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Product profile · United States

VTAMA

 ·  Patent Litigation & Settlement History ↓

IngredientTAPINAROF
Application typeNDA
Application215272
Product001
Dosage formCREAM
RouteTOPICAL
Strength1%
Approval date2022-05-23
Marketing statusPrescription
Status event—
ApplicantORGANON LLC
Product source

Current GenericRadar decision

Year2027
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeREGULATORY_EXCLUSIVITY
Anchor date2027-05-23
Patent anchor—
Exclusivity anchor2027-05-23
Protection date2039-12-18
First Final ANDA—
Status event—

GNR judgment: DEEP_REVIEW. Reference year: 2027. Anchor type: REGULATORY_EXCLUSIVITY. Patent anchor: not recorded. Exclusivity anchor: 2027-05-23. Anchor date: 2027-05-23. Patent tail: yes. Exclusivity tail: yes. 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
104267432036-05-19U U-2625NNU
English description not available.
———
104267432036-05-19U U-4048NNU
English description not available.
———
104267432036-05-19ORANGE_BOOK U-2625;U-4048NNU
English description not available.
———
114581082036-05-19DP —NNDP
English description not available.
———
114581082036-05-19ORANGE_BOOK —NNDP
English description not available.
———
116125732036-05-19U U-2625NNU
English description not available.
———
116125732036-05-19U U-4048NNU
English description not available.
———
116125732036-05-19ORANGE_BOOK U-2625;U-4048NNU
English description not available.
———
116177242036-05-19DP —NNDP
English description not available.
———
116177242036-05-19ORANGE_BOOK —NNDP
English description not available.
———
116229452036-05-19DP —NNDP
English description not available.
———
116229452036-05-19ORANGE_BOOK —NNDP
English description not available.
———
101951602036-05-23DP —NNDP
English description not available.
———
101951602036-05-23ORANGE_BOOK —NNDP
English description not available.
———
106476492038-11-13DS —NNPROCESS
English description not available.
———
106476492038-11-13ORANGE_BOOK —NNPROCESS
English description not available.
———
115976922038-11-13DS/DP —NNDP
English description not available.
———
115976922038-11-13ORANGE_BOOK —NNDP
English description not available.
———
114977182039-11-13U U-4048NNU
English description not available.
———
114977182039-11-13ORANGE_BOOK U-4048NNU
English description not available.
———
115900882039-11-13U U-2625NNU
English description not available.
———
115900882039-11-13ORANGE_BOOK U-2625NNU
English description not available.
———
119380992039-11-13U U-4048NNU
English description not available.
———
119380992039-11-13ORANGE_BOOK U-4048NNU
English description not available.
———
125694532039-12-18U U-4048NNU
English description not available.
———
125694532039-12-18ORANGE_BOOK U-4048NNU
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2022-05-232027-05-23English description not available.YY2027-05-23—Source
NCE2022-05-232027-05-23English description not available.YY2027-05-23
NCE
Full coverage date: 2027-05-23
Source
I-9562024-12-122027-12-12English description not available.NN——Source
I-9562024-12-122027-12-12English 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 (15)
TypeDateRoleBasisSource
PATENT2036-05-19FTO_TAILEnglish description not available.Source
PATENT2036-05-19FTO_TAILEnglish description not available.Source
PATENT2036-05-19FTO_TAILEnglish description not available.Source
PATENT2036-05-19FTO_TAILEnglish description not available.Source
PATENT2036-05-19FTO_TAILEnglish description not available.Source
PATENT2036-05-23FTO_TAILEnglish description not available.Source
PATENT2038-11-13FTO_TAILEnglish description not available.Source
PATENT2038-11-13FTO_TAILEnglish description not available.Source
PATENT2039-11-13FTO_TAILEnglish description not available.Source
PATENT2039-11-13FTO_TAILEnglish description not available.Source
PATENT2039-11-13FTO_TAILEnglish description not available.Source
PATENT2039-12-18FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—CANONICAL_ANCHOREnglish description not available.Source
REGULATORY_STATUS2027-05-23CANONICAL_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.