JORNAY PM Drug Patent Profile

Which patents cover Jornay Pm, and when can generic versions of Jornay Pm launch?

Jornay Pm is a drug marketed by Ironshore Pharms and is included in one NDA. There are sixteen patents protecting this drug.

This drug has forty-one patent family members in fourteen countries.

The generic ingredient in JORNAY PM is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Jornay Pm

A generic version of JORNAY PM was approved as methylphenidate hydrochloride by SPECGX LLC on November 27^th, 1998.

Summary for JORNAY PM

International Patents:	41
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	1
Patent Applications:	4,201
Drug Prices:	Drug price information for JORNAY PM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JORNAY PM
What excipients (inactive ingredients) are in JORNAY PM?	JORNAY PM excipients list
DailyMed Link:	JORNAY PM at DailyMed

See drug prices for JORNAY PM

Recent Clinical Trials for JORNAY PM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
NYU Langone Health	PHASE4

See all JORNAY PM clinical trials

Pharmacology for JORNAY PM

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

US Patents and Regulatory Information for JORNAY PM

JORNAY PM is protected by sixteen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-005	Aug 8, 2018		RX	Yes	Yes	11,911,518
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-003	Aug 8, 2018		RX	Yes	No	11,241,391
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-002	Aug 8, 2018		RX	Yes	No	10,182,995		Y
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-004	Aug 8, 2018		RX	Yes	No	8,916,588
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-004	Aug 8, 2018		RX	Yes	No	11,241,392		Y
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-003	Aug 8, 2018		RX	Yes	No	9,283,214		Y

International Patents for JORNAY PM

See the table below for patents covering JORNAY PM around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	112013024401	Composição farmacêutica sólida oral compreendendo um ingrediente ativo estimulante do sistema nervoso central e o uso terapêutico da mesma
Japan	6043785
Brazil	112013024401	Composição farmacêutica sólida oral compreendendo um ingrediente ativo estimulante do sistema nervoso central e o uso terapêutico da mesma
South Korea	20160135373	주의력 결핍 장애의 치료를 위한 방법 및 조성물 (METHODS AND COMPOSITIONS FOR TREATMENT OF ATTENTION DEFICIT DISORDER)
Singapore	193587	METHODS AND COMPOSITIONS FOR TREATMENT OF ATTENTION DEFICIT DISORDER
Mexico	383127	METODOS Y COMPOSICIONES PARA EL TRATAMIENTO DE TRASTORNO POR DEFICIT DE ATENCION. (METHODS AND COMPOSITIONS FOR TREATMENT OF ATTENTION DEFICIT DISORDER)

Market Dynamics and Financial Trajectory of JORNAY PM

Last updated: July 27, 2025

Introduction

JORNAY PM (methylphenidate hydrochloride), developed by Supernus Pharmaceuticals, Inc., represents a notable advancement in the management of Attention Deficit Hyperactivity Disorder (ADHD). Approved by the FDA in 2021, JORNAY PM offers a unique formulation designed to enhance patient adherence and optimize symptom control through a controlled-release mechanism timed to evening administration. Analyzing the market dynamics and financial trajectory of JORNAY PM offers critical insights into its commercial potential, competitive positioning, and future growth prospects within the evolving ADHD therapeutic landscape.

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Market Overview and Therapeutic Context

ADHD remains a prevalent neurodevelopmental disorder, affecting approximately 6-9% of children and 4-5% of adults globally (CDC, 2022). Pharmacotherapy, especially stimulant medications like methylphenidate and amphetamines, constitutes the cornerstone of treatment. Conventional formulations often lead to compliance challenges due to dosing schedules and side effect profiles.

JORNAY PM targets a specific unmet need: providing a sustained symptom control during school and work hours through an evening dosing regimen. Its unique extended-release formulation leverages a controlled-release mechanism facilitating early morning symptom management. This positions JORNAY PM within a growing niche—long-acting, once-daily stimulants optimized for developmental and adherence considerations.

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Market Dynamics Influencing JORNAY PM

1. Competitive Landscape

The ADHD medication market is highly competitive, dominated by brands like Concerta, Vyvanse, Adderall XR, and the newer non-stimulants. JORNAY PM's primary differentiation lies in its evening dosing and timed-release profile.

• Innovative Positioning: JORNAY PM's ability to deliver early morning symptom relief aligns with patient and caregiver preferences, setting it apart from competitors with same-day dosing schedules.
• Market Penetration Challenges: Entrenched brand loyalty and the dominance of established generic formulations threaten uptake. Pharma companies face barriers in educating clinicians about the advantages of JORNAY PM's timing and efficacy.

2. Regulatory and Reimbursement Factors

Insurance coverage, formulary inclusion, and pricing strategies substantially influence market penetration. Relative pricing, licensing agreements, and reimbursement policies will determine accessibility and physician preferences.

• Pricing Considerations: As a branded product with a novel formulation, JORNAY PM likely commands a premium. However, generic competition for methylphenidate formulations could pressure prices.
• Regulatory Environment: Ongoing approval processes may expand indications (e.g., adult ADHD), broadening the market potential, while supply chain disruptions or regulatory delays could hinder growth.

