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TOFACITINIB CITRATE

ANDA

TOFACITINIB CITRATE | A214264 | ZYDUS PHARMACEUTICALS USA INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: XELJANZ XR(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Pfizer Inc. et al v. Zydus Pharmaceuticals (USA) Inc. et al 1:2021cv00214 3 patentsANDA 214264tofacitinib citrate	D. Del.	2021-02-16	Terminated 2021-04-16	—

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

API Supply Chain30 active DMFs1 inactive

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

MSN LABORATORIES PRIVATE LTDTOFACITINIB CITRATE [ROUTE CODE - TT"]

DMF 277212013

ALIVUS LIFE SCIENCES LTDTOFACITINIB CITRATE

DMF 290022015

ZYDUS LIFESCIENCES LTDTOFACITINIB CITRATE

DMF 305312016

SHANDONG ANXIN PHARMACEUTICAL CO LTDTOFACITINIB CITRATE (NON-STERILE API)

DMF 305782016

SUN PHARMACEUTICAL INDUSTRIES LTDTOFACITINIB CITRATE

DMF 306172016

MICRO LABS LTDTOFACITINIB CITRATE

DMF 306212016

UNICHEM LABORATORIES LTDTOFACITINIB CITRATE

DMF 306542016

OLON SPATOFACITINIB CITRATE

DMF 306862016

YABAO PHARMACEUTICAL GROUP CO LTDTOFACITINIB CITRATE

DMF 320352019

BEIJING MESOCHEM TECHNOLOGY CO LTDTOFACITINIB CITRATE

DMF 324452018

APOTEX INCTOFACITINIB CITRATE

DMF 325472018

DELMAR CHEMICALS INCTOFACITINIB CITRATE

DMF 333322018

BEIJING SJAR TECHNOLOGY DEVELOPMENT CO LTDTOFACITINIB CITRATE

DMF 341562019

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDTOFACITINIB CITRATE

DMF 351522020

PHARMABLOCK PHARMACEUTICALS (ZHEJIANG) CO LTDTOFACITINIB CITRATE

DMF 357132021

CHANGZHOU PHARMACEUTICAL FACTORYTOFACITINIB CITRATE

DMF 357462021

AURORE LIFE SCIENCES PRIVATE LTDTOFACITINIB CITRATE

DMF 358442021

METROCHEM API PRIVATE LTDTOFACITINIB CITRATE

DMF 359762021

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDTOFACITINIB CITRATE

DMF 362972021

HONOUR LAB LTDTOFACITINIB CITRATE

DMF 365422022

MATRIX PHARMACORP PRIVATE LTDTOFACITINIB CITRATE

DMF 365762021

INTAS PHARMACEUTICALS LTDTOFACITINIB CITRATE

DMF 371562022

DR REDDYS LABORATORIES LTDTOFACITINIB CITRATE

DMF 371642022

HUNAN WARRANT CHIRAL PHARMACEUTICAL CO LTDTOFACITINIB CITRATE

DMF 374712022

LEE PHARMA LTDTOFACITINIB CITRATE

DMF 374962022

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDTOFACITINIB CITRATE

DMF 375322022

MACLEODS PHARMACEUTICALS LTDTOFACITINIB CITRATE

DMF 385232023

METROCHEM API PRIVATE LTDTOFACITINIB CITRATE (PAI)

DMF 389942023

YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU HAICI BIOLOGICAL PHARMACEUTICAL CO LTDTOFACITINIB CITRATE NON-STERILE DRUG SUBSTANCE

DMF 400262024

SHANDONG JINCHENG KUNLUN PHARMACEUTICAL CO LTDTOFACITINIB CITRATE

DMF 413642025

SINTENOVO SA DE CVInactiveTOFACITINIB CITRATE

DMF 305542016

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 2, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 11MG BASE

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Aug 19, 2021

No patent or exclusivity listings for this strength.

#002 — EQ 22MG BASE

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Aug 19, 2021