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Last Updated: June 14, 2021

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BYDUREON Drug Profile


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When do Bydureon patents expire, and what generic alternatives are available?

Bydureon is a drug marketed by Astrazeneca Ab and is included in two NDAs. There are thirty-six patents protecting this drug.

This drug has three hundred and sixty-two patent family members in forty-six countries.

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

DrugPatentWatch® Generic Entry Outlook for Bydureon

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 20, 2027. This may change due to patent challenges or generic licensing.

Annual sales in 2018 were $92mm indicating the motivation for generic entry (peak sales were $653mm in 2015).

There have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for BYDUREON
Drug Prices for BYDUREON

See drug prices for BYDUREON

Drug Sales Revenue Trends for BYDUREON

See drug sales revenues for BYDUREON

DrugPatentWatch® Estimated Generic Entry Opportunity Date for BYDUREON
Generic Entry Date for BYDUREON*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for BYDUREON

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

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

See all BYDUREON clinical trials

Pharmacology for BYDUREON

US Patents and Regulatory Information for BYDUREON

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 DISCN Yes No   Get Started Free   Get Started Free Y   Get Started Free
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No   Get Started Free   Get Started Free Y   Get Started Free
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No   Get Started Free   Get Started Free Y   Get Started Free
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012   Get Started Free   Get Started Free
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012   Get Started Free   Get Started Free
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012   Get Started Free   Get Started Free
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012   Get Started Free   Get Started Free
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for BYDUREON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 C 2014 029 Romania   Get Started Free PRODUCT NAME: COMBINATIE DE DAPAGLIFLOZIN SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA SI METFORMINA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/900; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/900; DATE OF FIRST AUTHORISATION IN EEA: 20140116
1734971 C20120006 00104 Estonia   Get Started Free PRODUCT NAME: EKSENATIID;REG NO/DATE: K(2011)4479 LOPLIK 23.06.2011
1140145 91343 Luxembourg   Get Started Free 91343, EXPIRES: 20211120
1140145 CA 2007 00033 Denmark   Get Started Free PRODUCT NAME: EXENATID, EXENDIN, EXENDINAGONISTER; REG. NO/DATE: EU/1/06/362/001-004 20061120
0996459 0790031-9 Sweden   Get Started Free 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:

Merck
Medtronic
Moodys
Dow
AstraZeneca
McKinsey

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