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Last Updated: January 18, 2020

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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 thirty-four patents protecting this drug.

This drug has five hundred and nine patent family members in forty-seven 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.

US ANDA Litigation and Generic Entry Outlook for Bydureon Pen

  Start Trial

Bydureon Pen was eligible for patent challenges on December 31st, 1968.

Drug patent expirations by year for BYDUREON PEN
Drug Prices for BYDUREON PEN

See drug prices for BYDUREON PEN

Recent Clinical Trials for BYDUREON PEN

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

SponsorPhase
Dasman Diabetes InstitutePhase 4
Peking Union Medical College HospitalPhase 4
Consano Clinical Research, LLCPhase 4

See all BYDUREON PEN clinical trials

Pharmacology for BYDUREON PEN
Synonyms for BYDUREON PEN
141732-76-5
141758-74-9
286014-72-0
335149-21-8
9P1872D4OL
AC 2993
AKOS015994651
Bydureon
DA 3091
Exenatide
Exenatide [USAN:INN:BAN:JAN]
Exenatide; Exendin-4
Exendin 3 (Heloderma horridum), 2-glycine-3-L-glutamic acid-
Exendin 4
Exendin-4
HS-2012
HSDB 7789
ITCA 650
LY 2148568
MolPort-009-194-177
PT302
SCHEMBL14634818
UNII-9P1872D4OL
Y-100006

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
>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
>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
1506211 CR 2014 00037 Denmark   Start Trial PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
1734971 C300526 Netherlands   Start Trial PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
1506211 2014C/041 Belgium   Start Trial PRODUCT NAME: LA COMBINAISON DE DAPAGLIFLOZINE (OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE); AUTHORISATION NUMBER AND DATE: EU/1/13/900 20140121
1506211 SPC/GB13/021 United Kingdom   Start Trial PRODUCT NAME: DAPAGLIFLOZIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/12/795/001 20121114; UK EU/1/12/795/002 20121114; UK EU/1/12/795/003 20121114; UK EU/1/12/795/004 20121114; UK EU/1/12/795/005 20121114; UK EU/1/12/795/006 20121114; UK EU/1/12/795/007 20121114; UK EU/1/12/795/008 20121114; UK EU/1/12/795/009 20121114; UK EU/1/12/795/010 20121114
1734971 2012C/017 Belgium   Start Trial PRODUCT NAME: BYDUREON-EXENATIDE; AUTHORISATION NUMBER AND DATE: EU/1/11/696/001 20110617
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
Express Scripts
Harvard Business School
Dow
Baxter

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