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Serving leading biopharmaceutical companies globally:

Express Scripts
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Daiichi Sankyo

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021773

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NDA 021773 describes BYETTA, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from two suppliers. There are eight patents protecting this drug and one Paragraph IV challenge. Additional details are available on the BYETTA profile page.

The generic ingredient in BYETTA 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 021773
Tradename:BYETTA
Applicant:Astrazeneca Ab
Ingredient:exenatide synthetic
Patents:8
Formulation / Manufacturing:see details
Pharmacology for NDA: 021773
Suppliers and Packaging for NDA: 021773
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773 NDA AstraZeneca Pharmaceuticals LP 0310-6512 0310-6512-01 1 CARTRIDGE in 1 CARTON (0310-6512-01) > 1.2 mL in 1 CARTRIDGE
BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773 NDA AstraZeneca Pharmaceuticals LP 0310-6524 0310-6524-01 1 CARTRIDGE in 1 CARTON (0310-6524-01) > 2.4 mL in 1 CARTRIDGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength300MCG/1.2ML (250MCG/ML)
Approval Date:Apr 28, 2005TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 24, 2017
Regulatory Exclusivity Use:LABELING CHANGES BASED ON STUDY H80-EW-GWDM
Patent:➤ SubscribePatent Expiration:Dec 1, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:STIMULATING INSULIN RELEASE BY ADMINISTERING EXENATIDE
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 021773

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
US Department of Justice
Federal Trade Commission
Healthtrust
Daiichi Sankyo
Harvard Business School
Cantor Fitzgerald
Queensland Health
QuintilesIMS

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