Last Updated: May 3, 2026

MEFLOQUINE HYDROCHLORIDE - Generic Drug Details


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

Mefloquine hydrochloride is the generic ingredient in two branded drugs marketed by Roche, Barr, Chartwell Rx, Hikma, Hikma Intl Pharms, and Us Army Walter Reed, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for mefloquine hydrochloride. Three suppliers are listed for this compound.

Summary for MEFLOQUINE HYDROCHLORIDE
US Patents:0
Tradenames:2
Applicants:6
NDAs:6
Drug Master File Entries: 6
Finished Product Suppliers / Packagers: 3
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 77
Patent Applications: 2,467
What excipients (inactive ingredients) are in MEFLOQUINE HYDROCHLORIDE?MEFLOQUINE HYDROCHLORIDE excipients list
DailyMed Link:MEFLOQUINE HYDROCHLORIDE at DailyMed
Recent Clinical Trials for MEFLOQUINE HYDROCHLORIDE

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

SponsorPhase
National Research and Innovation Agency of IndonesiaN/A
Universitas PadjadjaranN/A
Prodia Diacro Laboratories P.T.N/A

See all MEFLOQUINE HYDROCHLORIDE clinical trials

Pharmacology for MEFLOQUINE HYDROCHLORIDE
Drug ClassAntimalarial
Medical Subject Heading (MeSH) Categories for MEFLOQUINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for MEFLOQUINE HYDROCHLORIDE

US Patents and Regulatory Information for MEFLOQUINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell Rx MEFLOQUINE HYDROCHLORIDE mefloquine hydrochloride TABLET;ORAL 076175-001 Feb 20, 2002 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Barr MEFLOQUINE HYDROCHLORIDE mefloquine hydrochloride TABLET;ORAL 076392-001 Dec 29, 2003 AB RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma Intl Pharms MEFLOQUINE HYDROCHLORIDE mefloquine hydrochloride TABLET;ORAL 077699-001 Apr 21, 2010 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

MEFLOQUINE HYDROCHLORIDE: Market Dynamics and Financial Trajectory

Last updated: April 25, 2026

What is the commercial market profile for mefloquine hydrochloride?

Mefloquine hydrochloride is an older, established antimalarial used for malaria treatment and prophylaxis. Its commercial pattern is shaped by (1) endemic malaria burden shifts, (2) resistance patterns in target geographies, and (3) public-sector procurement cycles, where buyer power is high and formularies move slowly.

The observable market dynamics for mefloquine (as a drug category) follow these drivers:

  • Demand is procurement-driven rather than “brand-led.” Use concentrates in government and NGO tenders (malaria programs, military/expedition prophylaxis), not retail repeat prescribing.
  • Formulary access is constrained by safety and tolerability perceptions. Mefloquine has long-standing neuropsychiatric safety warnings (notably in prophylaxis contexts). That constrains share versus newer alternatives where those alternatives are available in a country’s essential medicines lists.
  • Resistance and guideline updates reallocate usage. When malaria treatment guidelines shift away from mefloquine (or restrict it to specific settings), commercial demand contracts quickly even if the molecule remains active.

How does demand move across geographies and use-cases?

Mefloquine demand splits into two commercial channels:

  1. Prophylaxis channel (limited by safety perception and guideline preference)

    • Procurement tends to be more conservative where modern prophylactic options (or non-mefloquine options) are positioned as first-line.
    • Military and traveler markets can still generate demand, but the product mix typically narrows when risk communication tightens.
  2. Treatment channel (more resilient, but still guideline-dependent)

    • In regions where mefloquine remains in treatment algorithms or as an option for specific resistance profiles, demand can stabilize.
    • However, as resistance patterns evolve, payers shift toward artemisinin-based combinations and other options.

What is the likely financial trajectory for sales and margins?

For an older antimalarial with constrained modern uptake, the financial trajectory typically has three phases:

1) Plateau-to-decline profile (post-peak maturity)

  • Once combination therapies and newer antimalarials dominate guideline recommendations, mefloquine generally transitions to a plateau followed by decline.
  • The decline is driven less by absolute loss of efficacy and more by channel rotation: procurement policies, formularies, and switching behavior among prescribers.

2) Margin compression from genericization and price competition

  • In the absence of patent-protected exclusivity in many markets, sales become more sensitive to price.
  • Generic competition usually compresses gross margins to levels consistent with mature public-sector procurement pricing.

3) Residual value through tenders and niche use

  • Even with declining center-of-gravity, the molecule can retain residual volume via:
    • emergency stockpiles,
    • procurement for specific resistance environments,
    • deployments where mefloquine remains a documented option.

What is the regulatory and safety landscape that shapes commercial outcomes?

Mefloquine carries safety constraints that influence buyer behavior, especially for prophylaxis. The risk profile has been reflected in major labeling and guideline communications over time, affecting uptake in some markets and limiting prescribing.

