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Product profile · United States

YUVIWEL

 ·  Patent Litigation & Settlement History ↓

IngredientNAVEPEGRITIDE
Application typeNDA
Application219164
Product002
Dosage formPOWDER
RouteSUBCUTANEOUS
Strength2.8MG/VIAL
Approval date2026-02-27
Marketing statusPrescription
Status event—
ApplicantASCENDIS
Product source

Current GenericRadar decision

Year2037
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typePATENT
Anchor date2037-01-05
Patent anchor2037-01-05
Exclusivity anchor2033-02-27
Protection date2042-11-12
First Final ANDA—
Status event—

GNR judgment: DEEP_REVIEW. Reference year: 2037. Anchor type: PATENT. Patent anchor: 2037-01-05. Exclusivity anchor: 2033-02-27. Anchor date: 2037-01-05. 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
89068472031-04-30DS/DP/U U-4425YNTRUE_DS
English description not available.
———
89068472031-04-30ORANGE_BOOK U-4425YNTRUE_DS
English description not available.
———
108355782037-01-05DS/DP/U U-4425YNTRUE_DS
English description not available.
———
108355782037-01-05ORANGE_BOOK U-4425YNTRUE_DS
English description not available.
———
111545932037-01-05DS/DP/U U-4425YNTRUE_DS
English description not available.
———
111545932037-01-05ORANGE_BOOK U-4425YNTRUE_DS
English description not available.
———
112246612037-01-05DS/DP —YNTRUE_DS
English description not available.
———
112246612037-01-05ORANGE_BOOK —YNTRUE_DS
English description not available.
———
113116042037-01-05DS/DP/U U-4425YNTRUE_DS
English description not available.
———
113116042037-01-05ORANGE_BOOK U-4425YNTRUE_DS
English description not available.
———
113895102037-01-05DS/DP —YNTRUE_DS
English description not available.
———
113895102037-01-05ORANGE_BOOK —YNTRUE_DS
English description not available.
———
113895112037-01-05DP/U U-4425NNDP
English description not available.
———
113895112037-01-05ORANGE_BOOK U-4425NNDP
English description not available.
———
114133512037-01-05DS/DP —YNTRUE_DS
English description not available.
———
114133512037-01-05ORANGE_BOOK —YNTRUE_DS
English description not available.
———
120831822037-01-05U U-4425NNU
English description not available.
———
120831822037-01-05ORANGE_BOOK U-4425NNU
English description not available.
———
121569172037-01-05U U-4425NYU
English description not available.
———
121569172037-01-05ORANGE_BOOK U-4425NYU
English description not available.
———
122396892037-01-05U U-4425NYU
English description not available.
———
122396892037-01-05ORANGE_BOOK U-4425NYU
English description not available.
———
123771332042-11-12DP/U U-4425NNDP
English description not available.
———
123771332042-11-12ORANGE_BOOK U-4425NNDP
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2026-02-272031-02-27English description not available.YY2031-02-27—Source
NCE2026-02-272031-02-27English description not available.YY2031-02-27
ODE-516
Full coverage date: 2031-02-27
Source
ODE-5162026-02-272033-02-27English description not available.YY2033-02-27—Source
ODE-5162026-02-272033-02-27English description not available.YY2033-02-27
ODE-516
Full coverage date: 2033-02-27
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 (15)
TypeDateRoleBasisSource
PATENT2031-04-30HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2037-01-05CANONICAL_ANCHOREnglish description not available.Source
PATENT2037-01-05CANONICAL_ANCHOREnglish description not available.Source
PATENT2037-01-05CANONICAL_ANCHOREnglish description not available.Source
PATENT2037-01-05CANONICAL_ANCHOREnglish description not available.Source
PATENT2037-01-05CANONICAL_ANCHOREnglish description not available.Source
PATENT2037-01-05HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2037-01-05CANONICAL_ANCHOREnglish description not available.Source
PATENT2037-01-05HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2037-01-05CANONICAL_ANCHOREnglish description not available.Source
PATENT2037-01-05CANONICAL_ANCHOREnglish description not available.Source
PATENT2042-11-12FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2037-01-05CANONICAL_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.