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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
UBS
Chubb
Daiichi Sankyo
Queensland Health
Boehringer Ingelheim
Fish and Richardson
Covington
Deloitte

Generated: June 25, 2018

DrugPatentWatch Database Preview

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. Two suppliers are 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
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 N 0310-6520-04
BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200 NDA AstraZeneca Pharmaceuticals LP 0310-6520 N 0310-6520-04

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

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Colorcon
Federal Trade Commission
Cantor Fitzgerald
Johnson and Johnson
Farmers Insurance
Queensland Health
AstraZeneca
Covington

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