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Last Updated: November 30, 2020

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Exenatide - Generic Drug Details

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What are the generic drug sources for exenatide and what is the scope of freedom to operate?

Exenatide is the generic ingredient in four branded drugs marketed by Astrazeneca Ab and is included in three NDAs. There are thirty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Exenatide has five hundred and fourteen patent family members in forty-eight countries.

There are seven drug master file entries for exenatide. One supplier is listed for this compound.

Recent Clinical Trials for exenatide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of WashingtonPhase 3
Naia PharmaceuticalsPhase 1/Phase 2
Antaros Medical ABPhase 4

See all exenatide clinical trials

Pharmacology for exenatide

US Patents and Regulatory Information for exenatide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for exenatide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017   Start Trial   Start Trial
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017   Start Trial   Start Trial
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for exenatide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 300677 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
1506211 122014000070 Germany   Start Trial PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211 PA 2013 008, C 1506211 Lithuania   Start Trial PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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