Viewing data from:

ROSUVASTATIN CALCIUM

ANDA

ROSUVASTATIN CALCIUM | A207453 | CADILA PHARMACEUTICALS LTD

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: CRESTOR(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Gilead Sciences, Inc. v. Mylan Pharmaceuticals Inc. 1:2017cv00217 1 patentANDA 207453atazanavir and cobicistat	WVND	2017-12-15	Terminated 2018-07-23	—

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

API Supply Chain51 active DMFs11 inactive

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

ALIVUS LIFE SCIENCES LTDROSUVASTATIN CALCIUM

DMF 205922007

APITORIA PHARMA PRIVATE LTDROSUVASTATIN CALCIUM (NON-STERILE DRUG SUBSTANCE)

DMF 206292007

TAPI NL BVROSUVASTATIN CALCIUM (BULK)

DMF 206712007

ZHEJIANG NEO DANKONG PHARMACEUTICAL CO LTDROSUVASTATIN CALCIUM INTERMEDIATE (RJS3)

DMF 206772007

CHANGZHOU PHARMACEUTICAL FACTORYROSUVASTATIN CALCIUM

DMF 207052007

MSN LABORATORIES PRIVATE LTDROSUVASTATIN CALCIUM USP [ROUTE CODE - RV"]

DMF 207122007

ZHEJIANG LEPU PHARMACEUTICAL CO LTDROSUVASTATIN CALCIUM INTERMEDIATE (R1.5)

DMF 207512007

LEK PHARMACEUTICALS DDROSUVASTATIN CALCIUM

DMF 207652007

MATRIX PHARMACORP PRIVATE LTDROSUVASTATIN CALCIUM

DMF 237662010

ZYDUS LIFESCIENCES LTDROSUVASTATIN CALCIUM USP

DMF 260732012

BIOCON LTDROSUVASTATIN CALCIUM

DMF 265402012

LUPIN LTDROSUVASTATIN CALCIUM

DMF 267812013

HETERO DRUGS LTDROSUVASTATIN CALCIUM (AMORPHOUS)

DMF 276332013

BIOCON LTDROSUVASTATIN CALCIUM USP (PROCESS-II)

DMF 276752013

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDROSUVASTATIN CALCIUM

DMF 277772013

JUBILANT PHARMOVA LTDROSUVASTATIN CALCIUM AMORPHOUS

DMF 278132014

MACLEODS PHARMACEUTICALS LTDROSUVASTATIN CALCIUM

DMF 280282014

ALIVUS LIFE SCIENCES LTDROSUVASTATIN CALCIUM USP

DMF 288882015

DELMAR CHEMICALS INCROSUVASTATIN CALCIUM

DMF 291902015

RUYUAN HEC PHARM CO LTDROSUVASTATIN CALCIUM NON-STERILE BULK DRUG SUBSTANCE

DMF 293972015

MELODY HEALTHCARE PVT LTDROSUVASTATIN CALCIUM

DMF 301332015

KOLON LIFE SCIENCE INCROSUVASTATIN CALCIUM

DMF 305562016

TAPI NL BVROSUVASTATIN CALCIUM PROCESS G 2410

DMF 308302016

LEK PHARMACEUTICALS DDROSUVASTATIN CALCIUM (PROCESS C)

DMF 309322016

SUN PHARMACEUTICAL INDUSTRIES LTDROSUVASTATIN CALCIUM USP

DMF 312912017

CENTRIENT PHARMACEUTICALS NETHERLANDS BVROSUVASTATIN CALCIUM

DMF 314102017

MOREPEN LABORATORIES LTDROSUVASTATIN CALCIUM PROCESS -2

DMF 326512018

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)ROSUVASTATIN CALCIUM

DMF 327942018

MOREPEN LABORATORIES LTDROSUVASTATIN CALCIUM

DMF 333482018

MSN LIFE SCIENCES PRIVATE LTDROSUVASTATIN CALCIUM USP

DMF 345182020

CHANGZHOU PHARMACEUTICAL FACTORYROSUVASTATIN CALCIUM (ROUTE CODE: RSF)

