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Serving leading biopharmaceutical companies globally:

Teva
Accenture
Express Scripts
US Department of Justice
Cipla
Medtronic
Daiichi Sankyo
Deloitte
Healthtrust
McKinsey

Generated: January 17, 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 two suppliers. There are thirty-seven 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. Three 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:37
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:
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
Patent:➤ SubscribePatent Expiration:Dec 1, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:TREATING TYPE 2 DIABETES MELLITUS WITH EXENATIDE BY STIMULATING INSULIN RELEASE

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 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Accenture
Covington
Dow
Cantor Fitzgerald
Federal Trade Commission
McKinsey
UBS
Cerilliant
Baxter

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