Key Features
Methylphenidate ER 72-mg (methylphenidate HCl) extended-release tablets are generic for branded methylphenidate HCl extended-release tablets.2 Consider these features:
- CONVENIENT – one 72-mg tablet daily vs two 36-mg tablets daily
- FEWER TABLETS (30 vs 60) – may reduce out-of-pocket costs when prescription plans impose a monthly quantity limit of 30 tablets of methylphenidate
- CONSISTENT – each fill has a consistent appearance from the same manufacturer
- GENERIC – may enhance access and affordability
Do you have similar ADHD patients in your practice?

Diagnosis: ADHD
Current Medications: (2x36-mg) methylphenidate ER tablets daily
Situation: Patient and parents may prefer the convenience of taking one 72-mg tablet daily vs two 36-mg tablets daily.

Diagnosis: ADHD
Current Medications: (2x36-mg) methylphenidate ER tablets daily
Situation: The patient’s prescription plan imposes a monthly quantity limit of 30 tablets of methylphenidate, incurring higher out-of-pocket costs.

Diagnosis: ADHD and generalized anxiety disorder
Current Medications: (2x36-mg) methylphenidate ER tablets daily and medications for anxiety
Situation: Patient switched from branded methylphenidate HCl extended-release tablets to a generic methylphenidate extended-release product to reduce out-of-pocket costs. She is now concerned about receiving tablets that vary in shape, size, and color from fill to fill. She prefers a consistent-looking product produced from the same manufacturer with each fill.

Diagnosis: ADHD
Current Medications: Patient started on 18-mg of methylphenidate ER 6 months ago and has recently titrated in weekly 18-mg increments to 54-mg daily
Situation: ADHD symptoms have improved, but a dose adjustment may provide better control. Patient requires titration to 72-mg daily but is resistant to taking a second tablet.
Not actual patients. Fictionalized for illustrative purposes.
Osmodex® – Drug delivery system
Osmotic Delivery Technology similar to branded methylphenidate HCl extended-release tablets1,2

Osmotic pressure delivers methylphenidate at a controlled release rate throughout the day1,2
- The immediate-release drug layer dissolves within one hour of administration
- The rate-controlling semipermeable membrane controls the rate at which water enters the tablet core
- The push layer in the tablet core expands and pushes drug through the laser-drilled orifice at a controlled release rate throughout the day
The only product to demonstrate bioequivalence to two 36-mg branded methylphenidate HCl extended-release tablets2
Pharmacokinetic study of mean methylphenidate plasma concentration over time — Administration of one Methylphenidate ER 72-mg tablet vs two 36-mg branded methylphenidate HCl extended-release tablets2
Per revised FDA guidance in 2014,
additional bioequivalence metrics are required to ensure that a new methylphenidate ER alternative is therapeutically equivalent to branded methylphenidate HCl extended-release tablets.3
Metrics
Cmax
AUC(0-∞)
AUC(0-3)
AUC(3-7)
AUC(7-12)
Meets FDA Bioequivalence Criteria
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A single-dose, two-treatment, four-period, two-sequence, fully replicated crossover study was conducted in 60 healthy volunteers to compare one Methylphenidate ER 72-mg tablet to two 36-mg branded methylphenidate HCl extended-release tablets.2