Approval status of ADHD drugs

• 1. Approval status of ADHD drugs in Germany
• 2. Approval status of ADHD drugs in France
• 3. Approval status of ADHD medications in the USA
  • 3.1. Methylphenidate approval in the USA
    • 3.1.1. Methylphenidate immediate release
    • 3.1.2. Methylphenidate half-day retard
    • 3.1.3. Methylphenidate all-day retard
  • 3.2. Amphetamine drugs, approval in the USA
    • 3.2.1. Amphetamine drugs immediate release
    • 3.2.2. Amphetamine medications semi-delayed
    • 3.2.3. Amphetamine drugs all-day retarded / all-day effect
  • 3.3. Noradrenaline reuptake inhibitor for ADHD, approval in the USA
  • 3.4. Alpha receptor agonists for ADHD, approval in the USA

1. Approval status of ADHD drugs in Germany¶

In Germany, the following substances are approved for the treatment of ADHD:¹

Active ingredient	Children and adolescents - approval	Adults - approval
Methylphenidate immediate release	Ritalin® immediate release; Methylphenidate HEXAL®; Methylpheni TAD® immediate release; various generics	off label only
Methylphenidate sustained release	Medikinet sustained release; Ritalin LA, Equasym, Methysym (since 2021)	Medikinet Adult; Ritalin Adult; Kinecteen (since 2023); Concerta (treatment continuation only)
Lisdexamphetamine (delayed release of D-Amp)	Vyvanse, various generics	Vyvanse adult (homogenization with Vyvanse in 2024), various generics
D-amphetamine immediate release	Attentin	only off label
Atomoxetine	Strattera, Agakalin	Strattera, Agakalin
Guanfacine	Intuniv	off label only

The Institute for Quality and Efficiency in Health Care (IQWiG), in the resolution of the Federal Joint Committee² and the Drug Commission of the German Medical Association (AkdÄ)³ found no additional benefit for lisdexamfetamine (Vyvanse) compared to a multimodal therapy consisting of behavioral therapy and methylphenidate.
This decision may have legal reasons. From a scientific point of view, it is not comprehensible and should therefore be clearly criticized.

35 % of people with ADHD are MPH nonresponders. In the case of amphetamine medication, only 25% are non-responders. In addition, the group of non-responders is not congruent, so that even among the 35% of people with ADHD for whom MPH does not work (sufficiently), only 25% of AMP does not have a sufficient effect - 75% , however, do, so that the MPH + AMP non-responder rate is only a good 8%.
Furthermore, lisdexamfetamine (EU: Vyvanse) shows an Effect size of up to 1.5, compared to 0.9 to 1.1 for MPH, with lower side effects.
Finally, compared to sustained release MPH preparations, lisdexamfetamine is virtually impossible to abuse as a drug. Especially for people with ADHD who have previously used addictive substances for self-medication, treatment with a drug that is highly effective in combating ADHD and at the same time has a much lower risk of abuse is a great advantage.

According to the updated European consensus on the diagnosis and treatment of ADHD in adults, amphetamine medication is the first choice of medication in adults and MPH is the second choice, while in children the order of priority is reversed. This description is consistent with our experience.

2. Approval status of ADHD drugs in France¶

In France, methylphenidate is approved for children and can be prescribed to adults if they were given methylphenidate as a child. In view of the decades of knowledge that ADHD persists in around 2/3 of people with ADHD in adulthood, this is extremely surprising and very regrettable for those persons with ADHD who had the misfortune of not being diagnosed and treated as a child.
Initial prescription to adults appears to be possible in the context of off-label use⁴

Overall, the diagnosis and treatment of ADHD in France appears to be decades out of date.

