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Product profile · United States

RYKINDO

 ·  Patent Litigation & Settlement History ↓

IngredientRISPERIDONE
Application typeNDA
Application212849
Product001
Dosage formFOR SUSPENSION, EXTENDED RELEASE
RouteINTRAMUSCULAR
Strength12.5MG
Approval date2023-01-13
Marketing statusDiscontinued
Status event—
ApplicantSHANDONG LUYE
Product source

Current GenericRadar decision

Year2025
SelectionDISCONTINUED
ReviewFINAL
Anchor typeNOT_APPLICABLE
Anchor date—
Patent anchor—
Exclusivity anchor—
Protection date—
First Final ANDA—
Status event—

GNR judgment: DISCONTINUED. Reference year: 2025. Anchor type: NOT_APPLICABLE. Patent anchor: not recorded. Exclusivity anchor: not recorded. Anchor date: not recorded. Patent tail: yes. Exclusivity tail: no. Review status: FINAL. Historical detailed rationale is retained in the evidence snapshot; this is a structured English summary, not a literal translation.

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
100988822032-04-10DP/U U-3513———
———
104061612032-04-10DP/U U-3513———
———
111100942032-04-10DP ————
———
94461352032-04-10DP/U U-3513———
———
95329912032-04-10DP/U U-3513———
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
No exclusivity facts are recorded in this product snapshot.

2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · Historical coverage: NOT_COMPLETE

Generic approval evidence

Application / productEventFinal dateTentative dateApplicantAuthorized genericExact mappingSource
No generic approval facts are linked to this product.

Market Entry Information

API filings, authorized generics and linked regulatory milestones.

API Master Files & Certifications 0 records

Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.

APIHolder / manufacturerHolder countryFiling typeNumberStatusFiled dateAvailable for referenceSourceLast verified
No master-file or certification records are linked through public manufacturer portfolios.

Authorized Generics 0 records

Authorized generics are shown separately from independent ANDA approvals.

Application / productApplicantEvent / status First marketed Product mappingSourceLast verified
No authorized-generic records are linked to this product.

Tentative ANDA Approvals 0 records

Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.

Application / productApplicantEvent / status Tentative date Follow-up final approvalProduct mappingSourceLast verified
No tentative-approval records are linked to this product.

Paragraph IV Challenges 0 records

Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.

Application / productApplicantEvent / status Certification event date Product mappingSourceLast verified
No structured Paragraph IV certification events are linked in the available approval evidence.

Final ANDA Approvals 0 records

Approval dates do not establish commercial launch. Product mapping is shown for each linked record.

Application / productApplicantEvent / status Final approval date Product mappingSourceLast verified
No final-approval records are linked to this product.
Independent legal-event information

Litigation & Settlement History

Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.

No litigation or settlement record currently linked to this product.