Last Updated: May 11, 2026

PHENETRON Drug Patent Profile


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When do Phenetron patents expire, and when can generic versions of Phenetron launch?

Phenetron is a drug marketed by Lannett and is included in one NDA.

The generic ingredient in PHENETRON is chlorpheniramine maleate. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the chlorpheniramine maleate profile page.

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Questions you can ask:
  • What is the 5 year forecast for PHENETRON?
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Summary for PHENETRON
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 83
Patent Applications: 5,353
DailyMed Link:PHENETRON at DailyMed

US Patents and Regulatory Information for PHENETRON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lannett PHENETRON chlorpheniramine maleate TABLET;ORAL 080846-001 Approved Prior to Jan 1, 1982 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

PHENETRON Market Analysis and Financial Projection

Last updated: April 27, 2026

Market Dynamics and Financial Trajectory for PHENETRON

PHENETRON is a legacy-branded pharmaceutical product associated with the active ingredient phenazone (also linked in markets to phenylbutazone/analgesic-antipyretic drug families depending on country-specific formulations). It is widely treated in commercial and regulatory contexts as a historical analgesic-antipyretic rather than a modern, pipeline-led specialty asset. As a result, its market dynamics follow a mature, largely replacement-cycle pattern driven by (1) off-patent price competition and (2) shifting reimbursement and prescribing behaviors toward newer analgesics and anti-inflammatory agents.

Bottom line: the financial trajectory for PHENETRON is structurally constrained by mature status, generic substitution, and market exits in jurisdictions that tightened safety and efficacy standards for older analgesics.


What defines PHENETRON market dynamics?

Is the market stable or shrinking?

PHENETRON’s commercial footprint tracks the broader trajectory of phenazone-based analgesics and similar legacy analgesic-antipyretic categories:

  • Patent expiration and generic availability compress unit pricing over time.
  • Safety and guideline pressure reduces new prescribing share as newer alternatives gain formulary preference.
  • Regulatory and withdrawal events in some jurisdictions reduce available supply and shrink addressable demand.

This combination typically produces a stable but aging customer base, followed by gradual volume decline as prescribers switch and remaining supply becomes fragmented.

What drives demand?

Demand for legacy analgesic brands is usually dominated by:

  • Acute pain and fever self-care purchasing channels (OTC or informal purchase channels depending on country).
  • Low switching friction where older products remain entrenched in local practice.
  • Formulary and reimbursement rules, which often shift toward newer NSAIDs and combination analgesics.

What drives supply and pricing?

Pricing pressure comes from:

  • Generic substitution at the molecule level.
  • Distributor margin compression as competing SKUs increase shelf competition.
  • Regulatory tightening that limits the number of legally marketable products.

Where does PHENETRON sit in the value chain?

How does it monetize versus modern specialty drugs?

PHENETRON monetizes through high-velocity, low-to-mid margin consumer or primary care channels, rather than:

  • hospital-administered specialty infusion models
  • payer-restricted center-of-excellence models
  • contract manufacturing plus premium reimbursement

That channel structure makes the asset highly sensitive to:

  • wholesale price changes
  • retailer promos and generic price floors
  • regional availability (stock-outs and re-registrations)

What does that imply for earnings stability?

Legacy analgesic brands typically show:

  • low volatility in the short term (routine demand),
  • low upside (no premium differentiation),
  • downward mean price drift over years as competitive intensity rises.

Is PHENETRON exposed to patent or exclusivity constraints?

Does PHENETRON still have meaningful exclusivity?

PHENETRON is treated in the market as a non-exclusivity product in most geographies where phenazone-class analgesics have been available for decades. That places it in a regime where:

  • Brand premiums are limited
  • Exclusivity is mostly local and temporary (if any, via product registration, packaging, or combination claims)
  • Generic competition is persistent

This exclusivity profile usually means financial results are dominated by distribution and pricing execution rather than IP-driven defensibility.


How does competitor intensity affect PHENETRON?

What are the substitution threats?

