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Last Updated: December 22, 2024

TRIPELENNAMINE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for tripelennamine hydrochloride and what is the scope of patent protection?

Tripelennamine hydrochloride is the generic ingredient in three branded drugs marketed by Novartis, Anabolic, Barr, Heather, Impax Labs, Lannett, Nylos, Parke Davis, and Watson Labs, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for tripelennamine hydrochloride.

Summary for TRIPELENNAMINE HYDROCHLORIDE

US Patents and Regulatory Information for TRIPELENNAMINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs TRIPELENNAMINE HYDROCHLORIDE tripelennamine hydrochloride TABLET;ORAL 085188-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs TRIPELENNAMINE HYDROCHLORIDE tripelennamine hydrochloride TABLET;ORAL 080790-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis PBZ tripelennamine hydrochloride TABLET;ORAL 005914-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs TRIPELENNAMINE HYDROCHLORIDE tripelennamine hydrochloride TABLET;ORAL 080713-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Anabolic TRIPELENNAMINE HYDROCHLORIDE tripelennamine hydrochloride TABLET;ORAL 083037-001 Approved Prior to Jan 1, 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

TRIPELENNAMINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tripelennamine Hydrochloride

Overview of Tripelennamine Hydrochloride

Tripelennamine hydrochloride is a histamine H1 antagonist used to treat various allergic reactions, including hay fever, urticaria, rhinitis, and asthma. It is known for its low sedative action but can cause frequent gastrointestinal irritation[1][4].

Market Context: Human Antihistamine Drug Market

The human antihistamine drug market, within which tripelennamine hydrochloride operates, is experiencing significant growth. Here are some key market dynamics:

Market Size and Growth

The human antihistamine drug market is projected to grow from USD 274.8 million in 2023 to USD 706.2 million by 2033, at a Compound Annual Growth Rate (CAGR) of 9.9%[3].

Dominant Drug Types

Second-generation antihistamines, known for their improved safety profiles and reduced sedative effects, hold over 62.7% of the market share in 2023. However, tripelennamine hydrochloride is a first-generation antihistamine, which, although less dominant, still maintains a niche presence due to its efficacy in specific indications[3].

Preferred Medication Type

Over-the-counter (OTC) drugs lead the market with a 60.7% share in 2023, reflecting consumer preference for accessible, non-prescription solutions. Tripelennamine hydrochloride, while available in various forms, is often prescribed or used under medical supervision[3].

Top Indications

Allergy treatments dominate the market, capturing 62.7% of the market share in 2023. Tripelennamine hydrochloride is specifically indicated for treating allergic reactions such as hay fever, urticaria, and rhinitis[3].

Route of Administration

Oral administration is the most common route, claiming 46.1% of the market share in 2023. Tripelennamine hydrochloride is administered orally, as well as topically in some cases[1][3].

Financial Trajectory

Current Market Position

While tripelennamine hydrochloride is not as widely used as second-generation antihistamines, it still maintains a presence in the market due to its specific indications and historical use. The drug is manufactured by several companies, including Novartis, Barr Laboratories, and Lannett Co Inc., among others[1].

Pricing

The pricing of tripelennamine hydrochloride varies depending on the form and manufacturer. For example, tripelennamine hydrochloride powder can cost around $7.35 per gram, indicating that the drug is relatively affordable compared to newer antihistamines[1].

Revenue Contribution

Given its niche market position, tripelennamine hydrochloride contributes a smaller fraction to the overall revenue of the human antihistamine drug market. However, its continued use in specific therapeutic areas ensures a steady, albeit modest, revenue stream.

Market Drivers

Increasing Allergy Prevalence

The growing global prevalence of allergic conditions drives the demand for antihistamines, including tripelennamine hydrochloride. This trend is expected to continue, supporting the market's overall growth[3].

Innovations in Drug Research and Development

While tripelennamine hydrochloride itself is not a new drug, innovations in the broader antihistamine market can indirectly benefit its sales by increasing awareness and improving treatment options for allergic conditions[3].

Healthcare Infrastructure Expansion

The expansion of healthcare infrastructure, particularly in regions with high allergy prevalence, can increase access to antihistamine medications, including tripelennamine hydrochloride[3].

Challenges

Competition from Second-Generation Antihistamines

Second-generation antihistamines, with their improved safety profiles and reduced sedative effects, pose a significant competitive challenge to tripelennamine hydrochloride. This competition may limit its market share and growth potential[3].

Regulatory Environment

The regulatory environment, especially in regions where tripelennamine hydrochloride is not approved or has limited approval, can affect its market dynamics. For instance, tripelennamine hydrochloride is not approved in the US, which can restrict its market reach[1].

Regional Analysis

North America

North America, particularly the US, is a significant market for antihistamines, with a substantial 37.2% market share in 2023. However, since tripelennamine hydrochloride is not US-approved, its presence in this region is limited compared to other antihistamines[3].

Other Regions

In regions where tripelennamine hydrochloride is approved, it may have a more significant market presence, particularly in areas with high incidence rates of allergic conditions.

Key Takeaways

  • Market Growth: The human antihistamine drug market is growing at a CAGR of 9.9%, driven by increasing allergy prevalence and innovations in drug research.
  • Niche Presence: Tripelennamine hydrochloride maintains a niche presence due to its specific indications and historical use.
  • Competition: Second-generation antihistamines pose a significant competitive challenge.
  • Regional Variations: Market dynamics vary by region, with North America being a key market for antihistamines but limited for tripelennamine hydrochloride due to lack of US approval.
  • Pricing and Revenue: The drug is relatively affordable, but its revenue contribution is modest compared to newer antihistamines.

FAQs

What is tripelennamine hydrochloride used for?

Tripelennamine hydrochloride is used to treat allergic reactions such as hay fever, urticaria, rhinitis, and asthma. It acts as a histamine H1 antagonist to provide relief from symptoms like sneezing, watery and itchy eyes, and runny nose[1][4].

Is tripelennamine hydrochloride approved in the US?

No, tripelennamine hydrochloride is not approved in the US. It is approved in other regions and used under medical supervision[1].

How does tripelennamine hydrochloride compare to second-generation antihistamines?

Tripelennamine hydrochloride is a first-generation antihistamine with a higher potential for sedative effects and gastrointestinal irritation compared to second-generation antihistamines, which have improved safety profiles and reduced sedative effects[3].

What is the market size of the human antihistamine drug market?

The human antihistamine drug market is projected to reach approximately USD 706.2 million by 2033, growing from USD 274.8 million in 2023 at a CAGR of 9.9%[3].

What are the primary drivers of the human antihistamine drug market?

The primary drivers include increasing global allergy prevalence rates, innovations in drug research and development, and expansions of healthcare infrastructure[3].

Sources

  1. DrugBank: Tripelennamine: Uses, Interactions, Mechanism of Action.
  2. FDA: Clinical comparison of carbinoxamine maleate, tripelennamine hydrochloride, and bromodiphenhydramine hydrochloride.
  3. Market.us: Human Antihistamine Drug Market Size | CAGR OF 9.9%.
  4. PubChem: Tripelennamine | C16H21N3 | CID 5587.

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