) 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets, in a fully replicated design, under fed conditions.
NCT01055756 ↗	Clinical Trial Of The Effectiveness Of The Product Cloratadd D (Loratadine + Pseudoephedrine Sulfate) Produced By The Laboratory EMS S/A, Compared To The Drug Claritin D Produced By Schering-Plough S/A, In Patients With Allergic Rhinitis	Withdrawn	Azidus Brasil	Phase 3	2010-01-01	The primary objective of this study is to evaluate the clinical efficacy of the drug Cloratadd D ® (loratadine + pseudoephedrine sulfate - EMS S/A) compared to the drug Claritin D ® (loratadine + pseudoephedrine sulfate - Schering Plough) in patients with allergic rhinitis by quantification of the scores of clinical parameters (signs and symptoms) and laboratory (nasal flow) down through time.
NCT03443843 ↗	A Study to Evaluate Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure	Completed	Bayer	Phase 4	2018-02-21	The purpose of the study is to evaluate changes in nasal airflow caused by loratadine 5 mg/pseudoephedrine sulfate 120 mg (Claritin D) tablet and fluticasone propionate 50 mcg per spray nasal spray (Flonase) in subjects suffering from nasal congestion and other allergy symptoms.
NCT03517930 ↗	A Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufacturers Under Fasted Conditions in Healthy Adult Subjects	Completed	Bayer	Phase 1	2018-04-17	To evaluate the bioequivalence of one extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer HealthCare LLC by SAG Manufacturing, S.L.U. Madrid, Spain (test treatment) to the extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer SA-NV by Schering-Plough Labo NV Heist (reference treatment) which is currently marketed in Europe.
NCT03517943 ↗	A Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufactuers Under Fed Conditions in Healthy Adult Subjects	Completed	Bayer	Phase 1	2018-04-24	To evaluate the bioequivalence of one extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer HealthCare LLC by SAG Manufacturing, S.L.U. Madrid, Spain (test treatment) to the extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer SA-NV by Schering- Plough Labo NV Heist (reference treatment) which is currently marketed in Europe.

Clinical Trial Conditions for Loratadine; Pseudoephedrine Sulfate

Condition Name

Condition Name for Loratadine; Pseudoephedrine Sulfate
Intervention	Trials
Clinical Pharmacology	2
Healthy	2
Allergic Rhinitis	1
Rhinitis, Allergic	1

Condition MeSH

Condition MeSH for Loratadine; Pseudoephedrine Sulfate
Intervention	Trials
Rhinitis	2
Malnutrition	2
Rhinitis, Allergic	2

Clinical Trial Locations for Loratadine; Pseudoephedrine Sulfate

Trials by Country

Trials by Country for Loratadine; Pseudoephedrine Sulfate
Location	Trials
Canada	3
United States	2
Brazil	1

Trials by US State

Trials by US State for Loratadine; Pseudoephedrine Sulfate
Location	Trials
New Jersey	2

Clinical Trial Progress for Loratadine; Pseudoephedrine Sulfate

Clinical Trial Phase

Clinical Trial Phase for Loratadine; Pseudoephedrine Sulfate
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 1	2

Clinical Trial Status

Clinical Trial Status for Loratadine; Pseudoephedrine Sulfate
Clinical Trial Phase	Trials
Completed	5
Withdrawn	1

Clinical Trial Sponsors for Loratadine; Pseudoephedrine Sulfate

Sponsor Name

Sponsor Name for Loratadine; Pseudoephedrine Sulfate
Sponsor	Trials
Bayer	3
Ranbaxy Laboratories Limited	2
Azidus Brasil	1

Sponsor Type

Sponsor Type for Loratadine; Pseudoephedrine Sulfate
Sponsor	Trials
Industry	6

Loratadine; Pseudoephedrine Sulfate: Clinical Trials, Market Analysis, and Projections

Introduction to Loratadine; Pseudoephedrine Sulfate

Loratadine and pseudoephedrine sulfate are commonly combined in medications like Claritin-D to treat allergic rhinitis and nasal congestion. Loratadine is an antihistamine, while pseudoephedrine is a decongestant. This combination is widely used for its efficacy in managing symptoms of allergies.

Clinical Trials Overview

Bioequivalence Studies

One notable clinical trial involves the evaluation of the bioequivalence of Claritin-D 12-Hour Extended Release tablets manufactured by different companies. This study, conducted by Bayer HealthCare LLC, compares the bioequivalence of loratadine 5 mg/pseudoephedrine sulfate 120 mg tablets produced by SAG Manufacturing, S.L.U. in Madrid, Spain, to those produced by Schering-Plough Labo NV in Heist, Belgium, which is the current reference treatment in Europe[1].

• Study Design: This is a randomized, crossover study involving healthy adult subjects aged 18 to 55 years.
• Inclusion Criteria: Healthy men or women with a body mass index (BMI) between 18.5 and 30.0 kg/m².
• Exclusion Criteria: Subjects with a history of hypersensitivity to loratadine or pseudoephedrine, severe allergies, or those who have consumed certain medications that could affect the study outcomes.

