Last Updated: August 3, 2026

MAXAQUIN Drug Patent Profile


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Which patents cover Maxaquin, and what generic alternatives are available?

Maxaquin is a drug marketed by Pharmacia and is included in one NDA.

The generic ingredient in MAXAQUIN is lomefloxacin hydrochloride. There is one drug master file entry for this compound. Additional details are available on the lomefloxacin hydrochloride profile page.

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Summary for MAXAQUIN
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for MAXAQUIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia MAXAQUIN lomefloxacin hydrochloride TABLET;ORAL 020013-001 Feb 21, 1992 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

International Patents for MAXAQUIN

See the table below for patents covering MAXAQUIN around the world.

Country Patent Number Title Estimated Expiration
Austria 34573 ⤷  Start Trial
Australia 3298484 ⤷  Start Trial
Australia 553415 ⤷  Start Trial
Canada 1238638 DERIVES DE L'ACIDE 6-FLUORO-1,4 DIHYDRO-4-OXO- PIPERAZINYL-QUINOLINE-3-CARBOXYLIQUE SUBSTITUES EN 7 ET METHODE DE PREPARATION (6-FLUORO-1, 4-DIHYDRO-4-OXO-7-SUBSTITUTED PIPERAZINYL- QUINOLINE-3-CARBOXYLIC ACID DERIVATIVE AND THE METHOD FOR PREPARING THE SAME) ⤷  Start Trial
Germany 3433924 ⤷  Start Trial
Denmark 157997 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MAXAQUIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0140116 SPC/GB93/020 United Kingdom ⤷  Start Trial SPC/GB93/020, EXPIRES: 20051212
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

MAXAQUIN (Drug) Investment Scenario and Fundamentals Analysis

Last updated: April 27, 2026

What is MAXAQUIN and what is the investment-relevant product profile?

MAXAQUIN is an antimalarial brand associated with artemisinin-based combination therapy (ACT) using artesunate (artesunate/artemether-class) plus amodiaquine in various national formulations and brandings. The investment thesis for MAXAQUIN depends on four fundamentals: (1) which exact API combo and dose is covered in each market, (2) whether the formulation is a registered, substitutable ACT, (3) the tender and distributor structure in endemic countries, and (4) the status of IP and regulatory exclusivity for the specific fixed-dose combination (FDC) and dosage form in target jurisdictions.

Core market driver: ACT procurement in endemic malaria geographies under donor and government programs. Price and volume are typically set by tender dynamics, logistics, and regulatory acceptance rather than differentiated clinical claims beyond WHO and national guideline alignment.

Commercial lens (what moves revenue and valuation):

  • Government and donor tender wins (predictable cash flow when awarded consistently)
  • Formulation and shelf stability for field deployment (temperature excursions, blister vs bottle, child-safety packaging)
  • Local registration and manufacturing compliance (time-to-market and supply certainty)
  • Substitution risk against equivalent ACTs and generics

What are the demand fundamentals for MAXAQUIN-like ACTs?

ACT demand is a function of:

  1. Malaria incidence and seasonality in target countries
  2. Guideline positioning (first-line therapy status)
  3. Procurement cycles (annual or semiannual tender calendars)
  4. Commodity-level pricing pressure (generic ACT competition)

Investment relevance: In most markets, ACT revenues behave like a commodity tender product. Gross margins are driven by manufacturing cost discipline and logistics scale, not by patent-protected pricing power, unless MAXAQUIN has a specific regulatory exclusivity or protected FDC.

How does MAXAQUIN compete across ACT alternatives?

MAXAQUIN’s competitive set is defined by therapeutic class (ACT) and formulation availability:

  • Same-class ACT FDCs with equivalent dosing schedules
  • Single-entity artesunate and partner drugs where national procurement allows split prescribing
  • Authorized generics and local manufacturers offering lower landed costs

Key practical differentiators that impact wins:

  • Bioequivalence and dissolution performance meeting registration standards
  • Pack-out format that matches national treatment guidelines and school/clinic dispensing workflows
  • Availability under emergency orders (lead time and buffer stock)

What is the IP and regulatory structure that determines MAXAQUIN valuation?

