GenericRadar
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Product profile · United States

BRIDION

 ·  Patent Litigation & Settlement History ↓

IngredientSUGAMMADEX SODIUM
Application typeNDA
Application022225
Product002
Dosage formSOLUTION
RouteINTRAVENOUS
StrengthEQ 200MG BASE/2ML (EQ 100MG BASE/ML)
Approval date2015-12-15
Marketing statusPrescription
Status event—
ApplicantMSD SUB MERCK
Product source

Current GenericRadar decision

Year2023
SelectionEXISTING_GENERIC
ReviewDISQUALIFIED
Anchor typeFINAL_ANDA
Anchor date2023-06-09
Patent anchor—
Exclusivity anchor—
Protection date—
First Final ANDA2023-06-09
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
RE447332026-01-27DS/DP/U U-1794———
———
RE447332026-07-27— ————
—2026-07-27—

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NPP—2027-12-12————Source
PED—2028-06-12————Source

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

Generic approval evidence

Application / productEventFinal dateTentative dateApplicantAuthorized genericExact mappingSource
215701 / 001APPLICATION_FINAL_OBSERVATION · FINAL_PRODUCT_DATE_UNVERIFIED——SHANDONGNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
214337 / 001FINAL_APPROVAL · FINAL_APPROVED2023-06-09—ASPIRO PHARMA LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
214290 / 001FINAL_APPROVAL · FINAL_APPROVED2023-10-04—ZYDUS PHARMACEUTICALS USA INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
214279 / 001FINAL_APPROVAL · FINAL_APPROVED2025-08-05—B BRAUN MEDICAL INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
213915 / 001FINAL_APPROVAL · FINAL_APPROVED2026-07-28—MYLAN PHARMACEUTICALS INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
214126 / 001FINAL_APPROVAL · FINAL_APPROVED2026-07-28—TEVA PHARMACEUTICALS USA INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
214230 / 001FINAL_APPROVAL · FINAL_APPROVED2026-07-28—MANKIND PHARMA LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
214236 / 001FINAL_APPROVAL · FINAL_APPROVED2026-07-28—DR REDDYS LABORATORIES LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
214306 / 001FINAL_APPROVAL · FINAL_APPROVED2026-07-28—ZENARA PHARMA PRIVATE LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
214311 / 001FINAL_APPROVAL · FINAL_APPROVED2026-07-28—SANDOZ INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
214319 / 001FINAL_APPROVAL · FINAL_APPROVED2026-07-28—SUN PHARMACEUTICAL INDUSTRIES INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
214338 / 001FINAL_APPROVAL · FINAL_APPROVED2026-07-28—LUPIN LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
214364 / 001FINAL_APPROVAL · FINAL_APPROVED2026-07-28—GLAND PHARMA LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
214368 / 001FINAL_APPROVAL · FINAL_APPROVED2026-07-28—MSN LABORATORIES PRIVATE LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
215260 / 001FINAL_APPROVAL · FINAL_APPROVED2026-07-28—TAMARANG SANEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
215575 / 001FINAL_APPROVAL · FINAL_APPROVED2026-07-28—QILU PHARMACEUTICAL HAINAN CO LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
218727 / 001FINAL_APPROVAL · FINAL_APPROVED2026-07-28—HIKMA PHARMACEUTICALS USA INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
218728 / 001FINAL_APPROVAL · FINAL_APPROVED2026-07-28—HIKMA PHARMACEUTICALS USA INCNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
218814 / 001FINAL_APPROVAL · FINAL_APPROVED2026-07-28—STERISCIENCE PTE LTDNEXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource
219448 / 001FINAL_APPROVAL · FINAL_APPROVED2026-07-28—FRESENIUS KABI USA LLCNEXACT_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
214337 / 001ASPIRO PHARMA LTDFINAL_APPROVAL · FINAL_APPROVED2023-06-09 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
214290 / 001ZYDUS PHARMACEUTICALS USA INCFINAL_APPROVAL · FINAL_APPROVED2023-10-04 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
214279 / 001B BRAUN MEDICAL INCFINAL_APPROVAL · FINAL_APPROVED2025-08-05 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
213915 / 001MYLAN PHARMACEUTICALS INCFINAL_APPROVAL · FINAL_APPROVED2026-07-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
214126 / 001TEVA PHARMACEUTICALS USA INCFINAL_APPROVAL · FINAL_APPROVED2026-07-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
214230 / 001MANKIND PHARMA LTDFINAL_APPROVAL · FINAL_APPROVED2026-07-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
214236 / 001DR REDDYS LABORATORIES LTDFINAL_APPROVAL · FINAL_APPROVED2026-07-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
214306 / 001ZENARA PHARMA PRIVATE LTDFINAL_APPROVAL · FINAL_APPROVED2026-07-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
214311 / 001SANDOZ INCFINAL_APPROVAL · FINAL_APPROVED2026-07-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
214319 / 001SUN PHARMACEUTICAL INDUSTRIES INCFINAL_APPROVAL · FINAL_APPROVED2026-07-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
214338 / 001LUPIN LTDFINAL_APPROVAL · FINAL_APPROVED2026-07-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
214364 / 001GLAND PHARMA LTDFINAL_APPROVAL · FINAL_APPROVED2026-07-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
214368 / 001MSN LABORATORIES PRIVATE LTDFINAL_APPROVAL · FINAL_APPROVED2026-07-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
215260 / 001TAMARANG SAFINAL_APPROVAL · FINAL_APPROVED2026-07-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
215575 / 001QILU PHARMACEUTICAL HAINAN CO LTDFINAL_APPROVAL · FINAL_APPROVED2026-07-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
218727 / 001HIKMA PHARMACEUTICALS USA INCFINAL_APPROVAL · FINAL_APPROVED2026-07-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
218728 / 001HIKMA PHARMACEUTICALS USA INCFINAL_APPROVAL · FINAL_APPROVED2026-07-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
218814 / 001STERISCIENCE PTE LTDFINAL_APPROVAL · FINAL_APPROVED2026-07-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
219448 / 001FRESENIUS KABI USA LLCFINAL_APPROVAL · FINAL_APPROVED2026-07-28 EXACT_PRODUCT · PENDING_PRODUCT_MAPPINGSource—
Decision evidence (1)
TypeDateRoleBasisSource
GENERIC2023-06-09TERMINAL_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.