GenericRadar
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Product profile · United States

EMBLAVEO

 ·  Patent Litigation & Settlement History ↓

IngredientAVIBACTAM SODIUM; AZTREONAM
Application typeNDA
Application217906
Product001
Dosage formPOWDER
RouteINTRAVENOUS
StrengthEQ 0.5GM BASE/VIAL;1.5GM/VIAL
Approval date2025-02-07
Marketing statusPrescription
Status event—
ApplicantABBVIE
Product source

Current GenericRadar decision

Year2033
SelectionCANDIDATE
ReviewFINAL
Anchor typeREGULATORY_EXCLUSIVITY
Anchor date2033-02-07
Patent anchor2026-11-12
Exclusivity anchor2033-02-07
Protection date2033-02-07
First Final ANDA—
Status event—

NO_POST_ANCHOR_CONFIRMED_RIGHTS; US:NDA:217906:001; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
71125922026-01-07DS/DP/U U-4147YNTRUE_DS
| B1C03P7 issued-claim review2026-10-15: TRUE_DS
———
71125922026-01-07ORANGE_BOOK U-4147YNTRUE_DS
English description not available.
———
76120872026-11-12DP —NYU
| B1C03P7 issued-claim review2026-10-15: U
———
76120872026-11-12ORANGE_BOOK —NYU
English description not available.
———
88354552030-10-08DP —NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
88354552030-10-08ORANGE_BOOK —NNDP
English description not available.
———
84710252031-08-12DS —NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
84710252031-08-12ORANGE_BOOK —NNDP
English description not available.
———
89695662032-06-15DS —NNOTHER
| B1C03P7 issued-claim review2026-10-15: OTHER
———
89695662032-06-15ORANGE_BOOK —NNOTHER
English description not available.
———
92843142032-06-15DS —NNOTHER
| B1C03P7 issued-claim review2026-10-15: OTHER
———
92843142032-06-15ORANGE_BOOK —NNOTHER
English description not available.
———
96951222032-06-15DS/DP —NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
96951222032-06-15ORANGE_BOOK —NNDP
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NP2025-02-072028-02-07English description not available.YY2028-02-07—Source
NP2025-02-072028-02-07English description not available.YY2028-02-07
GAIN
Full coverage date: 2028-02-07
Source
GAIN2025-02-072033-02-07English description not available.YY2033-02-07—Source
GAIN2025-02-072033-02-07English description not available.YY2033-02-07
GAIN
Full coverage date: 2033-02-07
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
PATENT2026-01-07HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2026-11-12CANONICAL_ANCHOREnglish description not available.Source
PATENT2030-10-08HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2031-08-12HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2032-06-15HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2032-06-15HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2032-06-15HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—CANONICAL_ANCHOREnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2033-02-07CANONICAL_DECISIONNO_POST_ANCHOR_CONFIRMED_RIGHTS; US:NDA:217906:001; exact Final ANDA not verified; not proof of generic absenceSource
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.