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Last Updated: December 22, 2024

FOCALIN Drug Patent Profile


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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.

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Drug patent expirations by year for FOCALIN
Drug Prices for FOCALIN

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Drug Sales Revenue Trends for FOCALIN

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Recent Clinical Trials for FOCALIN

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

SponsorPhase
Cingulate TherapeuticsPhase 1/Phase 2
Matthew O'BrienPhase 4
Matthew J O'Brien, PhD, BCBA-DPhase 4

See all FOCALIN clinical trials

Pharmacology for FOCALIN
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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-003 May 26, 2005 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-001 May 26, 2005 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-008 Apr 21, 2011 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-002 Nov 13, 2001 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-003 Nov 13, 2001 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-004 Aug 1, 2006 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for FOCALIN

International Patents for FOCALIN

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

Country Patent Number Title Estimated Expiration
Canada 2465077 ADMINISTRATION AMELIOREE DE DOSES MULTIPLES DE MEDICAMENTS (IMPROVED DELIVERY OF MULTIPLE DOSES OF MEDICATIONS) ⤷  Subscribe
Canada 2453510 TRAITEMENT DE LA FATIGUE ET DES EFFETS SECONDAIRES COGNITIFS ASSOCIES AU CANCER, AUX TRAITEMENTS CONTRE LE CANCER ET A LA MENOPAUSE AU MOYEN DE D-THREO-METHYPHENIDATE (TREATMENT OF FATIGUE AND COGNITIVE SIDE EFFECTS ASSOCIATED WITH CANCER, CANCER TREATMENTS AND MENOPAUSE WITH D-THREO-METHYPHENIDATE) ⤷  Subscribe
Australia 7834398 ⤷  Subscribe
Hong Kong 1077501 ⤷  Subscribe
Canada 2241611 ADMINISTRATION CHRONIQUE D'UN BOL DE D-THREO METHYLPHENIDATE (CHRONIC, BOLUS ADMINISTRATION OF D-THREO METHYLPHENIDATE) ⤷  Subscribe
New Zealand 530211 D-threo methylphenidate substantially free of the L-threo form to treat fatigue, neurobehavioral slowing and other cogitative disorders exacerbated by treatments associated with cancer therapy ⤷  Subscribe
Germany 69831869 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

FOCALIN Market Analysis and Financial Projection Experimental

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.

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