3. Prescriber and Patient Acceptance

Physician familiarity with the drug’s pharmacokinetics, safety, and efficacy is crucial. Early adoption hinges on clinical trial data and real-world evidence demonstrating superior outcomes.

• Patient Preference: The convenience of evening dosing coupled with morning efficacy enhances patient adherence and satisfaction.
• Safety Profile: Favorable safety and tolerability data will influence prescriber confidence, especially in pediatric populations.

4. Market Size and Growth Projections

The global ADHD market is projected to reach USD 15 billion by 2027, expanding at a CAGR of approximately 6% (Grand View Research, 2022). A significant share is attributable to stimulant medications, where novel formulations like JORNAY PM could carve out incremental market share through differentiated features.

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Financial Trajectory

1. Revenue Potential and Market Penetration

Given the initial approval in 2021, JORNAY PM’s revenue trajectory is influenced by launch strategies, competitive dynamics, and clinician adoption rates.

• Initial Sales: Early sales likely commenced modestly, aligned with phased market rollout and educational campaigns.
• Growth Factors: Expansion into adult ADHD markets, inclusion in treatment guidelines, and formulary acceptance are anticipated to drive revenue growth.

2. Revenue Drivers and Risks

• Price Positioning: Premium pricing could generate substantial per-unit revenue, but may limit healthcare payer reimbursement.
• Market Share Expansion: Gaining a significant share from existing long-acting stimulants depends on demonstrated clinical benefits and physicians’ willingness to shift prescribing habits.
• Patent and Patent Litigation: Patent exclusivity for JORNAY PM’s formulation and potential patent litigations may influence long-term revenue security.

3. Cost Considerations

• Research and Development: Ongoing investment in clinical trials, post-market surveillance, and formulation improvements.
• Market Access and Promotion: Marketing expenditure aimed at physician education and patient awareness campaigns.
• Manufacturing: Scaling production capacity to support demand surge.

4. Financial Forecasts and Challenges

While specific revenue forecasts for JORNAY PM remain limited due to its recent market entry, industry trends suggest an upward trajectory if the drug captures significant prescriber adoption. Challenges include competing against well-established brands and potential price erosion from generic methylphenidate products.

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Strategic Outlook

Supernus’s repositioning of JORNAY PM at the intersection of innovation and value creation suggests a cautiously optimistic financial outlook. The drug’s success hinges on its ability to demonstrate clinical superiority, secure broad reimbursement, and expand indications.

Investment in post-marketing studies and health economics evaluations could fortify its market position, encouraging payers to favor JORNAY PM over competitors. Strategic partnerships with payers and clinicians will accelerate adoption, underpinning sustained revenue growth.

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Key Takeaways

• Distinctive Formulation Advantage: JORNAY PM’s evening dosing with timed-release offers a differentiated value proposition in the ADHD market, addressing specific unmet needs related to adherence and symptom control.
• Market Expansion Opportunities: Growing global ADHD prevalence and potential adult indication approvals can expand JORNAY PM’s addressable market.
• Competitive Challenges: Entrenched brand loyalty, generic competition, and pricing pressures remain hurdles that must be navigated through strategic marketing, clinical validation, and payer negotiations.
• Revenue Outlook: Early sales are promising, but long-term financial success depends on prescriber acceptance, formulary inclusion, and possibly expanding indications.
• Future Growth Drivers: Post-marketing data substantiating clinical benefits, increased awareness, and favorable reimbursement policies will be key to capitalizing on market opportunities.

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FAQs

1. What distinguishes JORNAY PM from other ADHD medications?
JORNAY PM uniquely offers an evening dosing schedule with a controlled-release mechanism designed to deliver early morning symptom relief, reducing the need for multiple daily doses.

2. How does the market adoption of JORNAY PM compare to established ADHD drugs?
As a newer, branded formulation, JORNAY PM is still gaining prescriber familiarity. Its adoption depends on demonstrating superior patient outcomes and securing favorable formulary placements.

3. What are the main barriers to JORNAY PM’s market growth?
Barriers include strong competition from well-established brands, generic methylphenidate availability, reimbursement hurdles, and clinician inertia.

4. Can JORNAY PM expand beyond pediatric ADHD?
Yes, potential approval for adult ADHD could significantly broaden its market, especially as awareness of adult ADHD increases and treatment guidelines evolve.

5. What is the long-term financial outlook for JORNAY PM?
With appropriate clinical validation, market penetration, and reimbursement strategy, JORNAY PM has the potential for steady revenue growth but faces challenges related to competitive dynamics and pricing.

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Sources

[1] Centers for Disease Control and Prevention (CDC). (2022). ADHD Prevalence Data.
[2] Grand View Research. (2022). ADHD Market Size, Share & Trends Analysis.
[3] Supernus Pharmaceuticals. (2021). JORNAY PM FDA Approval Announcement.
[4] MarketWatch. (2023). ADHD Pharmacotherapy Market Analysis.