FOCALIN XR Drug Patent Profile

When do Focalin Xr patents expire, and what generic alternatives are available?

Focalin Xr is a drug marketed by Sandoz and is included in one NDA.

The generic ingredient in FOCALIN XR is dexmethylphenidate hydrochloride. There are six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Focalin Xr

A generic version of FOCALIN XR was approved as dexmethylphenidate hydrochloride by INTELLIPHARMACEUTICS on November 18^th, 2013.

Summary for FOCALIN XR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	12
Patent Applications:	2,169
Drug Prices:	Drug price information for FOCALIN XR
Drug Sales Revenues:	Drug sales revenues for FOCALIN XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FOCALIN XR
DailyMed Link:	FOCALIN XR at DailyMed

See drug prices for FOCALIN XR

See drug sales revenues for FOCALIN XR

Recent Clinical Trials for FOCALIN XR

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

Sponsor	Phase
Cingulate Therapeutics	Phase 1/Phase 2
Matthew J O'Brien, PhD, BCBA-D	Phase 4
Matthew O'Brien	Phase 4

See all FOCALIN XR clinical trials

Pharmacology for FOCALIN XR

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

Paragraph IV (Patent) Challenges for FOCALIN XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FOCALIN XR	Extended-release Capsules	dexmethylphenidate hydrochloride	25 mg	021802	1	2011-09-30
FOCALIN XR	Extended-release Capsules	dexmethylphenidate hydrochloride	35 mg	021802	1	2011-09-29
FOCALIN XR	Extended-release Capsules	dexmethylphenidate hydrochloride	40 mg	021802	1	2010-12-20
FOCALIN XR	Extended-release Capsules	dexmethylphenidate hydrochloride	30 mg	021802	1	2010-12-15
FOCALIN XR	Extended-release Capsules	dexmethylphenidate hydrochloride	15 mg	021802	1	2007-05-14
FOCALIN XR	Extended-release Capsules	dexmethylphenidate hydrochloride	5 mg, 10 mg and 20 mg	021802	1	2007-03-30

US Patents and Regulatory Information for FOCALIN XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-001	May 26, 2005	AB	RX	Yes	No
Sandoz	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-003	May 26, 2005	AB	RX	Yes	No
Sandoz	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-007	Apr 21, 2011	AB	RX	Yes	No

Expired US Patents for FOCALIN XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-005	Oct 23, 2009
Sandoz	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-003	May 26, 2005
Sandoz	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-005	Oct 23, 2009

International Patents for FOCALIN XR

See the table below for patents covering FOCALIN XR around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	196065
South Africa	200810221	Compositions comprising nanopaticulate naproxen and controlled release hydrocodone
South Korea	20040029360

Market Dynamics and Financial Trajectory for Focalin XR

Introduction

Focalin XR, a brand name for the medication dexmethylphenidate hydrochloride, is a central nervous system (CNS) stimulant used to treat Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. Here, we delve into the market dynamics and financial trajectory of Focalin XR, exploring its current status, market trends, and future projections.

ADHD Market Overview

The global ADHD therapeutics market is substantial and growing, valued at approximately $28.6 billion in 2022 and projected to reach $64.7 billion by 2030, with a Compound Annual Growth Rate (CAGR) of 10.8% during this period[5].

Market Segmentation by Drug Type

While the broader ADHD market is growing, the segment specific to dexmethylphenidate hydrochloride, including Focalin XR, is expected to decline at a CAGR of less than 1% from 2022 to 2032. This decline is primarily due to patent expirations and increasing generic competition[5].

Historical Pricing and Rebates

Focalin XR has experienced significant price fluctuations, particularly in recent times. In April 2024, the list price of Focalin XR decreased by 63.8%, the largest decrease of the month. This drop is attributed to the Medicaid Drug Rebate Program (MDRP) and the removal of the Average Manufacturer Price (AMP) cap, which can result in severe rebate penalties for drug price increases that exceed the rate of inflation[1].

Impact on Medicaid

The price decrease of Focalin XR had a substantial impact on Medicaid expenditures. Despite having a generic alternative available for over 10 years, the brand version of Focalin XR remains relatively cheap for Medicaid programs due to significant rebates and discounts. These rebates often make the net price of the brand version lower than that of the generic alternative for Medicaid programs[1].

Sales and Revenue

Historically, Focalin XR has been a notable player in the ADHD market. In 2011, it generated $487 million in sales, trailing behind other major ADHD medications like Concerta and Vyvanse[4].

