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Orange Book drug · Brand (NDA)

Risvan

Risperidone

DiscontinuedRLDNDA 214835 2 strengths Labs Farms Rovi Sa
Approved
Mar 29, 2024
Strengths
2
Listed patents
14

What does the FDA Orange Book show for Risvan?

Risvan contains Risperidone and is the new drug FDA Orange Book record for NDA 214835. The application has 2 presentations with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 214835

New drug application identity from the Orange Book snapshot.

Application holder
Laboratorios Farmaceuticos Rovi Sa

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
2

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Discontinued

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
14

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
1

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
00175MGFOR SUSPENSION, EXTENDED RELEASEINTRAMUSCULARDiscontinuedNone posted
RLD
002100MGFOR SUSPENSION, EXTENDED RELEASEINTRAMUSCULARDiscontinuedNone posted
RLD

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Laboratorios Farmaceuticos Rovi Sa

The Orange Book identifies this organization as the applicant responsible for NDA 214835.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

2 presentations listed as on the Discontinued Drug Product List

A discontinued-list entry does not, by itself, show why marketing stopped or whether FDA determined the product was withdrawn for safety or effectiveness.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

14 listed patent expirations and 1 exclusivity date remain on or after Jul 26, 2026

The latest future date recorded across those files is May 31, 2031. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

48 other ANDAs and 7 other NDAs found

29 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 214835 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

For Suspension, Extended Release · Intramuscular

Risperidone

2 applications
Product rows
6
Active applications
1
Active with AB row
0
Rykindo · NDA 212849

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-214835

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Strengths & dosage forms

2 approved presentations · NDA 214835
RLDDiscontinued
Strength
75MG
Dosage form
FOR SUSPENSION, EXTENDED RELEASE
Route
INTRAMUSCULAR
Marketing status
Discontinued

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    2 yr 4 mo ago

  2. Today

  3. Exclusivity ends · NP

    New product exclusivity (3 years)

    in 8 mo

  4. Patent 10058504 expires

    Listed drug product patent expiration.

    in 4 yr 11 mo

  5. Patent 10085936 expires

    Listed drug product patent expiration.

    in 4 yr 11 mo

  6. Patent 10182982 expires

    Listed method-of-use patent (U-3943) expiration.

    in 4 yr 11 mo

  7. Patent 10195138 expires

    Listed method-of-use patent (U-3943) expiration.

    in 4 yr 11 mo

  8. Patent 10335366 expires

    Listed drug product patent expiration.

    in 4 yr 11 mo

  9. Patent 10463607 expires

    Listed drug product patent expiration.

    in 4 yr 11 mo

  10. Patent 10881605 expires

    Listed drug product patent expiration.

    in 4 yr 11 mo

  11. Patent 11007139 expires

    Listed method-of-use patent (U-3942) expiration.

    in 4 yr 11 mo

  12. Patent 11173110 expires

    Listed method-of-use patent (U-3941) expiration.

    in 4 yr 11 mo

  13. Patent 11241377 expires

    Listed method-of-use patent (U-3939) expiration.

    in 4 yr 11 mo

  14. Patent 11752092 expires

    Listed method-of-use patent (U-3941) expiration.

    in 4 yr 11 mo

  15. Patent 11752093 expires

    Listed drug product patent expiration.

    in 4 yr 11 mo

  16. Patent 11752094 expires

    Listed method-of-use patent (U-3942) expiration.

    in 4 yr 11 mo

  17. Patent 11759416 expires

    Listed method-of-use patent (U-3939) expiration.

    in 4 yr 11 mo

Patent & exclusivity timeline

Protection horizon
2026202720282029203020312032TodayExclusivity NP: 2027-03-29Exclusivity NPPatent 10058504: 2031-05-31Patent 10058504Patent 10085936: 2031-05-31Patent 10085936Patent 10182982: 2031-05-31Patent 10182982Patent 10195138: 2031-05-31Patent 10195138Patent 10335366: 2031-05-31Patent 10335366Patent 10463607: 2031-05-31Patent 10463607Patent 10881605: 2031-05-31Patent 10881605Patent 11007139: 2031-05-31Patent 11007139Patent 11173110: 2031-05-31Patent 11173110Patent 11241377: 2031-05-31Patent 11241377Patent 11752092: 2031-05-31Patent 11752092Patent 11752093: 2031-05-31Patent 11752093Patent 11752094: 2031-05-31Patent 11752094Patent 11759416: 2031-05-31Patent 11759416
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

RISPERIDONE

Strength

75MG

Dosage form

FOR SUSPENSION, EXTENDED RELEASE

Route

INTRAMUSCULAR

TE code

Not listed

Application

NDA 214835

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Marketing exclusivity

Hatch-Waxman
  • NPNew product exclusivity (3 years)

    in 8 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10058504in 4 yr 11 mo
Product
10085936in 4 yr 11 mo
Product
10182982in 4 yr 11 mo
U-3943
10195138in 4 yr 11 mo
U-3943
10335366in 4 yr 11 mo
Product
10463607in 4 yr 11 mo
Product
10881605in 4 yr 11 mo
Product
11007139in 4 yr 11 mo
U-3942
11173110in 4 yr 11 mo
U-3941
11241377in 4 yr 11 mo
U-3939
11752092in 4 yr 11 mo
U-3941
11752093in 4 yr 11 mo
Product
11752094in 4 yr 11 mo
U-3942
11759416in 4 yr 11 mo
U-3939

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Risperidone family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Risvan: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 214835 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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