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Last Updated: May 14, 2021

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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 patent protection?

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

Exenatide has three hundred and ninety patent family members in forty-six 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 North Carolina, Chapel HillPhase 2
University of WashingtonPhase 3
Naia PharmaceuticalsPhase 1/Phase 2

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 BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 DISCN Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 DISCN Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 DISCN Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
>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   Get Started for $10   Get Started for $10
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017   Get Started for $10   Get Started for $10
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017   Get Started for $10   Get Started for $10
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017   Get Started for $10   Get Started for $10
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017   Get Started for $10   Get Started for $10
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for EXENATIDE

Country Patent Number Estimated Expiration
Canada 2619426   Get Started for $10
World Intellectual Property Organization (WIPO) 2010028257   Get Started for $10
World Intellectual Property Organization (WIPO) 2007022518   Get Started for $10
Hong Kong 1205120   Get Started for $10
Portugal 2139494   Get Started for $10
Portugal 1420762   Get Started for $10
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for EXENATIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 SPC/GB14/050 United Kingdom   Get Started for $10 PRODUCT NAME: A COMBINATION OF DAPAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND METFORMIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/900 20140121
1734971 C01734971/01 Switzerland   Get Started for $10 PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012
1506211 122014000071 Germany   Get Started for $10 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
2139494 CA 2020 00035 Denmark   Get Started for $10 PRODUCT NAME: SAXAGLIPTIN OG DAPAGLIFLOZIN; REG. NO/DATE: EU/1/16/1108 20160719
1734971 CA 2012 00015 Denmark   Get Started for $10 PRODUCT NAME: EXENATIDE; REG. NO/DATE: EU/1/11/696/001-002 20110623
1506211 CA 2013 00019 Denmark   Get Started for $10
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
McKinsey
Boehringer Ingelheim
Merck
Moodys
Harvard Business School

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