RISVAN Drug Patent Profile

Which patents cover Risvan, and when can generic versions of Risvan launch?

Risvan is a drug marketed by Labs Farms Rovi Sa and is included in one NDA. There are fourteen patents protecting this drug.

The generic ingredient in RISVAN is risperidone. There is one drug master file entry 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 Risvan

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

Summary for RISVAN

US Patents:	14
Applicants:	1
NDAs:	1
Patent Applications:	2,380
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RISVAN
What excipients (inactive ingredients) are in RISVAN?	RISVAN excipients list
DailyMed Link:	RISVAN at DailyMed

US Patents and Regulatory Information for RISVAN

RISVAN is protected by fourteen US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Labs Farms Rovi Sa	RISVAN	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	214835-002	Mar 29, 2024		DISCN	Yes	No	11,752,093		Y
Labs Farms Rovi Sa	RISVAN	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	214835-002	Mar 29, 2024		DISCN	Yes	No	10,335,366		Y
Labs Farms Rovi Sa	RISVAN	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	214835-001	Mar 29, 2024		DISCN	Yes	No	11,752,092
Labs Farms Rovi Sa	RISVAN	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	214835-002	Mar 29, 2024		DISCN	Yes	No	11,173,110
Labs Farms Rovi Sa	RISVAN	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	214835-002	Mar 29, 2024		DISCN	Yes	No	10,881,605		Y
Labs Farms Rovi Sa	RISVAN	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	214835-001	Mar 29, 2024		DISCN	Yes	No	11,759,416
Labs Farms Rovi Sa	RISVAN	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	214835-001	Mar 29, 2024		DISCN	Yes	No	11,007,139

EU/EMA Drug Approvals for RISVAN

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 RISVAN

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

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	3524
Australia	2011260318
Australia	2013269546
Australia	2013269547
Australia	2013298705
Brazil	112012030686
Brazil	112012030707

Supplementary Protection Certificates for RISVAN

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

Risvan market dynamics and financial trajectory: exclusivity, competition, pricing pressure, and revenue outlook

Last updated: July 30, 2026

Risvan’s market trajectory is shaped by a narrow set of drivers: FDA regulatory position, payer access and contracting, competitive entry risk tied to patent and exclusivity cliffs, and steady demand elasticity typical of chronic-use drugs. The practical question for licensing, investment, and litigation planning is when generic or authorized-entrant pressure turns from “watchful waiting” into observable share loss.

What is Risvan and how is it positioned commercially?

Featured snippet answer: Risvan’s commercial performance is determined by (1) whether it is an innovator product with active FDA exclusivity, (2) its payer formulary status and reimbursement rates, and (3) competitive entry timing tied to Orange Book-listed patents and any settlement-backed launch calendars.

What product claims and route drive uptake?

Rising prescription volume or sustained unit sales usually tracks three elements: prescriber familiarity, clinical guideline placement, and switching friction from incumbent therapies. For market modeling, those factors translate into adoption curves and switching speed once a lower-priced alternative appears.

Who are the main payer and channel influences?

For financial trajectory, net sales typically diverge from gross sales due to:

• Rebates tied to contracting tiers
• Patient assistance programs
• Pharmacy benefit manager formulary management
• Medicaid and Medicare Part D tier placement

What pricing pressures are typical at maturity?

If Risvan sits in a therapeutic area with established comparators, mature products face:

• Progressive discounts after biosimilar or generic arrivals in the class
• Acceleration of utilization management over time (prior authorization, step edits)
• Increased contracting pressure from large health plans

When does Risvan lose exclusivity and what does that mean for revenue?

Featured snippet answer: Revenue risk increases sharply as FDA exclusivity and Orange Book patent coverage approach expiration, because challengers can file Paragraph IV certifications on a predictable timeline and generics can launch quickly after the regulatory “trigger” dates.

How exclusivity cliffs typically work for financial modeling

A generic entry timeline commonly maps to:

• Latest patent expiration (Orange Book)
• Statutory exclusivity (if applicable: NCE/3-year/5-year pediatric, etc.)
• Any 180-day exclusivity for first-filer challengers
• Court-ordered stays or settlement-based launch dates

How to translate dates into a sales curve

For planning purposes, the revenue impact usually follows a three-stage pattern:

1. Pre-launch: steady-to-slow volume with gradual payer discounting
2. Launch: sharp price erosion and rapid share migration (depending on substitutes)
3. Post-launch: stabilization as pharmacies and PBMs finalize preferred tiers

What patents protect Risvan and what is the strength of the patent estate?

Featured snippet answer: The risk profile is determined by the number of Orange Book-listed, unexpired patents that cover the commercial product, including method-of-use and formulation claims; a dense estate can delay entry even when some patents are weak.

How many patent families typically control market entry?

Market access delays often come from the presence of multiple independent claim categories:

• Composition/formulation patents (protecting drug substance or drug product)
• Method-of-use patents (protecting dosing regimens, patient subsets, or therapeutic outcomes)
• Manufacturing method patents (less frequently decisive for generic feasibility, but can drive litigation)

What to look for in Orange Book listings

For entry risk assessment, prioritize:

• The number of unexpired patents as of the current date
• Which patents are likely the “non-design-around” ones (composition and key method claims)
• Whether later-expiring patents can block FDA approval even if earlier patents fall

How does generic entry risk develop for Risvan?

Featured snippet answer: Generic entry risk rises with Paragraph IV filings, 180-day exclusivity assignments, and settlement patterns that set launch dates earlier than the latest patent expiration.

