Triprolidine hydrochloride - Generic Drug Details

What are the generic drug sources for triprolidine hydrochloride and what is the scope of freedom to operate?

Triprolidine hydrochloride is the generic ingredient in three branded drugs marketed by Glaxosmithkline, Usl Pharma, Alpharma Us Pharms, Halsey, Pharm Assoc, Vitarine, and Watson Labs, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for triprolidine hydrochloride.

Summary for triprolidine hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	7
NDAs:	8
Drug Master File Entries:	7
Raw Ingredient (Bulk) Api Vendors:	51
Patent Applications:	967
DailyMed Link:	triprolidine hydrochloride at DailyMed

Medical Subject Heading (MeSH) Categories for triprolidine hydrochloride

Anti-Allergic Agents

Histamine H1 Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for triprolidine hydrochloride

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

US Patents and Regulatory Information for triprolidine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	ACTIDIL	triprolidine hydrochloride	TABLET;ORAL	011110-002	Jul 1, 1983		DISCN	No	No
Usl Pharma	MYIDYL	triprolidine hydrochloride	SYRUP;ORAL	087963-001	Jan 18, 1983		DISCN	No	No
Alpharma Us Pharms	TRIPROLIDINE HYDROCHLORIDE	triprolidine hydrochloride	SYRUP;ORAL	085940-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Glaxosmithkline	ACTIDIL	triprolidine hydrochloride	SYRUP;ORAL	011496-002	Jul 1, 1983		DISCN	No	No
Pharm Assoc	TRIPROLIDINE HYDROCHLORIDE	triprolidine hydrochloride	SYRUP;ORAL	087514-001	Feb 10, 1982		DISCN	No	No
Vitarine	TRIPROLIDINE HYDROCHLORIDE	triprolidine hydrochloride	TABLET;ORAL	085610-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Triprolidine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Triprolidine Hydrochloride

Introduction

Triprolidine hydrochloride is a first-generation antihistamine widely used to relieve symptoms of allergic rhinitis, the common cold, and as a short-acting sedative. This article delves into the market dynamics and financial trajectory of triprolidine hydrochloride, providing insights into its market share, sales, demand forecast, and other key financial aspects.

Market Overview

The global market for triprolidine hydrochloride is part of the broader antihistamine market, which has seen steady growth due to increasing prevalence of allergies and common colds. Triprolidine is often combined with other ingredients like pseudoephedrine and guaifenesin in various cold and allergy medications[2][5].

Market Share and Ranking

Triprolidine hydrochloride holds a significant share in the antihistamine market, particularly in the segment of over-the-counter (OTC) and prescription medications for cold and allergy relief. Its market share is influenced by its widespread use in combination products and its effectiveness in relieving allergy symptoms[1][4].

Sales and Revenue

The sales of triprolidine hydrochloride are driven by the demand for cold and allergy medications. The global market has seen consistent sales volumes, with the drug being a staple in many pharmaceutical formulations. The revenue generated from triprolidine hydrochloride is substantial, given its inclusion in numerous brand-name and generic products[1][4].

Demand Forecast

The demand for triprolidine hydrochloride is expected to remain stable or see a slight increase over the forecast period of 2024-2030. This is due to the ongoing need for effective allergy and cold medications. Seasonal fluctuations in demand, particularly during peak allergy and cold seasons, also contribute to the overall market dynamics[1].

Competitive Landscape

The market for triprolidine hydrochloride is competitive, with several pharmaceutical companies producing and marketing products that contain this active ingredient. Key players include GlaxoSmithKline, Sterling Products, and Breckenridge Pharmaceutical, among others. The competitive landscape is characterized by a mix of brand-name and generic products, each vying for market share[2][5].

Pricing and Cost

The pricing of triprolidine hydrochloride varies depending on the formulation and the region. For example, a liquid formulation of triprolidine hydrochloride combined with other ingredients can cost around $0.15 per milliliter. The cost-effectiveness of the drug, especially in combination products, makes it a preferred choice for many consumers[2].

Product Formulations and Brand Names

Triprolidine hydrochloride is available in various formulations, including syrups, capsules, and liquid oral solutions. It is often combined with pseudoephedrine, dextromethorphan, and guaifenesin. Representative brand names include Actifed, Histex, and Triacin-C. These formulations cater to different patient needs and preferences[2][5].

Regulatory Environment

The regulatory environment for triprolidine hydrochloride is well-established, with the drug being approved for use in many countries. It is classified as a first-generation antihistamine and is subject to standard regulatory oversight. The drug's safety profile and efficacy have been well-documented, ensuring its continued approval for OTC and prescription use[2][5].

Safety and Side Effects

Triprolidine hydrochloride is generally safe when used as directed. However, it can cause side effects such as sedation, dizziness, dry mouth, and urinary retention. The drug has not been linked to clinically apparent liver injury, making it a safe option for short-term use[5].

Financial Performance

The financial performance of triprolidine hydrochloride is robust, driven by its widespread use and the consistent demand for cold and allergy medications. The drug's inclusion in various products ensures a steady revenue stream for pharmaceutical companies. Here is a snapshot of the financial performance:

• Revenue Growth: The revenue from triprolidine hydrochloride has shown steady growth over the years, driven by the increasing demand for cold and allergy medications.
• Market Size: The global market size for triprolidine hydrochloride is significant, with the drug being a key component in many pharmaceutical products.
• Profit Margins: The profit margins for triprolidine hydrochloride are generally high due to its low production costs and high demand.

Future Outlook

The future outlook for triprolidine hydrochloride is positive, with the drug expected to continue playing a crucial role in the treatment of allergies and common colds. Here are some key points:

• Demand Forecast: The demand for triprolidine hydrochloride is expected to remain stable or increase slightly over the next few years.
• Market Expansion: The market for triprolidine hydrochloride is expected to expand into new regions, driven by increasing global demand for cold and allergy medications.
• Innovative Formulations: There is a potential for innovative formulations that combine triprolidine hydrochloride with other active ingredients to enhance its efficacy and patient compliance.

Key Takeaways

• Market Share: Triprolidine hydrochloride holds a significant share in the antihistamine market.
• Sales and Revenue: The drug generates substantial revenue due to its widespread use.
• Demand Forecast: The demand is expected to remain stable or increase slightly over the forecast period.
• Competitive Landscape: The market is competitive with several key players.
• Safety Profile: The drug is generally safe with well-documented side effects.

FAQs

What is triprolidine hydrochloride used for?

Triprolidine hydrochloride is used to relieve symptoms of allergic rhinitis, the common cold, and as a short-acting sedative.

What are the common side effects of triprolidine hydrochloride?

Common side effects include sedation, dizziness, dry mouth, urinary retention, and others.

Is triprolidine hydrochloride safe for liver health?

Triprolidine hydrochloride has not been linked to clinically apparent liver injury and is considered safe for short-term use.

What are the typical formulations of triprolidine hydrochloride?

It is available in syrups, capsules, and liquid oral solutions, often combined with other ingredients like pseudoephedrine and guaifenesin.

What is the expected demand forecast for triprolidine hydrochloride?

The demand is expected to remain stable or increase slightly over the forecast period of 2024-2030.

Sources

1. Market Research Reports: Triprolidine - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030.
2. DrugBank: Triprolidine: Uses, Interactions, Mechanism of Action.
3. Britannica: Should Birth Control Pills Be Available Over the Counter (OTC)?
4. Market Publishers: Triprolidine hydrochloride Market Research Report 2024.
5. NCBI Bookshelf: Triprolidine - LiverTox.