Pharmacokinetics

Another significant study focuses on the pharmacokinetics of loratadine and pseudoephedrine. This randomized, open-label, two-way crossover study in 24 healthy men evaluated the pharmacokinetic profiles of single and multiple doses of loratadine and pseudoephedrine in different formulations (once-daily and twice-daily)[3].

• Key Findings: The study showed that both formulations were safe and well-tolerated. The once-daily formulation had higher plasma concentrations of loratadine and its metabolite, descarboethoxyloratadine (DCL), compared to the twice-daily formulation. However, the area under the plasma concentration-time curve (AUC) for both formulations was equivalent.

Market Analysis

Global Market Size and Growth

The global loratadine market, which includes loratadine; pseudoephedrine sulfate combinations, was valued at USD 153.4 million in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 2.9% from 2024 to 2030. This growth is driven by the high prevalence of allergies worldwide, changing lifestyles, and a favorable regulatory landscape[5].

Sales and Price Analysis

A comprehensive report by Research and Markets provides detailed sales and price analysis of loratadine; pseudoephedrine sulfate worldwide. The report covers sales data by geography, including North America, Europe, Japan, BRIC countries, and Australia. It also forecasts sales until 2021 and provides unit prices by country, which is useful for market planning, competitive intelligence, and pricing strategies[2].

Market Segmentation

The loratadine market is segmented based on grade type, dosage form, and end-use.

• Grade Type: The USP standard grade segment held the largest market share in 2023 due to its emphasis on regulatory compliance and quality standards[5].
• Dosage Form: Tablets dominate the market due to their convenience, ease of administration, and high availability. Other forms include capsules and syrup[5].
• End-Use: The market is segmented into hospital pharmacy, retail pharmacy, and online pharmacy. The online pharmacy segment is expected to grow at the fastest CAGR due to increased adoption of online platforms and their integration with telemedicine services[5].

Regional Market

North America dominated the market share in 2023, driven by a high disease burden and the strong presence of several manufacturers. The Asia Pacific region is predicted to witness the fastest CAGR due to growing awareness of allergic ailments, a rising geriatric population, and increasing prevalence of lifestyle diseases[5].

Patent and Generic Landscape

Patent Expiration

The original patents for Claritin-D, which contains loratadine; pseudoephedrine sulfate, have expired. For example, the patent for the stable extended release oral dosage composition comprising loratadine and pseudoephedrine expired in 2012 and 2013[4].

Generic Versions

Several companies have introduced generic versions of loratadine; pseudoephedrine sulfate. These include Bionpharma, Heritage Pharma, P and L Development LLC, Perrigo Pharma International, and Sun Pharmaceutical Industries Ltd. These generics are available in various strengths, such as 5 mg/120 mg and 10 mg/240 mg, and are marketed as over-the-counter (OTC) products[4].

Key Takeaways

• Clinical Trials: Bioequivalence studies ensure that different manufacturers' products have similar efficacy and safety profiles.
• Market Growth: The global loratadine market is expected to grow at a CAGR of 2.9% from 2024 to 2030, driven by high allergy prevalence and favorable regulatory environments.
• Market Segmentation: The market is segmented by grade type, dosage form, and end-use, with tablets and online pharmacies showing significant growth potential.
• Regional Markets: North America and the Asia Pacific region are key markets, with the latter expected to grow rapidly.
• Generic Landscape: Multiple generic versions are available, indicating a competitive market post-patent expiration.

FAQs

What is the primary use of loratadine; pseudoephedrine sulfate?

Loratadine; pseudoephedrine sulfate is primarily used to treat allergic rhinitis and nasal congestion by combining an antihistamine (loratadine) and a decongestant (pseudoephedrine).

What is the current market size of the loratadine market?

The global loratadine market was valued at USD 153.4 million in 2023[5].

What is the expected growth rate of the loratadine market?

The loratadine market is expected to grow at a CAGR of 2.9% from 2024 to 2030[5].

Which region dominates the loratadine market?

North America currently dominates the loratadine market, but the Asia Pacific region is expected to grow at the fastest CAGR[5].

Are there generic versions of loratadine; pseudoephedrine sulfate available?

Yes, several companies have introduced generic versions of loratadine; pseudoephedrine sulfate in various strengths[4].

What are the common dosage forms of loratadine; pseudoephedrine sulfate?

The most common dosage form is tablets, but it is also available in capsules and syrup[5].

Sources

1. Clinical Pharmacology | Study 19625 | Bayer - Clinical Trials Explorer
2. Global Loratadine / Pseudoephedrine Sales, Price Analysis, & Sales Forecast - 2017
3. Pharmacokinetics of loratadine and pseudoephedrine following single and multiple doses in healthy men
4. Drug Patents containing Loratadine; Pseudoephedrine Sulfate
5. Loratadine Market Size, Share, Growth, Trends Report, 2030