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Last Updated: April 17, 2021

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BYDUREON PEN Drug Profile

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Which patents cover Bydureon Pen, and what generic alternatives are available?

Bydureon Pen is a drug marketed by Astrazeneca Ab and is included in one NDA. There are twenty-nine patents protecting this drug.

This drug has five hundred and twenty-three patent family members in forty-eight countries.

The generic ingredient in BYDUREON PEN is exenatide synthetic. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the exenatide synthetic profile page.

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Drug patent expirations by year for BYDUREON PEN
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Recent Clinical Trials for BYDUREON PEN

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SponsorPhase
University of WashingtonPhase 3
Dasman Diabetes InstitutePhase 4
Peking Union Medical College HospitalPhase 4

See all BYDUREON PEN clinical trials

Pharmacology for BYDUREON PEN

US Patents and Regulatory Information for BYDUREON PEN

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 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 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 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 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 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 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 BYDUREON PEN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014   Start Trial   Start Trial
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014   Start Trial   Start Trial
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014   Start Trial   Start Trial
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014   Start Trial   Start Trial
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014   Start Trial   Start Trial
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014   Start Trial   Start Trial
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for BYDUREON PEN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2139494 301054 Netherlands   Start Trial PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160719
2139494 2020C/533 Belgium   Start Trial PRODUCT NAME: QTERN -SAXAGLIPTINE ET DAPAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1108 20160719
1140145 SZ 30/2007 Austria   Start Trial PRODUCT NAME: EXENATIDE
2139494 CA 2020 00035 Denmark   Start Trial PRODUCT NAME: SAXAGLIPTIN OG DAPAGLIFLOZIN; REG. NO/DATE: EU/1/16/1108 20160719
1506211 DO 136; 5005-2013 Slovakia   Start Trial PRODUCT NAME: DAPAGLIFOZIN:REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112; FORMER OWNER: BRISTOL
1506211 C300677 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
0996459 0790031-9 Sweden   Start Trial PRODUCT NAME: EXANATID; REG. NO/DATE: EU/1/06/362/001 20061120
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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