Last Updated: May 30, 2026

NEGGRAM Drug Patent Profile


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When do Neggram patents expire, and what generic alternatives are available?

Neggram is a drug marketed by Sanofi Aventis Us and is included in two NDAs.

The generic ingredient in NEGGRAM is nalidixic acid. There are two drug master file entries for this compound. Additional details are available on the nalidixic acid profile page.

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Summary for NEGGRAM
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 4,524
DailyMed Link:NEGGRAM at DailyMed

US Patents and Regulatory Information for NEGGRAM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us NEGGRAM nalidixic acid SUSPENSION;ORAL 017430-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sanofi Aventis Us NEGGRAM nalidixic acid TABLET;ORAL 014214-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sanofi Aventis Us NEGGRAM nalidixic acid TABLET;ORAL 014214-005 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

Expired US Patents for NEGGRAM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us NEGGRAM nalidixic acid TABLET;ORAL 014214-005 Approved Prior to Jan 1, 1982 3,590,036 ⤷  Start Trial
Sanofi Aventis Us NEGGRAM nalidixic acid SUSPENSION;ORAL 017430-001 Approved Prior to Jan 1, 1982 3,590,036 ⤷  Start Trial
Sanofi Aventis Us NEGGRAM nalidixic acid TABLET;ORAL 014214-002 Approved Prior to Jan 1, 1982 3,590,036 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for NEGGRAM

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

Country Patent Number Title Estimated Expiration
Belgium 611000 ⤷  Start Trial
Sweden 306741 ⤷  Start Trial
Germany 1445153 1,2,3,4,5,6-HEXAHYDRO-3-(3-METHYL-2BUTENYL)-6,11-DIMETHYL-8-HYDROXY-2,6METHANO-3-BENZAZOCIN, SEINE SAEUREADDITIONSSALZE UND VERFAHREN ZU IHRER HERSTELLUNG ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration
Last updated: April 24, 2026

NEGGRAM: Market Dynamics and Financial Trajectory

NEGGRAM is a brand of nalidixic acid (quinolone-class antibacterial). Market dynamics for NEGGRAM are driven by three forces: regulatory tightening for older antibacterial classes, antibiotic resistance and stewardship limits, and persistent low-margin commoditization typical of “off-patent” small-molecule antibiotics. Financial trajectory in most markets follows a pattern common to legacy antibiotic brands: declining demand, shrinking physician preference, and erosion of pricing power, with volumes increasingly concentrated in narrow indications, institutional procurement, and price-led channels.

What is NEGGRAM and how is it positioned commercially?

NEGGRAM is marketed as nalidixic acid for bacterial infections, historically including urinary tract infections (UTIs). As an older small molecule, the brand competes in markets where the active ingredient is largely generic and where prescribers often favor newer agents with better safety profiles and broader clinical utility.

Commercial positioning pattern (typical for nalidixic-acid brands):

  • Low differentiation vs. multiple generic quinolones and alternative antibiotic classes.
  • Stewardship-driven restriction limiting routine use.
  • Procurement-based demand in some geographies (hospital formularies and tender economics).
  • Channel dependence on retail antibiotic sales where regulations still permit outpatient use.

What drives NEGGRAM demand? (Market dynamics)

Demand is shaped by the interaction of clinical practice and policy:

  1. Regulatory and stewardship constraints

    • Many regulators and stewardship frameworks have reduced preferred use of older antibiotics with narrower evidence bases or higher risk of adverse effects.
    • This shifts prescribing toward newer quinolones, nitrofurantoin, fosfomycin, beta-lactams, or guideline-directed regimens, depending on local resistance patterns and labeling.
  2. Resistance economics

    • Nalidixic acid resistance is widespread in settings with long exposure history to older quinolones.
    • Lower susceptibility reduces empirical utility and can push clinicians toward agents with higher local susceptibility.
  3. Generic commoditization

    • Nalidixic acid is mature and widely available as generics, which compresses brand pricing.
    • Brand-level marketing becomes less effective when prescribers and payers treat the molecule as interchangeable.
  4. Safety and tolerability tradeoffs

    • Older quinolones have more safety history than newer options in many guidelines and payer decisions.
    • Even where still used, the molecule tends to face “reserve” positioning.

Net effect: NEGGRAM’s usable market tends to contract as formularies and prescribers move toward modern alternatives and as stewardship reduces first-line use.


How does NEGGRAM typically perform financially across the lifecycle?

Because NEGGRAM is an off-patent brand tied to a mature active ingredient, the financial trajectory usually maps to a standard legacy-off-patent antibiotic profile.

What is the likely revenue trajectory?

A pragmatic trajectory for nalidixic-acid brands looks like:

  • Early stage (after peak): steady volume decline begins as clinicians switch to guideline-preferred antibiotics.
  • Mid stage: revenue becomes increasingly dependent on price and tender procurement rather than expanding prescriptions.
  • Late stage: brand differentiation weakens further; revenue stabilizes only where:
    • local regulation still permits broader use,
    • resistance patterns still keep nalidixic acid active for a subpopulation, or
    • payers/health systems keep it on formulary for cost reasons.

What happens to gross margin and pricing power?

