RISPERDAL Drug Patent Profile

Which patents cover Risperdal, and what generic alternatives are available?

Risperdal is a drug marketed by Janssen Pharms and is included in four NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Risperdal

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

Summary for RISPERDAL

US Patents:	0
Applicants:	1
NDAs:	4

Paragraph IV (Patent) Challenges for RISPERDAL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RISPERDAL	Orally Disintegrating Tablets	risperidone	0.25 mg	021444	1	2005-04-11
RISPERDAL	Orally Disintegrating Tablets	risperidone	3 mg and 4 mg	021444	1	2005-03-23

US Patents and Regulatory Information for RISPERDAL

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	risperidone	SOLUTION;ORAL	020588-001	Jun 10, 1996	AA	RX	Yes	Yes
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-008	May 10, 1999	AB	RX	Yes	No
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-003	Apr 2, 2003		DISCN	Yes	No
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-004	Dec 29, 1993	AB	RX	Yes	No
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-007	Jan 27, 1999	AB	RX	Yes	No

International Patents for RISPERDAL

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

Country	Patent Number	Title	Estimated Expiration
U.S.S.R.	1468419	CПOCOБ ПOЛУЧEHИЯ ПPOИЗBOДHЫX 1,2-БEHЗИЗOOKCAЗOЛИЛA-3 ИЛИ 1,2-БEHЗИЗOTИAЗOЛИЛA-3, ИЛИ ИX CTEPEOИЗOMEPOB, ИЛИ ИX KИCЛOTHO-AДДИTИBHЫX COЛEЙ (METHOD OF PRODUCING DERIVATIVES OF 1,2-BENZISOXAZOLYL-3, OR 1,2-BENZISOTHIAZOLYL-3 OR STEREOSIOMERS THEREOF OR ACID-ADDITIVE SALTS THEREOF)
Hong Kong	1019200
China	1022566
New Zealand	215462	1,2 BENZISOXAZOL-3-YL AND 1,2-BENZISOTHIAZOL-3-YL DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS
Latvia	5778	1,2-Benzizoksazol-3-il- un 1,2-benzizotiazol-3-il-atvasinajumi

Supplementary Protection Certificates for RISPERDAL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0368388	C300298	Netherlands		PRODUCT NAME: PALIPERIDON, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIE ZOUT; REGISTRATION NO/DATE: EU/1/07/395/001-064 20070625
0368388	SPC/GB07/065	United Kingdom		PRODUCT NAME: PALIPERIDONE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/07/395/001 20070625; UK EU/1/07/395/002 20070625; UK EU/1/07/395/003 20070625; UK EU/1/07/395/004 20070625; UK EU/1/07/395/005 20070625; UK EU/1/07/395/006 20070625; UK EU/1/07/395/007 20070625; UK EU/1/07/395/008 20070625; UK EU/1/07/395/009 20070625; UK EU/1/07/395/010 20070625; UK EU/1/07/395/011 20070625; UK EU/1/07/395/012 20070625; UK EU/1/07/395/013 20070625; UK EU/1/07/395/014 20070625; UK EU/1/07/395/015 20070625; UK EU/1/07/395/016 20070625; UK EU/1/07/395/017 20070625; UK EU/1/07/395/018 20070625; UK EU/1/07/395/019 20070625; UK EU/1/07/395/020 20070625; UK EU/1/07/395/021
0196132	94C0008	Belgium		PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208
0368388	91362	Luxembourg		91362, EXPIRES: 20141030
0368388	78/2007	Austria		PRODUCT NAME: PALIPERIDON, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEMBAREN SALZES; REGISTRATION NO/DATE: EU/1/07/395/001-064 20070625

RISPERDAL (risperidone): Investment Scenario and Fundamentals Analysis

Last updated: April 23, 2026

Risperdal is the long-running brand of risperidone, an antipsychotic from Janssen (J&J) that remains a mainstream option in schizophrenia and bipolar disorder. The investment setup for RISPERDAL is primarily driven by (1) continued generic substitution, (2) secondary-care pipeline strength in the broader antipsychotic class, and (3) patent and exclusivity timelines around specific formulations and geographies rather than the core molecule.

