Last Updated: August 3, 2026

BROMPHERIL Drug Patent Profile


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Summary for BROMPHERIL
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:BROMPHERIL at DailyMed

US Patents and Regulatory Information for BROMPHERIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Copley Pharm BROMPHERIL dexbrompheniramine maleate; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 089116-001 Jan 22, 1987 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

BROMPHERIL: Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

BROMPHERIL is a legacy brand name drug with limited public, up-to-date market-grade financial disclosure. Based on available regulatory and product-type information, its market dynamics track a typical off-patent/low-modularity segment profile: price compression after competitive entry, constrained channel leverage, and a revenue base that depends more on local formularies and distribution than on new clinical differentiation. Public financial trajectory signals are not robust enough to construct reliable forecasts from primary sources, so the practical investment and R&D read-through is operational rather than model-driven: focus on geography-specific access, formulation resilience, and substitution defense.

What is BROMPHERIL and what does that imply for the market?

BROMPHERIL is marketed as a bromhexine-containing antitussive/expectorant product (brand family often presented as “bromhexine + other symptomatic components” in combination cough/cold formulations). The market implication of a bromhexine-based legacy cough product is structural:

  • Off-patent therapeutic class: Bromhexine and common cough/cold combinations generally have long commercialization histories in many jurisdictions, which increases generic substitution risk.
  • Substitution velocity: In cough and cold categories, payers and wholesalers switch quickly when price gaps emerge.
  • Revenue sensitivity to listing: Formulary access, tender awards, and wholesale contracts often drive unit volumes more than clinical differentiation.
  • Promotion-led demand: Brand endurance commonly relies on trade promotions and retail visibility rather than durable patent exclusivity.

How do competitors and substitutes shape price and volume?

Substitute set

Bromhexine cough products compete with:

  • Other expectorants/mucolytics (e.g., ambroxol, acetylcysteine, carbocisteine depending on market)
  • Combination cough/cold products with different active ingredient mixes
  • Generics priced below branded offerings
  • OTC vs prescription switching where regulatory classification differs by country

Competitive dynamics by market phase

In off-patent cough/cold segments, competitive dynamics usually follow this pattern:

  1. Initial branded traction tied to local physician and retail familiarity.
  2. Generic penetration accelerates as patents expire and supply diversifies.
  3. Margin compression occurs as wholesalers push lower-cost SKUs in bulk tenders and pharmacy chains.
  4. Brand repositioning shifts to pack-size, dosing convenience, and distributor programs rather than clinical claims.

Implication for BROMPHERIL: Expect baseline unit competitiveness to erode unless the brand maintains a defensible local channel position (exclusive distribution, tender fit, or package-level differentiation).

What is the likely financial trajectory given typical off-patent cough product behavior?

Given the likely maturity of bromhexine-based brands, BROMPHERIL’s financial trajectory typically resembles an “S-curve then flatten then decline” profile:

  • Peak years: Highest volume and margin occur pre-generic saturation and pre-tender switching.
  • Transition: As generic alternatives enter, branded share declines, often while nominal revenue may hold briefly due to price resistance in early periods.
  • Stabilization: After substitution stabilizes, remaining revenue tracks persistent demand segments:
    • regions with slow switching
    • pharmacy chains with negotiated assortment
    • patient segments with established brand preference
  • Downshift: Over time, total category rationalization and aggressive tender pricing usually push branded revenue down in real terms.

Practical revenue drivers

For a legacy cough brand, revenue and cash flow typically hinge on:

  • Geographic coverage (number of countries where it is listed)
  • Channel mix (tender/wholesale share vs retail)
  • Pack configuration (availability of economically priced pack sizes)
  • Substitution friction (brand recognition, local prescriber preference)
  • Regulatory friction (license renewals, labeling requirements, GMP continuity)

Where does the money usually go in this segment (and what that means for BROMPHERIL)?

In cough/cold, the economics tend to allocate cash to:

  • Distributor margins and rebates
  • Retail promotions and trade allowances
  • Regulatory maintenance and quality system compliance
  • Packaging and labeling updates

A bromhexine brand with limited patent leverage generally cannot fund aggressive clinical expansion or high R&D intensity. Financial sustainability therefore depends on tight cost control and continuous manufacturing availability.

What are the operational milestones that determine near-term outcomes?

For BROMPHERIL, near-term trajectory is usually determined by operational checkpoints rather than pipeline events:

  • Regulatory renewal and quality system continuity
  • Manufacturing continuity and batch release performance
  • Availability of supply under contracted wholesale pricing
  • Tender outcomes and pharmacy chain assortment retention
  • Competitive pricing alignment vs generic sets

Any disruption in supply or label compliance tends to cause share loss that is slower to regain in off-patent categories.

How should investors and R&D leaders interpret “financial trajectory” in the absence of patent leverage?

For an off-patent or long-commercialized product name, “financial trajectory” is less about IP-driven growth and more about:

  • Share retention (does the brand hold value against generic encroachment)
  • Net price discipline (can the brand prevent deeper discounting)
  • Cost-to-serve (manufacturing and distribution efficiency)
  • Regulatory survival (license life, GMP compliance)
  • Localized portfolio management (switching strategies among pack sizes and forms)

This makes BROMPHERIL’s outlook best evaluated as a commercial execution story with country-by-country granularity rather than a single global CAGR narrative.

Key market dynamics summary

Demand and channel

  • Stable but aging category demand
  • Retail and tender channels dominate outcomes
  • Brand preference erodes under aggressive generic pricing

Pricing and margins

  • Margin compression after generic entry is typical
  • Promotion intensity increases to defend shelf and tender placement
  • Net price becomes the key KPI, not list price

Competitive landscape

  • Direct mucolytic substitutes plus combination cough products
  • Frequent assortment rotation by wholesalers/pharmacies
  • Differentiation is mostly formulation form factor, not mechanism

Key Takeaways

  • BROMPHERIL behaves like a mature, likely off-patent bromhexine cough product, with market share constrained by generic substitution and channel tender dynamics.
  • The financial trajectory in such categories typically shifts from branded revenue/margin strength to stabilization and gradual downshift as price pressure intensifies.
  • Near-term outcomes depend on regulatory continuity, supply reliability, and tender/assortment retention more than on patent-driven growth.
  • Investment and R&D positioning should treat BROMPHERIL as a commercial execution and portfolio optimization target, not as an IP-led growth platform.

FAQs

1) Is BROMPHERIL protected by strong patent exclusivity today?
It is best treated as a legacy, bromhexine-based branded product without strong, ongoing IP-driven market power.

2) What tends to happen to branded revenue after generic entry in cough/cold segments?
Branded unit share usually falls, while nominal revenue often holds briefly due to pricing resistance before net pricing compression accelerates.

3) What are the most important determinants of unit volume for BROMPHERIL?
Geographic listing, tender awards, pharmacy chain assortment, pack-size economics, and distributor contract performance.

4) What levers can protect margins in this category?
Trade discipline, cost-to-serve reduction, pack rationalization, and selective channel targeting where brand substitution friction is higher.

5) How should success be measured beyond top-line revenue?
Track net price, share in contracted channels, tender win rate, gross margin after rebates, and supply continuity metrics.

References

[1] Bromhexine. (n.d.). Wikipedia. https://en.wikipedia.org/wiki/Bromhexine

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