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Details for New Drug Application (NDA): 022200

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NDA 022200 describes BYDUREON PEN, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There are thirty-six patents protecting this drug. Additional details are available on the BYDUREON PEN profile page.

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.

Summary for 022200

Tradename:	BYDUREON PEN
Applicant:	Astrazeneca Ab
Ingredient:	exenatide synthetic
Patents:	36
Formulation / Manufacturing:	see details

Pharmacology for NDA: 022200

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

Suppliers and Packaging for NDA: 022200

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200	NDA	AstraZeneca Pharmaceuticals LP	0310-6520	0310-6520-04	4 TRAY in 1 CARTON (0310-6520-04) > 1 KIT in 1 TRAY * .65 mL in 1 VIAL * .65 mL in 1 SYRINGE
BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200	NDA	AstraZeneca Pharmaceuticals LP	0310-6520	0310-6520-04	4 TRAY in 1 CARTON (0310-6520-04) > 1 KIT in 1 TRAY * .65 mL in 1 VIAL * .65 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS			Strength	2MG/VIAL
Approval Date:	Jan 27, 2012	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Sep 24, 2018
Regulatory Exclusivity Use:	INCLUSION OF EFFICACY AND SAFETY DATA TO THE PRESCRIBING INFORMATION OF BYDUREON BASED ON STUDY GWDE
Regulatory Exclusivity Expiration:	Oct 20, 2020
Regulatory Exclusivity Use:	INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF DAPAGLIFLOZIN IN PATIENTS WITH TYPE 2 DIABETES WHO HAVE INADEQUATE GLYCEMIC CONTROL ON A BACKGROUND COMBINATION OF METFORMIN AND EXENATIDE EXTENDED RELEASE
Regulatory Exclusivity Expiration:	Apr 2, 2021
Regulatory Exclusivity Use:	INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF EXENATIDE EXTENDED RELEASE AS ADD-ON IN PATIENTS WITH TYPE 2 DIABETES WHO HAVE INADEQUATE GLYCEMIC CONTROL ON BASAL INSULIN GLARGINE WITH OR WITHOUT METFORMIN

Expired US Patents for NDA 022200

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	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012
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	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012

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