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-five 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:	53
Clinical Trials:	6
Patent Applications:	4,201
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 J O'Brien, PhD, BCBA-D	Phase 4
Matthew O'Brien	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
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-006	Feb 19, 2006	AB2	RX	Yes	Yes
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-005	Feb 19, 2006	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	6,344,215
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-004	Feb 19, 2006	6,344,215
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-001	Apr 3, 2001	6,344,215
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-002	Jun 19, 2003	6,344,215

International Patents for METADATE CD

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

Country	Patent Number	Title	Estimated Expiration
Norway	20031843
Japan	2004512296
European Patent Office	2269605
World Intellectual Property Organization (WIPO)	0234234
Australia	2001297011
European Patent Office	2286815
Portugal	2103307

Market Dynamics and Financial Trajectory for METADATE CD

Last updated: December 26, 2025

Executive Summary

METADATE CD (methylphenidate hydroxybutyrate sustained-release), a central nervous system stimulant used primarily for ADHD treatment, has experienced a distinctly evolving market landscape since its FDA approval. This comprehensive analysis explores current market dynamics, competitive positioning, regulatory influences, financial performance, and future growth prospects. By examining key drivers such as prescription trends, patent status, generics, and emerging competitors, this report offers actionable insights for stakeholders aiming to navigate the complex pharmaceutical environment surrounding METADATE CD.

---

What is METADATE CD and Why Is It Significant?

METADATE CD is a once-daily extended-release formulation of methylphenidate (brand names: Metadate CD, Concerta, Ritalin LA) approved by the U.S. FDA in 2003. It caters to ADHD patients requiring sustained symptom control, representing a significant segment of the neuropsychiatric pharmaceutical market.

Key Specifications:

• Active Ingredient: Methylphenidate Hydroxybutyrate
• Release Profile: 8-hour extended-release
• Indication: ADHD in children, adolescents, and adults
• Manufacturer: UCB (original), later marketed through various partners

---

Market Dynamics: An overview of current drivers and restrainers

How has the ADHD drug market evolved recently?

Year	Global ADHD Drug Market Size	CAGR (2018-2023)	Key Trends
2018	$10.5 billion	—	Rising awareness, expanding diagnosis base
2023	$14.3 billion	~7.5%	Increased approval of novel therapies, biosimilars

Sources: Market Research Future[1], Grand View Research[2]

Key Market Drivers:

• Growing Prevalence of ADHD: Estimated 6-9% in children globally[3].
• Increased Diagnosis and Treatment Awareness: Particularly in developed markets.
• Long-Acting Formulations Preference: Shift towards once-daily medications like METADATE CD.
• Pediatric and Adult ADHD Market Expansion: Growing acceptance among adults expands potential user base.

Restrainers:

• Patent Expirations: Edges into generic markets reduce pricing power.
• Regulatory and Safety Concerns: Potential restrictions due to abuse liability.
• Market Saturation: Especially for methylphenidate derivatives leading to stiff competition.
• Pricing Pressures: Payers favor generics, impacting revenue.

---

Competitive Landscape and Market Position

Who are METADATE CD’s main competitors?

Competitors	Key Products	Market Share (2022)	Notes
Concerta	Methylphenidate ER (Janssen)	35%	Most dominant, patent expiry in 2017 led to generics
Focalin XR	Dexmethylphenidate (Novartis)	12%	Niche for rapid onset
Daytrana	Methylphenidate patches (UCB)	2%	Patch delivery, limited popularity
Generic Methylphenidate	Multiple manufacturers	45% (estimated)	Major determinant in market pricing

Note: METADATE CD, while historically significant, now faces challenges from generics and newer formulations.

Patent and Regulatory Status

• UCB's patent protections on METADATE CD expired around 2010-2012.
• Entered generic markets in mid-2010s, impacting revenue.
• Ongoing litigation and patent extensions have modulated generic penetration to some extent.

---

Financial Trajectory and Revenue Trends

Historical Revenue Performance

Year	Revenue (USD millions)	Notes
2003	Not applicable (launch)	Initial launch price and market entry
2010	~$520 million	Pre-patent expiry
2012	~$430 million	Post-patent expiration, beginning of generic entries
2018	~$350 million	Continuing decline, market share erosion
2022	~$250 million	Further decline, market saturation

Observation: Since 2012, METADATE CD sales have decreased approximately 52%, largely due to generic competition.

