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Product profile · United States

XERAVA

 ·  Patent Litigation & Settlement History ↓

IngredientERAVACYCLINE DIHYDROCHLORIDE
Application typeNDA
Application211109
Product001
Dosage formPOWDER
RouteINTRAVENOUS
StrengthEQ 50MG BASE/VIAL
Approval date2018-08-27
Marketing statusPrescription
Status event—
ApplicantTETRAPHASE PHARMS
Product source

Current GenericRadar decision

Year2032
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeDS_EQUIVALENT_PATENT
Anchor date2032-08-27
Patent anchor2032-08-27
Exclusivity anchor2028-08-27
Protection date2037-10-19
First Final ANDA—
Status event—

POST_ANCHOR_RIGHTS_REMAIN; canonical=2032-08-27; exact Final ANDA not directly identified; not generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
87962452029-08-07U U-2380NYU
| B1C0201 issued-claim review2026-10-14: U
———
87962452029-08-07ORANGE_BOOK U-2380NYU
English description not available.
———
89068872032-08-27DP —NYDP
| B1C0201 issued-claim review2026-10-14: DP
———
89068872032-08-27ORANGE_BOOK —NYDP
English description not available.
———
109611902037-10-19DS —NNOTHER
| B1C0201 issued-claim review2026-10-14: OTHER
———
109611902037-10-19ORANGE_BOOK —NNOTHER
English description not available.
———
115780442037-10-19DS —NNOTHER
| B1C0201 issued-claim review2026-10-14: OTHER
———
115780442037-10-19ORANGE_BOOK —NNOTHER
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2018-08-272023-08-27English description not available.YY2023-08-27—Source
NCE2018-08-272023-08-27English description not available.YY2023-08-27Source
GAIN2023-08-272028-08-27English description not available.YY2028-08-27—Source
GAIN2023-08-272028-08-27English description not available.YY2028-08-27Source

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 (7)
TypeDateRoleBasisSource
PATENT2029-08-07HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2032-08-27CANONICAL_ANCHOREnglish description not available.Source
PATENT2037-10-19FTO_TAILEnglish description not available.Source
PATENT2037-10-19FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2032-08-27CANONICAL_DECISIONPOST_ANCHOR_RIGHTS_REMAIN; canonical=2032-08-27; exact Final ANDA not directly identified; not 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.