3. Approval status of ADHD medications in the USA¶

As of January 2023, the following ADHD medications are approved in the USA:⁵

Active ingredient	Authorization
Dexmepthyl phenidate immediate release	Focalin®
Dexmepthylhenidate sustained release	Focalin® XR
Methylphenidate immediate release	Methylin®, Ritalin®, Metadate CD®
Methylphenidate Half-Day Retard	Metadate® ER, Methylin® ER, QuilliChew ER™, Quillivant XR®, Ritalin LA®
Methylphenidate all-day retard	Adhansia XR™, Azstarys™, Aptensio XR™, Concerta®, Cotempla™XRODT, Daytrana®, Focalin XR®, Jornay PM™
Amphetamine drugs with immediate release	Adderall ®, Desoxyn®, Dexedrine®, Evekeo®, Evekeo ODT ™, ProCentra®, Zenzedi®
Amphetamine medication Half-day retard	Dexedrine®
Amphetamine medication all-day retard / all-day effect	Adderall XR®, Adzenys ER, Adzenys XR-ODT™, Dexedrine Spansule®, Dyanavel® XR, Dyanavel® XR, Mydayis™, Vyvanse® chewable tablet, Vyvanse® capsule, Xelstrym™
Noradrenaline reuptake inhibitors	Strattera (atomoxetine), Qelbree™ (viloxazine)
Alpha receptor agonists	Kapvay® (clonidine), Intuniv (guanfacine)

3.1. Methylphenidate approval in the USA¶

3.1.1. Methylphenidate immediate release¶

• Focalin®
  • Dexmethylphenidate (hydrochloride)
  • Tablet
  • 3 to 5 hours
  • 2.5 mg, 5 mg, 10 mg
• Methylin® Oral Solution
  • Methylphenidate (hydrochloride)
  • Liquid
  • 3 to 5 hours
  • 5 mg/5 ml, 10 mg/5 ml
• Ritalin®
  • Methylphenidate (hydrochloride)
  • Tablet
  • 3 to 5 hours (in practice usually 2.5 to 3.5 hours)
  • 5 mg, 10 mg, 20 mg

3.1.2. Methylphenidate half-day retard¶

• Metadate CD®
  • Methylphenidate (hydrochloride)
  • prolonged release
  • Capsule
  • 8 hours
  • 10 mg, 20 mg, 30 mg, 50 mg
• Metadate® ER
  • Methylphenidate (hydrochloride)
  • prolonged release
  • Tablet
  • 8 to 12 hours
  • 20 mg
• Methylin® ER
  • Methylphenidate (hydrochloride)
  • prolonged release
  • Tablet
  • 8 hours
  • 10 mg, 20 mg
• QuilliChew ER™
  • Methylphenidate (hydrochloride)
  • prolonged release
  • Chewable tablet
  • 8 to 12 hours
  • 20 mg, 30 mg, 40 mg
• Quillivant XR®
  • Methylphenidate (hydrochloride)
  • prolonged release
  • Liquid
  • 8, 10 and 12 hours
  • 25 mg/ 5ml (5 mg/ml)
• Ritalin LA®
  • Methylphenidate (hydrochloride)
  • prolonged release
  • Capsule
  • 8 hours
  • 10 mg, 20 mg, 30 mg, 40 mg

3.1.3. Methylphenidate all-day retard¶

• Adhansia XR™
  • Methylphenidate (hydrochloride)
  • prolonged release
  • Capsule
  • 16 hours
  • 25 mg, 35 mg, 45 mg, 55 mg, 70 mg, 85 mg
• Azstarys™
  • Serdexmethylphenidate and dexmethylphenidate
  • Capsule
  • 10 hours
  • 26.1 mg/5.2 mg; 39.2 mg/7.8 mg; 52.3 mg/10.4 mg
• Aptensio XR™
  • Methylphenidate (hydrochloride)
  • prolonged release
  • Capsule
  • 12 hours
  • 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
• Concerta®
  • Methylphenidate (hydrochloride)
  • prolonged release
  • Tablet (OROS)
  • 10 to 12 hours
  • 18mg 27mg 36mg 54mg 72mg
• Cotempla™XRODT
  • Methylphenidate
  • prolonged release
  • Tablet disintegrating in the mouth
  • 8 to 12 hours
  • 8.6 mg, 17.3 mg, 25.9 mg
• Daytrana®
  • Methylphenidate
  • Transdermal patch
  • 10 to 16 hours
  • 10 mg, 15 mg, 20 mg, 30 mg
• Focalin XR®
  • Dexmethylphenidate (hydrochloride)
  • prolonged release
  • Capsule
  • 12 hours
  • 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg
• Jornay PM™
  • Methylphenidate (hydrochloride)
  • prolonged release
  • Capsule
  • 12+ hours
  • 20 mg, 40 mg, 60 mg, 80 mg, 100 mg

