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Product profile · United States

RINVOQ

 ·  Patent Litigation & Settlement History ↓

IngredientUPADACITINIB
Application typeNDA
Application211675
Product003
Dosage formTABLET, EXTENDED RELEASE
RouteORAL
Strength45MG
Approval date2022-03-16
Marketing statusPrescription
Status event—
ApplicantABBVIE
Product source

Current GenericRadar decision

Year2033
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typePATENT
Anchor date2033-08-16
Patent anchor2033-08-16
Exclusivity anchor2025-03-16
Protection date2038-03-09
First Final ANDA—
Status event—

GNR judgment: DEEP_REVIEW. Reference year: 2033. Anchor type: PATENT. Patent anchor: 2033-08-16. Exclusivity anchor: 2025-03-16. Anchor date: 2033-08-16. 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
89626292031-01-15DS/U U-3624YNTRUE_DS
English description not available.
———
89626292031-01-15DS/U U-3341YNTRUE_DS
English description not available.
———
89626292031-01-15ORANGE_BOOK U-3341;U-3624YNTRUE_DS
English description not available.
———
RE472212033-08-16DS —YNTRUE_DS
English description not available.
———
RE472212033-08-16ORANGE_BOOK —YNTRUE_DS
English description not available.
———
102023932036-10-17DP —NNDP
English description not available.
———
102023932036-10-17ORANGE_BOOK —NNDP
English description not available.
———
109819232036-10-17DS —NNDP
English description not available.
———
109819232036-10-17ORANGE_BOOK —NNDP
English description not available.
———
111865842036-10-17DS —NNDP
English description not available.
———
111865842036-10-17ORANGE_BOOK —NNDP
English description not available.
———
111986972036-10-17DP —NNDP
English description not available.
———
111986972036-10-17ORANGE_BOOK —NNDP
English description not available.
———
116614252036-10-17DS/DP —NNDP
English description not available.
———
116614252036-10-17ORANGE_BOOK —NNDP
English description not available.
———
116800692036-10-17DS/DP —NNDP
English description not available.
———
116800692036-10-17ORANGE_BOOK —NNDP
English description not available.
———
117186272036-10-17DS/DP —NNDP
English description not available.
———
117186272036-10-17ORANGE_BOOK —NNDP
English description not available.
———
117731052036-10-17DS/DP —NNDP
English description not available.
———
117731052036-10-17ORANGE_BOOK —NNDP
English description not available.
———
120775452036-10-17DP —NNDP
English description not available.
———
120775452036-10-17ORANGE_BOOK —NNDP
English description not available.
———
121102982036-10-17DS/DP —NNDP
English description not available.
———
121102982036-10-17ORANGE_BOOK —NNDP
English description not available.
———
121346212036-10-17DP —NNDP
English description not available.
———
121346212036-10-17ORANGE_BOOK —NNDP
English description not available.
———
99510802036-10-17DS/DP —NNDP
English description not available.
———
99510802036-10-17ORANGE_BOOK —NNDP
English description not available.
———
115649222038-03-09U U-4303NNU
English description not available.
———
115649222038-03-09U U-3624NNU
English description not available.
———
115649222038-03-09ORANGE_BOOK U-3624;U-4303NNU
English description not available.
———
116074112038-03-09U U-3341NNU
English description not available.
———
116074112038-03-09U U-4302NNU
English description not available.
———
116074112038-03-09ORANGE_BOOK U-3341;U-4302NNU
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2019-08-162024-08-16English description not available.YY2024-08-16
I-886 + I-919
Full coverage date: 2024-08-16
Source
I-8862022-03-162025-03-16English description not available.NN—
I-886 + I-919
Full coverage date: —
Source
I-9192023-05-182026-05-18English description not available.NN——Source
I-9192023-05-182026-05-18English description not available.NN—
I-886 + I-919
Full coverage date: —
Source
I-9462024-04-262027-04-26English description not available.NN——Source
I-9462024-04-262027-04-26English description not available.NN—
I-886 + I-919
Full coverage date: —
Source
NPP2024-04-262027-04-26English description not available.NN——Source
NPP2024-04-262027-04-26English description not available.NN—
I-886 + I-919
Full coverage date: —
Source
ODE-4812024-04-262031-04-26English description not available.NN——Source
ODE-4812024-04-262031-04-26English description not available.NN—
I-886 + I-919
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 (23)
TypeDateRoleBasisSource
PATENT2031-01-15HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2033-08-16CANONICAL_ANCHOREnglish description not available.Source
PATENT2036-10-17FTO_TAILEnglish description not available.Source
PATENT2036-10-17FTO_TAILEnglish description not available.Source
PATENT2036-10-17FTO_TAILEnglish description not available.Source
PATENT2036-10-17FTO_TAILEnglish description not available.Source
PATENT2036-10-17FTO_TAILEnglish description not available.Source
PATENT2036-10-17FTO_TAILEnglish description not available.Source
PATENT2036-10-17FTO_TAILEnglish description not available.Source
PATENT2036-10-17FTO_TAILEnglish description not available.Source
PATENT2036-10-17FTO_TAILEnglish description not available.Source
PATENT2036-10-17FTO_TAILEnglish description not available.Source
PATENT2036-10-17FTO_TAILEnglish description not available.Source
PATENT2036-10-17FTO_TAILEnglish description not available.Source
PATENT2038-03-09FTO_TAILEnglish description not available.Source
PATENT2038-03-09FTO_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—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2033-08-16CANONICAL_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.