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Product profile · United States

VABOMERE

 ·  Patent Litigation & Settlement History ↓

IngredientMEROPENEM; VABORBACTAM
Application typeNDA
Application209776
Product001
Dosage formPOWDER
RouteINTRAVENOUS
Strength1GM/VIAL;1GM/VIAL
Approval date2017-08-29
Marketing statusPrescription
Status event—
ApplicantREMPEX
Product source

Current GenericRadar decision

Year2031
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typePATENT
Anchor date2031-08-29
Patent anchor2031-08-29
Exclusivity anchor2027-08-29
Protection date2039-04-06
First Final ANDA—
Status event—

GNR judgment: DEEP_REVIEW. Reference year: 2031. Anchor type: PATENT. Patent anchor: 2031-08-29. Exclusivity anchor: 2027-08-29. Anchor date: 2031-08-29. Patent tail: yes. Exclusivity tail: no. 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
101728742031-08-08DP —NYU
English description not available.
———
101728742031-08-08ORANGE_BOOK —NYU
English description not available.
———
101830342031-08-08U U-2490NYU
English description not available.
———
101830342031-08-08ORANGE_BOOK U-2490NYU
English description not available.
———
105616752031-08-08U U-2490NNU
English description not available.
———
105616752031-08-08ORANGE_BOOK U-2490NNU
English description not available.
———
110072062031-08-08U U-3128NNU
English description not available.
———
110072062031-08-08ORANGE_BOOK U-3128NNU
English description not available.
———
121717722031-08-08DS —NNDP
English description not available.
———
121717722031-08-08ORANGE_BOOK —NNDP
English description not available.
———
96940252031-08-08U U-2120NYU
English description not available.
———
96940252031-08-08ORANGE_BOOK U-2120NYU
English description not available.
———
86801362031-08-29DS/DP —YNTRUE_DS
English description not available.
———
86801362031-08-29ORANGE_BOOK —YNTRUE_DS
English description not available.
———
124786062038-01-08U U-3421NNU
English description not available.
———
124786062038-01-08ORANGE_BOOK U-3421NNU
English description not available.
———
113762372039-04-06U U-3421NNU
English description not available.
———
113762372039-04-06ORANGE_BOOK U-3421NNU
English description not available.
———
125333422039-04-06U U-3421NNU
English description not available.
———
125333422039-04-06ORANGE_BOOK U-3421NNU
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2017-08-292022-08-29English description not available.YY2022-08-29—Source
NCE2017-08-292022-08-29English description not available.YY2022-08-29
GAIN
Full coverage date: 2022-08-29
Source
GAIN2022-08-292027-08-29English description not available.YY2027-08-29—Source
GAIN2022-08-292027-08-29English description not available.YY2027-08-29
GAIN
Full coverage date: 2027-08-29
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 (13)
TypeDateRoleBasisSource
PATENT2031-08-08HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2031-08-08HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2031-08-08HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2031-08-08HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2031-08-08HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2031-08-08HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2031-08-29CANONICAL_ANCHOREnglish description not available.Source
PATENT2038-01-08FTO_TAILEnglish description not available.Source
PATENT2039-04-06FTO_TAILEnglish description not available.Source
PATENT2039-04-06FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2031-08-29CANONICAL_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.