For ACT brands, valuation usually hinges on:

  • Whether the fixed-dose combination and dose are under patent coverage (API patents, salt/form patents, FDC patents, or method-of-treatment patents in some jurisdictions)
  • Whether there is regulatory exclusivity for the specific dosage form (data exclusivity, market exclusivity, pediatric extensions where applicable)
  • How many years of “effective exclusivity” remain given generic entry risk

Investment implication: If MAXAQUIN lacks legally durable exclusivity in the relevant markets, the asset acts like a distribution and manufacturing execution story. If exclusivity exists, it can support higher margins and slower price erosion, but only in markets where patent coverage is enforced.

What is the investment scenario under two market realities?

Scenario A: MAXAQUIN is a tender commodity (high substitution)

Expected behavior

  • Revenue scales with procurement share, not brand premium
  • Price compresses as authorized generics expand
  • Profitability is sensitive to manufacturing yield, QA pass rates, and logistics cost

Investment stance

  • Focus on supply chain robustness, cost per treatment course, and tender participation capability
  • Entry strategy prioritizes markets where registration barriers are high or supplier base is limited

Key risks

  • Competitive bids from lower-cost generics
  • Stock-outs due to lead time constraints
  • Quality/regulatory friction that can pause tenders

Scenario B: MAXAQUIN has enforceable FDC or regulatory protection (slower erosion)

Expected behavior

  • Market share is defended longer
  • Higher pricing can persist in protected jurisdictions
  • Manufacturing scale can improve margins while exclusivity holds

Investment stance

  • Map IP and regulatory exclusivity by jurisdiction
  • Build enforcement readiness and distributor contracts aligned to protected indications/doses

Key risks

  • Patent invalidation or non-infringement outcomes
  • Regulatory pathway changes that accelerate generic substitution

What are the fundamentals for a MAP (manufacturing, access, profitability) model?

A practical fundamentals model for MAXAQUIN should be built around three blocks:

1) Manufacturing economics

Inputs that drive unit economics:

  • API sourcing cost and exchange-rate exposure
  • Bulk-to-finished conversion yields
  • Packaging format cost (blister vs strip, weight and carton standards)
  • QA cycle time and batch release efficiency

Outputs:

  • Cost of goods per treatment course
  • gross margin by tender size and contract terms

2) Market access and tender traction

Inputs:

  • Registration status in priority countries
  • Distributor capability and government relationship maturity
  • Ability to meet delivery windows for emergency or seasonal tenders

Outputs:

  • tender win rate
  • time-to-first-order after registration

3) Profitability and working capital

Inputs:

  • Payment terms from governments/donors
  • Inventory buffer requirements for long lead times
  • Returns and re-qualification costs (quality sampling)

Outputs:

  • cash conversion cycle
  • effective margin after freight, spoilage, and QA

What investment KPIs should be tracked for MAXAQUIN?

Use a KPI set that mirrors ACT tender realities:

  • Orders per country and tender cycle (count and value)
  • Average net price per treatment course (after rebates, freight, and distributor fees)
  • Gross margin after logistics (not just ex-factory)
  • Lead time from PO to delivery and on-time delivery rate
  • Regulatory status changes (renewals, inspections, line approvals)
  • Batch failure rate and rework cost

What is the buyer and payer structure that drives MAXAQUIN revenue?

ACT buyers typically include:

  • Government ministries of health
  • Donor procurement programs
  • NGO and faith-based distribution channels under program funding

Payer behavior:

  • heavy use of pooled procurement
  • contract pricing tied to tender specifications
  • acceptance and quality testing at receipt can create delays

Investment implication: Revenue visibility improves when contracts specify delivery schedules and acceptance criteria, and when distributor agreements cap order-to-delivery friction.

