BYDUREON PEN Drug Patent Profile

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 patents protecting this drug.

This drug has four hundred and eight 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.

DrugPatentWatch^® Generic Entry Outlook for Bydureon Pen

Indicators of Generic Entry

Summary for BYDUREON PEN

International Patents:	408
US Patents:	20
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	39
Patent Applications:	7
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for BYDUREON PEN
DailyMed Link:	BYDUREON PEN at DailyMed

See drug prices for BYDUREON PEN

Recent Clinical Trials for BYDUREON PEN

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

Sponsor	Phase
The University of Texas Health Science Center, Houston	Phase 2
University of Washington	Phase 3
Dasman Diabetes Institute	Phase 4

See all BYDUREON PEN clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for BYDUREON PEN

A10BJ	Glucagon-like peptide-1 (GLP-1) analogues
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

US Patents and Regulatory Information for BYDUREON PEN

BYDUREON PEN is protected by twenty US patents and two FDA Regulatory Exclusivities.

Patents protecting BYDUREON PEN

FDA Regulatory Exclusivity protecting 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		DISCN	Yes	No					Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No					Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No					Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No					Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No					Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No					Y

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
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014

International Patents for BYDUREON PEN

See the table below for patents covering BYDUREON PEN around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	1107883
Japan	2015071636	糖尿病の治療用ＳＧＬＴ２阻害剤としてのアミノ酸を有する（１Ｓ）−１，５−アンヒドロ−１−Ｃ−（３−（（フェニル）メチル）フェニル）−Ｄ−グルシトール誘導体の結晶性溶媒和物および複合体 (CRYSTALLINE SOLVATES AND COMPLEXES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL)METHYL)PHENYL)-D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR TREATMENT OF DIABETES)
China	104382880	Poly (lactide-co-glycolide)-based sustained release microcapsules comprising a polypeptide and a sugar
World Intellectual Property Organization (WIPO)	2009100549
European Patent Office	1224195	INHIBITEURS DE SGLT2 A BASE DE GLUCOSIDE C-ARYLE (C-ARYL GLUCOSIDE SGLT2 INHIBITORS)
European Patent Office	2347762	EXENDIN POUR LE TRAITEMENT DU DIABÈTE ET LA RÉDUCTION DU POIDS (EXENDIN FOR TREATING DIABETES AND REDUCING BODY WEIGHT)

Supplementary Protection Certificates for BYDUREON PEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	CR 2014 00037	Denmark		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
2139494	301054	Netherlands		PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160719
2139494	122020000043	Germany		PRODUCT NAME: SAXAGLIPTIN UND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160715
1506211	SPC/GB13/021	United Kingdom		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
2139494	SPC/GB20/028	United Kingdom		PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; REGISTERED: UK EU/1/16/1108 (NI) 20160719; UK PLGB 17901/0339 20160719
1506211	C300677	Netherlands		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