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Last Updated: December 22, 2024

Brompheniramine maleate - Generic Drug Details


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

Brompheniramine maleate is the generic ingredient in eight branded drugs marketed by Alpharma Us Pharms, Kv Pharm, Pharm Assoc, Usl Pharma, Watson Labs, Wyeth Ayerst, Wyeth Cons, Barr, Ivax Sub Teva Pharms, Newtron Pharms, Nexgen Pharma Inc, Par Pharm, Pioneer Pharms, Upsher Smith Labs, Vitarine, Wockhardt, Wockhardt Bio Ag, Acella, Alkem Labs Ltd, Bionpharma, Chartwell Molecular, Dr Reddys Labs Sa, Padagis Us, Rhodes Pharms, Taro, Wes Pharma Inc, Robins Ah, and Alza, and is included in thirty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for brompheniramine maleate.

Summary for brompheniramine maleate
Recent Clinical Trials for brompheniramine maleate

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

SponsorPhase
Ache Laboratorios Farmaceuticos S.A.Phase 3
Wyeth is now a wholly owned subsidiary of PfizerPhase 1

See all brompheniramine maleate clinical trials

Medical Subject Heading (MeSH) Categories for brompheniramine maleate

US Patents and Regulatory Information for brompheniramine maleate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pioneer Pharms BROMPHENIRAMINE MALEATE brompheniramine maleate TABLET;ORAL 088604-001 Jul 13, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Par Pharm BROMPHENIRAMINE MALEATE brompheniramine maleate TABLET;ORAL 087009-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Usl Pharma BROMPHENIRAMINE MALEATE brompheniramine maleate ELIXIR;ORAL 087964-001 Jan 25, 1983 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alpharma Us Pharms BROMANATE DM brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 088722-001 Mar 7, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Nexgen Pharma Inc BROMPHENIRAMINE MALEATE brompheniramine maleate TABLET;ORAL 086187-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bionpharma BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride SYRUP;ORAL 203997-001 Sep 30, 2020 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

Brompheniramine maleate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Brompheniramine Maleate

Overview of Brompheniramine Maleate

Brompheniramine maleate is a first-generation antihistamine belonging to the propylamine class, primarily used in the treatment of allergic conditions such as allergic rhinitis, hay fever, and other respiratory infections. It acts as an antagonist of the H1 receptor, alleviating symptoms like sneezing, itching, and a runny nose associated with allergic reactions[4][5].

Market Size and Projections

The brompheniramine market, which includes brompheniramine maleate, was valued at USD 10 billion in 2023 and is projected to reach USD 14 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4% from 2024 to 2031. This growth is driven by several key factors[1].

Key Drivers of Market Growth

Increasing Prevalence of Allergies

The rise in allergic disorders, particularly allergic rhinitis and associated respiratory conditions, is a significant driver. Environmental factors such as pollution and climate change are contributing to the global increase in allergy cases, thereby increasing the demand for antihistamines like brompheniramine maleate[1].

Accessibility and Self-Medication

The wide availability of brompheniramine in over-the-counter (OTC) forms supports market expansion. This accessibility allows consumers to self-medicate, which is a preferred option for many due to its convenience and cost-effectiveness[1].

Consumer Awareness and Healthcare Infrastructure

Rising consumer knowledge of allergy management and the benefits of early intervention are also driving the market. Additionally, the expanding healthcare infrastructure and increasing disposable incomes in emerging nations are contributing to the growth of the brompheniramine market[1].

Market Segmentation

The brompheniramine market is segmented based on several criteria:

By Type

  • Tablets
  • Syrup
  • Oral Suspension
  • Extended Release
  • Chewable Tablets

By Application

  • Allergy Relief
  • Cold and Flu
  • Antihistamine
  • Respiratory Infections
  • OTC Medications
  • Pharmaceuticals

By Geography

  • North America
  • Europe
  • Asia-Pacific
  • South America
  • Middle-East and Africa

Each segment offers unique opportunities and challenges, with North America and Europe currently dominating the market, and Asia-Pacific expected to witness significant growth due to rising awareness and increasing prevalence of allergic conditions[1].

