METADATE CD Drug Patent Profile

When do Metadate Cd patents expire, and when can generic versions of Metadate Cd launch?

Metadate Cd is a drug marketed by Aytu Biopharma and is included in one NDA.

The generic ingredient in METADATE CD 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 Metadate Cd

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

Summary for METADATE CD

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	6
Patent Applications:	3,740
Drug Prices:	Drug price information for METADATE CD
What excipients (inactive ingredients) are in METADATE CD?	METADATE CD excipients list
DailyMed Link:	METADATE CD at DailyMed

See drug prices for METADATE CD

See drug sales revenues for METADATE CD

Recent Clinical Trials for METADATE CD

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

Sponsor	Phase
Matthew O'Brien	Phase 4
Matthew J O'Brien, PhD, BCBA-D	Phase 4
Craig Rush	Early Phase 1

See all METADATE CD clinical trials

Pharmacology for METADATE CD

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

Paragraph IV (Patent) Challenges for METADATE CD

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
METADATE CD	Extended-release Capsules	methylphenidate hydrochloride	40 mg	021259	1	2007-03-15
METADATE CD	Extended-release Capsules	methylphenidate hydrochloride	10 mg, 20 mg and 30 mg	021259	1	2005-05-13

US Patents and Regulatory Information for METADATE CD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-003	May 27, 2003	AB2	RX	Yes	No
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-004	Feb 19, 2006	AB2	RX	Yes	No
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-001	Apr 3, 2001	AB2	RX	Yes	No
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-002	Jun 19, 2003	AB2	RX	Yes	No

Expired US Patents for METADATE CD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-003	May 27, 2003
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-004	Feb 19, 2006
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-002	Jun 19, 2003
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-001	Apr 3, 2001

International Patents for METADATE CD

See the table below for patents covering METADATE CD around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2103307	Formulations de libération modifiée de méthylphénidate (Methylphenidate modified release formulations)
Poland	361673
European Patent Office	2286815
Poland	203828

METADATE CD Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Metadate CD

Introduction to Metadate CD

Metadate CD, a central nervous system stimulant, is primarily used to treat attention deficit hyperactivity disorder (ADHD) in children, adolescents, and adults. The medication contains methylphenidate, the same active ingredient as Ritalin and Daytrana, and is classified as a federally controlled substance (CII) due to its potential for abuse and dependence[1].

Discontinuation of the Brand Name

The brand name Metadate CD was discontinued by its manufacturer in April 2017. However, multiple generic versions of the medication are still available. If a physician prescribes Metadate CD, it will be filled with a generic equivalent, which is identical to the original brand name medication[1].

Market Presence and Sales

Metadate CD, along with its generic counterparts, has a significant presence in the ADHD treatment market. The annual combined brand and generic sales of methylphenidate hydrochloride extended-release capsules, the generic version of Metadate CD, were approximately $151 million in the United States as of July 2016[4].

Competitive Landscape

The market for ADHD medications is highly competitive, with several extended-release formulations available. Metadate CD competes with other methylphenidate-based medications like Ritalin LA and Concerta. The unique formulation of Metadate CD, which includes a mix of immediate-release and extended-release beads, allows it to maintain a steady level of medication in the body for about 8-9 hours, slightly longer than Ritalin LA[1].

Generic Market and Players

The generic market for Metadate CD is dominated by several pharmaceutical companies. Impax Laboratories, for example, launched a generic version of Metadate CD in 2016, expanding its portfolio of generic products. This move was part of Impax's strategy to enhance its presence in the generic pharmaceutical market[4].

Financial Performance

The financial performance of Metadate CD and its generics is tied to the overall performance of the companies that manufacture and distribute these medications. For instance, in fiscal year 2018, the net sales of methylphenidate ER tablets, which include generics of Metadate CD, totaled $33.2 million. This figure is part of the broader financial landscape of generic pharmaceutical companies, which have seen significant growth in recent years[2].

Growth Strategies of Pharmaceutical Companies

Companies involved in the production and distribution of Metadate CD generics employ several strategies to maintain and expand their market share. These include:

• Internal Development and Strategic Partnerships: Companies focus on developing new products in-house and through partnerships with third-party developers and formulators[2].
• Expanding Product Lines: There is a continuous effort to broaden the portfolio of generic products, including controlled substances like methylphenidate[2].
• Cost Management and Efficiency: Companies aim to reduce costs, improve manufacturing efficiencies, and manage overhead and administrative expenses to enhance financial performance[2].

Impact of Regulatory Changes

Regulatory changes and the expiration of distribution agreements can significantly impact the financial trajectory of these medications. For example, the expiration of the JSP Distribution Agreement in 2019 forced companies to reassess their business strategies, including reducing costs, accelerating new product launches, and strengthening strategic partnerships[2].

Consumer and Market Trends

The demand for ADHD medications, including Metadate CD, is influenced by several factors, including the prevalence of ADHD, healthcare policies, and patient preferences. The ability to open and sprinkle the capsules on food, a feature unique to Metadate CD, can be a significant advantage in patient compliance and satisfaction[1].

Clinical Efficacy and Patient Outcomes

Clinical studies have shown that Metadate CD is effective in reducing ADHD symptoms. In one controlled clinical study, patients treated with Metadate CD showed a statistically significant improvement in ADHD symptoms as measured by the Conners’ Global Index Scale (TCGIS)[5].

Challenges and Opportunities

Despite its efficacy, Metadate CD faces challenges such as the potential for tolerance development over long-term use and the need for periodic monitoring by healthcare providers. However, these challenges also present opportunities for pharmaceutical companies to innovate and improve patient care through better formulations and treatment strategies[1].

Future Outlook

The future outlook for Metadate CD and its generics is promising, given the ongoing demand for effective ADHD treatments. As pharmaceutical companies continue to innovate and expand their product lines, and as regulatory environments evolve, the market dynamics for Metadate CD are likely to remain dynamic.

Key Takeaways

• Market Presence: Metadate CD and its generics have a significant presence in the ADHD treatment market.
• Competitive Landscape: The medication competes with other methylphenidate-based extended-release formulations.
• Financial Performance: The financial performance is tied to the overall growth of generic pharmaceutical companies.
• Growth Strategies: Companies employ strategies like internal development, strategic partnerships, and cost management.
• Regulatory Impact: Regulatory changes can significantly impact the financial trajectory.
• Clinical Efficacy: Metadate CD has shown statistically significant improvements in ADHD symptoms.

Frequently Asked Questions

Q: What is Metadate CD used for? A: Metadate CD is used to treat attention deficit hyperactivity disorder (ADHD) in children, adolescents, and adults.

Q: Why was the brand name Metadate CD discontinued? A: The brand name Metadate CD was discontinued by its manufacturer in April 2017, but generic versions are still available.

Q: How long does Metadate CD last? A: Metadate CD lasts about 8-9 hours after an oral dose due to its extended-release formulation.

Q: Can Metadate CD be opened and sprinkled on food? A: Yes, Metadate CD capsules can be opened and sprinkled on food like pudding, ice cream, or applesauce, but the beads must be swallowed without chewing.

Q: Is Metadate CD a controlled substance? A: Yes, Metadate CD is classified as a federally controlled substance (CII) due to its potential for abuse and dependence.

Cited Sources

1. Additude Magazine: Metadate CD for ADHD: Uses, Dosages, Side Effects & More.
2. Annual Reports: Annual Report Fiscal Year 2018.
3. GovInfo: FR-2016-01-11.xml.
4. Impax Laboratories: Impax Launches Generic Version of Metadate CD.
5. FDA: Metadate CD® (methylphenidate HCl, USP) Extended-Release Capsules.