drug

Quillivant XR

Marketedupdated 2mo ago

by Tris Pharma Inc

Approved

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Patent cliff

source: FDA Orange Book

first barrier falls

Mar 29, 2029

~2.7 years out

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

patents (7)

Feb 15, 2031formulationUS 82879034.6y
Feb 15, 2031formulationUS 84657654.6y
Feb 15, 2031formulationUS 85630334.6y
Feb 15, 2031formulationUS 87783904.6y
Feb 15, 2031formulationUS 89566494.6y
Feb 15, 2031formulationUS 90400834.6y
Mar 29, 2029formulationUS 80626672.7y

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Data sources

ClinicalTrials.gov

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top 8

Trials studying Quillivant XR

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