What is RISPERDAL’s market and revenue structure today?

Risperdal is sold as oral tablets and multiple long-acting injectable (LAI) formats (notably the microsphere-based LAI marketed globally as Risperdal Consta, where applicable by country). In practice, brand economics depend on where the market is in the generic and LAI transition curve:

• Oral risperidone tablets: typically face high generic penetration in most developed markets, which compresses brand pricing and share.
• LAI risperidone: often maintains higher persistence because payer and prescriber behavior favors established administration pathways, but it still competes with long-acting alternatives and generics where allowed.

Key implication for investors: RISPERDAL’s fundamentals behave more like a mature-care cash-flow asset than a growth compound, with upside and downside driven by LAI durability, switching patterns, and country-by-country exclusivity.

How does the competitive landscape pressure RISPERDAL?

Competition in antipsychotics is multidimensional: molecule class substitution (other SGAs), LAI device and formulation substitution, and aggressive payer contracting.

Competitive pressure generally comes from:

• Competing LAIs (same therapeutic class, different agents and dosing intervals).
• Oral SGA erosion through generics and lower WAC dynamics.
• Formulary steering toward products with better payer rebates, pathway alignment, or clinical positioning.

RISPERDAL’s ability to hold share depends on its perceived clinical fit (tolerability, symptom control, conversion to LAIs) and contract terms rather than patent protection in many markets.

Where does RISPERDAL sit on the IP timeline?

What patents and exclusivities have historically mattered?

For mature branded drugs, investment diligence focuses on:

• Primary composition-of-matter coverage for risperidone (largely expired in most jurisdictions).
• Product patents and formulation patents (tablet compositions, LAI microsphere/vehicle systems, and specific release profiles).
• Data and marketing exclusivities tied to first approvals and specific manufacturing routes.

For RISPERDAL, the practical IP outcome for investors is that most core-molecule brand protection has already run. Remaining leverage typically comes from:

• formulation-specific patents (where still active),
• country-specific regulatory exclusivities,
• and protection around certain LAI manufacturing details.

How does this translate into a commercial risk profile?

• High probability of continued generic erosion on oral forms.
• Lower but persistent erosion risk on LAI if local generic entry or competitor substitution occurs.
• Legal and regulatory enforcement risk remains relevant, but the central driver is the market structure after exclusivity expiry.

What fundamentals drive RISPERDAL’s long-term cash flows?

1) Share stability in LAIs

LAIs are the main lever for durability because:

• patient adherence is higher with scheduled administration,
• discontinuation patterns are slower once stable,
• and clinics follow repeatable workflows.

Investment interpretation: RISPERDAL LAI performance is the key determinant of how “defensive” the brand behaves against generic oral erosion.

2) Payer contracting and rebate pressure

In mature therapy areas, brand survival is often a function of:

• rebate structures,
• preferred formulary positioning,
• and budget impact negotiations.

For RISPERDAL, rebate-driven dynamics can offset price pressure, but they rarely reverse margin compression once generic share saturates.

3) Conversion dynamics from oral to LAI

Clinicians frequently convert stable patients to LAI to reduce relapse risk and hospitalization drivers. This conversion supports unit demand for LAIs, even when oral tablets are commoditized.

Investment interpretation: the rate of conversion and the retention rate after conversion are more predictive than headline market growth.

What does RISPERDAL’s clinical positioning imply for demand?

Risperidone has an established role in:

• schizophrenia,
• bipolar disorder (including manic episodes and maintenance depending on jurisdiction/labeling),
• and related indications where clinicians use it based on historical evidence and guideline inclusion.

For long-running brands, label breadth and the stability of guideline recommendations support baseline demand, but they do not overcome systemic generic substitution in oral formulations.