DMF 349742020

LEE PHARMA LTDROSUVASTATIN CALCIUM USP

DMF 351152020

JIANGSU ALPHA PHARMACEUTICAL CO LTDROSUVASTATIN CALCIUM INTERMEDIATE (R1)

DMF 359062021

ZHEJIANG YONGTAI PHARMACEUTICAL CO LTDROSUVASTATIN CALCIUM USP

DMF 360122021

NENTER AND CO INCROSUVASTATIN CALCIUM INTERMEDIATE (R-1)

DMF 361182022

CHROMO LABORATORIES INDIA PRIVATE LTDROSUVASTATIN CALCIUM USP

DMF 362082022

MANKIND PHARMA LTDROSUVASTATIN CALCIUM USP

DMF 364932021

CHROMO LABORATORIES INDIA PRIVATE LTDROSUVASTATIN CALCIUM USP

DMF 372202023

NINGBO MENOVO PHARMACEUTICAL CO LTDROSUVASTATIN CALCIUM INTERMEDIATE

DMF 386612023

INNOVARE LABS PRIVATE LTDROSUVASTATIN CALCIUM USP

DMF 388352023

SHAOXING JINGXIN PHARMACEUTICALS CO LTDROSUVASTATIN CALCIUM

DMF 389392024

LEWENS LABS PRIVATE LTDROSUVASTATIN CALCIUM USP

DMF 390432024

ZHEJIANG HONGYUAN PHARMACEUTICAL CO LTDROSUVASTATIN CALCIUM INTERMEDIATE (R-2)

DMF 392182023

CTX LIFESCIENCES PVT LTDROSUVASTATIN CALCIUM USP

DMF 392792023

BIOCON LTDROSUVASTATIN CALCIUM USP (PROCESS-III)

DMF 400772024

ZHEJIANG MENOVO PHARMACEUTICAL CO LTDROSUVASTATIN CALCIUM

DMF 401482024

SHAOXING JINGXIN PHARMACEUTICALS CO LTDROSUVASTATIN CALCIUM INTERMEDIATE (R1)

DMF 404002024

APITORIA PHARMA PRIVATE LTDROSUVASTATIN CALCIUM USP (PROCESS-II)

DMF 405232024

JIANGSU ALPHA GROUP FURUI PHARMACEUTICAL (SUQIAN) CO LTDROSUVASTATIN CALCIUM INTERMEDIATE (R1)

DMF 414392025

ZHEJIANG HONGYUAN PHARMACEUTICAL CO LTDROSUVASTATIN CALCIUM INTERMEDIATE (R-2) (PROCESS 2)

DMF 421712025

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)ROSUVASTATIN CALCIUM USP PROCESS-II

DMF 422852025

EGIS PHARMACEUTICALS PLCInactiveROSUVASTATIN

DMF 235922010

MSN LABORATORIES PRIVATE LTDInactiveROSUVASTATIN CALCIUM USP [ROUTE CODE - "RT"]

DMF 239752010

PORTON FINE CHEMICALS LTDInactiveROSUVASTATIN CALCIUM

DMF 250502011

PHARMACEUTICAL WORKS POLPHARMA SAInactiveROSUVASTATIN CALCIUM

DMF 251172011

SIGNA SA DE CVInactiveROSUVASTATIN CALCIUM

DMF 261502012

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveROSUVASTATIN CALCIUM

DMF 277692013

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveROSUVASTATIN CALCIUM PROCESS G

DMF 278792014

LEK PHARMACEUTICALS DDInactiveROSUVASTATIN CALCIUM (PROCESS B)

DMF 280222014

DR REDDYS LABORATORIES LTDInactiveROSUVASTATIN CALCIUM USP

DMF 283342014

AMOLI ORGANICS PVT LTDInactiveROSUVASTATIN CALCIUM

DMF 286592014

NINGBO MENOVO PHARMACEUTICAL CO LTDInactiveROSUVASTATIN CALCIUM

DMF 334812019

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

Products (4)

Sort:

#001 — EQ 5MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 23, 2016

No patent or exclusivity listings for this strength.

#002 — EQ 10MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 23, 2016

#003 — EQ 20MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 23, 2016

#004 — EQ 40MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 23, 2016