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 Lannett 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-two 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:	4,334
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
National Institute on Drug Abuse (NIDA)	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
Lannett	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-003	May 27, 2003	AB2	RX	Yes	No
Lannett	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-004	Feb 19, 2006	AB2	RX	Yes	No
Lannett	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-001	Apr 3, 2001	AB2	RX	Yes	No
Lannett	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-002	Jun 19, 2003	AB2	RX	Yes	No
Lannett	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-006	Feb 19, 2006	AB2	RX	Yes	Yes
Lannett	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
Lannett	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-003	May 27, 2003
Lannett	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-002	Jun 19, 2003
Lannett	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-004	Feb 19, 2006
Lannett	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
Australia	2001297011
Australia	9701101
Canada	2426883	FORMULATIONS A LIBERATION MODIFIEE PAR METHYLPHENIDATE (METHYLPHENIDATE MODIFIED RELEASE FORMULATIONS)
Cyprus	1118946
Denmark	2103307
European Patent Office	1328251
European Patent Office	2103307	Formulations de libération modifiée de méthylphénidate (Methylphenidate modified release formulations)

Last updated: July 20, 2026

METADATE CD Market Dynamics and Financial Trajectory (Methylphenidate CD)

METADATE CD (methylphenidate hydrochloride extended-release capsules) remains a long-established ADHD franchise with mature unit economics, periodic generic and authorized generic pressure, and revenue that tracks U.S. stimulant demand, formulary access, and payer reimbursement rather than platform-style innovation. Commercial performance is constrained by generics of methylphenidate ER, shifting coverage tiers, and margin compression typical of older, off-patent stimulant products.

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What is METADATE CD’s market size exposure and revenue drivers?

Core revenue exposure: U.S. ADHD and stimulant demand, sales share vs. methylphenidate ER peers (including other ER capsule/ODT formulations), and net pricing through pharmacy benefit management (PBM) and wholesaler channel dynamics.

ADHD stimulant demand: what moves METADATE CD revenue

• Prescribing volume: pediatric and adolescent ADHD diagnosis rates and persistence of stimulant therapy.
• Switching within methylphenidate ER: formulary edits, prior authorization, step therapy, and quantity limits.
• Channel fill cycles: wholesalers’ inventory behavior and pull-through timing after list-price resets or generic entry.
• Net-to-gross compression: rebate and discount intensity tied to competitive contracting with PBMs.

Competitive category reality

METADATE CD is one product among many methylphenidate extended-release options. Competitive dynamics concentrate on:

• Therapeutic equivalence within methylphenidate ER dosing ranges.
• Formulary preference for specific delivery systems (capsules, tablets, ODT, beads) and preferred generics/authorized generics.
• Switching costs for patients and prescribers (dose titration, seizure risk screening, and tolerability differences among release profiles).

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How do generics and authorized generics impact METADATE CD financial trajectory?

General outcome: margin compression and share dilution after generic entry windows and PBM contracting shifts.

What generic pressure typically looks like in mature methylphenidate ER

• Price erosion: list price may stabilize while net price falls as contracting intensifies.
• Share redistribution: payers steer to the lowest net-cost products, often leading to abrupt step-down in brand units.
• Authorized generic effects: when an NDA/brand holder launches an “authorized generic” through the same supply chain or partner networks, it can accelerate market price normalization and reduce brand purchasing.

Business implication for financial trajectory

METADATE CD’s revenue path is expected to show:

• Plateau phases when fewer preferred generics are contested.
• Downward steps after meaningful shifts in PBM tiering, NDC-based contracting, or competitor launch waves.

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When did METADATE CD likely face off-patent and exclusivity dilution?

METADATE CD is a long-market product for methylphenidate ER. For established stimulants, revenue trajectory typically follows a predictable lifecycle:

1. Monopoly/near-monopoly years under brand protection and pediatric/label exclusivity periods.
2. First generic inroads causing unit and pricing declines.
3. Multi-wave erosion as more strengths, dosage forms, and manufacturers enter.
4. Consolidation on a smaller subset of products that remain preferred.

No specific exclusivity or patent expiration dates can be stated here without a product-level Orange Book and patent list for METADATE CD and the corresponding FDA application and NDC mappings.

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What is the Orange Book status of METADATE CD (patent and exclusivity listings)?

A complete Orange Book-derived status for METADATE CD requires the FDA “Orange Book” listing for the exact brand (including strength and dosage form) tied to the NDA and NDCs.

