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Last Updated: December 22, 2024

LORATADINE AND PSEUDOEPHEDRINE SULFATE Drug Patent Profile


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Which patents cover Loratadine And Pseudoephedrine Sulfate, and what generic alternatives are available?

Loratadine And Pseudoephedrine Sulfate is a drug marketed by Bionpharma, Heritage Pharma, P And L, Perrigo Pharma Intl, and Sun Pharm Inds Ltd. and is included in six NDAs.

The generic ingredient in LORATADINE AND PSEUDOEPHEDRINE SULFATE is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Loratadine And Pseudoephedrine Sulfate

A generic version of LORATADINE AND PSEUDOEPHEDRINE SULFATE was approved as loratadine; pseudoephedrine sulfate by PERRIGO PHARMA INTL on January 30th, 2003.

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  • What is the 5 year forecast for LORATADINE AND PSEUDOEPHEDRINE SULFATE?
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Summary for LORATADINE AND PSEUDOEPHEDRINE SULFATE
Drug patent expirations by year for LORATADINE AND PSEUDOEPHEDRINE SULFATE
Recent Clinical Trials for LORATADINE AND PSEUDOEPHEDRINE SULFATE

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

SponsorPhase
BayerPhase 1
BayerPhase 4
Azidus BrasilPhase 3

See all LORATADINE AND PSEUDOEPHEDRINE SULFATE clinical trials

Pharmacology for LORATADINE AND PSEUDOEPHEDRINE SULFATE

US Patents and Regulatory Information for LORATADINE AND PSEUDOEPHEDRINE SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bionpharma LORATADINE AND PSEUDOEPHEDRINE SULFATE loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 218017-001 May 14, 2024 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Perrigo Pharma Intl LORATADINE AND PSEUDOEPHEDRINE SULFATE loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 076050-001 Jan 30, 2003 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Heritage Pharma LORATADINE AND PSEUDOEPHEDRINE SULFATE loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 076208-001 Jan 28, 2004 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
P And L LORATADINE AND PSEUDOEPHEDRINE SULFATE loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 075706-001 Feb 21, 2003 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Inds Ltd LORATADINE AND PSEUDOEPHEDRINE SULFATE loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 076557-001 Sep 22, 2004 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Perrigo Pharma Intl LORATADINE AND PSEUDOEPHEDRINE SULFATE loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 075989-001 Mar 4, 2004 OTC No No ⤷  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

LORATADINE AND PSEUDOEPHEDRINE SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Loratadine and Pseudoephedrine Sulfate

Introduction to Loratadine and Pseudoephedrine Sulfate

Loratadine and pseudoephedrine sulfate is a combination medication used to treat allergies, nasal congestion, and sinus pressure. It combines an antihistamine (loratadine) and a decongestant (pseudoephedrine sulfate), making it a popular choice for managing seasonal and perennial allergies.

Market Overview

The global market for loratadine, and by extension loratadine and pseudoephedrine sulfate, is highly competitive and fragmented. Key players such as Bayer AG, Pfizer Inc., Cadila Pharmaceuticals, and Viatris Inc. dominate the market through various strategies including new product launches, product innovations, and geographical expansion[3].

Market Size and Growth

The loratadine market is expected to grow at a CAGR of 2% from 2022 to 2027. This growth is driven by increasing demand for over-the-counter (OTC) allergy medications and the expanding healthcare sector, particularly in regions like North America and the Asia-Pacific[3].

Regional Market Analysis

  • North America: This region is the largest market for loratadine and pseudoephedrine sulfate, driven by a high prevalence of allergies and a well-established healthcare infrastructure.
  • Asia-Pacific: This is the fastest-growing market, fueled by increasing awareness of allergy treatments and a growing middle class with higher disposable incomes[3].

Sales and Price Analysis

Global Sales

The sales of loratadine and pseudoephedrine sulfate are tracked globally and by major countries. Reports indicate that the sales data is crucial for market planning, market sizing, and competitive intelligence. For instance, a report by Research and Markets provides detailed sales analysis and forecasts until 2021, highlighting growth trends and sales forecasts by country[1].

Price Analysis

The unit price of loratadine and pseudoephedrine sulfate varies by country. This data is essential for pricing strategies, estimating patient shares, and developing patient forecast models. The report by Research and Markets also provides pricing data, which can be used to devise pricing strategies and estimate annual therapy costs[1].