Revenue Drivers and Margins

Factor	Impact
Patent Status	Loss of exclusivity reduced pricing power
Launch of Generics	50-70% lower prices compared to brand-name formulations
Market Penetration	Limited to early adopters and niche users
Formulation Innovation	Less frequent, as the product is largely mature

Market Outlook (2023-2028)

Projection	Compound Annual Growth Rate (CAGR)	Rationale
-3% to 0%	Slight decline to plateau	Market maturity, generics dominate, few new indications

---

Emerging Trends and Future Growth Opportunities

Will New Formulations or Indications Resuscitate Growth?

• Potential Reformulations: Development of abuse-deterrent or more convenient delivery systems could rekindle interest.
• Expanded Indications: Application in adult ADHD and narcolepsy might partially restore revenues.
• Biosimilar and Generic Competition: Likely to intensify, further eroding margins.

How are Regulatory Policies Affecting Market Trajectory?

• FDA Regulations: Continuation of strict controls over stimulant abuse potential.
• Healthcare Policies: Payers pushing for cost-effective generics.
• Global Variations: Emerging markets show increasing ADHD treatment adoption, but growth remains variable.

---

Comparison: METADATE CD vs. Major Competitors

Attribute	METADATE CD	Concerta	Focalin XR	Generic Methylphenidate
Launch Year	2003	2000	2005	Varies
Delivery System	Extended-release capsule	Extended-release osmoticpump	Extended-release capsules	Immediate/Extended-release
Patent Expiry	2010-2012	Patent expired 2017	Patent expiry pending/modded?	Multiple manufacturers
Price Point	Premium (original)	Premium initially, now generic	Moderate	Low
Market Share (2022)	Diminished	~35%	~12%	~45%

---

Key Factors Influencing Financial Outcomes

Factor	Impact
Patent Expirations	Accelerates generic entry, reduces revenue
Formulation Innovation	Limited; most products are mature with minimal innovation
Prescription Trends	Sustainable demand for long-acting formulations with once-daily dosing
Pricing Strategies	Shift from premium pricing to competitive pricing due to generics
Market Penetration in New Regions	Potential growth in Asia and Latin America; regulatory hurdles apply

---

Conclusion: Is METADATE CD Still a Viable Asset?

While historically significant, METADATE CD faces a contracting market landscape dominated by generics and competing formulations. Its financial trajectory shows a downward trend since patent expiry, with modest potential for growth mainly tied to niche applications and emerging markets. Stakeholders must weigh the declining revenues against the costs of maintenance and marketing, considering whether innovation pipelines or indications expansions can provide renewed value.

---

Key Takeaways

• The global ADHD pharmaco-market continues to grow, but METADATE CD's revenue has declined sharply due to patent expiration and generic competition.
• Market share for METADATE CD has diminished from its peak (~35%) to negligible levels, with generics dominating the segment.
• Future prospects hinge on innovation, expanded indications, and emerging markets but face strong headwinds from regulatory and pricing pressures.
• Companies should focus on formulations offering abuse-deterrent features or novel delivery mechanisms to regain market presence.
• Investment decisions should consider the mature status of the product and the fiercely competitive environment.

---

FAQs

1. What factors led to the decline of METADATE CD’s market share?

Patent expiration in 2010-2012 precipitated entry of low-cost generics, leading to significant price competition and market erosion.

2. Are there any ongoing efforts to develop new formulations of METADATE CD?

Current efforts focus on abuse-deterrent formulations and alternative delivery systems; however, no major reformulations have yet penetrated the market.

3. How does the global outlook for ADHD treatments impact METADATE CD?

Growing awareness and diagnosis globally present opportunities, especially in emerging markets, but regulatory hurdles and local preferences influence adoption.

4. What role do regulatory policies play in shaping the future of METADATE CD?

Stringent regulations regarding stimulant misuse and patent protections significantly influence market viability and innovation strategies.

5. Will the introduction of biosimilars or patent challenges revive interest in METADATE CD?

Biosimilars are less relevant for methylphenidate products; however, patent challenges and legal proceedings could influence remaining exclusivity and pricing.

---

References

[1] Market Research Future, Global ADHD Market Analysis, 2022.
[2] Grand View Research, Neuropsychiatric Drugs Market Size & Trends, 2023.
[3] American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders (DSM-5), 2013.