Investment scenario: base case, bull case, bear case

Base case (most likely)

• Oral RISPERDAL continues to decline in branded share and price as generic uptake persists.
• LAI RISPERDAL maintains relative stability, supported by conversion and retention.
• Net brand revenue tracks modest decline with periodic stabilization.

Core assumption: LAI competitive position holds through the medium term.

Bull case

• LAI durability extends due to favorable contracting and limited generic disruption (or successful defense of formulation-specific protections).
• Conversion to LAI accelerates due to payer-friendly adherence programs and clinic-level adoption.
• Competitor substitution is slower than expected, especially in patient cohorts with established tolerance and good disease control.

Core assumption: LAI share holds better than the oral erosion suggests.

Bear case

• LAI face increased substitution via competitor LAIs with stronger payer positioning.
• Formulation-related generic entry or forced pricing drives sharper LAI unit and price declines.
• Contract changes reduce net revenue even if gross prescriptions remain stable.

Core assumption: LAI economics compress, making the brand more “oral-like” in cash-flow behavior.

Key diligence checkpoints for RISPERDAL investments

Regulatory and IP

• Confirm country-by-country remaining exclusivity for LAI and any protected formulations (tablet compositions, LAI microsphere manufacturing, and specific dosage forms).
• Track any regulatory filings targeting risperidone LAI products that could signal near-term substitution risk.

Commercial

• Track LAI vs oral prescription mix as the primary KPI.
• Track net pricing and rebate changes for branded exposure, not WAC alone.
• Monitor tender activity and formulary shifts for antipsychotics at payer or regional group levels.

Manufacturing and supply

• LAIs are supply-chain-sensitive; disruptions or quality events can change prescriber habits, which affects demand durability.

What are the actionable investment conclusions?

Risperdal’s fundamentals support a view of mature defensible cash flows driven by LAI persistence, offset by ongoing oral generic erosion. The investment quality hinges on whether LAI economics continue to dominate brand P&L and whether remaining formulation-specific IP or payer strategy prevents step-down in net revenue.

For business decisions, the key is not whether risperidone is “good,” but whether RISPERDAL’s net revenue per treated patient and patient retention on LAIs remain resilient against payer contracting and competitor substitution.

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Key Takeaways

• RISPERDAL is a mature branded risperidone franchise where oral economics face sustained generic substitution.
• The LAI franchise is the primary durability lever, with demand driven by conversion and retention.
• The investment outcome depends on country-specific residual IP/exclusivity for formulations, plus payer contracting and LAI competitive substitution.
• Base case expects modest brand revenue decline, bull case depends on LAI resilience, bear case depends on LAI pricing/unit compression.

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FAQs

1) Is RISPERDAL primarily a growth or cash-flow asset?

Cash-flow. The franchise behaves like a mature brand with competitive erosion, with LAI performance providing the main stability.

2) What matters most for investment returns: IP or commercial execution?

Commercial execution dominates day-to-day results, but IP determines the ceiling for how long LAI economics can stay elevated by blocking near-term substitution.

3) Why is RISPERDAL LAI more investable than oral RISPERDAL?

LAIs typically have stronger persistence, driven by dosing schedules and clinic workflows, which slows the rate of market share loss compared with oral generics.

4) What KPI should be monitored most closely?

The LAI-to-oral prescription mix and the resulting net revenue trajectory for the brand.

5) What are the highest-risk failure modes?

Accelerating LAI substitution, unfavorable contract renegotiations that compress net prices, and any formulation-specific disruption that enables faster competitor or generic entry.

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References

[1] Janssen Pharmaceuticals. RISPERDAL (risperidone) prescribing information.
[2] U.S. Food and Drug Administration. Drug Approval Reports and label database for risperidone products. https://www.accessdata.fda.gov
[3] World Health Organization. ATC classification and therapeutic categorization for antipsychotics (risperidone). https://www.who.int/health-topics/antipsychotic-medicines