Viewing data from:

APIXABAN

ANDA

APIXABAN | A210026 | AUROBINDO PHARMA LTD

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Bristol-Myers Squibb Company et al v. Aurobindo Pharma USA Inc. 1:2017cv00374 2 patentsANDA 210026apixaban	D. Del.	2017-04-05	Terminated 2020-08-13	—

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

API Supply Chain57 active DMFs5 inactive

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

MSN LABORATORIES PRIVATE LTDAPIXABAN [ROUTE CODE "AX"]

DMF 280092014

ALEMBIC PHARMACEUTICALS LTDAPIXABAN

DMF 296602015

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDAPIXABAN

DMF 296672015

DR REDDYS LABORATORIES LTDAPIXABAN

DMF 297072015

ALIVUS LIFE SCIENCES LTDAPIXABAN

DMF 300602015

DELMAR CHEMICALS INCAPIXABAN

DMF 303362016

HONOUR LAB LTDAPIXABAN

DMF 304612016

TAPI NL BVAPIXABAN

DMF 304792016

INDOCO REMEDIES LTDAPIXABAN

DMF 306132016

MICRO LABS LTDAPIXABAN

DMF 306192016

ZYDUS LIFESCIENCES LTDAPIXABAN

DMF 306302016

MEDICHEM MANUFACTURING (MALTA) LTDAPIXABAN

DMF 306462016

APITORIA PHARMA PRIVATE LTDAPIXABAN

DMF 307042016

SIGMAPHARM LABORATORIES LLCAPIXABAN AMORPHOUS (6.58%)

DMF 307742016

SUN PHARMACEUTICAL INDUSTRIES LTDAPIXABAN

DMF 307882016

NATCO PHARMA LTDAPIXABAN

DMF 308452016

RUYUAN HEC PHARM CO LTDAPIXABAN NON-STERILE BULK DRUG SUBSTANCE

DMF 308742016

UNICHEM LABORATORIES LTDAPIXABAN

DMF 309292016

MSN LABORATORIES PRIVATE LTDAPIXABAN

DMF 310892016

ZAKLADY FARMACEUTYCZNE POLPHARMA SAAPIXABAN

DMF 311662016

JUBILANT PHARMOVA LTDAPIXABAN

DMF 320712017

HIKAL LTDAPIXABAN

DMF 323642017

NEULAND LABORATORIES LTDAPIXABAN

DMF 324222018

JIANGXI SYNERGY PHARMACEUTICAL CO LTDAPIXABAN

DMF 327812018

MATRIX PHARMACORP PRIVATE LTDAPIXABAN

DMF 334492018

SMS PHARMACEUTICALS LTDAPIXABAN

DMF 335202019

ZHEJIANG LIAOYUAN PHARMACEUTICAL CO LTDAPIXABAN

DMF 340712019

ALP PHARM BEIJING CO LTDAPIXABAN

DMF 349542020

COHANCE LIFESCIENCES LTDAPIXABAN

DMF 349882020

SRINI PHARMACEUTICALS PRIVATE LTDAPIXABAN

DMF 352502020

BIOCON LTDAPIXABAN

DMF 353882020

METROCHEM API PRIVATE LTDAPIXABAN

DMF 355182020

MOREPEN LABORATORIES LTDAPIXABAN

DMF 357992021

MOREPEN LABORATORIES LTDAPIXABAN FORM H3

DMF 359002021

AARTI PHARMALABS LTDAPIXABAN

DMF 359692021

MOREPEN LABORATORIES LTDAPIXABAN AMORPHOUS

DMF 366412021

OPTIMUS DRUGS PRIVATE LTDAPIXABAN

DMF 366512022

LEE PHARMA LTDAPIXABAN

DMF 370402022

SCINOPHARM TAIWAN LTDAPIXABAN

DMF 376692022

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDAPIXABAN

DMF 377702022

CHANGZHOU PHARMACEUTICAL FACTORYAPIXABAN

DMF 378832022

MACLEODS PHARMACEUTICALS LTDAPIXABAN

DMF 381682023

SICHUAN QINGMU PHARMACEUTICAL CO LTDAPIXABAN UREA

DMF 385302023

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)APIXABAN

DMF 389002023

VIYASH LIFE SCIENCES PRIVATE LTDAPIXABAN

DMF 393382024

NEULAND LABORATORIES LTDAPIXABAN (PROCESS-II)

DMF 394442024

LINHAI TIANYU PHARMACEUTICAL CO LTDAPIXABAN

DMF 396042024

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTDAPIXABAN

DMF 402492024

CTX LIFESCIENCES PVT LTDAPIXABAN (ROUTE-I)

DMF 406912024

MEGAFINE PHARMA P LTDAPIXABAN (NON-STERILE DRUG SUBSTANCE)

DMF 408332025

CIPLA LTDAPIXABAN

DMF 409642024

SHAOXING JINGXIN PHARMACEUTICALS CO LTDAPIXABAN

DMF 411632025

EMNAR PHARMA PRIVATE LTDAPIXABAN

DMF 417052025

RAKSHIT DRUGS PRIVATE LTDAPIXABAN

DMF 417432025

TAPI NL BVAPIXABAN P

DMF 419222025

APISYN HEALTHCARE PRIVATE LTDAPIXABAN

DMF 423652025

GOLD PHARMA PRIVATE LIMITEDAPIXABAN

DMF 429202025

SCINOPHARM TAIWAN LTDInactiveAPIXABAN

DMF 304402016

APOTEX PHARMACHEM INDIA PVT LTDInactiveAPIXABAN

DMF 304992016

WATSON PHARMA PRIVATE LTDInactiveAPIXABAN

DMF 306352016

SINTENOVO SA DE CVInactiveAPIXABAN

DMF 306532016

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveAPIXABAN

DMF 332982018

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 6, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 2.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 26, 2023

No patent or exclusivity listings for this strength.

#002 — 5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 26, 2023