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RIVAROXABAN

ANDA

RIVAROXABAN | A210301 | ALEMBIC PHARMACEUTICALS LTD

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: XARELTO(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Bayer Intellectual Property GmbH et al v. Alembic Pharmaceuticals Limited et al 1:2017cv00675 1 patentANDA 210301rivaroxaban	D. Del.	2017-06-02	Terminated 2020-12-22	—

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

API Supply Chain64 active DMFs2 inactive

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

BAYER AGRIVAROXABAN COATED TABLETS, 10 MG

DMF 215802008

BAYER AGRIVAROXABAN (MICRONIZED) DRUG SUBSTANCE

DMF 215812008

JANSSEN ORTHO LLCRIVAROXABAN 10 MG FILM COATED TABLETS

DMF 215922008

ZAKLADY FARMACEUTYCZNE POLPHARMA SARIVAROXABAN

DMF 276612013

MSN LABORATORIES PRIVATE LTDRIVAROXABAN USP [ROUTE CODE "RR")

DMF 278072013

ALEMBIC PHARMACEUTICALS LTDRIVAROXABAN USP

DMF 280562014

DR REDDYS LABORATORIES LTDRIVAROXABAN USP

DMF 281212014

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDRIVAROXABAN USP

DMF 283232014

LUPIN MANUFACTURING SOLUTIONS LTDRIVAROXABAN

DMF 287982015

SYMED LABS LTDRIVAROXABAN

DMF 288072014

TARO PHARMACEUTICAL INDUSTRIES LTDRIVAROXABAN USP MICRONIZED

DMF 288162015

TAPI NL BVRIVAROXABAN

DMF 288192017

ALIVUS LIFE SCIENCES LTDRIVAROXABAN

DMF 288642015

MEDICHEM MANUFACTURING (MALTA) LTDRIVAROXABAN

DMF 289162014

APOTEX INCRIVAROXABAN

DMF 289222014

MEGAFINE PHARMA P LTDRIVAROXABAN (NON-STERILE DRUG SUBSTANCE)

DMF 289272014

INTERQUIM SARIVAROXABAN

DMF 289932015

APITORIA PHARMA PRIVATE LTDRIVAROXABAN

DMF 290482015

RAKS PHARMA PVT LTDRIVAROXABAN

DMF 290662015

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDRIVAROXABAN

DMF 294392015

PIRAMAL PHARMA LTDRIVAROXABAN

DMF 304032016

INTAS PHARMACEUTICALS LTDRIVAROXABAN FORM- I (MICRONIZED)

DMF 305622016

NEULAND LABORATORIES LTDRIVAROXABAN

DMF 306092016

TIANJIN WEIJIE PHARMACEUTICAL CO LTDRIVAROXABAN

DMF 311352016

JUBILANT BIOSYS LTDRIVAROXABAN

DMF 313812017

MICRO LABS LTDRIVAROXABAN

DMF 314182017

JIANGXI SYNERGY PHARMACEUTICAL CO LTDRIVAROXABAN

DMF 316012017

MACLEODS PHARMACEUTICALS LTDRIVAROXABAN

DMF 317832017

COHANCE LIFESCIENCES LTDRIVAROXABAN

DMF 321152017

UNICHEM LABORATORIES LTDRIVAROXABAN

DMF 323742018

HOLIDAY LABS MEXICO SA DE CVRIVAROXABAN

DMF 328272018

OPTIMUS DRUGS PRIVATE LTDRIVAROXABAN

DMF 328462019

FUXIN LONG RUI PHARMACEUTICAL CO LTDRIVAROXABAN

DMF 337932019

SRINI PHARMACEUTICALS PRIVATE LTDRIVAROXABAN

DMF 339842019

SMS PHARMACEUTICALS LTDRIVAROXABAN

DMF 342122020

MATRIX PHARMACORP PRIVATE LTDRIVAROXABAN USP

DMF 342262019

YUNG ZIP CHEMICAL IND CO LTDRIVAROXABAN

DMF 342642019

CHANGZHOU PHARMACEUTICAL FACTORYRIVAROXABAN

DMF 344362019

BIOCON LTDRIVAROXABAN USP

DMF 353872020

TOPHARMAN SHANDONG CO LTDRIVAROXABAN

DMF 356022021

CIPLA LTDRIVAROXABAN

DMF 356492021

INNOVARE LABS PRIVATE LTDRIVAROXABAN

DMF 358202021

MOREPEN LABORATORIES LTDRIVAROXABAN

DMF 362522021

SHAOXING JINGXIN PHARMACEUTICALS CO LTDRIVAROXABAN

DMF 364182023

LEE PHARMA LTDRIVAROXABAN

DMF 366722022

AMI LIFESCIENCES PRIVATE LTDRIVAROXABAN

DMF 371732022

INDOCO REMEDIES LTDRIVAROXABAN USP

DMF 375702022

CHENGDA PHARMACEUTICALS CO LTDRIVAROXABAN

DMF 378202023

HETERO DRUGS LTDRIVAROXABAN

DMF 380612023

USV PRIVATE LTDRIVAROXABAN USP (MICRONISED)

DMF 381192023

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)RIVAROXABAN USP

DMF 381222023

VASUDHA PHARMA CHEM LTDRIVAROXABAN

DMF 382112023

HIKAL LTDRIVAROXABAN USP

DMF 387082023

ZHEJIANG JINHUA CONBA BIO-PHARM CO LTDRIVAROXABAN USP

DMF 388972023

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTDRIVAROXABAN

DMF 392192023

QUIMICA SINTETICA SARIVAROXABAN

DMF 392272024

ZHEJIANG TIANYU PHARMACEUTICAL CO LTDRIVAROXABAN

DMF 396812024

DIVIS LABORATORIES LTDRIVAROXABAN USP

DMF 400602024

DR REDDYS LABORATORIES LTDRIVAROXABAN USP [PROCESS-II]

DMF 416092025

WANBURY LTDRIVAROXABAN USP

DMF 416482025

CHIERON ACTIVE INGREDIENTS PRIVATE LTDRIVAROXABAN USP

DMF 420172025

SS PHARMA INCRIVAROXABAN USP

DMF 426912025

SAI SREYAS PHARMACEUTICAL PRIVATE LIMITEDRIVAROXABAN INTERMEDIATE (2-{[(2S)OXIRAN-2-YL]METHYL}-1H-ISOINDOLE-1,3(2H)-DIONE (RIVB)), CAS NO. [161596-47-0]

DMF 428062025

SAI SREYAS PHARMACEUTICAL PRIVATE LIMITEDRIVAROXABAN INTERMEDIATE- (5-CHLOROTHIOPHENE-2-CARBOXYLIC ACID (RIV-C)), (CAS NO. 24065-33-6)

DMF 428072025

VIWIT PHARMACEUTICAL CO LTDInactiveRIVAROXABAN (DRUG SUBSTANCE, NON-STERILE)

DMF 281992014

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDInactiveRIVAROXABAN

DMF 319002017

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

Products (4)

Sort:

#001 — 2.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 14, 2025

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 14, 2025

#003 — 15MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 14, 2025

#004 — 20MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 14, 2025