Last Updated: September 24, 2026

Details for New Drug Application (NDA): 209210

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NDA 209210 describes BYDUREON BCISE, which is a drug marketed by Astrazeneca Ab and is included in one NDA. There are seven patents protecting this drug. Additional details are available on the BYDUREON BCISE profile page.

The generic ingredient in BYDUREON BCISE is exenatide synthetic. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the exenatide synthetic profile page.

Summary for 209210

Tradename:	BYDUREON BCISE
Applicant:	Astrazeneca Ab
Ingredient:	exenatide synthetic
Patents:	7

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS			Strength	2MG/0.85ML (2MG/0.85ML)
Approval Date:	Oct 20, 2017	TE:		RLD:	Yes
Patent:	6,515,117*PED	Patent Expiration:	Apr 4, 2026	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	8,329,648*PED	Patent Expiration:	Feb 18, 2027	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	8,361,972*PED	Patent Expiration:	Sep 21, 2028	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 209210

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017	6,414,126	⤷ Start Trial
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017	9,198,925	⤷ Start Trial
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017	7,741,269	⤷ Start Trial
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017	6,872,700	⤷ Start Trial
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017	6,667,061	⤷ Start Trial
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017	6,936,590	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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