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  1. pharmadog
  2. ›drugs
  3. ›Cotempla XR-ODT
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methylphenidate hydrochloride XR-ODT

Marketedupdated 3mo ago
by $AYTU AYTU BIOPHARMA, INC
Approved
community read0 votes

🐶 often sniffed alongside

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all catalysts(0)

nothing on the calendar yet

Trials studying methylphenidate hydrochloride XR-ODT

  • phase3Efficacy, Safety & Pharmacokinetic (PK) Study of HLD200 in Children Aged 4-5 Years With ADHDterminatedn=26
  • phase1Dexmethylphenidate Hydrochloride Tablets Under Fasting Conditionscompletedn=24
  • phase1Dexmethylphenidate Hydrochloride Tablets Under Non-Fasting Conditionscompletedn=24
  • phase4A 14 Week, Randomized, Placebo-Controlled Cross-Over Study of Methylphenidate Hydrochloride Controlled Release Capsules in Adult ADHD With and Without Anxiety Disorder Comorbiditycompletedn=60

Patent cliff

source: FDA Orange Book
first barrier falls
Jun 28, 2032
~5.9 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (12)

  • Jan 25, 2038method-of-use (U-3299)US 11166947
  • Jan 25, 2038method-of-use (U-3299)US 11166947
  • Jan 25, 2038method-of-use (U-3299)US 11166947
  • Jun 28, 2032formulationUS 9072680
  • Jun 28, 2032formulationUS 9072680
  • Jun 28, 2032formulationUS 9072680
  • Jun 28, 2032formulationUS 9089496
  • Jun 28, 2032formulationUS 9089496
  • Jun 28, 2032formulationUS 9089496
  • Jun 5, 2026formulationUS 8840924
  • Jun 5, 2026formulationUS 8840924
  • Jun 5, 2026formulationUS 8840924

News(0)

no news has mentioned this drug yet

brand
Cotempla XR-ODT
generic
methylphenidate hydrochloride
indication
Attention Deficit Hyperactivity Disorder (ADHD)
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 6m ago
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