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 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-seven 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:	40
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Patent Applications:	3,740
Drug Prices:	Drug price information 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

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
European Patent Office	2688557	PROCÉDÉS ET COMPOSITIONS DESTINÉS AU TRAITEMENT DU TROUBLE DÉFICITAIRE DE L'ATTENTION (METHODS AND COMPOSITIONS FOR TREATMENT OF ATTENTION DEFICIT DISORDER)
Australia	2018202002
Japan	2016117767
Denmark	4011364
Australia	2018202002	METHODS AND COMPOSITIONS FOR TREATMENT OF ATTENTION DEFICIT DISORDER
Denmark	3272342

JORNAY PM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Jornay PM

Introduction to Jornay PM

Jornay PM, a central nervous system (CNS) stimulant, is a prescription medication for the treatment of attention deficit hyperactivity disorder (ADHD) in individuals six years of age and older. It is distinguished by its evening dosing, smooth therapeutic effect, and dose-dependent duration, making it a highly differentiated treatment in the ADHD market[1][3][4].

Market Position and Growth

The acquisition of Ironshore Therapeutics by Collegium Pharmaceutical marks a significant strategic move into the neurology sector, specifically the ADHD market. Here are some key points highlighting the market dynamics:

• Growth in Prescriptions: In the first half of 2024, Jornay PM prescriptions grew by 32% year-over-year. For the full-year 2023, the product generated approximately 490,000 prescriptions, a 58% increase compared to 2022[1][3][4].
• Unique Selling Proposition: Jornay PM's evening dosing mechanism is a significant differentiator in the ADHD treatment market. This unique feature, along with its smooth therapeutic effect and dose-dependent duration, positions it as a preferred option for patients and healthcare providers[1][3][4].

Financial Trajectory

The financial outlook for Jornay PM is robust and aligns with Collegium's broader financial goals.

Revenue Projections

• Net revenue for Jornay PM is expected to exceed $100 million in 2024, making it Collegium's leading growth driver[1][3][4].
• The acquisition has led to an update in Collegium's 2024 financial guidance, with product revenues now expected to be in the range of $620.0 million to $635.0 million[3][4].

Adjusted EBITDA

• The acquisition is expected to be immediately accretive to Collegium's adjusted EBITDA, which is projected to be in the range of $395.0 million to $405.0 million for 2024. This represents an increase from the previous guidance of $380.0 million to $395.0 million[3][4].

Funding and Debt

• The acquisition of Ironshore Therapeutics was funded by $200 million of Collegium’s existing cash on hand and a $325 million term loan, part of a larger $646 million term loan provided by investment funds managed by Pharmakon Advisors, LP[3][4].

Patent Protection and Long-Term Viability

Jornay PM is supported by 16 Orange Book-listed patents, with expiries in 2032. This extensive patent protection ensures that the product will remain a significant revenue generator for Collegium over the next several years, providing a stable financial foundation[1][3][4].

Integration and Operational Impact

The integration of Jornay PM into Collegium's portfolio is expected to be seamless, leveraging Collegium's core commercial competencies and proven track record of efficiently integrating commercial products. This integration is anticipated to maximize the performance of both the pain portfolio and the newly acquired ADHD product[4].

Executive Insights

Michael Heffernan, Chairman and Interim President and Chief Executive Officer of Collegium, emphasized the strategic importance of the acquisition: "With the addition of Jornay PM to our portfolio, we are establishing our presence in the large and growing ADHD market with a highly differentiated product that is poised to become our leading growth driver."[4]

Financial Strength and Cash Flow Generation

The acquisition further strengthens Collegium’s financial position through an increased revenue base, expected immediate accretion to adjusted EBITDA, and accelerated cash flow generation. This financial robustness positions Collegium for continued growth and expansion in the specialty pharmaceutical market[3][4].

Key Takeaways

• Market Growth: Jornay PM has shown significant growth in prescriptions, with a 32% year-over-year increase in the first half of 2024.
• Financial Projections: Net revenue for Jornay PM is expected to exceed $100 million in 2024, contributing to Collegium's overall revenue guidance of $620.0 million to $635.0 million.
• Adjusted EBITDA: The acquisition is expected to be immediately accretive, with adjusted EBITDA projected to be $395.0 million to $405.0 million for 2024.
• Patent Protection: Jornay PM is protected by 16 Orange Book-listed patents until 2032.
• Integration and Operational Impact: The integration is expected to be seamless, leveraging Collegium's commercial competencies.

FAQs

Q: What is Jornay PM used for? A: Jornay PM is a central nervous system (CNS) stimulant used for the treatment of attention deficit hyperactivity disorder (ADHD) in individuals six years of age and older.

Q: How does Jornay PM differentiate itself in the ADHD market? A: Jornay PM is distinguished by its evening dosing, smooth therapeutic effect, and dose-dependent duration.

Q: What are the financial projections for Jornay PM in 2024? A: Net revenue for Jornay PM is expected to exceed $100 million in 2024, contributing to Collegium's overall revenue guidance of $620.0 million to $635.0 million.

Q: How was the acquisition of Ironshore Therapeutics funded? A: The acquisition was funded by $200 million of Collegium’s existing cash on hand and a $325 million term loan.

Q: What is the patent status of Jornay PM? A: Jornay PM is supported by 16 Orange Book-listed patents, with expiries in 2032.

Cited Sources

1. BioSpace: Collegium to Acquire Ironshore Therapeutics, Expanding into Neurology[1].
2. GlobeNewswire: Knight Therapeutics Reports Second Quarter 2024[2].
3. StockTitan: Collegium Completes Acquisition of Ironshore Therapeutics[3].
4. Collegium Pharmaceutical: Collegium Completes Acquisition of Ironshore Therapeutics[4].