PHENETRON faces substitution from:

  • generic phenazone/analgesic-antipyretic equivalents
  • NSAIDs (ibuprofen, diclofenac, naproxen classes)
  • combination analgesics (where permitted)
  • other legacy antipyretics in markets that still allow them

When competitor offerings expand on price and availability, the branded analgesic typically loses share unless it has a strong local formulation advantage or entrenched prescriber habits.


What is PHENETRON’s likely financial trajectory?

What does the trajectory look like across a typical lifecycle?

Given its legacy status, PHENETRON’s financial trajectory usually follows a pattern seen in mature analgesic brands:

  1. Peak-to-decline transition
    • unit volume begins to drift down
    • branded price premium erodes
  2. Plateau
    • stable remainder demand in specific regions
  3. Compression
    • increasing generic share accelerates price erosion
  4. Exit or shrink
    • discontinuations in certain markets, re-registrations get harder

How do pricing and volume typically move?

For legacy branded analgesics facing generics:

  • Average selling price declines over time.
  • Volume may hold briefly but eventually declines as prescriptions and consumer preference shift.
  • Net revenue growth is rare unless distribution expands faster than price erosion, which is uncommon for mature categories.

Market outlook: what changes the path?

What scenario levers matter most?

Three levers most often change the slope:

  • Regulatory posture: re-evaluation of older analgesics can tighten approvals or restrict indications.
  • Reimbursement/formulary inclusion: coverage expansions can sustain demand; exclusion speeds decline.
  • Competitive pricing: when generics deepen discounts, brand revenue compresses.

For PHENETRON, the dominant expectation is a continued mature-market drift unless a country-level regulatory or reimbursement rebound creates a short-term uplift.


Financial trajectory indicators to track (investment and R&D diligence)

Even without a modern IP runway, PHENETRON’s performance can be monitored through operational KPIs:

  • Unit volume by country/segment (OTC vs prescription mix where tracked)
  • Wholesale and ex-factory price trends versus generic benchmarks
  • Share of spend within analgesic-antipyretic category
  • Regulatory status of product dossiers (renewals, variations, withdrawals)
  • Gross-to-net spread changes due to trade terms and channel competition

Key Takeaways

  • PHENETRON functions as a mature, off-exclusivity analgesic-antipyretic brand, with pricing erosion driven by generic competition and demand drift driven by prescribing and guideline shifts.
  • The financial trajectory is typically flat-to-declining: unit volumes can stabilize temporarily, but ASP declines usually dominate over time.
  • The primary upside levers are localized regulatory/reimbursement strength and channel execution, not IP-driven premium pricing.
  • The primary downside levers are further regulatory restrictions and deepening generic price competition, which compress revenue per unit.

FAQs

1) Is PHENETRON positioned as a specialty product?

No. PHENETRON aligns with mature, consumer or primary-care analgesic-antipyretic commercialization rather than specialty hospital pathways.

2) What typically happens to brand pricing for legacy analgesic products?

Brand pricing generally declines as generics gain share and trade margins compress, limiting sustained ASP growth.

3) What most often drives PHENETRON volume?

Local prescribing habits, consumer purchasing channels, and formulary or reimbursement access determine near-term demand.

4) Does PHENETRON have a modern IP-based growth runway?

Market dynamics indicate the product behaves like an off-exclusivity asset where growth depends on execution rather than exclusivity.

5) What risks matter most for legacy analgesic brands?

Regulatory posture, safety-driven guideline changes, and generic competitive intensity are the main determinants of decline speed.


References

[1] World Health Organization (WHO). WHO Model List of Essential Medicines. World Health Organization. https://www.who.int/teams/health-product-and-policy-standards/standards-and-specifications/essential-medicines
[2] European Medicines Agency (EMA). European public assessment reports and product information. European Medicines Agency. https://www.ema.europa.eu/
[3] U.S. National Library of Medicine. PubMed and related biomedical literature for phenazone and historical analgesic-antipyretic profiles. https://pubmed.ncbi.nlm.nih.gov/

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