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Last Updated: April 21, 2025

TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES Drug Patent Profile


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Which patents cover Triprolidine And Pseudoephedrine Hydrochlorides, and what generic alternatives are available?

Triprolidine And Pseudoephedrine Hydrochlorides is a drug marketed by Kv Pharm and Cenci and is included in three NDAs.

The generic ingredient in TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES is codeine phosphate; pseudoephedrine hydrochloride; triprolidine hydrochloride. There are nineteen drug master file entries for this compound. Additional details are available on the codeine phosphate; pseudoephedrine hydrochloride; triprolidine hydrochloride profile page.

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Summary for TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES
Drug patent expirations by year for TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES

US Patents and Regulatory Information for TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Kv Pharm TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES pseudoephedrine hydrochloride; triprolidine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 071798-001 Mar 16, 1989 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Kv Pharm TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES pseudoephedrine hydrochloride; triprolidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 072758-001 Nov 25, 1991 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Cenci TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES W/ CODEINE codeine phosphate; pseudoephedrine hydrochloride; triprolidine hydrochloride SYRUP;ORAL 089018-001 Jul 23, 1986 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>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 3 of 3 entries

Market Dynamics and Financial Trajectory for Triprolidine and Pseudoephedrine Hydrochlorides

Introduction

Triprolidine and pseudoephedrine hydrochlorides are commonly used in combination to treat symptoms associated with allergies, the common cold, and sinus congestion. Understanding the market dynamics and financial trajectory of these medications is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Overview

The market for over-the-counter (OTC) and prescription medications targeting cold, allergy, and sinus symptoms is highly competitive and dynamic. Here are some key points to consider:

Demand and Consumer Behavior

  • The demand for cold and allergy medications is seasonal, with peak sales typically occurring during the fall and spring when allergy seasons are at their highest[5].
  • Consumer behavior is influenced by the availability of generic and brand-name options, as well as the presence of alternative treatments such as natural remedies and prescription medications.

Product Offerings

  • Triprolidine and pseudoephedrine are often combined with other active ingredients like codeine, acetaminophen, and dextromethorphan to create multi-symptom relief products[5].
  • Various formulations, including syrups, tablets, and capsules, cater to different patient preferences and needs.

Competitive Landscape

The competitive landscape for triprolidine and pseudoephedrine hydrochlorides is characterized by:

Brand and Generic Competition

  • Several brand-name products, such as Sudafed, Claritin-D, and Allegra-D, dominate the market. However, generic versions are also widely available, which can impact pricing and market share[4][5].

Market Players

  • Major pharmaceutical companies like Johnson & Johnson, Pfizer, and Sanofi, as well as generic manufacturers like Teva and Mylan, are key players in this market.
  • Smaller companies and regional players also contribute to the market, especially with niche or specialty products.

Financial Trajectory

Revenue Trends

  • The revenue from triprolidine and pseudoephedrine hydrochlorides is influenced by seasonal demand and the overall health of the economy. During economic downturns, consumers may opt for more affordable generic options, affecting brand-name sales.
  • According to industry reports, the global market for cold, cough, and allergy medications has seen steady growth, driven by increasing healthcare spending and a growing population[5].

Pricing Strategies

  • Pricing is a critical factor in this market. Generic versions of triprolidine and pseudoephedrine hydrochlorides are generally cheaper than brand-name products, which can lead to price competition and erosion of brand-name market share.
  • Companies often employ pricing strategies such as discounts, promotions, and loyalty programs to maintain market share.

Cost Structure

  • The cost structure for these medications includes research and development (R&D) expenses, manufacturing costs, marketing expenditures, and regulatory compliance costs.
  • Generic manufacturers typically have lower R&D costs since they do not bear the initial development expenses of the brand-name products.

Regulatory Environment

Approval and Compliance

  • Regulatory approvals play a crucial role in the market dynamics. For example, the FDA's approval process for new formulations or combinations of triprolidine and pseudoephedrine hydrochlorides can significantly impact market entry and competition[1].
  • Compliance with safety and efficacy standards is mandatory, and any adverse effects or safety concerns can lead to recalls or changes in labeling, affecting sales.

