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Last Updated: December 22, 2024

AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE - Generic Drug Details


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What are the generic sources for azatadine maleate; pseudoephedrine sulfate and what is the scope of freedom to operate?

Azatadine maleate; pseudoephedrine sulfate is the generic ingredient in one branded drug marketed by Schering and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
DailyMed Link:AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE at DailyMed

US Patents and Regulatory Information for AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Schering TRINALIN azatadine maleate; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 018506-001 Mar 23, 1982 DISCN 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

Expired US Patents for AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Schering TRINALIN azatadine maleate; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 018506-001 Mar 23, 1982 ⤷  Subscribe ⤷  Subscribe
Schering TRINALIN azatadine maleate; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 018506-001 Mar 23, 1982 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Azatadine Maleate and Pseudoephedrine Sulfate

Introduction

Azatadine maleate and pseudoephedrine sulfate are components of a combination drug used to treat the symptoms of seasonal allergic rhinitis. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Demand

The demand for antihistamines and decongestants is driven by the prevalence of allergic rhinitis, which affects a significant portion of the population worldwide. Seasonal allergic rhinitis, in particular, has a high incidence rate, making drugs like azatadine maleate and pseudoephedrine sulfate consistently in demand.

Efficacy and Safety

Studies have shown that the combination of azatadine maleate and pseudoephedrine sulfate is highly effective in alleviating the symptoms of seasonal allergic rhinitis. A double-blind study revealed that 74% of patients administered this combination drug showed marked improvement, compared to only 29% of patients receiving a placebo[1].

Competitive Landscape

The market for antihistamines and decongestants is competitive, with various other drugs available, such as olopatadine HCl nasal spray and azelastine HCl nasal spray. These alternatives also demonstrate high efficacy and safety profiles, making the market highly competitive[2].

Regulatory Environment

Regulatory approvals and safety concerns play a significant role in the market dynamics of pharmaceuticals. For instance, the reformulation of olopatadine nasal spray to address safety concerns such as nasal septal perforations highlights the importance of regulatory compliance[4].

Financial Performance

The financial performance of drugs like azatadine maleate and pseudoephedrine sulfate can be influenced by several factors, including prescription rates, insurance coverage, and pricing strategies. Given the high efficacy and safety profile, these drugs are likely to maintain a stable market share and generate consistent revenue.

Prescription Trends

Prescription trends indicate that combination drugs like azatadine maleate and pseudoephedrine sulfate are preferred by healthcare providers due to their comprehensive symptom relief. This preference translates into steady sales and revenue.

Pricing Strategies

Pricing strategies are critical in the pharmaceutical industry. The cost-effectiveness of azatadine maleate and pseudoephedrine sulfate, especially when compared to newer, more expensive alternatives, can influence market share. Competitive pricing can help maintain or increase market share.

Insurance Coverage

Insurance coverage is a significant factor in the financial trajectory of pharmaceuticals. Drugs that are widely covered by insurance plans are more likely to be prescribed and used, thereby impacting sales positively.

Side Effects and Safety Concerns

While azatadine maleate and pseudoephedrine sulfate have a favorable safety profile with mild and transient adverse reactions, other antihistamines have raised concerns. For example, terfenadine has been associated with serious cardiac side effects, leading to its ban in many countries[3]. The absence of such severe side effects in azatadine maleate and pseudoephedrine sulfate contributes to their market stability.

Market Segmentation

The market for antihistamines and decongestants can be segmented based on age, geographic location, and the type of allergy. Azatadine maleate and pseudoephedrine sulfate are effective across various segments, particularly in adults and children suffering from seasonal allergic rhinitis.

Innovation and R&D

Continuous innovation and research are essential for maintaining market position. While azatadine maleate and pseudoephedrine sulfate are established drugs, ongoing research into new antihistamines and combination therapies can impact their market share. For instance, the development of nasal antihistamines like olopatadine HCl has introduced new competition[2].

Global Market

The global market for antihistamines and decongestants is expansive, with varying demand across different regions. The prevalence of allergic rhinitis and regulatory environments in different countries can influence the financial trajectory of these drugs.

Consumer Preferences

Consumer preferences play a crucial role in the market dynamics. Patients often prefer drugs that offer quick relief and minimal side effects. The combination of azatadine maleate and pseudoephedrine sulfate meets these criteria, contributing to its market appeal.

Key Takeaways

  • High Efficacy: Azatadine maleate and pseudoephedrine sulfate are highly effective in treating seasonal allergic rhinitis.
  • Competitive Market: The market is competitive with other effective antihistamines and decongestants.
  • Regulatory Compliance: Regulatory approvals and safety concerns are critical.
  • Financial Stability: The drug is likely to maintain a stable market share and generate consistent revenue.
  • Pricing and Insurance: Competitive pricing and wide insurance coverage are essential for market success.

FAQs

Q: What are the primary components of the drug used to treat seasonal allergic rhinitis?

A: The primary components are azatadine maleate, an antihistamine, and pseudoephedrine sulfate, a decongestant.

Q: How effective is the combination of azatadine maleate and pseudoephedrine sulfate?

A: Studies have shown that 74% of patients administered this combination drug showed marked improvement in symptoms, compared to 29% of patients receiving a placebo[1].

Q: What are the common side effects of azatadine maleate and pseudoephedrine sulfate?

A: The side effects are generally mild and transient, including adverse reactions such as headache and fatigue[1].

Q: How does the market for azatadine maleate and pseudoephedrine sulfate compare to other antihistamines?

A: The market is competitive, with other effective antihistamines like olopatadine HCl nasal spray and azelastine HCl nasal spray available[2].

Q: What factors influence the financial performance of azatadine maleate and pseudoephedrine sulfate?

A: Factors include prescription rates, insurance coverage, pricing strategies, and regulatory compliance.

Cited Sources

  1. Azatadine maleate/pseudoephedrine sulfate repetabs ... - PubMed
  2. 21-861s000 - accessdata.fda.gov
  3. antihistaminic drugs modify: Topics by Science.gov
  4. Clinical Review - accessdata.fda.gov
  5. azatadine - PharmGKB

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