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Product profile · United States

PONVORY

 ·  Patent Litigation & Settlement History ↓

IngredientPONESIMOD
Application typeNDA
Application213498
Product002
Dosage formTABLET
RouteORAL
Strength3MG
Approval date2021-03-18
Marketing statusPrescription
Status event—
ApplicantVANDA PHARMS INC
Product source

Current GenericRadar decision

Year2035
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typePATENT
Anchor date2035-12-10
Patent anchor2035-12-10
Exclusivity anchor2026-03-18
Protection date2044-12-24
First Final ANDA—
Status event—

GNR judgment: DEEP_REVIEW. Reference year: 2035. Anchor type: PATENT. Patent anchor: 2035-12-10. Exclusivity anchor: 2026-03-18. Anchor date: 2035-12-10. 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
US90000182024-11-16ORANGE_BOOK U-3102NYU
English description not available.
———
US82737792025-12-17ORANGE_BOOK U-2774NYU
English description not available.
———
RE437282029-11-16DS/DP —YNTRUE_DS
English description not available.
———
RE437282029-11-16ORANGE_BOOK —YNTRUE_DS
English description not available.
———
90620142032-05-06DS/DP/U U-2774NNDP
English description not available.
———
90620142032-05-06ORANGE_BOOK U-2774NNDP
English description not available.
———
102200232035-12-10U U-3103NYU
English description not available.
———
102200232035-12-10ORANGE_BOOK U-3103NYU
English description not available.
———
123369802035-12-10U U-3103NYU
English description not available.
———
123369802035-12-10ORANGE_BOOK U-3103NYU
English description not available.
———
119510972042-10-10U U-3891NNU
English description not available.
———
119510972042-10-10ORANGE_BOOK U-3891NNU
English description not available.
———
US127281162044-12-24ORANGE_BOOK U-4610NNU
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2021-03-182026-03-18English description not available.YY2026-03-18—Source
NCE2021-03-182026-03-18English description not available.YY2026-03-18
NCE
Full coverage date: 2026-03-18
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 (10)
TypeDateRoleBasisSource
PATENT2024-11-16HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2025-12-17HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2029-11-16HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2032-05-06HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2035-12-10CANONICAL_ANCHOREnglish description not available.Source
PATENT2035-12-10CANONICAL_ANCHOREnglish description not available.Source
PATENT2042-10-10FTO_TAILEnglish description not available.Source
PATENT2044-12-24FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2035-12-10CANONICAL_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.