Key safety and usage constraints that shape sales behavior include:

  • Neuropsychiatric warnings that affect prophylactic use eligibility.
  • Use-case narrowing in settings where clinicians and procurement officers prefer alternatives with fewer flagged risks.

This safety positioning generally increases:

  • administrative friction (screening, contraindication checks),
  • switching pressure to alternative prophylaxis regimens,
  • buyer preference for procurement items with lower risk flags.

How do malaria control programs and procurement cycles affect revenue timing?

The commercial timing for antimalarials is typically seasonal and program-cycle aligned:

  • Budget and tender windows determine quarterly revenue spikes.
  • Stock replenishment cycles create lumpy demand rather than steady run-rate.
  • Program renewals decide whether volume continues year over year.

For mefloquine specifically, revenue is expected to remain volatile at the program level even as the molecule’s overall market shrinks.

What does the competitive landscape look like versus newer antimalarials?

Competition is primarily between antimalarial classes used in similar settings:

  • Artemisinin-based combination therapies (ACTs) dominate many treatment algorithms.
  • Newer antimalarials with preferred safety and efficacy profiles can displace prophylaxis and treatment roles depending on guideline placement.
  • In markets where ACTs and other alternatives exist in procurement formularies, mefloquine’s share tends to reduce.

Commercial implication:

  • Even when mefloquine remains available, it often becomes a secondary option, reducing pricing power and sales stability.

What patent and exclusivity signals matter for the financial trajectory?

A precise patent-to-financial mapping requires dossier-level patent status and jurisdiction-by-jurisdiction exclusivity timelines. Without confirmed exclusivity status for the specific manufactured product(s), the defensible conclusion at business level is:

  • Mefloquine hydrochloride is functionally a mature molecule with sales determined by generic competition and procurement inclusion, not by active monograph exclusivity.

This maturity expectation aligns with typical financial patterns for established antimalarials:

  • higher sensitivity to tender pricing,
  • lower ability to sustain premium pricing,
  • limited upside absent new clinical or guideline expansion.

What market scenarios drive the upside and downside?

Upside scenario (volume stabilization or modest recovery)

  • Re-escalation of malaria outbreaks in areas where mefloquine remains positioned as an option.
  • Procurement tenders that specifically include mefloquine based on stock strategy or resistance considerations.
  • Use-case persistence in military and expedition prophylaxis where screening and risk management are implemented.

Downside scenario (accelerated share loss)

  • Guideline updates that deprioritize mefloquine in prophylaxis and restrict treatment positioning.
  • Further shift to alternative regimens with preferred safety perception.
  • Increased generic entry driving faster price erosion.

What are the actionable investment and R&D implications from this trajectory?

For a company holding an interest in mefloquine hydrochloride supply or derivatives, the business actions that typically align with the market reality are:

  • Operate procurement-focused commercial strategy: tender participation, fast bid cycles, and supply reliability for public-sector buyers.
  • Prioritize lifecycle extension pathways: if expansion requires new clinical positioning, it must overcome safety and guideline constraints.
  • Treat mefloquine as cash-flow stabilizer, not growth engine, unless a specific programmatic demand channel expands.

Key Takeaways

  • Mefloquine hydrochloride is a mature antimalarial whose market is shaped by procurement cycles and guideline-driven switching rather than brand growth.
  • Financial trajectory is expected to be plateau-to-decline with margin pressure from generics, with residual value tied to tenders and niche use.
  • Safety warnings constrain prophylaxis uptake, which reduces pricing power and raises switching pressure to alternative regimens.
  • Upside depends on outbreak-driven procurement and specific resistance or stock strategies; downside follows guideline restriction and faster price competition.

FAQs

1) Is mefloquine hydrochloride a retail-driven product?

No. Market demand typically concentrates in public-sector and program procurement (malaria control) and limited prophylaxis use channels, not sustained retail repeat demand.

2) What most affects mefloquine sales: efficacy or guideline placement?

Guideline placement and buyer risk tolerance dominate. Safety perceptions and algorithm inclusion determine whether volume flows through treatment or prophylaxis pathways.

3) Why does generic competition matter more than differentiation?

Because procurement tenders prioritize price and consistent supply when the molecule is not protected by strong exclusivity in many markets, generic availability compresses margins.

4) Does malaria seasonality impact financial performance?

Yes. Antimalarial purchases tend to cluster around program budget and tender windows, making revenue lumpy rather than smooth.

5) What is the most realistic growth path for mefloquine?

Growth is most plausible through program-specific procurement inclusion (stock strategies, resistance environments) rather than a broad market re-expansion driven by routine prescribing.


References

[1] World Health Organization. (n.d.). Guidelines and recommendations on malaria prevention and treatment. https://www.who.int/
[2] U.S. Food and Drug Administration. (n.d.). Drug Safety Communications and labeling resources for antimalarials (mefloquine information). https://www.fda.gov/
[3] Centers for Disease Control and Prevention. (n.d.). Malaria information, including prevention and drug recommendations. https://www.cdc.gov/

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