  • Gross margins compress as generic competition intensifies and as brand pricing aligns to the lowest-cost providers.
  • Pricing power deteriorates because prescribers and procurement teams can switch to alternative generics without meaningful clinical penalty in many settings.
  • Promotional spend becomes less efficient because switching costs remain low.

What is the risk profile for earnings stability?

Earnings stability declines with:

  • policy shifts that restrict quinolone use,
  • antibiotic guideline updates that reclassify older agents,
  • resistance-driven changes in clinical outcomes,
  • tender price resets that force periodic price erosion.

Net effect: revenue can remain but earnings volatility rises, driven by procurement pricing cycles and formulary decisions.


Where does NEGGRAM sell and how does that shape growth?

NEGGRAM’s market footprint is typically segmented by regulatory strictness, local resistance patterns, and hospital versus retail share.

Which segments matter most?

  1. Hospital and institutional procurement

    • Demand depends on formulary inclusion and tender cycles.
    • Pricing resets are frequent; volume is steadier than retail but margin is thin.
  2. Outpatient retail

    • Growth is constrained by stewardship and prescribing norms.
    • Where outpatient access remains active, volume can persist, but pricing still trends toward generics.
  3. Geographies with continued guideline tolerance

    • Some markets keep nalidixic acid in narrower recommendations.
    • These markets often support “reserve-use” or susceptibility-guided prescribing rather than broad first-line use.

What competitive set pressures NEGGRAM?

NEGGRAM faces two layers of competition:

  1. Direct generic nalidixic acid brands

    • Same active ingredient, lower cost, and minimal clinical differentiation.
  2. Therapeutic competition from other antibiotic classes

    • Alternatives with better guideline fit, broad evidence, or improved safety profiles.
    • In UTI care, this often means shifting to agents like nitrofurantoin, fosfomycin, and modern fluoroquinolones (where appropriate).

Market implication: even if nalidixic acid retains some susceptibility-based niche use, the competitive gravity pulls usage toward other antibiotics, shrinking the addressable market.


Is NEGGRAM facing patent or exclusivity constraints?

NEGGRAM is not positioned as a new molecular entity; nalidixic acid is an established substance, so brand-level exclusivity is limited. Commercial protection therefore relies on:

  • label and brand presence in specific formularies,
  • supply chain reliability,
  • procurement relationships,
  • and local manufacturing/registration timelines.

Market implication: once generics dominate, long-term pricing depends on being among the lowest-cost suppliers and on retaining formulary access.


What do the broader quinolone dynamics imply for NEGGRAM?

Quinolones as a class have experienced a multi-year shift in clinical placement driven by:

  • rising resistance in gram-negative pathogens,
  • stewardship initiatives,
  • and periodic guideline recalibration.

For legacy quinolone brands tied to older molecules:

  • use becomes narrower
  • empirical prescribing declines
  • and susceptibility testing determines value, which reduces total addressable volume.

Market implication: NEGGRAM’s financial trajectory is more likely to show volume erosion with partial stabilization in niches rather than expansion.


Financial trajectory framework for NEGGRAM (actionable model)

For business planning, NEGGRAM’s financial outcomes typically depend on three measurable drivers:

1) Formulary and policy sensitivity

Track:

  • inclusion status in hospital formularies,
  • outpatient prescribing restrictions,
  • antibiogram trends affecting suitability.

2) Pricing and tender mechanics

Track:

  • unit price movements in tender procurement,
  • share of lowest-cost bids,
  • replacement by alternative antibiotics in tenders.

3) Supply and compliance execution

Track:

  • manufacturing disruptions and import lead times,
  • registration renewals by market,
  • regulatory quality inspections affecting availability.

Expected outcome if these drivers move in a negative direction: margins and revenues drift downward with intermittent stabilization.


Key Takeaways

  • NEGGRAM is a legacy antibacterial brand tied to nalidixic acid, and its market is shaped by stewardship, resistance patterns, and generic substitution.
  • Demand typically contracts as guidelines shift away from older quinolone placement and as susceptibility-guided use limits empirical prescriptions.
  • Pricing power is structurally weak under generic commoditization; revenue can persist mainly through formulary access and procurement share rather than differentiated clinical value.
  • Financial trajectory typically shows volume decline with margin compression, and earnings stability is increasingly determined by tender cycles and policy/formulary decisions.

FAQs

1) What type of market does NEGGRAM operate in?

A mature, generic-heavy antibiotic market where prescribing and procurement decisions depend on guideline placement, resistance, and cost.

2) What is the main demand headwind for NEGGRAM?

Antibiotic stewardship and guideline shifts that reduce routine use of older quinolones, plus resistance-driven limits on empirical effectiveness.

3) How does generic competition affect NEGGRAM pricing?

It compresses pricing because many alternatives offer the same active ingredient at lower prices, forcing brands to compete on cost and availability.

4) What segment can keep NEGGRAM sales from collapsing?

Often institutional procurement where it remains on formulary for cost or for narrow susceptibility-defined use.

5) What determines NEGGRAM profitability the most?

Tender pricing and procurement share, since brand-level differentiation is limited and margins erode under competitive bidding.


References (APA)

[1] World Health Organization. (2019). WHO antibacterial agents in clinical development. World Health Organization.
[2] World Health Organization. (2024). Global antimicrobial resistance and use surveillance system (GLASS) report. World Health Organization.

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