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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Chinese Patent Office
US Department of Justice
Merck
Fish and Richardson
Cerilliant
Johnson and Johnson
Baxter
Accenture

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202293

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NDA 202293 describes FARXIGA, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There are eighteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FARXIGA profile page.

The generic ingredient in FARXIGA is dapagliflozin. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dapagliflozin profile page.
Summary for 202293
Tradename:FARXIGA
Applicant:Astrazeneca Ab
Ingredient:dapagliflozin
Patents:18
Formulation / Manufacturing:see details
Pharmacology for NDA: 202293
Suppliers and Packaging for NDA: 202293
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FARXIGA dapagliflozin TABLET;ORAL 202293 NDA AstraZeneca Pharmaceuticals LP 0310-6205 N 0310-6205-30
FARXIGA dapagliflozin TABLET;ORAL 202293 NDA AstraZeneca Pharmaceuticals LP 0310-6205 N 0310-6205-95

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jan 8, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 11, 2018
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF DAPAGLIFLOZIN 10MG ONCE DAILY IN PATIENTS WITH TYPE 2 DIABETES WHO HAVE INADEQUATE GLYCEMIC CONTROL ON A BACKGROUND COMBINATION OF METFORMIN AND SULFONYLUREA
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:Jan 8, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

Expired US Patents for NDA 202293

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 ➤ Sign Up ➤ Sign Up
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 ➤ Sign Up ➤ Sign Up
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 ➤ Sign Up ➤ Sign Up
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 ➤ 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:

McKinsey
Colorcon
Federal Trade Commission
AstraZeneca
Cantor Fitzgerald
Fuji
Cerilliant
Baxter
Medtronic

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