3.2. Amphetamine drugs, approval in the USA¶

3.2.1. Amphetamine drugs immediate release¶

• Adderall ®
  • Amphetamines and dextroamphetamine (mixed salts)
  • Tablet
  • 4 to 8 hours
  • 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, 30 mg
• Desoxyn®
  • Methamphetamine (hydrochloride)
  • Tablet
  • 4 to 8 hours
  • 5 mg
• Dexedrine®
  • Dextroamphetamine (sulfate)
  • Tablet
  • 4 to 6 hours
  • 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg
• Evekeo®
  • Amphetamine (sulfate)
  • Tablet
  • 4 to 7 hours
  • 5 mg, 10 mg
• Evekeo ODT ™
  • Amphetamine (sulfate)
  • Tablet disintegrating in the mouth
  • 4 to 6 hours
  • 5 mg, 10 mg, 15 mg, 20 mg
• ProCentra®
  • Dextroamphetamine sulfate
  • Liquid
  • 4 to 8 hours
  • 5 mg/5 ml
• Zenzedi®
  • Dextroamphetamine sulfate
  • Tablet
  • 4 to 8 hours
  • 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg

3.2.2. Amphetamine medications semi-delayed¶

• Dexedrine®
  • Dextroamphetamine (sulfate)
  • prolonged release
  • Tablet
  • 6 to 9 hours
  • 15 mg

3.2.3. Amphetamine drugs all-day retarded / all-day effect¶

• Adderall XR®
  • Amphetamine and dextroamphetamine (mixed salts)
  • prolonged release
  • Capsule
  • 8 to 12 hours
  • 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg
• Adzenys ER
  • Amphetamine
  • prolonged release
  • Oral suspension
  • 9 to 12 hours
  • 3.1 mg/ 2.5 ml; 6.3 mg/5 ml; 9.4 mg/7.5 ml; 12.5 mg/10 ml; 15.7 mg/12.5 ml; 18.8 mg/15 ml
• Adzenys XR-ODT™
  • Amphetami
  • prolonged release
  • tablet disintegrating in the mouth
  • 9 to 12 hours
  • 3.1 mg, 6.3 mg, 9.4 mg; 12.5 mg; 15.7 mg, 18.8 mg
• Dexedrine Spansule®
  • Dextroamphetamine (sulfate)
  • prolonged release
  • Capsule
  • 8 to 12 hours
  • 15 mg
• Dyanavel® XR
  • Amphetamine
  • prolonged release
  • Tablet
  • 8 to 12 hours
  • 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg
• Dyanavel® XR
  • Amphetamine
  • prolonged release
  • Oral suspension
  • 8 to 12 hours
  • 2.5 mg/ml, 12.5 mg/tsp
• Mydayis™
  • Mixed salts of an amphetamine
  • prolonged release
  • Capsule
  • 16 hours
  • 12.5 mg, 25 mg, 37.5 mg, 50 mg
• Vyvanse®
  • Lisdexamfetamine (dimesylate)
  • Chewable tablet
  • 8 to 12 hours
  • 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
• Vyvanse®
  • Lisdexamfetamine (dimesylate)
  • Capsule
  • 10 to 12 hours
  • 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg
• Xelstrym™
  • Dextroamphetamine
  • Transdermal patch
  • 9 hours
  • 15 mg
  • 10 mg, 15 mg, 20 mg, 30 mg

3.3. Noradrenaline reuptake inhibitor for ADHD, approval in the USA¶

• Strattera®
  • Atomoxetine (hydrochloride)
  • Capsule
  • 24 hours
  • 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg
• Qelbree™
  • Viloxazine
  • prolonged release
  • Capsule
  • 24 hours
  • 100 mg, 150 mg, 200 mg

3.4. Alpha receptor agonists for ADHD, approval in the USA¶

• Kapvay®
  • Clonidine (hydrochloride)
  • Extended release
  • Tablet
  • 12 to 24 hours
  • 0.1 mg, 0.2 mg
• Intuniv®
  • Guanfacine (hydrochloride)
  • Extended release
  • Tablet
  • 12 to 24 hours
  • 1 mg, 2 mg, 3 mg, 4 mg