RISPERDAL CONSTA Drug Patent Profile

When do Risperdal Consta patents expire, and when can generic versions of Risperdal Consta launch?

Risperdal Consta is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in RISPERDAL CONSTA is risperidone. There are thirty drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the risperidone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Risperdal Consta

A generic version of RISPERDAL CONSTA was approved as risperidone by RISING on October 8^th, 2008.

Summary for RISPERDAL CONSTA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	45
Patent Applications:	4,717
Drug Prices:	Drug price information for RISPERDAL CONSTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RISPERDAL CONSTA
What excipients (inactive ingredients) are in RISPERDAL CONSTA?	RISPERDAL CONSTA excipients list
DailyMed Link:	RISPERDAL CONSTA at DailyMed

See drug prices for RISPERDAL CONSTA

Recent Clinical Trials for RISPERDAL CONSTA

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

Sponsor	Phase
Otsuka America Pharmaceutical	Phase 4
Gazda, Thomas D., M.D., PC	Phase 4
Zogenix, Inc.	Phase 1

See all RISPERDAL CONSTA clinical trials

US Patents and Regulatory Information for RISPERDAL CONSTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	RISPERDAL CONSTA	risperidone	POWDER;INTRAMUSCULAR	021346-004	Apr 12, 2007	AB	RX	Yes	Yes
Janssen Pharms	RISPERDAL CONSTA	risperidone	POWDER;INTRAMUSCULAR	021346-003	Oct 29, 2003	AB	RX	Yes	Yes
Janssen Pharms	RISPERDAL CONSTA	risperidone	POWDER;INTRAMUSCULAR	021346-001	Oct 29, 2003	AB	RX	Yes	Yes
Janssen Pharms	RISPERDAL CONSTA	risperidone	POWDER;INTRAMUSCULAR	021346-002	Oct 29, 2003	AB	RX	Yes	Yes

Expired US Patents for RISPERDAL CONSTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	RISPERDAL CONSTA	risperidone	POWDER;INTRAMUSCULAR	021346-001	Oct 29, 2003
Janssen Pharms	RISPERDAL CONSTA	risperidone	POWDER;INTRAMUSCULAR	021346-003	Oct 29, 2003
Janssen Pharms	RISPERDAL CONSTA	risperidone	POWDER;INTRAMUSCULAR	021346-002	Oct 29, 2003

EU/EMA Drug Approvals for RISPERDAL CONSTA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Laboratorios Farmacéuticos Rovi, S.A.	Okedi	risperidone	EMEA/H/C/005406Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.	Authorised	no	no	no	2022-02-14

International Patents for RISPERDAL CONSTA

See the table below for patents covering RISPERDAL CONSTA around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	79379
Australia	5529786
Australia	579232
Bulgaria	60432
Canada	1256867	DERIVES DE 3-PIPERIDINYL-1,2-BENZISOXAZOL ET DE 3-PIPERIDINYL-1,2-BENZISOTHIAZOL (1,2-BENZISOXAZOL-3-YL AND 1,2-BENZISOTHIAZOL-3-YL DERIVATIVES)
China	1022566
China	86101906

Supplementary Protection Certificates for RISPERDAL CONSTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0196132	SPC/GB93/036	United Kingdom		SPC/GB93/036:, EXPIRES: 20071207
0196132	94C0008	Belgium		PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208

Risperdal Consta (risperidone long-acting injectable): Market dynamics, sales trajectory, exclusivity timeline, and generic/biosimilar risks

Last updated: July 21, 2026

Executive summary: Risperdal Consta (risperidone long-acting injection, LAI) is an established antipsychotic depot in schizophrenia and related psychiatric indications. Post-2018 U.S. patent expiry and steady competitive pressure from other LAIs have shifted the market toward volume sharing, price pressure, and payor-driven formulary management. The product’s financial trajectory has been dominated by: (1) loss of composition and LAI-specific exclusivity, (2) sustained competition from alternative second-generation LAIs (notably olanzapine pamoate, aripiprazole LAIs, and paliperidone palmitate), and (3) channel and contracting dynamics for depot antipsychotics. The economic outlook in the U.S. hinges on residual patent barriers (formulation, manufacturing, and method-of-use claims), substitution risk during switching, and payer tolerance for therapeutic interchange among LAIs.

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What drives Risperdal Consta market share and pricing dynamics?

Core demand drivers

• Depot adherence: Clinicians and payors favor LAIs for reduced relapse and hospitalization risk in patients with poor adherence to oral antipsychotics.
• Site-of-care economics: Depot LAIs carry administration workflows that can be managed through specialty pharmacy, office-administered billing, or institutional purchasing contracts.
• Payer controls: Managed care emphasizes step therapy, prior authorization, and preferential tiering among LAIs, with negotiated rebates and contracting carve-outs affecting net pricing more than list price.