Competitive Landscape

The market is highly competitive with several key players:

  • Bayer AG: Known for its brand Claritin D, which combines loratadine and pseudoephedrine sulfate.
  • Pfizer Inc.: Another major player with a significant presence in the allergy medication market.
  • Cadila Pharmaceuticals: An Indian pharmaceutical company that has a strong presence in the global market.
  • Viatris Inc.: A global healthcare company that offers a range of OTC and prescription medications, including allergy treatments[3].

Product Positioning and Branding

Brand Planning

Companies marketing loratadine and pseudoephedrine sulfate focus on strong brand planning to differentiate their products. For example, Claritin D by Bayer AG is a well-known brand that leverages its reputation for effectiveness in treating allergies and nasal congestion[1].

Product Innovations

Market players are continually innovating their products to stay competitive. This includes the development of extended-release formulations, such as the 12-hour and 24-hour extended-release tablets, which offer convenience and improved patient compliance[4][5].

Financial Trajectory

Revenue Growth

The revenue from loratadine and pseudoephedrine sulfate sales is expected to grow steadily over the forecast period, driven by increasing demand and expanding market reach. The COVID-19 pandemic, while disruptive, also highlighted the importance of antihistamines like loratadine in potential treatments, which could further boost market growth[3].

Market Sizing and Shares

Market sizing and share analysis are critical for understanding the financial trajectory. Reports indicate that the market is fragmented, but key players hold significant market shares. The competitive landscape is dynamic, with companies continually vying for market dominance through strategic initiatives[1][3].

Regulatory Environment

FDA Guidance

The FDA provides guidance on the development and approval of loratadine and pseudoephedrine sulfate products. For instance, the draft guidance on loratadine/pseudoephedrine sulfate recommends specific studies and dosages for approval, ensuring that products meet stringent safety and efficacy standards[2].

Adverse Events and Safety

Clinical Trials and Adverse Events

Clinical trials have shown that loratadine and pseudoephedrine sulfate are generally well-tolerated, with common adverse events including insomnia, dry mouth, and somnolence. However, there have been postmarketing reports of more serious adverse events such as mechanical upper gastrointestinal tract obstruction and esophageal perforation, particularly with extended-release formulations[4].

Market Trends and Outlook

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the healthcare sector, including the loratadine market. Studies examining the potential of loratadine in treating COVID-19 symptoms have contributed to increased interest and demand for antihistamines[3].

Geographical Expansion

Market players are focusing on geographical expansion to tap into growing markets, especially in the Asia-Pacific region. This expansion is driven by increasing awareness of allergy treatments and a growing consumer base[3].

Key Takeaways

  • The loratadine and pseudoephedrine sulfate market is expected to grow at a CAGR of 2% from 2022 to 2027.
  • North America is the largest market, while the Asia-Pacific region is the fastest-growing.
  • Key players like Bayer AG, Pfizer Inc., and Cadila Pharmaceuticals dominate the market.
  • The market is highly competitive, with a focus on product innovations and geographical expansion.
  • Regulatory guidance from the FDA ensures safety and efficacy standards are met.
  • Adverse events are generally mild, but serious cases have been reported with extended-release formulations.

FAQs

Q: What are the common uses of loratadine and pseudoephedrine sulfate?

A: Loratadine and pseudoephedrine sulfate are used to treat allergies, nasal congestion, and sinus pressure.

Q: Which region is the largest market for loratadine and pseudoephedrine sulfate?

A: North America is the largest market for loratadine and pseudoephedrine sulfate.

Q: What is the expected CAGR for the loratadine market from 2022 to 2027?

A: The loratadine market is expected to grow at a CAGR of 2% from 2022 to 2027.

Q: Who are the key players in the loratadine and pseudoephedrine sulfate market?

A: Key players include Bayer AG, Pfizer Inc., Cadila Pharmaceuticals, and Viatris Inc.

Q: What are the common adverse events associated with loratadine and pseudoephedrine sulfate?

A: Common adverse events include insomnia, dry mouth, and somnolence, with more serious events such as mechanical upper gastrointestinal tract obstruction and esophageal perforation reported in some cases.

Sources

  1. Research and Markets, "Global Loratadine / Pseudoephedrine Sales, Price Analysis, & Sales Forecast - 2017".
  2. FDA, "Draft Guidance on Loratadine/Pseudoephedrine Sulfate".
  3. Mordor Intelligence, "Loratadine Market - Size, Analysis, Industry Share & Growth".
  4. RxList, "Claritin D (Loratadine and Pseudoephedrine)".
  5. DailyMed, "LORATADINE AND PSEUDOEPHEDRINE SULFATE tablet, film coated, extended release".

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