Market LIVE
Published markets; coverage varies by country
Product profile · United States

EXBLIFEP

 ·  Patent Litigation & Settlement History ↓

IngredientCEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM
Application typeNDA
Application216165
Product001
Dosage formPOWDER
RouteINTRAVENOUS
StrengthEQ 2GM BASE/VIAL;0.5GM/VIAL
Approval date2024-02-22
Marketing statusDiscontinued
Status event—
ApplicantORCHID PHARMA
Product source

Current GenericRadar decision

Year2026
SelectionDISQUALIFIED
ReviewFINAL
Anchor typeFDA_DISCONTINUATION
Anchor date—
Patent anchor2027-12-03
Exclusivity anchor2034-02-22
Protection date—
First Final ANDA—
Status event—

FDA_DISCONTINUED; EXBLIFEP; canonical rights anchor 2034-02-22; tail 11124526 DP 2034-11-07; 2026 is FDA DISC confirmation year, not cessation event year/date

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
76874882027-12-03DS/DP/U U-3851———
———
111245262034-11-07U U-3852———
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE—2029-02-22————Source
GAIN—2034-02-22————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.