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Product profile · United States

VOYDEYA

 ·  Patent Litigation & Settlement History ↓

IngredientDANICOPAN
Application typeNDA
Application218037
Product001
Dosage formTABLET
RouteORAL
Strength50MG
Approval date2024-03-29
Marketing statusPrescription
Status event—
ApplicantALEXION PHARMS INC
Product source

Current GenericRadar decision

Year2038
SelectionCANDIDATE
ReviewFINAL
Anchor typePATENT
Anchor date2038-08-02
Patent anchor2038-08-02
Exclusivity anchor2031-03-29
Protection date—
First Final ANDA—
Status event—

NO_POST_ANCHOR_RIGHTS

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
97967412038-03-29DS/U U-3933YNTRUE_DS
———
97967412038-03-29DS;U U-3933———
OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed.
———
120763192038-08-02U U-3933NYDS_EQUIVALENT
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE—2029-03-29————Source
ODE-476—2031-03-29————Source

2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · 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.
Decision evidence (1)
TypeDateRoleBasisSource
REGULATORY_STATUS2038-08-02CANONICAL_DECISIONNO_POST_ANCHOR_RIGHTSSource
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.