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Product profile · United States

ZORYVE

 ·  Patent Litigation & Settlement History ↓

IngredientROFLUMILAST
Application typeNDA
Application215985
Product002
Dosage formCREAM
RouteTOPICAL
Strength0.15%
Approval date2024-07-09
Marketing statusPrescription
Status event—
ApplicantARCUTIS
Product source

Current GenericRadar decision

Year2027
SelectionDEEP_REVIEW
ReviewFINAL_CHECKING
Anchor typeREGULATORY_EXCLUSIVITY
Anchor date2027-07-09
Patent anchor—
Exclusivity anchor2027-07-09
Protection date—
First Final ANDA—
Status event—

GNR judgment: DEEP_REVIEW. Reference year: 2027. Anchor type: REGULATORY_EXCLUSIVITY. Patent anchor: not recorded. Exclusivity anchor: 2027-07-09. Anchor date: 2027-07-09. Patent tail: yes. Exclusivity tail: no. Review status: FINAL_CHECKING. 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
109401422037-06-07DP ————
———
117937962037-06-07DP ————
———
118194962037-06-07U U-3970———
———
119924802037-06-07U U-3970———
———
120050512037-06-07U U-3970———
———
120050522037-06-07DP ————
———
120114372037-06-07DP ————
———
120168482037-06-07DP ————
———
120424872037-06-07DP ————
———
122204092037-06-07DP ————
———
122572422037-06-07DP ————
———
123109562037-06-07U U-3970———
———
123369832037-06-07DP ————
———
126973292037-06-07DP ————
OB official listing only. TRUE_DS/DS-equivalent/claim scope/PTE-PED effective anchor remains unconfirmed.
———
98840502037-06-07DP ————
———
99077882037-06-07U U-3970———
———
111298182037-08-25U U-3970———
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NS—2027-07-09————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.
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.