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NONMEM license cost and NONMEM software pricing, from 12 FDA awards to ICON

ICON publishes no price for NONMEM. Twelve FDA awards show what the license actually costs, how rarely it moved, and what else a population PK stack needs.

28 September 2026 8 min read Buying

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Sample output Ciprofloxacin Fluoroquinolone
Worked example, replaced when you run
Strain MIC (µg/mL) Call Resistance risk Conf.
S. aureus (MRSA) 0.5->32 R Resistant target mutation, grlA and gyrA Fluoroquinolone resistance is widespread in methicillin resistant lineages.
E. coli <=0.015-0.06 S Susceptible efflux, AcrAB-TolC in resistant isolates Potent against wild type; qnr carriage and gyrA changes shift the band sharply.
K. pneumoniae (CRE) 0.5->64 R Resistant gyrA mutation with plasmid qnr Carbapenemase producing isolates almost always carry quinolone resistance too.
A. baumannii 8->64 R Resistant efflux, AdeABC Constitutive efflux plus target changes leave little room at achievable exposure.
P. aeruginosa 0.25-2 I Intermediate efflux, MexAB-OprM Borderline: active on many isolates, lost quickly once efflux is derepressed.
E. faecium (VRE) 4->32 R Resistant target mutation, parC Enterococci are intrinsically poor fluoroquinolone targets.

Why

Ciprofloxacin is a well characterised fluoroquinolone, so the Gram-negative bands are strongly supported by published activity data. The deciding factor across this panel is not target affinity but exposure: efflux in P. aeruginosa and A. baumannii, and acquired target mutation everywhere resistance is already common. Against a modern ESKAPE panel it reads as a Gram-negative agent with two reliable losses.

Closest published analogs

  • Levofloxacin Broadly similar Gram-negative bands, better Gram-positive coverage
  • Delafloxacin Retains activity against many ciprofloxacin resistant staphylococci
Strain MIC (µg/mL) Call Resistance risk Conf.

Why

Closest published analogs

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Computational prediction from published literature. Research use only, not a lab measurement and not clinical guidance.

ICON publishes no price for NONMEM. Its licensing FAQ says a NONMEM and PDx-Pop license is effective for one year, that renewal quotes go out about 90 days before expiry, and that you get a license by emailing the software team. There is no figure, no tier and no per user rate anywhere on it. What turns up in a search for the price is a university installation slide deck, a couple of tender aggregators and some scraped spam pages.

The FDA, though, has licensed NONMEM for its clinical pharmacology reviewers for well over a decade, and every one of those awards is public. Twelve of them name a NONMEM license, from 2010 to 2023. They are signed numbers, and they happen to form the cleanest pricing series we have found for any software in this category.

The short answer

The FDA paid $10,000 a year for its NONMEM license for seven consecutive annual awards, from 2013 to 2019, then $10,900 in 2021 and again in 2022. Before that the same license cost $5,050 in 2010 and $7,000 in 2011. Government buyers order against their own price terms, so treat these as a floor for a commercial quote rather than a forecast, but they are the only NONMEM license figures in the public record, and they show a vendor that holds a rate for years at a time.

One license, renewed every July

Almost every term in the run ends on July 14. That shared anniversary is what makes this one continuing agreement rather than eleven unrelated purchases. The awards are written to ICON Development Solutions until 2016 and to ICON Clinical Research LLC after that, which is the same NONMEM business under a different ICON entity. One further award in 2016, described as a renewal of an enterprise NONMEM license, is recorded at zero dollars and is left out of the table.

Term How the award describes it Amount Change
Sep 2010 to Jul 2011 Annual license renewal for NONMEM software $5,050 Baseline
Sep 2011 NONMEM annual software renewal $7,000 Up 38.6 percent
Aug 2013 to Jul 2014 OCP NONMEM software license $10,000 Up 42.9 percent on 2011
Jul 2014 to Jul 2015 NONMEM software license renewal $10,000 Flat
Apr 2015 to Jul 2016 NONMEM software license renewal $10,000 Flat
Jul 2016 to Jul 2017 NONMEM license renewal $10,000 Flat
Jun 2017 to Jul 2018 NONMEM licenses, FY 17 $10,000 Flat
Jul 2018 to Jul 2019 NONMEM software for clinical pharmacology reviewers and pharmacometricians $10,000 Flat
Jul 2019 to Jul 2020 NONMEM software, same wording $10,000 Flat
May 2021 to Jul 2022 CDER NONMEM license renewal, FY 21 $10,900 Up 9.0 percent
Jul 2022 to Jul 2023 CDER software license renewal for ICON NONMEM, FY 22 $10,900 Flat

Two things stand out. The early steps were steep: the license roughly doubled between 2010 and 2013. Then it sat at exactly $10,000 for seven years, and the one increase after that was 9 percent, held flat again the following year. Over the whole flat stretch, a license that did not move while prices generally rose was getting cheaper every year in real terms. If you are holding a NONMEM renewal with an increase on it, that is the comparison to put in the reply.

