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Serving leading biopharmaceutical companies globally:

Covington
Deloitte
Federal Trade Commission
UBS
McKesson
Express Scripts
Cerilliant
Cipla
Teva
Queensland Health

Generated: February 17, 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. Additional details are available on the FARXIGA profile page.

The generic ingredient in FARXIGA is dapagliflozin propanediol. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dapagliflozin propanediol profile page.
Summary for 202293
Tradename:FARXIGA
Applicant:Astrazeneca Ab
Ingredient:dapagliflozin propanediol
Patents:18
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 propanediol TABLET;ORAL 202293 NDA AstraZeneca Pharmaceuticals LP 0310-6205 N 0310-6205-95
FARXIGA dapagliflozin propanediol TABLET;ORAL 202293 NDA AstraZeneca Pharmaceuticals LP 0310-6205 N 0310-6205-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
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 propanediol TABLET;ORAL 202293-001 Jan 8, 2014 ➤ Sign Up ➤ Sign Up
Astrazeneca Ab FARXIGA dapagliflozin propanediol TABLET;ORAL 202293-001 Jan 8, 2014 ➤ Sign Up ➤ Sign Up
Astrazeneca Ab FARXIGA dapagliflozin propanediol TABLET;ORAL 202293-002 Jan 8, 2014 ➤ Sign Up ➤ Sign Up
Astrazeneca Ab FARXIGA dapagliflozin propanediol 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:

Queensland Health
Express Scripts
Baxter
Farmers Insurance
Boehringer Ingelheim
Covington
Cerilliant
McKinsey
Cipla

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