What generic launch scenarios are most common

For a branded drug, the practical scenarios are:

• Full launch at the earliest unblocked date after patent expiry
• Launch at a later date due to ongoing injunctions or court stays
• Authorized generic arrangements that compress switching economics for true generics

How do PBM contracting dynamics change after first generic launch?

After entry, PBMs often:

• Move the branded product down the formulary
• Require step therapy
• Use rebate recalculations tied to formulary placement This can accelerate branded revenue erosion even if statutory exclusivity still exists for some indications or formulations.

What patent litigation affects Risvan and how can it change the timeline?

Featured snippet answer: Litigation affects the timeline through court-ordered automatic stays upon Paragraph IV filings, injunction risk, and settlement-driven “designated launch dates.”

What litigation milestones matter for forecasting

High signal events include:

• Filing of Paragraph IV certifications (start of stay clock)
• Court rulings on validity and infringement
• Settlement announcements that specify agreed entry dates
• Dismissal orders or consent decrees that close appeals

Why settlement terms dominate market timing

Even when patent expiration dates look far away, settlements can move entry earlier by trading:

• Confidential launch triggers
• Licensing of certain claims
• Payment or supply arrangements

What is the Orange Book status of Risvan right now?

Featured snippet answer: Orange Book status determines whether FDA approvals for generic or biosimilar equivalents are blocked or permitted for each strength, dosage form, and route.

What dosage-form granularity usually controls entry

Entry barriers differ by:

• Strength-specific patents
• Tablet versus capsule versus solution coverage
• Labeling-specific method-of-use claims So financial models should map revenue by strength and formulation where possible.

How does Risvan compare with competing drugs in its therapeutic class?

Featured snippet answer: The competitive outcome is driven by comparative efficacy or tolerability claims reflected in label, real-world persistence, and payer preference driven by negotiated net prices.

What drives share loss after entry

The most common drivers of post-entry share erosion are:

• Net price gaps after rebates and discounts
• Switch incentives from PBMs and health systems
• Convenience factors like dosing frequency and formulation stability

What to track to benchmark resilience

Monitor:

• Script volume trends versus class comparators
• Time-on-therapy and discontinuation rates
• Formulary position changes across major plans

What formulations are protected by Risvan patents and how does that change design-around risk?

Featured snippet answer: Formulation coverage can delay entry if generic applicants cannot equivalently reproduce key drug product attributes without infringing, or if patents specifically claim critical process parameters.

What formulation patent types often matter

• Controlled-release or modified-release technology
• Bioavailability or Cmax/AUC targets
• Device-associated or integrated delivery systems (if applicable)

Does labeling carve-out reduce enforceability?

If method-of-use claims are limited to specific populations or dosing regimens, generic uptake can shift to label-permitted uses where infringement risk is lower.

How does FDA regulatory status for Risvan affect launch and competition?

Featured snippet answer: The FDA pathway determines the approval framework for competitors and the evidence required for equivalence, which influences launch speed and the practical risk of regulatory delays.

What to watch in FDA databases

Financially relevant FDA events include:

• Label expansion or indication changes (can open new revenue pools)
• Changes in REMS requirements (if applicable)
• Manufacturing changes that affect supply stability

Which companies are challenging Risvan and what settlements exist?

Featured snippet answer: The number of Paragraph IV filers and their chosen launch partners determines whether entry is one-sided or multi-filer, which affects price declines and speed of share loss.

How to map challenger count to revenue impact

• Single first-filer often yields slower erosion if other challengers are delayed
• Multi-filer scenarios can compress the post-launch window and deepen price pressure

What settlement structures typically signal

• Early entry dates imply weaker enforceability or negotiated risk
• Narrow stipulations imply continued litigation and potential injunction scenarios

What is the revenue exposure of Risvan to exclusivity and patent expiration?

Featured snippet answer: Revenue exposure is highest in the period from 12 to 36 months before the earliest Orange Book or exclusivity trigger, when competitors finalize product development and payers adjust contracting.

How to build a revenue-risk bridge

Create a bridge from:

• Product-level net sales split by strength and channel
• Historical discounting and rebate intensity
• Relative share volatility after similar class entries Then align the bridge to the earliest unblocked date.

Sensitivity levers

The largest levers are:

• Formulary exclusivity versus “preferred but not exclusive”
• Supply reliability that determines whether competitors capture demand immediately
• Court outcomes that alter stays and launch calendars

Key takeaways

• Risvan’s financial trajectory hinges on an exclusivity-and-patent calendar, not on standalone demand alone.
• Patent estate density across composition/formulation and method-of-use claims determines whether generic entry is delayed, carved out, or accelerated via settlement.
• Revenue risk rises materially in the 12 to 36 months window before the earliest unblocked date, when PBMs and health systems pre-position contracting and switching behavior.
• Challenger count and settlement structures are leading indicators of how steep price erosion will be after launch.

FAQs

1. How do Paragraph IV certification dates translate into generic launch expectations for Risvan?
2. What Orange Book patent types most often block generic entry for branded small-molecule therapies like Risvan?
3. How does PBM formulary tier movement typically affect net sales after generic launch?
4. When settlements set earlier launch dates, what signals indicate whether courts will still enjoin?
5. What metrics best forecast branded persistence through the exclusivity cliff for chronic-use drugs like Risvan?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Orange Book database).
2. FDA. Drug Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman framework) and Paragraph IV certification overview.
3. U.S. Court of Appeals for the Federal Circuit. Case law related to Hatch-Waxman automatic stays, injunctions, and patent infringement determinations.