GenericRadar
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Product profile · United States

AUBAGIO

 ·  Patent Litigation & Settlement History ↓

IngredientTERIFLUNOMIDE
Application typeNDA
Application202992
Product001
Dosage formTABLET
RouteORAL
Strength7MG
Approval date2012-09-12
Marketing statusPrescription
Status event—
ApplicantSANOFI AVENTIS US
Product source

Current GenericRadar decision

Year2018
SelectionEXISTING_GENERIC
ReviewDISQUALIFIED
Anchor typeFINAL_ANDA
Anchor date2018-07-27
Patent anchor—
Exclusivity anchor—
Protection date—
First Final ANDA2018-07-27
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
67944102026-09-12U U-1285———
———
67944102027-03-12— ————
—2027-03-12—
88027352030-09-14DP ————
———
88027352031-03-14— ————
—2031-03-14—
91863462034-02-04U U-1786———
———
91863462034-08-04— ————
—2034-08-04—

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
No exclusivity facts are recorded in this product snapshot.

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

Generic approval evidence

Application / productEventFinal dateTentative dateApplicantAuthorized genericExact mappingSource
209549 / 001FINAL_APPROVAL · FINAL_APPROVED2018-07-27—WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
209700 / 001FINAL_APPROVAL · FINAL_APPROVED2018-09-04—TEVA PHARMACEUTICALS USA INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
209613 / 001FINAL_APPROVAL · FINAL_APPROVED2018-09-28—AMNEAL PHARMACEUTICALS CO GMBHNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
209638 / 001FINAL_APPROVAL · FINAL_APPROVED2018-10-26—AUROBINDO PHARMA LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
209601 / 001FINAL_APPROVAL · FINAL_APPROVED2018-11-02—APOTEX INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
209663 / 001FINAL_APPROVAL · FINAL_APPROVED2018-11-15—GLENMARK SPECIALTY SANEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
209668 / 001FINAL_APPROVAL · FINAL_APPROVED2018-11-30—ZYDUS PHARMACEUTICALS USA INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
209710 / 001FINAL_APPROVAL · FINAL_APPROVED2019-01-03—SANDOZ INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
209690 / 001FINAL_APPROVAL · FINAL_APPROVED2019-01-07—ACCORD HEALTHCARE INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
209572 / 001FINAL_APPROVAL · FINAL_APPROVED2019-04-19—ALEMBIC PHARMACEUTICALS LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
209623 / 001FINAL_APPROVAL · FINAL_APPROVED2019-04-24—MSN LABORATORIES PRIVATE LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
209702 / 001FINAL_APPROVAL · FINAL_APPROVED2020-02-28—SOMERSET THERAPEUTICS LLCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
209583 / 001FINAL_APPROVAL · FINAL_APPROVED2021-09-24—BRECKENRIDGE PHARMACEUTICAL INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
209598 / 001FINAL_APPROVAL · FINAL_APPROVED2023-03-13—HETERO LABS LTD UNIT VNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
209639 / 001FINAL_APPROVAL · FINAL_APPROVED2023-03-13—BIOCON PHARMA LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
209555 / 001FINAL_APPROVAL · FINAL_APPROVED2023-05-15—NATCO PHARMA LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
209677 / 002FINAL_APPROVAL · FINAL_APPROVED2023-09-28—SOLA PHARMACEUTICALSNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
209697 / 001FINAL_APPROVAL · FINAL_APPROVED2024-04-04—TORRENT PHARMA INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
218663 / 001FINAL_APPROVAL · FINAL_APPROVED2025-04-07—CONCORD BIOTECH LTDNEXACT_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 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 19 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
209549 / 001WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INCFINAL_APPROVAL · FINAL_APPROVED2018-07-27 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
209700 / 001TEVA PHARMACEUTICALS USA INCFINAL_APPROVAL · FINAL_APPROVED2018-09-04 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
209613 / 001AMNEAL PHARMACEUTICALS CO GMBHFINAL_APPROVAL · FINAL_APPROVED2018-09-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
209638 / 001AUROBINDO PHARMA LTDFINAL_APPROVAL · FINAL_APPROVED2018-10-26 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
209601 / 001APOTEX INCFINAL_APPROVAL · FINAL_APPROVED2018-11-02 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
209663 / 001GLENMARK SPECIALTY SAFINAL_APPROVAL · FINAL_APPROVED2018-11-15 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
209668 / 001ZYDUS PHARMACEUTICALS USA INCFINAL_APPROVAL · FINAL_APPROVED2018-11-30 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
209710 / 001SANDOZ INCFINAL_APPROVAL · FINAL_APPROVED2019-01-03 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
209690 / 001ACCORD HEALTHCARE INCFINAL_APPROVAL · FINAL_APPROVED2019-01-07 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
209572 / 001ALEMBIC PHARMACEUTICALS LTDFINAL_APPROVAL · FINAL_APPROVED2019-04-19 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
209623 / 001MSN LABORATORIES PRIVATE LTDFINAL_APPROVAL · FINAL_APPROVED2019-04-24 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
209702 / 001SOMERSET THERAPEUTICS LLCFINAL_APPROVAL · FINAL_APPROVED2020-02-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
209583 / 001BRECKENRIDGE PHARMACEUTICAL INCFINAL_APPROVAL · FINAL_APPROVED2021-09-24 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
209598 / 001HETERO LABS LTD UNIT VFINAL_APPROVAL · FINAL_APPROVED2023-03-13 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
209639 / 001BIOCON PHARMA LTDFINAL_APPROVAL · FINAL_APPROVED2023-03-13 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
209555 / 001NATCO PHARMA LTDFINAL_APPROVAL · FINAL_APPROVED2023-05-15 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
209677 / 002SOLA PHARMACEUTICALSFINAL_APPROVAL · FINAL_APPROVED2023-09-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
209697 / 001TORRENT PHARMA INCFINAL_APPROVAL · FINAL_APPROVED2024-04-04 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
218663 / 001CONCORD BIOTECH LTDFINAL_APPROVAL · FINAL_APPROVED2025-04-07 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
Decision evidence (1)
TypeDateRoleBasisSource
GENERIC2018-07-27TERMINAL_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.