Recent Financials

In the second quarter of 2023, Intellipharmaceutics, a company involved in the production and licensing of generic Focalin XR, reported revenues primarily from licensing agreements. The company saw a net loss of $54,121, attributed to ongoing research and development (R&D) and administrative expenses, but also noted an increase in licensing revenue from commercial sales of generic Focalin XR[2].

Clinical Benefits and Approval

Focalin XR has been approved by the FDA for its rapid onset of action, providing significant improvements in attention, behavior, and academic productivity within 30 minutes of administration. This early onset is particularly beneficial for school preparation and improving academic productivity in children with ADHD[3].

Market Trends and Developments

New Drug Approvals

Recent approvals of innovative ADHD treatments, such as Tris Pharma’s Onyda XR, indicate a trend towards more convenient and effective treatment options. These approvals are expected to drive market growth by offering patients more choices and improving treatment outcomes[5].

Increasing Awareness and Diagnoses

The rising incidence of ADHD diagnoses, fueled by increased awareness and better diagnostic tools, is a significant driver of market growth. This trend is expected to continue, contributing to the overall expansion of the ADHD therapeutics market[5].

Distribution Channels

The ADHD therapeutics market, including Focalin XR, is distributed through various channels such as hospital pharmacies, retail pharmacies, and e-commerce platforms. Hospital pharmacies held the largest market share in 2022 and are expected to continue growing at a high CAGR[5].

Pricing and Cost Considerations

The cost of Focalin XR varies based on dosage and formulation. The extended-release formulation has a daily dosing cost ranging from $2.97 to $5.73, depending on the dosage strength. These costs are influenced by the complex interplay of list prices, rebates, and discounts, especially within Medicaid programs[5].

Competitive Landscape

Focalin XR competes in a market dominated by other ADHD medications like Concerta, Vyvanse, and Adderall XR. Despite the presence of generic alternatives, brand medications like Focalin XR continue to offer unique benefits such as less frequent dosing and improved delivery systems, allowing them to compete effectively[4].

Future Projections

While the specific segment of dexmethylphenidate hydrochloride is expected to decline due to generic competition, the broader ADHD market is poised for significant growth. The increasing prevalence of ADHD, new drug approvals, and improved patient affordability are key drivers of this growth. However, manufacturers of Focalin XR and similar medications must navigate the complexities of pricing and rebate policies to maintain market share[5].

Key Takeaways

• Market Growth: The global ADHD therapeutics market is projected to grow significantly, reaching $64.7 billion by 2030.
• Pricing Dynamics: Focalin XR has seen significant price decreases due to MDRP and AMP-cap removal.
• Clinical Benefits: Focalin XR offers rapid onset of action and significant improvements in ADHD symptoms.
• Distribution: Hospital pharmacies dominate the distribution channels for ADHD medications.
• Competitive Landscape: Focalin XR competes with other major ADHD medications, leveraging its unique benefits.

FAQs

What is Focalin XR used for?

Focalin XR is a central nervous system (CNS) stimulant used to treat Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older[5].

How has the pricing of Focalin XR changed recently?

In April 2024, the list price of Focalin XR decreased by 63.8%, largely due to the Medicaid Drug Rebate Program (MDRP) and the removal of the Average Manufacturer Price (AMP) cap[1].

What are the clinical benefits of Focalin XR?

Focalin XR provides rapid and significant improvements in attention, behavior, and academic productivity within 30 minutes of administration, which is particularly beneficial for school preparation and improving academic productivity in children with ADHD[3].

How does Focalin XR compete in the ADHD market?

Despite the presence of generic alternatives, Focalin XR competes effectively by offering less frequent dosing and improved delivery systems, among other unique benefits[4].

What are the future projections for the ADHD market?

The global ADHD therapeutics market is projected to reach $64.7 billion by 2030, driven by the increasing prevalence of ADHD, new drug approvals, and improved patient affordability[5].

Sources

1. 46brooklyn, "New drops in prescription drug costs means NADAC is cool (again)", May 31, 2024.
2. BioSpace, "Intellipharmaceutics Announces Second Quarter 2023 Results", July 14, 2023.
3. BioSpace, "FDA Approves 30-Minute Onset of Action for Novartis Pharmaceuticals Corporation’s Focalin XR", November 12, 2008.
4. PM360, "ADHD Market: Focus on Brands", August 1, 2011.
5. DrugPatentWatch, "DEXMETHYLPHENIDATE HYDROCHLORIDE - Generic Drug Details".