Safety and Efficacy

  • The safety profile of triprolidine and pseudoephedrine hydrochlorides is well-documented. However, adverse effects such as sedation, anticholinergic effects, and cardiovascular issues can influence prescribing patterns and consumer choice[2][4].

Pharmacokinetics and Pharmacodynamics

Bioavailability and Metabolism

  • The bioavailability and metabolism of triprolidine and pseudoephedrine hydrochlorides are important factors in their efficacy. Triprolidine is rapidly absorbed and has a half-life of 4 to 6 hours, while pseudoephedrine is also quickly absorbed and has a half-life of approximately 6 hours[2][3][4].

Mechanism of Action

  • Triprolidine acts as an antihistamine by blocking histamine H1 receptors, while pseudoephedrine is an alpha and beta adrenergic agonist that reduces nasal congestion by narrowing blood vessels[2][4].

Market Segmentation

Demographics

  • The market for triprolidine and pseudoephedrine hydrochlorides can be segmented by demographics such as age, gender, and geographic location. For instance, children and older adults may require different formulations or dosages.
  • Women may experience different pharmacokinetic profiles compared to men, as seen in studies on triprolidine[3].

Therapeutic Uses

  • These medications are used for various therapeutic purposes, including relief from cold and allergy symptoms, cough suppression, and decongestion. The specific use can influence the formulation and dosage.

Future Outlook

Emerging Trends

  • The trend towards personalized medicine and the development of new delivery systems (e.g., nasal sprays, extended-release formulations) could shape the future market for triprolidine and pseudoephedrine hydrochlorides.
  • Increased focus on safety and efficacy, driven by regulatory bodies and consumer demand, will continue to influence product development and marketing strategies.

Challenges and Opportunities

  • Challenges include competition from new entrants, regulatory changes, and shifts in consumer preferences towards natural or alternative treatments.
  • Opportunities exist in expanding into new markets, particularly in regions with growing healthcare needs and increasing disposable incomes.

Key Takeaways

  • The market for triprolidine and pseudoephedrine hydrochlorides is driven by seasonal demand and influenced by brand and generic competition.
  • Regulatory approvals and compliance are critical for market entry and maintenance.
  • Understanding pharmacokinetics, pharmacodynamics, and safety profiles is essential for product development and marketing.
  • Emerging trends and demographic segmentation offer opportunities for growth and innovation.

FAQs

What are the common uses of triprolidine and pseudoephedrine hydrochlorides?

Triprolidine and pseudoephedrine hydrochlorides are commonly used to relieve symptoms of allergies, the common cold, and sinus congestion, including cough, sneezing, itchy or runny nose, and nasal congestion[5].

How do triprolidine and pseudoephedrine hydrochlorides work?

Triprolidine works by blocking histamine H1 receptors to prevent allergic symptoms, while pseudoephedrine acts as a decongestant by narrowing blood vessels and reducing blood flow to the nasal passage[2][4].

What are the potential side effects of triprolidine and pseudoephedrine hydrochlorides?

Potential side effects include sedation, anticholinergic effects, and cardiovascular issues. The safety profile can vary between individuals, with women sometimes experiencing different adverse effects compared to men[2][3][4].

Are there any regulatory considerations for these medications?

Yes, regulatory approvals and compliance with safety and efficacy standards are mandatory. Any adverse effects or safety concerns can lead to recalls or changes in labeling, affecting sales[1].

What is the future outlook for the market of triprolidine and pseudoephedrine hydrochlorides?

The future outlook includes emerging trends such as personalized medicine and new delivery systems, as well as challenges from competition and regulatory changes. Opportunities exist in expanding into new markets and addressing growing healthcare needs[5].

Sources

  1. FDA NDA 202-245: Clinical Review of Codeine Sulfate Oral Solution.
  2. DrugBank: Triprolidine - Uses, Interactions, Mechanism of Action.
  3. PubMed: Bioavailability of Triprolidine as a Single Agent or in Combination.
  4. DrugBank: Pseudoephedrine - Uses, Interactions, Mechanism of Action.
  5. Mayo Clinic: Triprolidine, pseudoephedrine, and codeine (oral route).

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