GenericRadar
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Product profile · United States

REZZAYO

 ·  Patent Litigation & Settlement History ↓

IngredientREZAFUNGIN ACETATE
Application typeNDA
Application217417
Product001
Dosage formPOWDER
RouteINTRAVENOUS
StrengthEQ 200MG BASE/VIAL
Approval date2023-03-22
Marketing statusPrescription
Status event—
ApplicantMUNDIPHARMA
Product source

Current GenericRadar decision

Year2037
SelectionDEEP_REVIEW
ReviewFINAL
Anchor typeDS_EQUIVALENT_PATENT
Anchor date2037-03-15
Patent anchor2037-03-15
Exclusivity anchor2033-03-22
Protection date2038-07-14
First Final ANDA—
Status event—

POST_ANCHOR_RIGHTS_EXIST; US:NDA:217417:001; exact Final ANDA not verified; not proof of generic absence

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
116541962032-03-02DS/DP/U U-3566NYU
| B1C03P7 issued-claim review2026-10-15: U
———
116541962032-03-02ORANGE_BOOK U-3566NYU
English description not available.
———
107025732033-03-14DS/DP/U U-3566NYU
| B1C03P7 issued-claim review2026-10-15: U
———
107025732033-03-14ORANGE_BOOK U-3566NYU
English description not available.
———
95268352033-03-14DS/DP/U U-3566NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
95268352033-03-14ORANGE_BOOK U-3566NNDP
English description not available.
———
87226192036-05-09DS/DP/U U-3566YNTRUE_DS
| B1C03P7 issued-claim review2026-10-15: TRUE_DS
———
87226192036-05-09ORANGE_BOOK U-3566YNTRUE_DS
English description not available.
———
117124592037-03-15DP/U U-3566NYU
| B1C03P7 issued-claim review2026-10-15: U
———
117124592037-03-15ORANGE_BOOK U-3566NYU
English description not available.
———
118195332038-07-11DS/DP/U U-3566NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
118195332038-07-11ORANGE_BOOK U-3566NNDP
English description not available.
———
111979092038-07-14DS/DP/U U-3566NNDP
| B1C03P7 issued-claim review2026-10-15: DP
———
111979092038-07-14ORANGE_BOOK U-3566NNDP
English description not available.
———

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NCE2023-03-222028-03-22English description not available.YY2028-03-22—Source
NCE2023-03-222028-03-22English description not available.YY2028-03-22
GAIN
Full coverage date: 2028-03-22
Source
ODE-4262023-03-222030-03-22English description not available.NN——Source
ODE-4262023-03-222030-03-22English description not available.NN—
GAIN
Full coverage date: —
Source
GAIN2023-03-222033-03-22English description not available.YY2033-03-22—Source
GAIN2023-03-222033-03-22English description not available.YY2033-03-22
GAIN
Full coverage date: 2033-03-22
Source
GAIN2023-03-222035-03-22English description not available.NN——Source
GAIN2023-03-222035-03-22English description not available.NN—
GAIN
Full coverage date: —
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
PATENT2032-03-02HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2033-03-14HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2033-03-14HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2036-05-09HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2037-03-15CANONICAL_ANCHOREnglish description not available.Source
PATENT2038-07-11FTO_TAILEnglish description not available.Source
PATENT2038-07-14FTO_TAILEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—REGULATORY_SCOPE_CONTEXTEnglish description not available.Source
REGULATORY_STATUS—REGULATORY_SCOPE_CONTEXTFDA OOPD exclusivity end date TBD; no invented term; excluded from granted-right anchorSource
REGULATORY_STATUS2037-03-15CANONICAL_DECISIONPOST_ANCHOR_RIGHTS_EXIST; US:NDA:217417:001; 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.