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. 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

A generic version of FOCALIN was approved as dexmethylphenidate hydrochloride by INTELLIPHARMACEUTICS 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:	23
Clinical Trials:	12
Patent Applications:	36
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 O'Brien	Phase 4
Matthew J O'Brien, PhD, BCBA-D	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	021802-001	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	021802-008	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	021278-001	Nov 13, 2001
Sandoz	FOCALIN	dexmethylphenidate hydrochloride	TABLET;ORAL	021278-001	Nov 13, 2001

International Patents for FOCALIN

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

Country	Patent Number	Title	Estimated Expiration
Austria	368458
Canada	2240329	ADMINISTRATION AMELIOREE DE DOSES MULTIPLES DE MEDICAMENTS (IMPROVED DELIVERY OF MULTIPLE DOSES OF MEDICATIONS)
Israel	159313
Mexico	PA04000249	METODOS PARA TRATAMIENTO DE TRASTORNOS COGNITIVOS Y MENOPAUSICOS CON D-TREO-METILFENIDATO. (METHODS FOR TREATMENT OF COGNITIVE AND MENOPAUSAL DISORDERS WITH D-THREO METHYLPHENIDATE.)

Market Dynamics and Financial Trajectory for Focalin

Introduction to Focalin

Focalin, known generically as dexmethylphenidate hydrochloride, is a central nervous system (CNS) stimulant used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. It is available in both immediate-release and extended-release formulations, with the extended-release version known as Focalin XR.

Market Growth and Trends

The ADHD market, within which Focalin operates, has experienced significant growth over the past few decades. Here are some key trends and statistics:

Historical Growth

• In the 12 months ending in August 2011, the ADHD market saw over 51 million prescriptions filled, more than doubling the 22 million prescriptions from the same period in 2002. This growth was driven by an increase in diagnoses and the introduction of new treatments[1].

Future Projections

• The global ADHD therapeutics market is projected to reach $64.7 billion by 2030, growing at a CAGR of 10.8% from 2022 to 2030. This growth is fueled by increasing diagnoses, new drug approvals, and improved patient affordability[5].

Market Segmentation and Competition

Brand vs. Generic

• Despite the presence of generic alternatives, brand-name medications like Focalin XR continue to dominate the market. In 2011, 62% of ADHD prescriptions were for brand-name medications, with Focalin XR being a significant player[1].

Market Share

• Focalin XR, along with other brand-name medications like Vyvanse and Concerta, has maintained a strong market presence. In 2011, Concerta led in retail sales with $1.3 billion, followed by Vyvanse with $1.17 billion, and Focalin XR with $487 million[1].

Advantages of Focalin XR

Rapid Onset of Action

• Focalin XR is notable for its rapid onset of action, with significant improvements in attention, behavior, and academic productivity observed within 30 minutes of dosing. This makes it particularly beneficial for morning school preparation[2].

Delivery System

• Focalin XR utilizes the SODAS® (Spheroidal Oral Drug Absorption System) technology, releasing 50% of its dose immediately and the remaining 50% gradually over several hours. This extended-release mechanism provides sustained symptom control throughout the day[4].

Financial Trajectory

Revenue and Sales

• The financial performance of Focalin XR has been robust. In the 12 months ending in August 2011, Focalin XR generated $487 million in retail sales, making it one of the top-selling ADHD medications[1].

Cost Considerations

• The cost of Focalin XR varies based on dosage strength, with a daily dosing cost ranging from $2.97 to $5.73. This pricing is competitive within the ADHD market, especially considering the medication's efficacy and convenience[5].

Challenges and Risks

Patent Expirations and Generic Competition

• The ADHD market segment that includes dexmethylphenidate hydrochloride is expected to decline at a CAGR of less than 1% from 2022 to 2032 due to patent expirations and increasing generic competition. This could impact the financial trajectory of Focalin XR in the long term[5].

Safety and Side Effects

• Focalin XR, like other CNS stimulants, has a high potential for abuse and misuse, leading to substance use disorders. It also carries risks such as weight loss, slowing of growth rate in pediatric patients, and potential for acute angle closure glaucoma. These factors require careful monitoring and management[3].

Regional Analysis

Dominant Markets

• The United States holds the largest market share for ADHD therapeutics, including Focalin XR. Other significant markets include Germany, France, the United Kingdom, Italy, Spain, and Japan[4].

Distribution Channels

Retail and Hospital Pharmacies

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

Key Takeaways

• Market Growth: The ADHD market is expected to grow significantly, reaching $64.7 billion by 2030.
• Competitive Advantage: Focalin XR's rapid onset of action and extended-release mechanism provide it a competitive edge.
• Financial Performance: Focalin XR has generated substantial revenue, but faces challenges from patent expirations and generic competition.
• Regional Dominance: The United States is the largest market for ADHD therapeutics.
• Safety Considerations: Focalin XR carries risks such as abuse potential, weight loss, and growth suppression in pediatric patients.

FAQs

1. What is the primary use of Focalin XR? Focalin XR is used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older.

2. What is the unique delivery system of Focalin XR? Focalin XR uses the SODAS® (Spheroidal Oral Drug Absorption System) technology, releasing 50% of its dose immediately and the remaining 50% gradually over several hours.

3. What are the common side effects of Focalin XR? Common side effects include motor and vocal tics, anorexia, insomnia, and anxiety. It also carries risks such as weight loss and slowing of growth rate in pediatric patients.

4. How does Focalin XR compare to other ADHD medications in terms of onset of action? Focalin XR has a rapid onset of action, with significant improvements in attention, behavior, and academic productivity observed within 30 minutes of dosing.

5. What are the financial projections for the ADHD market, and how does Focalin XR fit into this landscape? The global ADHD therapeutics market is projected to reach $64.7 billion by 2030, growing at a CAGR of 10.8%. However, the segment including dexmethylphenidate hydrochloride is expected to decline due to patent expirations and generic competition.

Sources

1. PM360: ADHD Market: Focus on Brands.
2. BioSpace: FDA Approves 30-Minute Onset of Action for Novartis Pharmaceuticals Corporation’s Focalin XR.
3. FDA: Focalin XR Label.
4. BioSpace: Attention Deficit Hyperactivity Disorder Market Size to Reach USD 13.6 Billion by 2034.
5. Drug Patent Watch: DEXMETHYLPHENIDATE HYDROCHLORIDE - Generic Drug Details.