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CANAGLIFLOZIN

ANDA

CANAGLIFLOZIN | A210386 | AUROBINDO PHARMA LTD

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
MITSUBISHI TANABE PHARMA CORPORATION et al v. AUROBINDO PHARMA USA INC. 3:2017cv12082 2 patentsANDA 210386canagliflozin	D.N.J.	2017-11-27	Terminated 2021-03-24	—

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

API Supply Chain25 active DMFs2 inactive

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

BEIJING HUIKANG BOYUAN CHEMICAL TECH CO LTDCANAGLIFLOZIN HEMIHYDRATE

DMF 294342015

MSN LIFE SCIENCES PRIVATE LTDCANAGLIFLOZIN [HEMIHYDRATE] [ROUTE CODE "CG"]

DMF 294962015

MSN LIFE SCIENCES PRIVATE LTDCANAGLIFLOZIN (AMORPHOUS) [ROUTE CODE "CU"]

DMF 298672015

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDCANAGLIFLOZIN

DMF 303662015

MACLEODS PHARMACEUTICALS LTDCANAGLIFLOZIN

DMF 307532016

MATRIX PHARMACORP PRIVATE LTDCANAGLIFLOZIN

DMF 307712016

CHONGQING CARELIFE PHARMACEUTICAL CO LTDCANAGLIFLOZIN MONOHYDRATE (NON-STERILE BULK DRUG SUBSTANCE)

DMF 308532016

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDCANAGLIFLOZIN

DMF 308792016

ALKEM LABORATORIES LTDCANAGLIFLOZIN

DMF 309412016

INDOCO REMEDIES LTDCANAGLIFLOZIN

DMF 309512016

APITORIA PHARMA PRIVATE LTDCANAGLIFLOZIN

DMF 309642016

DASAMI LAB PRIVATE LTDCANAGLIFLOZIN (AMORPHOUS)

DMF 309722016

DR REDDYS LABORATORIES LTDCANAGLIFLOZIN

DMF 310252016

ALEMBIC PHARMACEUTICALS LTDCANAGLIFLOZIN

DMF 311612016

DASAMI LAB PRIVATE LTDCANAGLIFLOZIN HEMIHYDRATE

DMF 312312017

LAURUS LABS LTDCANAGLIFLOZIN

DMF 312332017

SUN PHARMACEUTICAL INDUSTRIES LTDCANAGLIFLOZIN

DMF 312902017

LUPIN MANUFACTURING SOLUTIONS LTDCANAGLIFLOZIN HEMIHYDRATE

DMF 315042017

ZYDUS LIFESCIENCES LTDCANAGLIFLOZIN

DMF 322262017

FUXIN LONG RUI PHARMACEUTICAL CO LTDCANAGLIFLOZIN HEMIHYDRATE

DMF 333762018

SUN PHARMACEUTICAL INDUSTRIES LTDCANAGLIFLOZIN CRYSTALLINE

DMF 340512019

MATRIX PHARMACORP PRIVATE LTDCANAGLIFLOZIN HEMIHYDRATE

DMF 343062019

CHANGZHOU PHARMACEUTICAL FACTORYCANAGLIFLOZIN HEMIHYDRATE

DMF 367392022

JIANGXI SYNERGY PHARMACEUTICAL CO LTDCANAGLIFLOZIN HEMIHYDRATE

DMF 387342023

ZHEJIANG HUAYI PHARMACEUTICAL CO LTDCANAGLIFLOZIN

DMF 401442024

LUPIN LTDInactiveCANAGLIFLOZIN

DMF 304492016

PORTON PHARMA SOLUTIONS LTDInactiveCANAGLIFLOZIN

DMF 397032024

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

Products (2)

Sort:

#001 — 100MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 20, 2026

No patent or exclusivity listings for this strength.

#002 — 300MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 20, 2026