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

ZAYNICH

 ·  Patent Litigation & Settlement History ↓

IngredientCEFEPIME HYDROCHLORIDE; ZIDEBACTAM
Application typeNDA
Application220787
Product001
Dosage formPOWDER
RouteINTRAVENOUS
StrengthEQ 2GM BASE/VIAL;1GM/VIAL
Approval date2026-05-29
Marketing statusPrescription
Status event—
ApplicantWOCKHARDT BIO AG
Product source

Current GenericRadar decision

Year2036
SelectionCANDIDATE
ReviewFINAL
Anchor typeREGULATORY_EXCLUSIVITY
Anchor date2036-05-29
Patent anchor2032-08-24
Exclusivity anchor2036-05-29
Protection date2036-05-29
First Final ANDA—
Status event—

NO_POST_ANCHOR_CONFIRMED_RIGHTS; US:NDA:220787:001; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
88224502032-08-24DS/DP —YNTRUE_DS
| B1C03P7 issued-claim review2026-10-15: TRUE_DS
———
88224502032-08-24ORANGE_BOOK —YNTRUE_DS
English description not available.
———
88531972032-08-24DS —YNTRUE_DS
| B1C03P7 issued-claim review2026-10-15: TRUE_DS
———
88531972032-08-24ORANGE_BOOK —YNTRUE_DS
English description not available.
———
91321332032-08-24U U-4558NYU
| B1C03P7 issued-claim review2026-10-15: U
———
91321332032-08-24ORANGE_BOOK U-4558NYU
English description not available.
———
93812002032-08-24DP —NYU
| B1C03P7 issued-claim review2026-10-15: U
———
93812002032-08-24ORANGE_BOOK —NYU
English description not available.
———
98272352032-08-24DP/U U-4558NYU
| B1C03P7 issued-claim review2026-10-15: U
———
98272352032-08-24ORANGE_BOOK U-4558NYU
English description not available.
———
96570212033-10-12DS —NNOTHER
| B1C03P7 issued-claim review2026-10-15: OTHER
———
96570212033-10-12ORANGE_BOOK —NNOTHER
English description not available.
———
98345572033-10-12DS —NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
98345572033-10-12ORANGE_BOOK —NNDP
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2026-05-292031-05-29English description not available.YY2031-05-29—Source
NCE2026-05-292031-05-29English description not available.YY2031-05-29
GAIN
Full coverage date: 2031-05-29
Source
GAIN2026-05-292036-05-29English description not available.YY2036-05-29—Source
GAIN2026-05-292036-05-29English description not available.YY2036-05-29
GAIN
Full coverage date: 2036-05-29
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 (10)
TypeDateRoleBasisSource
PATENT2032-08-24CANONICAL_ANCHOREnglish description not available.Source
PATENT2032-08-24CANONICAL_ANCHOREnglish description not available.Source
PATENT2032-08-24CANONICAL_ANCHOREnglish description not available.Source
PATENT2032-08-24CANONICAL_ANCHOREnglish description not available.Source
PATENT2032-08-24CANONICAL_ANCHOREnglish description not available.Source
PATENT2033-10-12HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2033-10-12HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—CANONICAL_ANCHOREnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS2036-05-29CANONICAL_DECISIONNO_POST_ANCHOR_CONFIRMED_RIGHTS; US:NDA:220787:001; 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.