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SOLIFENACIN SUCCINATE

ANDA

SOLIFENACIN SUCCINATE | A209839 | CIPLA LTD

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Astellas Pharma Inc. et al v. Cipla Limited 1:2018cv00844 1 patentANDA 209839solifenacin succinate	D. Del.	2018-06-05	Terminated 2018-08-23	—

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

API Supply Chain25 active DMFs7 inactive

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

TAPI NL BVSOLIFENACIN SUCCINATE

DMF 221732008

DR REDDYS LABORATORIES LTDSOLIFENACIN SUCCINATE

DMF 222632008

ALIVUS LIFE SCIENCES LTDSOLIFENACIN SUCCINATE

DMF 224182009

MSN LABORATORIES PRIVATE LTDSOLIFENACIN SUCCINATE [ROUTE CODE - "SF"]

DMF 237472010

UNIMARK REMEDIES LTDSOLIFENACIN SUCCINATE

DMF 239652010

INTERQUIM SASOLIFENACIN SUCCINATE

DMF 241542010

MEGAFINE PHARMA P LTDSOLIFENACIN SUCCINATE

DMF 241862010

JUBILANT BIOSYS LTDSOLIFENACIN SUCCINATE

DMF 247652011

HETERO DRUGS LTDSOLIFENACIN SUCCINATE

DMF 248712011

ALEMBIC PHARMACEUTICALS LTDSOLIFENACIN SUCCINATE

DMF 258872012

APITORIA PHARMA PRIVATE LTDSOLIFENACIN SUCCINATE

DMF 275502013

WEIHAI DISU PHARMACEUTICAL CO LTDSOLIFENACIN SUCCINATE

DMF 283732015

ISOCHEM SASSOLIFENACIN SUCCINATE

DMF 288702014

CIPLA LTDSOLIFENACIN SUCCINATE

DMF 294892015

QILU PHARMACEUTICAL CO LTDSOLIFENACIN SUCCINATE (NON-STERILE, API)

DMF 295032015

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)SOLIFENACIN SUCCINATE

DMF 295812015

UNICHEM LABORATORIES LTDSOLIFENACIN SUCCINATE

DMF 303832016

RAKS PHARMA PVT LTDSOLIFENACIN SUCCINATE

DMF 305412016

DELMAR CHEMICALS INCSOLIFENACIN SUCCINATE

DMF 306712016

OPTIMUS DRUGS PRIVATE LTDSOLIFENACIN SUCCINATE

DMF 309652016

MICRO LABS LTDSOLIFENACIN SUCCINATE

DMF 314592017

AMOLI ORGANICS PVT LTDSOLIFENACIN SUCCINATE

DMF 317892017

NOVUGEN PHARMA MALAYSIA SDN BHDSOLIFENACIN SUCCINATE

DMF 333062019

RUYUAN HEC PHARM CO LTDSOLIFENACIN SUCCINATE NON-STERILE BULK DRUG SUBSTANCE

DMF 351402020

SMS PHARMACEUTICALS LTDSOLIFENACIN SUCCINATE

DMF 361332022

CADILA HEALTHCARE LTDInactiveSOLIFENACIN SUCCINATE

DMF 236892010

ZAKLADY FARMACEUTYCZNE POLPHARMA SAInactiveSOLIFENACIN SUCCINATE

DMF 240442010

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveSOLIFENACIN SUCCINATE

DMF 244472010

PHF SAInactiveSOLIFENACIN SUCCINATE

DMF 254882011

CRYSTAL PHARMA LTDInactiveSOLIFENACIN SUCCINATE

DMF 261252012

FIS FABBRICA ITALIANA SINTETICI SPAInactiveSOLIFENACIN SUCCINATE

DMF 261902012

KYONGBO PHARMACEUTICAL CO LTDInactiveSOLIFENACIN SUCCINATE

DMF 289772015

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

Products (2)

Sort:

#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 20, 2019

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 20, 2019