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Concerta
Concerta, marketed by Lei Lei, MD, is an established treatment for attention deficit hyperactivity disorder (ADHD). The drug's key strength lies in its well-established market presence, supported by a key composition patent that remains in effect until 2028. The primary risk to Concerta is the eventual patent expiry in 2028, which could lead to increased competition from generic alternatives.
At a glance
| Generic name | Concerta |
|---|---|
| Also known as | Methylphenidate Hydrochloride Extended-Release Tablets, methylphenidate hydrochloride, Methylphenidate, Methylphenidate HCL, Methylphenidate hydrochloride (HCl) |
| Sponsor | Lei Lei, MD |
| Target | Alpha-2A adrenergic receptor, Alpha-2B adrenergic receptor, Alpha-2C adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
- Attention deficit hyperactivity disorder
- Narcolepsy
Common side effects
- Anxiety
- Irritability
- Increased blood pressure
- Nervousness
- Insomnia
- Decreased appetite
- Tic
Serious adverse events
- Priapism
- Peripheral Vasculopathy, including Raynaud's Phenomenon
- Long-Term Suppression of Growth in Pediatric Patients
- Acute Angle Closure Glaucoma
- Increased Intraocular Pressure and Glaucoma
- Gastrointestinal Obstruction
- Hypersensitivity Reactions
- Abuse, Misuse, and Addiction
- Psychiatric Adverse Reactions
- Risks to Patients with Serious Cardiac Disease
Key clinical trials
- Orexin s Role in the Neurobiology of Substance Use Disorder (NA)
- The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome (PHASE4)
- Benefits of ADHD Treatment in Detained People (PHASE3)
- Methylphenidate to Address Attention and Executive Deficits Among Children With Sickle Cell Disease (PHASE1)
- A Trial to Assess How Centanafadine Interacts With Stimulants in the Body (PHASE1)
- Comorbidity Between Attention Deficit Hyperactivity Disorder and Fibromyalgia (NA)
- The Effect Of Methylphenıdate Treatment On Neuroınflammatıon Levels In Chıldren Wıth Attentıon Defıcıt Hyperactıvıty Dısorder
- Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy (PHASE2)
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 CI brief — competitive landscape report
- Concerta updates RSS · CI watch RSS
- Lei Lei, MD portfolio CI