Loratadine; pseudoephedrine sulfate - Generic Drug Details

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

Loratadine; pseudoephedrine sulfate is the generic ingredient in three branded drugs marketed by Bayer Healthcare Llc, Bionpharma, Heritage Pharma, P And L, Perrigo Pharma Intl, and Sun Pharm Inds Ltd, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-one suppliers are listed for this compound.

Summary for loratadine; pseudoephedrine sulfate

US Patents:	0
Tradenames:	3
Applicants:	6
NDAs:	8
Finished Product Suppliers / Packagers:	31
Clinical Trials:	6
DailyMed Link:	loratadine; pseudoephedrine sulfate at DailyMed

Recent Clinical Trials for loratadine; pseudoephedrine sulfate

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

Sponsor	Phase
Bayer	Phase 1
Bayer	Phase 4
Azidus Brasil	Phase 3

See all loratadine; pseudoephedrine sulfate clinical trials

Pharmacology for loratadine; pseudoephedrine sulfate

Drug Class	alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists

Anatomical Therapeutic Chemical (ATC) Classes for loratadine; pseudoephedrine sulfate

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01BA	Sympathomimetics
R01B	NASAL DECONGESTANTS FOR SYSTEMIC USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03CA	Alpha- and beta-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

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

S01FB	Sympathomimetics excl. antiglaucoma preparations
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for loratadine; pseudoephedrine sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Heritage Pharma	LORATADINE AND PSEUDOEPHEDRINE SULFATE	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	076208-001	Jan 28, 2004		DISCN	No	No
P And L	LORATADINE AND PSEUDOEPHEDRINE SULFATE	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	075706-001	Feb 21, 2003		OTC	No	No
Bayer Healthcare Llc	CLARITIN-D	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	019670-002	Nov 27, 2002		OTC	Yes	Yes
Perrigo Pharma Intl	LORATADINE AND PSEUDOEPHEDRINE SULFATE	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	075989-001	Mar 4, 2004		OTC	No	No
Bionpharma	LORATADINE AND PSEUDOEPHEDRINE SULFATE	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	218017-001	May 14, 2024		OTC	No	No
Perrigo Pharma Intl	LORATADINE AND PSEUDOEPHEDRINE SULFATE	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	076050-001	Jan 30, 2003		OTC	No	No

Expired US Patents for loratadine; pseudoephedrine sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Healthcare Llc	CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470-002	Nov 27, 2002	5,314,697*PED
Bayer Healthcare Llc	CLARITIN-D	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	019670-002	Nov 27, 2002	4,659,716*PED
Bayer Healthcare Llc	CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470-002	Nov 27, 2002	4,863,931*PED
Bayer Healthcare Llc	CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470-002	Nov 27, 2002	4,659,716*PED
Bayer Healthcare Llc	CLARITIN-D	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	019670-002	Nov 27, 2002	4,863,931*PED

Loratadine; pseudoephedrine sulfate Market Analysis and Financial Projection Experimental

Loratadine and Pseudoephedrine Sulfate Market Dynamics and Financial Trajectory

Market Overview

The global market for loratadine and pseudoephedrine sulfate, commonly used in the treatment of allergic rhinitis and nasal congestion, is characterized by several key dynamics that influence its growth and financial trajectory.

Market Size and Growth

As of 2023, the global loratadine market was valued at USD 153.4 million and is projected to grow at a compound annual growth rate (CAGR) of 2.9% from 2024 to 2030[1]. This growth is driven by the high prevalence of allergies worldwide, changing lifestyles, and a favorable regulatory landscape.

Drivers of Market Growth

High Prevalence of Allergies

The global prevalence of allergic rhinitis is estimated to be between 10% and 30% worldwide, according to the American Academy of Allergy, Asthma & Immunology. This high prevalence rate significantly contributes to the demand for antihistamines like loratadine[1].

Increased Focus on Respiratory Health

The COVID-19 pandemic has heightened awareness regarding respiratory health, leading to increased demand for medications that manage allergic conditions. Loratadine, being a non-drowsy antihistamine, has seen a surge in demand due to its effectiveness and patient preference[1].

Changing Allergen Exposure

Changes in allergens and exposure patterns, such as increased indoor allergies from dust mites and pet dander, have also boosted the demand for loratadine[1].

Market Segmentation

By Grade Type

The market is segmented into USP Standard Grade, EP Standard Grade, Medicine Standard Grade, and others. The USP standard grade segment held the largest market share in 2023 due to its emphasis on regulatory compliance and quality standards[1].

By Dosage Form

The market is segmented into tablets, capsules, syrup, and others. The tablets segment dominated the market in 2023 due to patient convenience, ease of administration, high availability, and longer shelf life[1].

By 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 during the forecast period due to the large availability and accessibility of products, affordable pricing, and integration with telemedicine services[1].

Regional Analysis

North America

North America dominated the market share in 2023, driven by the high disease burden and the strong presence of several manufacturers. The increasing prevalence of seasonal and perennial allergies in this region is expected to propel market growth[1].

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 of allergic ailments, a rising geriatric population prone to allergic conditions, and the increasing prevalence of lifestyle diseases[1].

Key Players and Market Strategies

The loratadine market is highly fragmented and competitive, with key players such as Bayer AG, Morepen Laboratories Ltd, Cadila Pharmaceuticals, Pfizer Inc., Viatris Inc., Sun Pharmaceutical Industries Limited, and Perrigo Company PLC. These companies are focusing on new product developments, mergers and acquisitions, and strategic alliances to expand their market share.

For instance, in February 2022, Morepen Laboratories Ltd. received FDA approval for its generic anti-allergy drug Fexofinadine Hydrochloride, which has strengthened its product portfolio including loratadine[1].

Pharmacokinetics and Safety

Pharmacokinetic Profiles

Studies have shown that loratadine and its active metabolite, descarboethoxyloratadine (DCL), have favorable pharmacokinetic profiles. A study comparing once-daily (QD) and twice-daily (BID) formulations of loratadine and pseudoephedrine found that both regimens were safe and well-tolerated, with the QD formulation showing higher plasma concentrations of loratadine and DCL on day 1 and equivalent AUC0-24 values following multiple dosing[2].

Safety and Regulatory Compliance

Loratadine and pseudoephedrine-containing products have been evaluated for their safety and efficacy. A referral procedure initiated by Sweden in 2002 to assess the risk of hypospadia associated with loratadine use during pregnancy concluded that the benefit/risk profile of these products remains unchanged, and their marketing authorizations were maintained[4].

Financial Trajectory

Revenue Growth

The market's revenue growth is expected to be steady, driven by the increasing demand for antihistamines and the expanding online pharmacy segment. The integration of online pharmacy platforms with telemedicine services is anticipated to provide significant growth opportunities[1].

Investment and Innovation

Market participants are investing in new product developments and strategic alliances to gain market share. This includes approvals for generic versions of related drugs, which can expand their product portfolios and attract more customers[1].

Impact of COVID-19

The COVID-19 pandemic had a moderate impact on the loratadine market. While it disrupted supply chains and healthcare services, it also heightened awareness about respiratory health and increased the demand for antihistamines like loratadine. Studies have even explored the potential of loratadine in treating COVID-19 symptoms, further boosting its market relevance[3].

Key Takeaways

• The global loratadine market is valued at USD 153.4 million as of 2023 and is expected to grow at a CAGR of 2.9% from 2024 to 2030.
• High prevalence of allergies, increased focus on respiratory health, and changing allergen exposure patterns drive market growth.
• The market is segmented by grade type, dosage form, and end-use, with the USP standard grade and tablets segments dominating.
• North America is the largest market, while the Asia Pacific region is expected to grow the fastest.
• Key players are focusing on new product developments and strategic alliances.
• The pharmacokinetic profiles of loratadine and pseudoephedrine are favorable, and the products are safe and well-tolerated.

FAQs

Q: What is the current market size of the loratadine market?

The global loratadine market was valued at USD 153.4 million in 2023[1].

Q: What is the expected CAGR of the loratadine market from 2024 to 2030?

The loratadine market is expected to grow at a CAGR of 2.9% from 2024 to 2030[1].

Q: Which region is expected to witness the fastest CAGR in the loratadine market?

The Asia Pacific region is predicted to witness the fastest CAGR over the forecast period[1].

Q: What are the key drivers of the loratadine market growth?

Key drivers include the high prevalence of allergies, increased focus on respiratory health, and changing allergen exposure patterns[1].

Q: Which dosage form dominates the loratadine market?

The tablets segment dominates the market due to patient convenience, ease of administration, and longer shelf life[1].

Sources

1. Grand View Research: Loratadine Market Size, Share, Growth, Trends Report, 2030.
2. PubMed: Pharmacokinetics of loratadine and pseudoephedrine following single and multiple doses.
3. Mordor Intelligence: Loratadine Market - Size, Analysis, Industry Share & Growth.
4. European Medicines Agency: Loratadine and pseudoephedrine - referral.
5. FDA: Draft Guidance on Loratadine/Pseudoephedrine Sulfate Recommended Feb 2019.