RITALIN LA Drug Patent Profile

Which patents cover Ritalin La, and what generic alternatives are available?

Ritalin La is a drug marketed by Sandoz and is included in one NDA.

The generic ingredient in RITALIN LA 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 Ritalin La

A generic version of RITALIN LA was approved as methylphenidate hydrochloride by SPECGX LLC on November 27^th, 1998.

Summary for RITALIN LA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	126
Patent Applications:	3,710
Drug Prices:	Drug price information for RITALIN LA
Drug Sales Revenues:	Drug sales revenues for RITALIN LA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RITALIN LA
DailyMed Link:	RITALIN LA at DailyMed

See drug prices for RITALIN LA

See drug sales revenues for RITALIN LA

Recent Clinical Trials for RITALIN LA

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

Sponsor	Phase
Johns Hopkins University	Phase 4
University of Florida	Early Phase 1
University of Zurich	Phase 1

See all RITALIN LA clinical trials

Pharmacology for RITALIN LA

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

Paragraph IV (Patent) Challenges for RITALIN LA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RITALIN LA	Extended-release Capsules	methylphenidate hydrochloride	10 mg	021284	1	2007-05-21
RITALIN LA	Extended-release Capsules	methylphenidate hydrochloride	20 mg, 30 mg and 40 mg	021284		2006-08-21

US Patents and Regulatory Information for RITALIN LA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-004	Apr 10, 2004	AB1	RX	Yes	No
Sandoz	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-003	Jun 5, 2002	AB1	RX	Yes	No
Sandoz	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-001	Jun 5, 2002	AB1	RX	Yes	No

Expired US Patents for RITALIN LA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-002	Jun 5, 2002	6,228,398
Sandoz	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-003	Jun 5, 2002	6,228,398
Sandoz	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-001	Jun 5, 2002	5,837,284

International Patents for RITALIN LA

See the table below for patents covering RITALIN LA around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006130091
Japan	2009517485
Canada	2465077	ADMINISTRATION AMELIOREE DE DOSES MULTIPLES DE MEDICAMENTS (IMPROVED DELIVERY OF MULTIPLE DOSES OF MEDICATIONS)

RITALIN LA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ritalin LA

Introduction

Ritalin LA, an extended-release formulation of methylphenidate hydrochloride, is a central nervous system (CNS) stimulant used primarily for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Here, we will delve into the market dynamics and financial trajectory of Ritalin LA, exploring its market position, competition, financial performance, and future outlook.

Market Position and Indications

Ritalin LA is indicated for the treatment of ADHD and is known for its bi-modal release profile, which provides both immediate and delayed release of methylphenidate. This unique formulation helps in maintaining therapeutic levels of the drug throughout the day, making it a preferred option for patients and healthcare providers[1].

Market Size and Growth

The global market for methylphenidate, including Ritalin LA, has been growing steadily. While specific figures for Ritalin LA alone are not readily available, the broader ADHD treatment market has seen significant growth. The global ADHD treatment market is expected to continue its upward trend, driven by increasing diagnosis rates and the need for effective treatments[3].

Financial Performance

As of 2007, Ritalin LA had substantial sales, with revenues of approximately $109 million in the U.S. alone, based on IMS sales data. This figure highlights the drug's commercial success and its position as a significant player in the ADHD treatment market[2].

Competition and Patent Challenges

Ritalin LA faces competition from other extended-release methylphenidate formulations, such as Concerta. Comparative studies have shown that Ritalin LA achieves statistically greater improvements in some parameters compared to Concerta, although the differences can be nuanced[5].

The drug has also been subject to patent challenges. In 2007, Barr Pharmaceuticals initiated a challenge to the patents listed by Novartis Pharmaceuticals Corporation for Ritalin LA, filing an Abbreviated New Drug Application (ANDA) with the FDA. This challenge was part of the broader landscape of generic competition and patent disputes in the pharmaceutical industry[2].

