Summary
Only the abuse/misuse/addiction-related content is directly supported by the provided labeling excerpts; the remaining claims provided (patent/ownership/manufacturer, indication age, formulation, and DREAM technology/mechanism) are not supported or contradicted by the supplied prescribing-information excerpts.
Category Scores
Accurate Statements
JORNAY PM has a high potential for abuse and misuse, which can lead to substance use disorder/addiction, and misuse/abuse can result in overdose and death, with increased risk at higher doses or unapproved methods such as snorting or injection.
Supported by provided excerpts: Boxed Warning; 5.1 Abuse, Misuse, and Addiction; 9.2 Abuse; and Patient Counseling (17).
Unsupported Statements
A generic version of Jornay PM in 2026 is uncertain due to patent protection.
No patent-expiration or generic-availability information is present in the supplied prescribing-information excerpts.
U.S. Patent No. 11,160,759 for Jornay PM is listed as expiring on February 20, 2031.
Patent listing/expiration dates are not provided in the supplied prescribing-information excerpts.
U.S. Patent No. 11,497,802 for Jornay PM is set to expire on February 20, 2031.
Patent listing/expiration dates are not provided in the supplied prescribing-information excerpts.
Jornay PM is manufactured by Ironshore Pharmaceuticals.
Manufacturer information is not provided in the supplied prescribing-information excerpts.
Jornay PM is prescribed for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in individuals aged 6 years and older.
The supplied excerpts concern abuse/misuse/addiction and do not include the approved indication or age range.
Jornay PM is a once-daily, extended-release capsule.
The supplied excerpts do not include dosage form or dosing frequency details.
Jornay PM uses delayed-release, extended-release (DREAM) technology.
The supplied excerpts do not include technology/mechanism (e.g., DREAM) descriptions.
Jornay PM’s DREAM technology allows administration in the evening for symptom control the following day.
The supplied excerpts do not include administration timing rationale or symptom-onset timing descriptions.
Contradictions
Important Omissions
No missing safety/boxed-warning details are identified as omissions for the abuse/misuse claim, because the provided labeling excerpts already cover that topic and the AI response does not attempt to add beyond them. Other claims (indication/age, formulation, DREAM technology, manufacturer, patent dates) cannot be evaluated against label text because the label excerpts supplied do not contain that information.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
The only directly label-supported content pertains to abuse/misuse/addiction and overdose risk; other claims about indication, age, and administration/technology are not supported by the provided labeling excerpts, limiting confidence and increasing the chance of inaccurate label-alignment for those topics.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Mostly Unaligned
Primary Issue
Only abuse/misuse/addiction content is supported by the provided labeling excerpts; other claims (patent status, manufacturer, indication/age, formulation/frequency, and DREAM technology/administration timing) are not supported by the supplied excerpts.
Suggested Improvement
Limit assertions to label-supported sections present in the provided excerpts (5.1, 9.2, Boxed Warning, 17). For indication/age, dosage form/frequency, and administration/technology (DREAM), provide label excerpts that include those exact statements before claiming alignment.