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. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the BYDUREON BCISE profile page.

The generic ingredient in BYDUREON BCISE 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.

Summary for 209210

Tradename:	BYDUREON BCISE
Applicant:	Astrazeneca Ab
Ingredient:	exenatide synthetic
Patents:	13

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 209210

Generic Entry Date for 209210^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: 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.

Pharmacology for NDA: 209210

Mechanism of Action	Glucagon-like Peptide-1 (GLP-1) Agonists

Suppliers and Packaging for NDA: 209210

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210	NDA	AstraZeneca Pharmaceuticals LP	0310-6540	0310-6540-04	4 CARTRIDGE in 1 CARTON (0310-6540-04) / .85 mL in 1 CARTRIDGE (0310-6540-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS			Strength	2MG/0.85ML (2MG/0.85ML)
Approval Date:	Oct 20, 2017	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jul 22, 2024
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:	Jan 22, 2025
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Patent:	⤷ Sign Up	Patent Expiration:	Apr 4, 2026	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	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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