Generic Competition

The entry of generic versions of Ritalin LA into the market can significantly impact its financial trajectory. Generic competition often leads to price reductions and market share erosion for the branded product. However, the timing and outcome of such challenges can be unpredictable and depend on various legal and regulatory factors[2].

Safety and Efficacy

Ritalin LA has been shown to be effective in clinical trials, with patients experiencing statistically significant improvements in ADHD symptoms. However, like other CNS stimulants, it carries risks such as potential for abuse, peripheral vasculopathy, and long-term suppression of growth in pediatric patients. These factors can influence prescribing patterns and patient adherence, impacting the drug's market performance[1][4].

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of pharmaceutical products. FDA approvals, patent exclusivity periods, and post-marketing surveillance are key factors. Ritalin LA, being a well-established product, has navigated these regulatory hurdles but remains subject to ongoing scrutiny and potential changes in regulatory policies[1][4].

Future Outlook

The future outlook for Ritalin LA is influenced by several factors, including the growing ADHD treatment market, competition from generics and other branded products, and ongoing regulatory oversight. Despite potential challenges, the drug's unique formulation and established efficacy are likely to maintain its market presence.

Key Trends

• Increasing Diagnosis Rates: Growing awareness and diagnosis rates of ADHD are expected to drive demand for effective treatments.
• Generic Competition: The entry of generic versions will likely impact pricing and market share.
• Regulatory Changes: Ongoing regulatory scrutiny and potential changes in policies could affect the drug's market dynamics.
• Patient Safety: Continued monitoring of safety profiles and potential side effects will be crucial.

Financial Projections

While specific financial projections for Ritalin LA are not available, the broader ADHD treatment market is expected to grow. The global ADHD treatment market's growth rate and the drug's market share will be key determinants of its financial performance.

Illustrative Statistics

• Market Growth: The global ADHD treatment market is expected to grow, driven by increasing diagnosis rates and the need for effective treatments.
• Sales Figures: As of 2007, Ritalin LA had sales of approximately $109 million in the U.S.[2].

Conclusion

Ritalin LA's market dynamics are shaped by its unique formulation, efficacy in treating ADHD, and the competitive landscape of the ADHD treatment market. While facing challenges from generic competition and regulatory oversight, the drug's established position and growing demand for ADHD treatments suggest a stable, if not growing, financial trajectory.

Key Takeaways

• Market Position: Ritalin LA is a well-established treatment for ADHD with a unique bi-modal release profile.
• Financial Performance: The drug had significant sales in 2007 and is expected to continue contributing to the growing ADHD treatment market.
• Competition: Generic competition and other branded products are key challenges.
• Regulatory Environment: Ongoing regulatory scrutiny is crucial for the drug's market dynamics.
• Future Outlook: The drug is likely to maintain its market presence despite potential challenges.

FAQs

Q1: What is Ritalin LA used for?

Ritalin LA is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Q2: How does Ritalin LA differ from other methylphenidate formulations?

Ritalin LA has a bi-modal release profile, providing both immediate and delayed release of methylphenidate, which helps maintain therapeutic levels throughout the day[1].

Q3: What are the potential side effects of Ritalin LA?

Potential side effects include abuse and misuse, peripheral vasculopathy, and long-term suppression of growth in pediatric patients[1][4].

Q4: Has Ritalin LA faced any patent challenges?

Yes, in 2007, Barr Pharmaceuticals initiated a patent challenge against Novartis Pharmaceuticals Corporation for Ritalin LA[2].

Q5: How does generic competition affect Ritalin LA's market performance?

Generic competition can lead to price reductions and market share erosion, impacting the financial trajectory of the branded product.

Sources

1. Ritalin LA - accessdata.fda.gov: Prescribing Information for Ritalin LA.
2. Barr Pharmaceuticals, Inc. Confirms Patent Challenge of Ritalin(R) LA: Press release on patent challenge.
3. Global Methylphenidate Drug Market Size By Product, By ...: Market report highlights.
4. Ritalin LA - accessdata.fda.gov: Updated prescribing information.
5. Methylphenidate hydrochloride, extended release capsules, 20 mg ...: Comparative study results.