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Product profile · United States

FARXIGA

 ·  Patent Litigation & Settlement History ↓

IngredientDAPAGLIFLOZIN
Application typeNDA
Application202293
Product001
Dosage formTABLET
RouteORAL
Strength5MG
Approval date2014-01-08
Marketing statusPrescription
Status event—
ApplicantASTRAZENECA AB
Product source

Current GenericRadar decision

Year2026
SelectionEXISTING_GENERIC
ReviewDISQUALIFIED
Anchor typeFINAL_ANDA
Anchor date2026-04-06
Patent anchor—
Exclusivity anchor—
Protection date—
First Final ANDA2026-04-06
Status event—

Exact product/strength Final ANDA confirmed. Date is earliest verified official product approval for the batch. AG and tentative excluded. Approval date is not commercial launch date. No DS classification asserted.

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
65151172025-10-04DS/DP/U U-2139———
———
65151172025-10-04DS/DP/U U-493———
———
65151172026-04-04— ————
—2026-04-04—
83296482026-08-18U U-2139———
———
83296482026-08-18U U-2213———
———
83296482026-08-18U U-2212———
———
89068512026-08-18U U-2139———
———
83296482027-02-18— ————
—2027-02-18—
89068512027-02-18— ————
—2027-02-18—
85016982027-06-20DP/U U-493———
———
85016982027-12-20— ————
—2027-12-20—
82217862028-03-21DP ————
———
83619722028-03-21U U-493———
———
83619722028-03-21U U-2139———
———
87162512028-03-21DP ————
———
78515022028-08-19DP ————
———
82217862028-09-21— ————
—2028-09-21—
83619722028-09-21— ————
—2028-09-21—
87162512028-09-21— ————
—2028-09-21—
78515022029-02-19— ————
—2029-02-19—
79195982029-12-16DS ————
———
87216152030-01-18DP ————
———
86859342030-05-26U U-1522———
———
79195982030-06-16— ————
—2030-06-16—
87216152030-07-18— ————
—2030-07-18—
86859342030-11-26— ————
—2030-11-26—

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
M-298—2026-05-08————Source
PED—2026-11-08————Source
NPP—2027-06-12————Source
PED—2027-12-12————Source

2026-10-10 · CURRENT_SOURCE_RECORDS_FOUND · Historical coverage: NOT_COMPLETE

Generic approval evidence

Application / productEventFinal dateTentative dateApplicantAuthorized genericExact mappingSource
202293 / 001AUTHORIZED_GENERIC_REPORTED · AUTHORIZED_GENERIC_REPORTED——AstraZeneca ABYEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
211439 / 001APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED——HETERO LABS UNIT IIINEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
211442 / 001APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED——APOTEX INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
211564 / 001APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED——GLENMARK GENERICSNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
216119 / 001APPLICATION_TENTATIVE_OBSERVATION · TENTATIVE_PRODUCT_SCOPE_UNVERIFIED——JIANGSU HANSOH PHARMNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
211156 / 001FINAL_APPROVAL · FINAL_APPROVED2026-04-06—INVENTIA HEALTHCARE LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
211312 / 001FINAL_APPROVAL · FINAL_APPROVED2026-04-06—SANDOZ INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
211467 / 001FINAL_APPROVAL · FINAL_APPROVED2026-04-06—MICRO LABS LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
211468 / 001FINAL_APPROVAL · FINAL_APPROVED2026-04-06—AUROBINDO PHARMA LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
211470 / 001FINAL_APPROVAL · FINAL_APPROVED2026-04-06—BIOCON PHARMA LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
211478 / 001FINAL_APPROVAL · FINAL_APPROVED2026-04-06—MSN LABORATORIES PRIVATE LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
211482 / 001FINAL_APPROVAL · FINAL_APPROVED2026-04-06—AJANTA PHARMA LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
211506 / 001FINAL_APPROVAL · FINAL_APPROVED2026-04-06—MACLEODS PHARMACEUTICALS LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
211523 / 001FINAL_APPROVAL · FINAL_APPROVED2026-04-06—AIZANT DRUG RESEARCH SOLUTIONS PRIVATE LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
211531 / 001FINAL_APPROVAL · FINAL_APPROVED2026-04-06—LUPIN LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
211535 / 001FINAL_APPROVAL · FINAL_APPROVED2026-04-06—CIPLA LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
211541 / 001FINAL_APPROVAL · FINAL_APPROVED2026-04-06—TEVA PHARMACEUTICALS USA INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
211545 / 001FINAL_APPROVAL · FINAL_APPROVED2026-04-06—ALKEM LABORATORIES LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
211560 / 001FINAL_APPROVAL · FINAL_APPROVED2026-04-06—ALEMBIC PHARMACEUTICALS LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
211582 / 001FINAL_APPROVAL · FINAL_APPROVED2026-04-06—ZYDUS PHARMACEUTICALS USA INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource

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 1 records

Authorized generics are shown separately from independent ANDA approvals.

Application / productApplicantEvent / status First marketed Product mappingSourceLast verified
202293 / 001AstraZeneca ABAUTHORIZED_GENERIC_REPORTED · AUTHORIZED_GENERIC_REPORTED— EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—

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 15 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
211156 / 001INVENTIA HEALTHCARE LTDFINAL_APPROVAL · FINAL_APPROVED2026-04-06 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
211312 / 001SANDOZ INCFINAL_APPROVAL · FINAL_APPROVED2026-04-06 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
211467 / 001MICRO LABS LTDFINAL_APPROVAL · FINAL_APPROVED2026-04-06 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
211468 / 001AUROBINDO PHARMA LTDFINAL_APPROVAL · FINAL_APPROVED2026-04-06 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
211470 / 001BIOCON PHARMA LTDFINAL_APPROVAL · FINAL_APPROVED2026-04-06 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
211478 / 001MSN LABORATORIES PRIVATE LTDFINAL_APPROVAL · FINAL_APPROVED2026-04-06 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
211482 / 001AJANTA PHARMA LTDFINAL_APPROVAL · FINAL_APPROVED2026-04-06 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
211506 / 001MACLEODS PHARMACEUTICALS LTDFINAL_APPROVAL · FINAL_APPROVED2026-04-06 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
211523 / 001AIZANT DRUG RESEARCH SOLUTIONS PRIVATE LTDFINAL_APPROVAL · FINAL_APPROVED2026-04-06 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
211531 / 001LUPIN LTDFINAL_APPROVAL · FINAL_APPROVED2026-04-06 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
211535 / 001CIPLA LTDFINAL_APPROVAL · FINAL_APPROVED2026-04-06 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
211541 / 001TEVA PHARMACEUTICALS USA INCFINAL_APPROVAL · FINAL_APPROVED2026-04-06 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
211545 / 001ALKEM LABORATORIES LTDFINAL_APPROVAL · FINAL_APPROVED2026-04-06 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
211560 / 001ALEMBIC PHARMACEUTICALS LTDFINAL_APPROVAL · FINAL_APPROVED2026-04-06 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
211582 / 001ZYDUS PHARMACEUTICALS USA INCFINAL_APPROVAL · FINAL_APPROVED2026-04-06 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
Decision evidence (1)
TypeDateRoleBasisSource
GENERIC2026-04-06TERMINAL_GENERIC_BASISExact product/strength Final ANDA confirmed. Date is earliest verified official product approval for the batch. AG and tentative excluded. Approval date is not commercial launch date. No DS classification asserted.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.