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Product profile · United States

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 ·  Patent Litigation & Settlement History ↓

IngredientDAROLUTAMIDE
Application typeNDA
Application212099
Product001
Dosage formTABLET
RouteORAL
Strength300MG
Approval date2019-07-30
Marketing statusPrescription
Status event—
ApplicantBAYER HEALTHCARE
Product source

Current GenericRadar decision

Year2033
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typePATENT
Anchor date2033-03-25
Patent anchor2033-03-25
Exclusivity anchor2024-07-30
Protection date2042-06-17
First Final ANDA—
Status event—

GNR judgment: DEEP_REVIEW. Reference year: 2033. Anchor type: PATENT. Patent anchor: 2033-03-25. Exclusivity anchor: 2024-07-30. Anchor date: 2033-03-25. 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
107110132030-10-27DS/DP —YNTRUE_DS
English description not available.
———
107110132030-10-27ORANGE_BOOK —YNTRUE_DS
English description not available.
———
110467132030-10-27DS —YNTRUE_DS
English description not available.
———
110467132030-10-27ORANGE_BOOK —YNTRUE_DS
English description not available.
———
96570032030-10-27DS/DP/U U-4209YNTRUE_DS
English description not available.
———
96570032030-10-27DS/DP/U U-4208YNTRUE_DS
English description not available.
———
96570032030-10-27DS/DP/U U-4210YNTRUE_DS
English description not available.
———
96570032030-10-27ORANGE_BOOK U-4208;U-4209;U-4210YNTRUE_DS
English description not available.
———
89752542033-03-25DS/DP/U U-4208YNTRUE_DS
English description not available.
———
89752542033-03-25DS/DP/U U-4209YNTRUE_DS
English description not available.
———
89752542033-03-25DS/DP/U U-4210YNTRUE_DS
English description not available.
———
89752542033-03-25ORANGE_BOOK U-4208;U-4209;U-4210YNTRUE_DS
English description not available.
———
100105302036-01-28DS —NNDP
English description not available.
———
100105302036-01-28ORANGE_BOOK —NNDP
English description not available.
———
103838532036-01-28DS —NNDP
English description not available.
———
103838532036-01-28ORANGE_BOOK —NNDP
English description not available.
———
108355152036-01-28DP/U U-4208NNDP
English description not available.
———
108355152036-01-28DP/U U-2605NNDP
English description not available.
———
108355152036-01-28DP/U U-4210NNDP
English description not available.
———
108355152036-01-28DP/U U-4209NNDP
English description not available.
———
108355152036-01-28ORANGE_BOOK U-2605;U-4208;U-4209;U-4210NNDP
English description not available.
———
111680582038-02-27DS/DP —NNDP
English description not available.
———
111680582038-02-27ORANGE_BOOK —NNDP
English description not available.
———
126113972040-07-02DP —NNDP
English description not available.
———
126113972040-07-02ORANGE_BOOK —NNDP
English description not available.
———
123297422042-06-17DP —NNDP
English description not available.
———
123297422042-06-17ORANGE_BOOK —NNDP
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2019-07-302024-07-30English description not available.YY2024-07-30
NCE
Full coverage date: 2024-07-30
Source
I-9002022-08-052025-08-05English description not available.NN—
NCE
Full coverage date: —
Source
I-9712025-06-032028-06-03English description not available.NN——Source
I-9712025-06-032028-06-03English description not available.NN—
NCE
Full coverage date: —
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 (14)
TypeDateRoleBasisSource
PATENT2030-10-27HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2030-10-27HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2030-10-27HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2033-03-25CANONICAL_ANCHOREnglish description not available.Source
PATENT2036-01-28FTO_TAILEnglish description not available.Source
PATENT2036-01-28FTO_TAILEnglish description not available.Source
PATENT2036-01-28FTO_TAILEnglish description not available.Source
PATENT2038-02-27FTO_TAILEnglish description not available.Source
PATENT2040-07-02FTO_TAILEnglish description not available.Source
PATENT2042-06-17FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2033-03-25CANONICAL_DECISIONEnglish description not available.Source
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.