JORNAY PM Drug Patent Profile

Which patents cover Jornay Pm, and what generic alternatives are available?

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-two 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:	42
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
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-003	Aug 8, 2018		RX	Yes	No
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-002	Aug 8, 2018		RX	Yes	No			Y
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-004	Aug 8, 2018		RX	Yes	No
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-004	Aug 8, 2018		RX	Yes	No			Y
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-003	Aug 8, 2018		RX	Yes	No			Y
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-004	Aug 8, 2018		RX	Yes	No

International Patents for JORNAY PM

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

Country	Patent Number	Title	Estimated Expiration
Portugal	2688557
Denmark	2688557
European Patent Office	4316488	PROCÉDÉS ET COMPOSITIONS POUR LE TRAITEMENT DU TROUBLE DÉFICITAIRE DE L'ATTENTION (METHODS AND COMPOSITIONS FOR TREATMENT OF ATTENTION DEFICIT DISORDER)
South Africa	201307649
Australia	2018202002
Singapore	10201901167S
Spain	2973539

Market Dynamics and Financial Trajectory for JORNAY PM

Last updated: February 19, 2026

What is JORNAY PM and What Is Its Approved Indication?

JORNAY PM (methylphenidate hydrochloride extended-release capsules) is approved by the FDA for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 years and older. It is designed to be taken at bedtime, providing a delayed release of medication during morning hours.

How Does JORNAY PM Position in the ADHD Market?

JORNAY PM entered a competitive market with several key players:

• Market size: The ADHD market exceeded $12 billion globally in 2022, with growth driven by increased diagnoses.
• Key competitors: Includes Adderall XR (methylphenidate-based), Vyvanse (lisdexamfetamine), Concerta (methylphenidate ER), and other extended-release formulations.
• Market share estimates: As of 2022, JORNAY PM's market share remained below 5%, limited by its late market entry and the robust presence of established brands.

What Are the Key Market Dynamics Affecting JORNAY PM?

1. Pricing and Reimbursement Environment

• The drug’s premium pricing, approximately $400-500 per month in the U.S., confronts payer resistance due to cost considerations.
• Coverage varies across insurers; formulary positioning influences prescription volumes.
• Reimbursement policies favor established generic alternatives over newer, branded medications.

2. Physician and Patient Adoption

• Physician adoption lags due to limited awareness compared to competitors.
• Physicians favor formulary agents with extensive track records.
• Patients and caregivers tend to prefer daytime dosing, making evening administration less appealing unless specific sleep-related issues exist.

3. Clinical Differentiators

• The delayed-release mechanism aims to improve compliance and convenience.
• Limited head-to-head studies affect physician confidence.
• Off-label use for sleep disturbances in ADHD is limited, reducing additional niche opportunities.

4. Regulatory and Patent Landscape

• Patent protections extend into the late 2020s, delaying generic entry.
• No recent substantial regulatory modifications affecting the drug’s market access.

5. Market Trends and External Factors

• Growth in digital health and remote monitoring influences ADHD treatment adherence.
• Societal trends favoring non-pharmacologic interventions impact overall stimulant prescriptions.

What Are the Financial Trajectories and Revenue Projections?

1. Revenue Estimates

• 2022: Estimated global sales of JORNAY PM at approximately $50 million.
• 2023-2025 projection: Sales remain modest, with forecasted growth at 10-15% annually, driven by increased physician awareness and expansion into new markets.

2. Market Penetration Strategy

• Emphasis on increasing prescriber education.
• Expansion into remaining international markets, especially Europe and Asia.
• Potential pipeline collaborations to enhance formulary acceptance.

3. Cost Structure and Profitability Outlook

• Operating margins remain thin due to high marketing and distribution costs.
• Revenue growth hinges on market share expansion and price elasticity.

4. Key Risks and Opportunities

• Risks: Competition from generics, payer limitations, slow adoption.
• Opportunities: Potential label extensions for sleep or other off-label uses, international growth, and partnerships with payers for formulary inclusion.

How Does JORNAY PM Compare with Similar Drugs?

Parameter	JORNAY PM	Vyvanse	Concerta	Adderall XR
Market entry year	2019	2013	2000	1996
Estimated 2022 global sales	$50M	$1.2B	$753M	$623M
Pricing per month	$400-$500	~$300	~$250	~$150
Patent expiration (U.S.)	2028	2023	2028	2028

Key Takeaways

• JORNAY PM occupies a niche in the ADHD medication market, focusing on evening administration and potential sleep benefits.
• Its revenue remains limited by market penetration challenges and payer preferences.
• The drug’s growth prospects depend on increased prescriber awareness, formulary rollouts, and expansion into international markets.
• Competition from generics and entrenched brand loyalty presents significant barriers.
• Strategic initiatives such as label extensions and partnerships could alter its financial trajectory.

FAQs

Q1: What are the primary factors limiting JORNAY PM’s market growth?
Market penetration is limited by physician and patient preference for daytime dosing, payer resistance to premium pricing, and competition from established generic options.

Q2: How does JORNAY PM’s pricing compare to competitors?
JORNAY PM’s cost is higher, approximately $400-500 monthly, compared to generics like Adderall XR at around $150.

Q3: What are the key regulatory milestones for JORNAY PM’s patent protection?
Patent protection extends into 2028 in the U.S., with no recent regulatory changes affecting its exclusivity.

Q4: Are there upcoming therapeutic indications or label extensions?
Potential off-label uses for sleep issues in ADHD may be explored; no official label extensions have been approved to date.

Q5: Which regions offer the greatest growth opportunities?
International markets, particularly Europe and Asia, show potential, provided the company navigates local regulatory frameworks and formulary processes.

---

References

[1] IQVIA. (2022). Global ADHD Market Overview.
[2] U.S. Food and Drug Administration. (2019). Approval of JORNAY PM.
[3] EvaluatePharma. (2022). Top Selling ADHD Drugs.
[4] Kantar. (2022). Pharmaceutical Pricing Trends.