Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 24, 2019

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 three suppliers. 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-six drug master file entries for this compound. Three suppliers are 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
Generic Entry Opportunity Date for 202293
Generic Entry Date for 202293*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 0310-6205-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-30)
FARXIGA dapagliflozin TABLET;ORAL 202293 NDA AstraZeneca Pharmaceuticals LP 0310-6205 0310-6205-95 1 BLISTER PACK in 1 CARTON (0310-6205-95) > 7 TABLET, FILM COATED in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 202293
Tradename Dosage Ingredient NDA Submissiondate
FARXIGA TABLET;ORAL dapagliflozin 202293 2018-01-08

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jan 8, 2014TE:RLD:Yes
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:Feb 22, 2022
Regulatory Exclusivity Use:INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO REFLECT THAT NO DOSE ADJUSTMENT IS NEEDED FOR PATIENTS WITH AN ESTIMATED GLOMERULAR FILTRATION RATE (EGFR) OF 45 ML/MIN/1.73 M2 OR GREATER AS SUPPORTED BY CLINICAL STUDY REPORT
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   Start Trial   Start Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014   Start Trial   Start Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014   Start Trial   Start Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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