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Last Updated: October 19, 2019

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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-four 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:34
Formulation / Manufacturing:see details
Pharmacology for NDA: 022200
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 SYRINGE * .65 mL in 1 VIAL
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 SYRINGE * .65 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUSStrength2MG/VIAL
Approval Date:Jan 27, 2012TE:RLD:Yes
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
Patent:  Start TrialPatent Expiration:Oct 4, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF TYPE 2 DIABETES MELLITUS

Expired US Patents for NDA 022200

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012   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 exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012   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

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