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Product profile · United States

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 ·  Patent Litigation & Settlement History ↓

IngredientELAMIPRETIDE HYDROCHLORIDE
Application typeNDA
Application215244
Product001
Dosage formSOLUTION
RouteSUBCUTANEOUS
StrengthEQ 280MG BASE/3.5ML (EQ 80MG BASE/ML)
Approval date2025-09-19
Marketing statusPrescription
Status event—
ApplicantSTEALTH BIOTHERAPS
Product source

Current GenericRadar decision

Year2034
SelectionCANDIDATE
ReviewFINAL
Anchor typeDS_EQUIVALENT_PATENT
Anchor date2034-02-28
Patent anchor2034-02-28
Exclusivity anchor2032-09-19
Protection date2034-02-28
First Final ANDA—
Status event—

US11083771 c1 covers approved Barth scope;97 claim texts reviewed across6 patents.

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
75760612027-01-20DS/DP —NNU
| B1C03 issued-claim review2026-10-15: U
———
75760612027-01-20ORANGE_BOOK —NNU
English description not available.
———
110837712034-02-28U U-4277NYU
| B1C03 issued-claim review2026-10-15: U
———
110837712034-02-28ORANGE_BOOK U-4277NYU
English description not available.
———
110837722034-02-28U U-4277NNU
| B1C03 issued-claim review2026-10-15: U
———
110837722034-02-28ORANGE_BOOK U-4277NNU
English description not available.
———
117717342034-02-28U U-4277NNU
| B1C03 issued-claim review2026-10-15: U
———
117717342034-02-28ORANGE_BOOK U-4277NNU
English description not available.
———
122687242034-02-28U U-4277NNU
| B1C03 issued-claim review2026-10-15: U
———
122687242034-02-28ORANGE_BOOK U-4277NNU
English description not available.
———
96875192034-02-28U U-4277NNU
| B1C03 issued-claim review2026-10-15: U
———
96875192034-02-28ORANGE_BOOK U-4277NNU
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2025-09-192030-09-19English description not available.YY2030-09-19—Source
NCE2025-09-192030-09-19English description not available.YY2030-09-19
ODE-551
Full coverage date: 2030-09-19
Source
ODE-5512025-09-192032-09-19English description not available.YY2032-09-19—Source
ODE-5512025-09-192032-09-19English description not available.YY2032-09-19
ODE-551
Full coverage date: 2032-09-19
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 (1)
TypeDateRoleBasisSource
ANNUAL_DECISION_RECHECK—ANCHOR_AND_TAILUS11083771 c1 covers approved Barth scope;97 claim texts reviewed across6 patents.Source
Decision history
CurrentYearStatusReviewAnchorJudged
Y2034CANDIDATEFINAL2034-02-282026-10-17 20:32:21
N2034CANDIDATEFINAL2034-02-282026-10-15 00:10:28
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.