Granted Patent
B2
US 12,383,506 · App. 18/416,548 · Granted Aug 12, 2025
Compositions for treatment of attention deficit hyperactivity disorder
A61K9/5073A61K9/0053A61K9/1676A61K9/4808A61K9/4866A61K9/5015A61K9/5026A61K9/5042A61K9/5047A61K9/5078A61K9/5084A61K31/137A61K31/4458
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Abstract
Therapeutic compositions deliver a therapeutic amount of methylphenidate in a delayed and extended release formulation. The dosage form exhibits a lag time prior to release of from 6 to 8 hours or longer, followed by a sustained release period.
Claims (13)
1. A solid, oral pharmaceutical composition comprising a plurality of particles, each of the particles comprising:
a core comprising an effective amount of methylphenidate or a pharmaceutical salt thereof;
a sustained release layer; and
a delayed release layer;
wherein the composition comprising the plurality of particles provides at least a 6 hour lag time during which the composition releases no more than 5% of the total methylphenidate or a pharmaceutical salt thereof followed by a sustained release period with a median T max of about 12-16 hours when administered to healthy adults.
2. The composition of claim 1 , wherein the composition provides at least an 8 hour lag time during which the composition releases no more than about 5% of the total methylphenidate or pharmaceutical salt thereof.
3. The composition of claim 1 , wherein the composition provides at least a 10 hour lag time during which the composition releases no more than 10% of the total methylphenidate or a pharmaceutical salt thereof.
4. The solid, oral pharmaceutical composition of claim 1 , wherein the composition is contained in a capsule.
5. The solid, oral pharmaceutical composition of claim 1 , wherein the composition provides pediatric or adolescent subjects having Attention Deficit Hyperactivity Disorder (ADHD) with a significant improvement compared to a placebo in Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP) combined scores for a period from about 11 hours through about 23 hours after administration in the evening.
6. The solid, oral pharmaceutical composition of claim 1 , wherein the composition provides pediatric or adolescent subjects having Attention Deficit Hyperactivity Disorder (ADHD) with a significant improvement compared to a placebo in ADHD Rating Scale (ADHD-RS-IV) Total Score, Before School Functioning Questionnaire (BSFQ) score, and/or Parent Rating of Evening and Morning Behavior-Revised (PREMB-R AM) score when administered in the evening.
7. The solid, oral pharmaceutical composition of claim 1 , wherein the composition comprises 20 mg, 40 mg, 60 mg, 80 mg or 100 mg of methylphenidate or a pharmaceutical salt thereof.
8. The solid, oral pharmaceutical composition of claim 1 , wherein, following the lag time, the remaining methylphenidate or a pharmaceutical salt thereof that is released from the composition is released during the sustained release period.
9. The solid, oral pharmaceutical composition of claim 1 , wherein when administered to a subject having Attention Deficit Hyperactivity Disorder (ADHD), the composition provides an improvement in an ADHD related behavior or cognitive ability.
Assignments (7)
RELEASE OF SECURITY INTEREST
Recorded Dec 23, 2025
From: BIOPHARMA CREDIT PLC
To: IRONSHORE PHARMACEUTICALS & DEVELOPMENT, INC.
Reel/Frame 073308/0416 →
SECURITY INTEREST
Recorded Dec 23, 2025
From: COLLEGIUM PHARMACEUTICAL, INC.; BIODELIVERY SCIENCES INTERNATIONAL, INC.; IRONSHORE PHARMACEUTICALS & DEVELOPMENT, INC.
To: TRUIST BANK, A NORTH CAROLINA CHARTERED BANK
Reel/Frame 073302/0334 →
PATENT SECURITY AGREEMENT
Recorded Sep 3, 2024
From: IRONSHORE PHARMACEUTICALS & DEVELOPMENT, INC.
To: BIOPHARMA CREDIT PLC
Reel/Frame 068826/0711 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jan 22, 2024
From: HIGHLAND THERAPEUTICS INC.
To: IRONSHORE PHARMACEUTICALS & DEVELOPMENT, INC.
Reel/Frame 066197/0263 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jan 22, 2024
From: ZHANG, FENG
To: FORMULATION TECHNOLOGIES, LLC DBA PHARMAFORM
Reel/Frame 066196/0493 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jan 22, 2024
From: LICKRISH, DAVID
To: IRONSHORE PHARMACEUTICALS & DEVELOPMENT, INC.
Reel/Frame 066196/0263 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jan 22, 2024
From: FORMULATION TECHNOLOGIES, LLC DBA PHARMAFORM
To: HIGHLAND THERAPEUTICS INC.
Reel/Frame 066196/0986 →
Continuity (14)
Provisional Application
61591129
· Jan 26, 2012
Provisional Application
61561763
· Nov 18, 2011
Provisional Application
61466684
· Mar 23, 2011
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