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Product profile · United States

BYDUREON BCISE

 ·  Patent Litigation & Settlement History ↓

IngredientEXENATIDE SYNTHETIC
Application typeNDA
Application209210
Product001
Dosage formSUSPENSION, EXTENDED RELEASE
RouteSUBCUTANEOUS
Strength2MG/0.85ML (2MG/0.85ML)
Approval date2017-10-20
Marketing statusDISCONTINUED
Status event—
ApplicantASTRAZENECA AB
Product source

Current GenericRadar decision

Year2025
SelectionDISQUALIFIED
ReviewFINAL
Anchor typeFDA_DISCONTINUATION
Anchor date—
Patent anchor—
Exclusivity anchor—
Protection date2031-04-04
First Final ANDA—
Status event—

FDA_DISCONTINUED; FDA DISC action month 2025-03

Patent estate

PatentEffective dateOfficial listingTRUE_DSDS gradeClaim classification / basisPTEPEDFamily
65151172025-10-04DS/DP/U U-2588———
———
65151172026-04-04— ————
—2026-04-04—
65151172026-04-04ORANGE_BOOK U-2588NNU
English description not available.
—2026-04-04—
83296482026-08-18U U-2594———
———
83296482026-08-18U U-2589———
———
83296482026-08-18U U-3190———
———
83296482026-08-18U U-2596———
———
83296482026-08-18U U-2588———
———
83296482026-08-18U U-2590———
———
83296482026-08-18U U-2595———
———
83296482026-08-18U U-3188———
———
83296482026-08-18U U-3189———
———
83296482026-08-18U U-2593———
———
89068512026-08-18U U-2597———
———
89068512026-08-18U U-3188———
———
89068512026-08-18U U-2593———
———
89068512026-08-18U U-2590———
———
89068512026-08-18U U-3190———
———
89068512026-08-18U U-3189———
———
89068512026-08-18U U-2589———
———
89068512026-08-18U U-2588———
———
98840922026-08-18U U-3188———
———
98840922026-08-18U U-2594———
———
98840922026-08-18U U-2597———
———
98840922026-08-18U U-3189———
———
98840922026-08-18U U-2589———
———
98840922026-08-18U U-2593———
———
98840922026-08-18U U-2596———
———
98840922026-08-18U U-2595———
———
98840922026-08-18U U-2590———
———
98840922026-08-18U U-3190———
———
98840922026-08-18U U-2588———
———
83296482027-02-18— ————
—2027-02-18—
83296482027-02-18ORANGE_BOOK U-2588,U-2589,U-2590,U-2593,U-2594,U-2595,U-2596,U-3188,U-3189,U-3190NNU
English description not available.
—2027-02-18—
89068512027-02-18— ————
—2027-02-18—
89068512027-02-18ORANGE_BOOK U-2588,U-2589,U-2590,U-2593,U-2597,U-3188,U-3189,U-3190NNU
English description not available.
—2027-02-18—
98840922027-02-18— ————
—2027-02-18—
98840922027-02-18ORANGE_BOOK U-2588,U-2589,U-2590,U-2593,U-2594,U-2595,U-2596,U-2597,U-3188,U-3189,U-3190NNU
English description not available.
—2027-02-18—
85016982027-06-20U U-2588———
———
85016982027-12-20— ————
—2027-12-20—
85016982027-12-20ORANGE_BOOK U-2588NNU
English description not available.
—2027-12-20—
83619722028-03-21U U-2588———
———
83619722028-09-21— ————
—2028-09-21—
83619722028-09-21ORANGE_BOOK U-2588NNU
English description not available.
—2028-09-21—
88950332030-10-04DP/U U-2590———
———
88950332030-10-04DP/U U-2602———
———
88950332030-10-04DP/U U-3188———
———
88950332030-10-04DP/U U-3190———
———
88950332030-10-04DP/U U-2601———
———
88950332030-10-04DP/U U-3189———
———
88950332030-10-04DP/U U-2589———
———
88950332030-10-04DP/U U-2597———
———
88950332031-04-04— ————
—2031-04-04—
88950332031-04-04ORANGE_BOOK U-2589,U-2590,U-2597,U-2601,U-2602,U-3188,U-3189,U-3190NNDP
English description not available.
—2031-04-04—

Regulatory exclusivity

CodeStart dateEnd dateScopeEntire productAll indicationsFull coverage dateCombinationSource
NP2017-10-202020-10-20English description not available.NN—Source
M-2402019-02-152022-02-15INFORMATION ADDED TO LABELING REGARDING A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE CARDIOVASCULAR OUTCOMES AFTER TREATMENT WITH EXENATIDE ONCE WEEKLY IN PATIENTS WITH TYPE 2 DIABETES MELLITESNN—Source
PED2023-02-152023-08-15English description not available.NN—Source
NPP2021-07-222024-07-22English description not available.NN—Source
PED2024-07-222025-01-22English description not available.NN—Source

2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · 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
PATENT2026-04-04HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2027-02-18HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2027-02-18HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2027-02-18HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2027-12-20HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2028-09-21HISTORICAL_CONTEXTEnglish description not available.Source
PATENT2031-04-04HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTINFORMATION ADDED TO LABELING REGARDING A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE CARDIOVASCULAR OUTCOMES AFTER TREATMENT WITH EXENATIDE ONCE WEEKLY IN PATIENTS WITH TYPE 2 DIABETES MELLITESSource
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_EXCLUSIVITY—HISTORICAL_CONTEXTEnglish description not available.Source
REGULATORY_STATUS—TERMINAL_STATUSFDA_DISCONTINUED; FDA DISC action month 2025-03Source
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.