GenericRadar
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Product profile · United States

SKYCLARYS

 ·  Patent Litigation & Settlement History ↓

IngredientOMAVELOXOLONE
Application typeNDA
Application216718
Product001
Dosage formCAPSULE
RouteORAL
Strength50MG
Approval date2023-02-28
Marketing statusPrescription
Status event—
ApplicantBIOGEN US
Product source

Current GenericRadar decision

Year2037
SelectionCANDIDATE
ReviewFINAL
Anchor typeTRUE_DS_PATENT
Anchor date2037-02-28
Patent anchor2037-02-28
Exclusivity anchor2030-02-28
Protection date2037-02-28
First Final ANDA—
Status event—

NO_POST_ANCHOR_CONFIRMED_RIGHTS; US:NDA:216718:001; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
110914302029-04-20U U-3552NYU
| B1C03P7 issued-claim review2026-10-15: U
———
110914302029-04-20ORANGE_BOOK U-3552NYU
English description not available.
———
119198382029-04-20U U-3862NYU
| B1C03P7 issued-claim review2026-10-15: U
———
119198382029-04-20U U-3863NYU
| B1C03P7 issued-claim review2026-10-15: U
———
119198382029-04-20ORANGE_BOOK U-3862;U-3863NYU
English description not available.
———
84408542029-04-20DP —NYU
| B1C03P7 issued-claim review2026-10-15: U
———
84408542029-04-20ORANGE_BOOK —NYU
English description not available.
———
96701472029-04-20DS —YNTRUE_DS
| B1C03P7 issued-claim review2026-10-15: TRUE_DS
———
96701472029-04-20ORANGE_BOOK —YNTRUE_DS
English description not available.
———
81247992029-12-03DS —YNTRUE_DS
| B1C03P7 issued-claim review2026-10-15: TRUE_DS
———
81247992029-12-03ORANGE_BOOK —YNTRUE_DS
English description not available.
———
97017092033-04-24DS/DP —NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
97017092033-04-24ORANGE_BOOK —NNDP
English description not available.
———
89936402037-02-28DS/DP —YNTRUE_DS
| B1C03P7 issued-claim review2026-10-15: TRUE_DS
———
89936402037-02-28ORANGE_BOOK —YNTRUE_DS
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
M-2702024-12-202027-12-20English description not available.NN——Source
M-2702024-12-202027-12-20English description not available.NN—
ODE-427
Full coverage date: —
Source
NCE2023-02-282028-02-28English description not available.YY2028-02-28—Source
NCE2023-02-282028-02-28English description not available.YY2028-02-28
ODE-427
Full coverage date: 2028-02-28
Source
ODE-4272023-02-282030-02-28English description not available.YY2030-02-28—Source
ODE-4272023-02-282030-02-28English description not available.YY2030-02-28
ODE-427
Full coverage date: 2030-02-28
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 (11)
TypeDateRoleBasisSource
PATENT2029-04-20HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2029-04-20HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2029-04-20HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2029-04-20HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2029-12-03HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2033-04-24HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2037-02-28CANONICAL_ANCHOREnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2037-02-28CANONICAL_DECISIONNO_POST_ANCHOR_CONFIRMED_RIGHTS; US:NDA:216718:001; 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.