Key competitive pressures Risperdal Consta is a risperidone-based LAI competing with next-generation and adjacent-depot products that often have:

• Established formularies at scale (high formulary “stickiness”)
• Administration familiarity and patient switching pathways
• Demonstrated dosing convenience (depending on product) that influences payer preferences

Where value shifts in LAIs

• Net-to-list discounting and rebate pressure tends to accelerate after major competitor entries and after patent protection narrows.
• Switching inertia is real but not absolute; patients and payors may move to alternative LAIs when clinical and coverage conditions align.

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How has Risperdal Consta sales and financial trajectory changed over time?

Sales profile characteristics (typical LAI pattern)

• Peak years track patent-protected exclusivity and broad commercial access.
• After exclusivity and increased LAI competition, revenue generally transitions from growth to steady decline or plateau, with sharper declines when:
  • Alternative LAIs gain preferential payer placement
  • Therapeutic interchange becomes easier via contracting
  • Residual IP barriers weaken or are challenged

What to watch in the financial trajectory

• U.S. prescription trends versus international distribution: depot adoption often differs by market due to formulary and guideline adoption.
• Net price versus volume: LAIs can hold gross demand while net revenues fall due to rebates and contraction.
• Loss of brand insulation: when generics or authorized competitors gain share in adjacent products or through contracting, brands can face “indirect substitution” pressure.

Practical implication for stakeholders

• For investors and licensors, the relevant question is not only “does the brand remain sold?” but “how much net revenue per dose remains after contracting and competitor mix shifts?”

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What is the FDA status of Risperdal Consta and what does that mean commercially?

Regulatory posture

• Risperidone LAI is an FDA-approved product for schizophrenia (and, historically in some jurisdictions, other uses under specific labeling).
• Commercial stability depends on continued market supply, REMS-like infrastructure (if any is applicable for the product), and maintaining manufacturing continuity for sterile injectable products.

Commercial impact of regulatory constraints

• For sterile injectables, supply-chain constraints can create short-term pricing volatility but usually do not arrest longer-term competitive share declines.
• FDA postmarketing commitments and manufacturing controls can raise the cost and time for would-be challengers to restart or sustain production.

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What patents protect Risperdal Consta and how strong is the patent estate?

Patent estate drivers Risperdal Consta’s durability typically depends on whether remaining claims cover:

• Composition or formulation specifics of the LAI
• Manufacturing methods (including particle size, crystallinity, viscosity, suspension stability, sterility assurance)
• Method-of-use claims tied to schizophrenia treatment regimens

How “strong” estates behave in real-world LAI markets

• Even when composition patents expire, manufacturing and formulation patents can delay generic launch or limit “at-risk” competition.
• If method-of-use claims exist and are not easily designed around, ANDA filers may choose non-launch or pursue settlement.

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When does Risperdal Consta lose exclusivity in the U.S., and what is the litigation timeline?

Exclusivity and litigation mechanics

• U.S. brand exclusivity typically flows from the original NDA or supplemental applications, but for many mature injectables, patent expiration is the dominant driver rather than statutory exclusivity.
• Patent expiration plus Paragraph IV outcomes decide launch timing for ANDA challengers.

How to interpret “loss of exclusivity” for LAIs

• Even after headline patents expire, settlement agreements and remaining listed patents can keep launch barriers in place.
• For LAIs, manufacturing readiness is often a gating factor even when a legal launch date arrives.

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What Orange Book listings cover Risperdal Consta, and how many patents are listed?

How stakeholders should read Orange Book coverage

• Focus on patents listed as covering:
  • Drug substance (risperidone) versus drug product
  • Formulation or release characteristics
  • Methods of use
  • Any delisting events that signal loss of protection

Commercial significance

• Dense Orange Book listings often correlate with:
  • Higher settlement likelihood
  • Longer “potential launch” windows for generics
  • Greater risk of court injunctions or revised label designs

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Which companies are challenging Risperdal Consta via ANDA or Paragraph IV?

ANDA challenge signals

• Paragraph IV filings imply a challenger believes claims are invalid and/or not infringed.
• For mature depot products, challenges often cluster around:
  • Formulation/manufacturing patents
  • Specific release or suspension characteristics
  • Method-of-use claims tied to dosing schedules

What matters commercially

• The identity of filers affects settlement leverage because:
  • Some filers pursue rapid market entry, while others coordinate via co-marketing or authorized supply.
  • Launch scale and distribution partnerships determine how quickly any generic captures share.

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What patent litigation affects Risperdal Consta and how do settlements change generic entry?

Litigation outcomes that matter

• A final decision sustaining patents can block launch.
• A finding of invalidity or non-infringement can enable at-risk entry if the FDA approves the ANDA.
• Section 505(j) settlement agreements often:
  • Delay effective launch dates
  • Define carve-outs on labeling or formulation design
  • Create launch calendars that shift commercial dynamics

Why settlement matters in LAIs

• LAI market entry requires supply chain credibility and injection-ready product manufacturing.
• Even with legal freedom, manufacturing scale can delay real-world revenue capture.

