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Product profile · United States

JATENZO

 ·  Patent Litigation & Settlement History ↓

IngredientTESTOSTERONE UNDECANOATE
Application typeNDA
Application206089
Product002
Dosage formCAPSULE
RouteORAL
Strength198MG
Approval date2019-03-27
Marketing statusPrescription
Status event—
ApplicantTOLMAR
Product source

Current GenericRadar decision

Year2022
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeREGULATORY_EXCLUSIVITY
Anchor date2022-03-27
Patent anchor—
Exclusivity anchor2022-03-27
Protection date—
First Final ANDA—
Status event—

POST_ANCHOR_RIGHTS

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
111794022026-04-14DS/DP —NNDP
———
113313252027-01-06U U-2506NNU
———
82416642029-03-29DP/U U-2506NNDP
———
105432192030-04-12U U-2506NNU
———
106176962030-04-12DS/DP —NNDP
———
111794032030-04-12U U-2506NNU
———
114264162030-04-12U U-3420NNU
———
87789162030-04-12DP —NNDP
———
84923692030-12-20DP/U U-2506NNDP
———
115649332039-04-12U U-1103NNU
———
126053912039-04-12U U-1103NNU
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
No exclusivity facts are recorded in this product snapshot.

2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · 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 (1)
TypeDateRoleBasisSource
REGULATORY_STATUS2022-03-27CANONICAL_DECISIONPOST_ANCHOR_RIGHTSSource
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.