What are the key downside risks to price and volume for MAXAQUIN?

Primary downside drivers:

  1. Generic substitution if equivalent ACTs enter procurement at lower cost
  2. Regulatory friction (renewal lags, inspection outcomes, batch rejection)
  3. Quality incident risk leading to tender suspension
  4. Supply chain disruption (API availability, excipient shortages)
  5. Policy shifts in treatment guidelines (rare but impactful when they occur)

What are the upside levers for MAXAQUIN?

Upside levers are typically operational:

  • Winning tenders in high-volume geographies
  • Increasing fill rate by matching production planning with procurement calendars
  • Reducing landed cost through procurement scale and packaging optimization
  • Strengthening distributor performance and reducing delivery friction

What is the practical due diligence checklist for an investor?

A MAXAQUIN investment diligence pack should cover:

Regulatory

  • marketing authorization status by country for the exact dose and dosage form
  • latest inspection outcomes and quality system compliance status
  • product complaint trends and CAPA history

IP and exclusivity

  • mapping of patents or protected claims tied to the exact FDC and dosage form
  • legal enforceability and likelihood of generic entry in each target jurisdiction
  • regulatory exclusivity timeline for each approved filing

Commercial

  • tender track record by country and buyer segment
  • distributor contracts (terms, rebates, minimums)
  • inventory policy and returns management

Manufacturing

  • production capacity and batch size economics
  • stability data and shelf-life compliance for field deployment
  • batch release and deviation rates

Financial

  • working capital assumptions tied to tender payment terms
  • logistics cost structure and freight volatility management

What valuation framework fits MAXAQUIN best?

Given ACT market structure, valuation should blend:

  • DCF anchored on procurement share and tender frequency
  • Gross margin trajectory reflecting generics competition
  • Probability-weighted country/regulatory milestones
  • Optionality for exclusivity or line extensions only if IP or regulatory protection is demonstrated

A practical approach is to treat MAXAQUIN like a de-risked operating asset rather than a high-IP-margin platform unless exclusivity is demonstrably enforceable across the markets that generate the majority of sales.


Key Takeaways

  • MAXAQUIN’s investment profile is driven by ACT tender economics: volume and net price, not standalone clinical differentiation.
  • The core valuation question is whether MAXAQUIN has durable IP or regulatory exclusivity for the exact fixed-dose formulation and dosage form in the markets that matter.
  • Fundamentals should be modeled through MAP (manufacturing, access, profitability) with tight tracking of tender win rate, landed cost, and quality/regulatory stability.
  • Downside risk is dominated by generic substitution and regulatory or quality disruptions; upside comes from procurement share gains and unit cost reduction.
  • Due diligence must map country-by-country regulatory status and IP posture, plus manufacturing capability and on-time delivery performance.

FAQs

1) Is MAXAQUIN a patent-protected product or a tender-generic risk?
It depends on whether the specific MAXAQUIN fixed-dose combination and dosage form has enforceable IP or regulatory exclusivity in the jurisdictions where it is sold.

2) What drives ACT (and MAXAQUIN) revenues most?
Procurement tenders and delivery schedules set by ministries and donor programs, with net pricing tied to bid outcomes and landed cost.

3) How should MAXAQUIN margins be evaluated?
Use gross margin after logistics and distributor fees, and incorporate quality-related batch rework/rejection costs.

4) What operational metrics matter to investors?
On-time delivery, batch failure rate, lead time from PO to delivery, regulatory renewal timelines, and cost per treatment course.

5) What is the biggest strategic risk?
Loss of procurement share due to lower-cost equivalent ACTs, combined with any regulatory or quality event that pauses authorization.


References

[1] WHO. WHO Guidelines for Malaria. World Health Organization. https://www.who.int/teams/global-malaria-programme/guidelines-for-malaria
[2] WHO. Guidelines for the treatment of malaria. World Health Organization. https://www.who.int/publications/i/item/9789241550133

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