GenericRadar
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Product profile · United States

ZILBRYSQ

 ·  Patent Litigation & Settlement History ↓

IngredientZILUCOPLAN SODIUM
Application typeNDA
Application216834
Product001
Dosage formSOLUTION
RouteSUBCUTANEOUS
StrengthEQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)
Approval date2023-10-17
Marketing statusPrescription
Status event—
ApplicantUCB INC
Product source

Current GenericRadar decision

Year2035
SelectionCANDIDATE
ReviewFINAL
Anchor typePATENT
Anchor date2035-06-12
Patent anchor2035-06-12
Exclusivity anchor2030-10-17
Protection date2035-06-12
First Final ANDA—
Status event—

NO_POST_ANCHOR_RIGHTS; US:NDA:216834:001; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
101065792035-06-12DS/DP/U U-3735YNTRUE_DS
English description not available.
———
101065792035-06-12ORANGE_BOOK U-3735YNTRUE_DS
English description not available.
———
102080892035-06-12DS/U U-3735YNTRUE_DS
English description not available.
———
102080892035-06-12ORANGE_BOOK U-3735YNTRUE_DS
English description not available.
———
104354382035-06-12DS/U U-3735YNTRUE_DS
English description not available.
———
104354382035-06-12ORANGE_BOOK U-3735YNTRUE_DS
English description not available.
———
105629342035-06-12DS —YNTRUE_DS
English description not available.
———
105629342035-06-12ORANGE_BOOK —YNTRUE_DS
English description not available.
———
108355742035-06-12DP —NNDP
English description not available.
———
108355742035-06-12ORANGE_BOOK —NNDP
English description not available.
———
110149652035-06-12DS/U U-3735YNTRUE_DS
English description not available.
———
110149652035-06-12ORANGE_BOOK U-3735YNTRUE_DS
English description not available.
———
115356502035-06-12DP —NYU
English description not available.
———
115356502035-06-12ORANGE_BOOK —NYU
English description not available.
———
117521902035-06-12DP/U U-3735NNDP
English description not available.
———
117521902035-06-12ORANGE_BOOK U-3735NNDP
English description not available.
———
119650402035-06-12DP —NYU
English description not available.
———
119650402035-06-12ORANGE_BOOK —NYU
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2023-10-172028-10-17English description not available.YY2028-10-17—Source
NCE2023-10-172028-10-17English description not available.YY2028-10-17
ODE-446
Full coverage date: 2028-10-17
Source
ODE-4462023-10-172030-10-17English description not available.YY2030-10-17—Source
ODE-4462023-10-172030-10-17English description not available.YY2030-10-17
ODE-446
Full coverage date: 2030-10-17
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 (12)
TypeDateRoleBasisSource
PATENT2035-06-12CANONICAL_ANCHOREnglish description not available.Source
PATENT2035-06-12CANONICAL_ANCHOREnglish description not available.Source
PATENT2035-06-12CANONICAL_ANCHOREnglish description not available.Source
PATENT2035-06-12CANONICAL_ANCHOREnglish description not available.Source
PATENT2035-06-12HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2035-06-12CANONICAL_ANCHOREnglish description not available.Source
PATENT2035-06-12CANONICAL_ANCHOREnglish description not available.Source
PATENT2035-06-12HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2035-06-12CANONICAL_ANCHOREnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2035-06-12CANONICAL_DECISIONNO_POST_ANCHOR_RIGHTS; US:NDA:216834:001; exact Final ANDA not verified; not proof of generic absenceSource
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.