The 90 day quote window matters as much as the number. ICON sends the renewal quote about three months before the license lapses, and it takes payment by wire, ACH or card. At a company that renews a dozen scientific licenses a year, a quote that sits in a shared inbox past its anniversary is how a modeling group loses a working week, which is why routing those invoices through accounts payable software with approval deadlines tends to matter more than the few hundred dollars anyone argues about.

What the license does not include

A NONMEM license buys the estimation engine. It does not buy a working modeling environment on its own, and the rest of the stack is where a first time buyer's budget usually slips.

  • A Fortran compiler. NONMEM compiles each model, so it needs a Fortran compiler on the machine or cluster that runs it. Many groups use the free GNU compiler; some prefer a commercial one.
  • PDx-Pop. ICON's own graphical interface. ICON licenses NONMEM and PDx-Pop together on the same one year term, and its FAQ is explicit that PDx-Pop needs NONMEM installed to run.
  • Run management and diagnostics. Most teams add tools such as PsN and Pirana. Certara says it gives Pirana free for academic use, and the NIH bought Phoenix and Pirana licenses together for $16,441 in December 2024.
  • Compute. Parallel estimation spreads a model across cores, so a heavy user ends up paying for a server or cloud capacity as well as the license.
  • Training. The FDA itself paid ICON $18,000 in 2021 for online NONMEM workshops, separately from the license. NONMEM's control stream syntax is not something a new hire picks up in a week.

NONMEM against Phoenix NLME, on the same evidence

The usual commercial alternative for population PK is Certara's Phoenix NLME, and it has a public price trail too. An annual NLME node license cost $6,620 at the NIH in 2014, an NLME node cost $10,832 at the Army in 2012, and a 2020 NIH order for one WinNonlin and one NLME named user seat together came to $11,218. So the two sit in the same range for a single license, and the real difference is the workflow: NONMEM is code first and runs alongside separately sourced tools, while Phoenix wraps NLME in the same graphical platform most PK groups already use for noncompartmental analysis. Our Phoenix WinNonlin price breakdown has the full Certara record, from single named user seats to the FDA's server agreement.

If the population model you are budgeting for sits on top of a physiologically based one, the Simcyp Simulator price record covers that layer, and the drug discovery software cost pillar puts every vendor we have priced side by side.

Where NONMEM stops for an antibacterial program

Population PK is how antibacterial doses get chosen. A NONMEM model of clearance and volume across patients feeds a Monte Carlo simulation, and the output that matters is the probability of target attainment: the share of simulated patients whose free drug exposure clears a PK/PD target, such as AUC over MIC or time above MIC, at each MIC value. That calculation is only as good as the MIC it is run against. NONMEM fits the exposure with real rigor; it does not tell you what concentration inhibits Klebsiella or Acinetobacter.

That is the part we sell, and it comes first. Before a compound earns a population model, somebody has to know which organisms it is active against and roughly at what concentration. A pre-trained antibacterial model returns a predicted MIC band per strain across the ESKAPE panel in about ten seconds, with the mechanism class and the closest published analogs. Lab is $149 a month, which is $1,788 across a year, against a NONMEM license the FDA last paid $10,900 a year for. Run the compounds you already know through the tool above, check the bands against your own assay data, and spend modeling time only on the ones that pass.

Questions people ask before buying

How much does a NONMEM license cost?

ICON publishes no price. The FDA's own NONMEM license, renewed every July, cost $10,000 a year for seven consecutive annual awards from 2013 to 2019 and $10,900 a year in 2021 and 2022, after starting at $5,050 in 2010. Those are government figures, so a commercial quote should be expected to start higher rather than lower.

Is NONMEM a one time purchase or a subscription?

A subscription. ICON's licensing FAQ states that a NONMEM and PDx-Pop license is effective for one year, and renewal quotes are sent about 90 days before the license expires. Every FDA award in the public record is an annual renewal of that kind, which is why the same license appears in the record year after year.

How do I buy a NONMEM license?

ICON's FAQ says to email its software licensing team, complete the license agreement and pay, after which you receive the program information to install it. Payment is accepted by wire transfer, ACH or credit card. There is no online checkout and no public price, so the first step is always a quote request.

Is NONMEM cheaper than Phoenix NLME?

They overlap on the public evidence. The FDA paid $10,000 to $10,900 a year for NONMEM, while Phoenix NLME node licenses cost $6,620 and $10,832 in federal awards from 2012 and 2014. The larger cost difference is usually what surrounds the engine: NONMEM needs a Fortran compiler, run management tools and training, while Phoenix NLME comes inside a graphical platform.

Does NONMEM predict antibacterial activity?

No. NONMEM estimates pharmacokinetic and pharmacodynamic model parameters from measured data. For an antibacterial, dose selection compares the exposure it models with the MIC of each organism, and that MIC has to come from a susceptibility assay or from a model trained on antibacterial activity.

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