Without the Orange Book record set, the analysis cannot state:

• which patents remain listed,
• patent expiration years,
• whether Orange Book “use” patents are present,
• or which patents would drive Paragraph IV timing.

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How does METADATE CD compare with other methylphenidate ER brands on financial resilience?

Revenue resilience across methylphenidate ER products depends on:

• Formulary position (preferred vs. non-preferred),
• patient adherence and switching (release-profile tolerability),
• PBM contracting (rebate intensity and formulary placement),
• packaging and dosing coverage (availability across multiple strengths).

Relative risk factors for older branded methylphenidate ER

• High generic interchangeability: stimulants are typically treated as therapeutically substitutable at equivalent doses.
• PBS/PBM substitution behavior: substitution often happens at the pharmacy counter.
• Dose coverage breadth: products with fuller strength coverage gain advantage when titration schedules align with available generics.

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Which companies supply competing methylphenidate ER products versus METADATE CD?

This is driven by manufacturer participation across methylphenidate ER capsule/tablet SKUs and PBM preferred lists.

A company-level competitive mapping requires a current list of:

• competing NDCs,
• their FDA app numbers,
• and the active manufacturer label claims tied to those NDCs.

That mapping cannot be produced accurately here without the current Orange Book and labeling dataset for METADATE CD.

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What generic entry risks exist for METADATE CD?

Generic entry risk is highest when:

• the brand is fully out of listed patent protection,
• remaining listed patents (if any) have weak enforceability or are easy to design around via formulation or method-of-use changes,
• and PBMs support fast substitution.

In stimulants, the primary real-world risk is less litigation and more:

• contracting speed after generic approvals,
• automatic switching programs at PBMs,
• and authorized generic availability.

A precise entry-risk forecast for METADATE CD requires the Orange Book patent and exclusivity inventory for the product.

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How do payer formularies and PBM contracting dynamics affect METADATE CD net sales?

Net sales for older methylphenidate brands are primarily determined by:

• formulary tier placement (preferred vs. step therapy),
• prior authorization requirements,
• quantity limits and coverage restrictions,
• rebate structures that lower net price as competition increases.

Mechanisms of revenue impact

• A tier downgrade changes patient out-of-pocket costs and can reduce filled prescriptions.
• Step edits can delay therapy initiation and cause switching to another stimulant.
• Contracting rounds can reduce unit net price even if gross remains stable.

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What does METADATE CD’s financial trajectory typically look like over a multi-year horizon?

For a mature stimulant brand, the financial trajectory typically follows:

• Early plateau (when fewer generics compete aggressively).
• Gradual decline driven by incremental generic strength availability and contracting.
• Discrete drops tied to PBM formulary shifts or authorized generic releases.
• Stabilization only if the brand retains preferred status in key managed care contracts or if generics are not fully aligned with dosing needs.

This product-specific multi-year chart cannot be quantified here without:

• company financial disclosures tied to the METADATE CD product line or NDA,
• NDC-level sales from a commercial dataset,
• or brand-level sales disclosed in 10-K/10-Q filings.

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What financial KPIs best track METADATE CD performance?

Use NDC- and patient-flow metrics rather than only brand-level “stimulant category” indicators:

• U.S. prescription units by strength and dosage form
• Net price per unit (post-rebates)
• Formulary penetration (share of lives covered)
• PBM tier mix shift (preferred vs. non-preferred)
• Wholesale inventory days (channel fill/pull-through)

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Key Takeaways

• METADATE CD’s market dynamics are dominated by mature stimulant category competition, PBM contracting, and generic/authorized generic pressure.
• The financial trajectory for older methylphenidate ER products typically shows plateau-to-decline patterns with step changes after contracting and competitive waves.
• Quantifying the exact trajectory for METADATE CD requires current Orange Book status and product-level sales disclosures/NDC sales data, which are not provided in the available inputs here.
• Decision focus for R&D, licensing, and litigation strategy should be formulary positioning and NDC-level competitive substitution behavior more than technical differentiation.

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FAQs

1. How do PBMs decide which methylphenidate ER products become preferred?
2. What dosing strengths drive METADATE CD share versus alternative methylphenidate ER capsules?
3. How often do stimulant formulary changes trigger unit step-downs for older brands?
4. What role do authorized generics play in stabilizing or accelerating brand erosion?
5. Which KPIs forecast METADATE CD sales better: units, net price, or share of lives?

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. FDA. Drug Labeling and Approval History (access via Drugs@FDA).