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How do generics and “authorized” competition typically perform versus Risperdal Consta?

What generally happens after generic entry

• Price compression tends to be rapid in the first 6 to 24 months after meaningful competition.
• Net revenue per dose declines even when volume holds because:
  • payers demand rebate adjustments
  • hospitals and specialty distributors switch to best-value products
• Brand retention depends on:
  • patient continuity programs
  • physician familiarity
  • payer preferred drug lists and prior authorization criteria

LAI-specific risk

• Switching stability: patients can be stable on a given LAI, which slows forced conversion.
• Contracting triggers: payer changes and formulary updates can override clinical inertia.

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How does Risperdal Consta compare with competing LAIs (paliperidone, aripiprazole, olanzapine)?

Strategic comparison dimensions

• Formulary positioning: which LAI is preferred by major payers in schizophrenia?
• Dosing and administration preferences: dose frequency and patient management convenience.
• Clinical guidance alignment: guideline endorsements and real-world prescribing habits influence payor acceptance.
• Net price and rebate strength: LAI competition often becomes a contracting contest.

Commercial implications

• If competitors achieve broader formulary placement, Risperdal Consta net sales can face structural decline even absent direct generic substitution.

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What formulation and manufacturing IP barriers can delay generic LAI entry?

Common IP choke points for depot injectables

• Suspension stability and particle attributes (e.g., consistent release kinetics)
• Wetting/dispersibility and aggregation control
• Sterility assurance steps and aseptic processing specifics
• Lyophilization or preparation workflow claims, if present in the patent estate

Why manufacturing claims matter

• For injectable depots, small process deviations can change the drug product’s in vivo performance.
• Competitors often need to lock manufacturing controls before commercial launch.

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What is the commercial risk from biosimilars to Risperdal Consta?

Risperdal Consta is a small-molecule drug product (risperidone), not a biologic. Biosimilar frameworks do not apply.

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How do worldwide dynamics affect Risperdal Consta revenue exposure?

Market segmentation

• LAI adoption varies by country based on reimbursement models, guideline uptake, and availability of alternative LAIs.
• Tender-driven markets can shift pricing faster than prescription-driven systems.

Regulatory and supply dynamics

• Sterile injectable supply continuity becomes a recurring operating risk.
• Competing LAI portfolios in local markets can change faster than in the U.S.

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What are the key generic launch scenarios for Risperdal Consta?

Scenario 1: Full clearance and rapid entry

• ANDA approval without remaining injunction risk.
• Strong distribution partners enable quick share capture.
• Price compression drives net revenue decline.

Scenario 2: Design-around plus labeling negotiation

• Generic launches later with narrower labeling claims or dosing constraints.
• Contracting may still displace the brand in formularies if therapeutic interchange is permitted.

Scenario 3: Settlement delay

• Paragraph IV resolution postpones effective entry.
• Brand competes on contracting during the delay period.
• Generic entry occurs only after the agreed calendar date.

Scenario 4: Manufacturing or supply bottleneck

• Legal readiness arrives, but product readiness delays launch revenue.
• Competitor LAIs capture incremental share during the gap.

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Key Takeaways

• Risperdal Consta’s revenue trajectory is shaped more by LAI competitive contracting and therapeutic interchange than by any single event after initial exclusivity windows.
• The U.S. market outlook depends on Orange Book patent listings, Paragraph IV challenge outcomes, and any settlement calendars that govern generic entry timing.
• LAI-specific formulation and manufacturing IP can delay actual launch even after legal clearance.
• Commercial risk comes primarily from competitor LAIs (paliperidone, aripiprazole, olanzapine) gaining formulary placement, not from biosimilar pathways.

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FAQs

1. What drives net price declines for long-acting injectable antipsychotics like Risperdal Consta?
Payor rebates, formulary contracting, and preferred drug list placement for competing LAIs drive net price more than list price.

2. How do Orange Book method-of-use patents affect ANDA launch timing for depot antipsychotics?
They can create infringement defenses and settlement leverage, delaying approval-effective or injunction-risk launch.

3. Do generic long-acting injectable risks center on legal clearance or manufacturing readiness?
Both. Legal clearance enables approval-attempts, but manufacturing readiness and sterile injectable controls often gate real-world launch.

4. Does therapeutic interchange slow brand erosion for Risperdal Consta?
It slows it. It does not prevent erosion if payers impose preferred LAI selection through authorization and contracting.

5. What competitive signals matter most for future Risperdal Consta revenue?
Formulary movement among major payers, competitor contracting strength, and any Orange Book delistings or post-litigation settlement calendars.

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References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Drugs@FDA: Risperdal Consta. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/