Competitive Landscape

The brompheniramine market is highly competitive, with several major pharmaceutical companies involved:

Key Market Players

  • Pfizer
  • Merck
  • Sanofi
  • GlaxoSmithKline
  • Johnson & Johnson
  • Novartis
  • Bayer
  • Teva Pharmaceutical
  • Mylan
  • Perrigo
  • Cipla
  • Lupin

These companies are profiled based on their market entry year, product offerings, and other market-related factors. The report also includes a detailed competitive analysis, including Porter’s Five Forces analysis, to help stakeholders make informed business decisions[1].

Financial Trajectory

The financial trajectory of the brompheniramine market is positive, with steady growth anticipated over the forecast period.

Revenue Projections

  • The market was valued at USD 10 billion in 2023.
  • It is expected to reach USD 14 billion by 2031, growing at a CAGR of 4% from 2024 to 2031[1].

Regional Contributions

  • North America and Europe are currently the largest markets, but Asia-Pacific is expected to grow at the highest rate due to increasing prevalence of allergic conditions and rising consumer awareness[1].

Challenges and Restraints

While the market is growing, there are several challenges that could impact its trajectory:

Regulatory Changes

Regulatory actions, such as the FDA's decision to remove certain cough and cold products from the market, can affect the revenues of companies manufacturing these drugs[2].

Alternative Medications

The availability of alternative medications to treat allergies can pose a threat to the growth of the brompheniramine market. Additionally, potential side effects of brompheniramine, such as drowsiness and dry mouth, may also hamper market growth[3].

Conclusion

The brompheniramine maleate market is poised for steady growth driven by increasing allergy prevalence, consumer awareness, and expanding healthcare infrastructure. However, it must navigate regulatory challenges and competition from alternative medications.

Key Takeaways

  • The brompheniramine market is valued at USD 10 billion in 2023 and is expected to reach USD 14 billion by 2031.
  • The market is driven by the increasing prevalence of allergies, accessibility of OTC formulations, and rising consumer awareness.
  • Key market players include major pharmaceutical companies like Pfizer, Merck, and GlaxoSmithKline.
  • Asia-Pacific is expected to witness the highest growth rate due to rising awareness and increasing prevalence of allergic conditions.
  • Regulatory changes and the availability of alternative medications are potential restraints on market growth.

FAQs

What is brompheniramine maleate used for?

Brompheniramine maleate is primarily used in the treatment of allergic conditions such as allergic rhinitis, hay fever, and other respiratory infections by targeting the H1 receptor[4].

What are the key drivers of the brompheniramine market?

The key drivers include the increasing prevalence of allergies, accessibility of OTC formulations, rising consumer awareness, and expanding healthcare infrastructure in emerging nations[1].

Which regions are expected to dominate the brompheniramine market?

North America and Europe currently dominate the market, but Asia-Pacific is expected to witness significant growth during the forecast period[1].

What are the potential challenges to the brompheniramine market?

Regulatory changes, the availability of alternative medications, and potential side effects of brompheniramine are potential challenges to market growth[2][3].

Who are the major players in the brompheniramine market?

Major players include Pfizer, Merck, Sanofi, GlaxoSmithKline, Johnson & Johnson, and others[1].

Sources

  1. Market Research Intellect, "Global Brompheniramine Market Size and Forecast", December 2024.
  2. BioSpace, "FDA to Remove Two Drugs Manufactured by Elite Pharmaceuticals Inc", March 4, 2011.
  3. Allied Market Research, "Chlorpheniramine Maleate Market Statistics and Forecast - 2032".
  4. Synapse by Patsnap, "Unleashing the Power of Brompheniramine maleate: A Comprehensive Review on R&D Breakthroughs", September 21, 2023.
  5. DrugBank, "Brompheniramine: Uses, Interactions, Mechanism of Action".

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