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DAPAGLIFLOZIN

ANDA

DAPAGLIFLOZIN | A211582 | ZYDUS PHARMACEUTICALS USA INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: FARXIGA(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
AstraZeneca AB v. Zydus Pharmaceuticals (USA) Inc. 1:2018cv00664 3 patentsANDA 211582dapagliflozin	D. Del.	2018-05-01	Terminated 2022-07-28	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain62 active DMFs

47 active API suppliers hold Drug Master Files for this ingredient.

ALP PHARM BEIJING CO LTDDAPAGLIFLOZIN PROPANEDIOL

DMF 278382015

MSN LABORATORIES PRIVATE LTDDAPAGLIFLOZIN PROPANEDIOL (MONOHYDRATE) USP [ROUTE CODE - "DQ"]

DMF 280862014

MSN LABORATORIES PRIVATE LTDDAPAGLIFLOZIN (AMORPHOUS) [ROUTE CODE "DQa"]

DMF 302992016

ZAKLADY FARMACEUTYCZNE POLPHARMA SADAPAGLIFLOZIN

DMF 305552016

DR REDDYS LABORATORIES LTDDAPAGLIFLOZIN (AMORPHOUS)

DMF 307292016

HONOUR LAB LTDDAPAGLIFLOZIN (AMORPHOUS)

DMF 312352017

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDDAPAGLIFLOZIN PROPANEDIOL USP

DMF 312702017

ALIVUS LIFE SCIENCES LTDDAPAGLIFLOZIN AMORPHOUS

DMF 312842017

LUPIN MANUFACTURING SOLUTIONS LTDDAPAGLIFLOZIN PREMIX

DMF 318672017

BIOCON LTDDAPAGLIFLOZIN

DMF 317622017

APITORIA PHARMA PRIVATE LTDDAPAGLIFLOZIN

DMF 318412017

MACLEODS PHARMACEUTICALS LTDDAPAGLIFLOZIN PREMIX

DMF 318802017

RAKS PHARMA PVT LTDDAPAGLIFLOZIN

DMF 319512017

ZYDUS LIFESCIENCES LTDDAPAGLIFLOZIN

DMF 319922017

ALEMBIC PHARMACEUTICALS LTDDAPAGLIFLOZIN

DMF 320052017

BIONPHARMA INCDAPAGLIFLOZIN

DMF 320362017

SUN PHARMACEUTICAL INDUSTRIES LTDDAPAGLIFLOZIN

DMF 320842017

JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTDDAPAGLIFLOZIN

DMF 321172017

MICRO LABS LTDDAPAGLIFLOZIN

DMF 321392017

HARMAN FINOCHEM LTDDAPAGLIFLOZIN

DMF 321702017

HIKAL LTDDAPAGLIFLOZIN (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE)

DMF 325712018

HONOUR LAB LTDDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE

DMF 329722018

DR REDDYS LABORATORIES LTDDAPAGLIFLOZIN PROPANEDIOL

DMF 330262018

PIRAMAL PHARMA LTDDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE

DMF 332822018

FUXIN LONG RUI PHARMACEUTICAL CO LTDDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE

DMF 333792018

ZAKLADY FARMACEUTYCZNE POLPHARMA SADAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE

DMF 333872018

COHANCE LIFESCIENCES LTDDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE

DMF 342352019

MOREPEN LABORATORIES LTDDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE

DMF 346902020

LEE PHARMA LTDDapagliflozin Propanediol Monohydrate

DMF 357922021

BIOCON LTDDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE

DMF 359282021

METROCHEM API PRIVATE LTDDAPAGLIFLOZIN PROPENEDIOL MONOHYDRATE

DMF 360482021

EMNAR PHARMA PRIVATE LTDDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE

DMF 364712021

METROCHEM API PRIVATE LTDDAPAGLIFLOZIN (AMORPHOUS)

DMF 366082022

MOREPEN LABORATORIES LTDDAPAGLIFLOZIN AMORPHOUS

DMF 368982022

USV PRIVATE LTDDAPAGLIFLOZIN (DAPAGLIFLOZIN 30% W/W SOLUTION IN ISOPROPYL ALCOHOL)

DMF 369032022

LEE PHARMA LTDDAPAGLIFLOZIN

DMF 369942023

OPTIMUS DRUGS PRIVATE LTDDAPAGLIFLOZIN

DMF 370892022

AMI LIFESCIENCES PRIVATE LTDDAPAGLIFLOZIN AMORPHOUS

DMF 380092023

AMI LIFESCIENCES PRIVATE LTDDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE

DMF 380102023

AZICO BIOPHORE INDIA PVT LTDDAPAGLIFLOZIN AMORPHOUS

DMF 383702023

WISDOM PHARMACEUTICAL CO LTDDAPAGLIFLOZIN

DMF 390062023

PORTON PHARMA SOLUTIONS LTDDAPAGLIFLOZIN

DMF 390282023

GRANULES INDIA LTDDAPAGLIFLOZIN

DMF 391202023

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDDAPAGLIFLOZIN PROPANEDIOL (PROCESS II) USP

DMF 391922023

ZHEJIANG HONGYUAN PHARMACEUTICAL CO LTDDAPAGLIFLOZIN INTERMEDIATE (DP3)

DMF 392842023

ZHEJIANG JINGSHENG PHARMACEUTICAL CO LTDDAPAGLIFLOZIN

DMF 396562024

VIYASH LIFE SCIENCES PRIVATE LTDDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE USP

DMF 397162024

NEULAND LABORATORIES LTDDAPAGLIFLOZIN PROPANEDIOL USP (MONOHYDRATE)

DMF 397602024

AZICO BIOPHORE INDIA PVT LTDDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE

DMF 398612024

JIANGXI SYNERGY PHARMACEUTICAL CO LTDDAPAGLIFLOZIN (AMORPHOUS)

DMF 399752024

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)DAPAGLIFLOZIN AMORPHOUS

DMF 402372024

ZYDUS LIFESCIENCES LTDDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE USP

DMF 410742024

LINHAI TIANYU PHARMACEUTICAL CO LTDDAPAGLIFLOZIN

DMF 411882025

ZHEJIANG JINGSHENG PHARMACEUTICAL CO LTDDAPAGLIFLOZIN (FREE BASE)

DMF 414712025

SCL LIFESCIENCES LTDDAPAGLIFLOZIN PROPANEDIOL

DMF 417512025

LAURUS LABS LTDDAPAGLIFLOZIN

DMF 418222025

ZENJI PHARMACEUTICALS (SUZHOU) LTDDAPAGLIFLOZIN

DMF 419132025

RAKSHIT DRUGS PRIVATE LTDDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE

DMF 419332025

CAMBREX PROFARMACO MILANO SRLDAPAGLIFLOZIN PROPYLENE GLYCOL MONOHYDRATE

DMF 423002025

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)DAPAGLIFLOZIN AMORPHOUS PROCESS-II

DMF 424862025

CHIERON ACTIVE INGREDIENTS PRIVATE LTDDAPAGLIFLOZIN PROPANEDIOL

DMF 426172025

ALEMBIC PHARMACEUTICALS LTDDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE USP

DMF 432022025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

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#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 6, 2026

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 6, 2026