Last reviewed 2026-06-01 · How we verify

Concerta EG formulation

Janssen Research & Development, LLC · Phase 2 active Small molecule ✓ Verified Jun 2026

Concerta EG formulation is a Central Nervous System Stimulant Small molecule drug developed by Janssen Research & Development, LLC. It is currently in Phase 2 development for Attention Deficit Hyperactivity Disorder (ADHD). Also known as: Methylphenidate.

Methylphenidate acts as a norepinephrine-dopamine reuptake inhibitor.

Concerta EG is a formulation of the small molecule methylphenidate, used to treat Attention Deficit Disorder With Hyperactivity. It is a generic version of Concerta, which is also available in an AG formulation.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
Big-pharma sponsor +3.0pp
Janssen Research & Development, LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Concerta EG formulation
Also known as	Methylphenidate
Sponsor	Janssen Research & Development, LLC
Drug class	Central Nervous System Stimulant
Target	Norepinephrine transporter
Modality	Small molecule
Therapeutic area	Neurology
Phase	Phase 2

Mechanism of action

Methylphenidate increases the levels of norepinephrine and dopamine in the brain by preventing their reuptake, which improves attention and impulse control.

Approved indications

Attention Deficit Hyperactivity Disorder (ADHD)

Common side effects

Insomnia
Headache
Nausea
Vomiting
Abdominal Pain
Dizziness
Fatigue
Anxiety
Irritability
Aggression

Key clinical trials

Concerta (Methylphenidate) -To-Generic Switch Study

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Concerta EG formulation CI brief — competitive landscape report
Concerta EG formulation updates RSS · CI watch RSS
Janssen Research & Development, LLC portfolio CI

Frequently asked questions about Concerta EG formulation

What is Concerta EG formulation?

Concerta EG formulation is a Central Nervous System Stimulant drug developed by Janssen Research & Development, LLC, indicated for Attention Deficit Hyperactivity Disorder (ADHD).

How does Concerta EG formulation work?

Methylphenidate acts as a norepinephrine-dopamine reuptake inhibitor.

What is Concerta EG formulation used for?

Concerta EG formulation is indicated for Attention Deficit Hyperactivity Disorder (ADHD).

Who makes Concerta EG formulation?

Concerta EG formulation is developed by Janssen Research & Development, LLC (see full Janssen Research & Development, LLC pipeline at /company/johnson-johnson).

Is Concerta EG formulation also known as anything else?

Concerta EG formulation is also known as Methylphenidate.

What drug class is Concerta EG formulation in?

Concerta EG formulation belongs to the Central Nervous System Stimulant class. See all Central Nervous System Stimulant drugs at /class/central-nervous-system-stimulant.

What development phase is Concerta EG formulation in?

Concerta EG formulation is in Phase 2.

What are the side effects of Concerta EG formulation?

Common side effects of Concerta EG formulation include Insomnia, Headache, Nausea, Vomiting, Abdominal Pain, Dizziness.

What does Concerta EG formulation target?

Concerta EG formulation targets Norepinephrine transporter and is a Central Nervous System Stimulant.

Drug class: All Central Nervous System Stimulant drugs
Target: All drugs targeting Norepinephrine transporter
Manufacturer: Janssen Research & Development, LLC — full pipeline
Therapeutic area: All drugs in Neurology
Indication: Drugs for Attention Deficit Hyperactivity Disorder (ADHD)
Also known as: Methylphenidate

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing