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BARICITINIB

ANDA

BARICITINIB | A217542 | AUROBINDO PHARMA LTD

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Eli Lilly and Company et al v. MSN Laboratories Private Limited 1:2022cv01114 2 patentsANDA 217542baricitinib	D. Del.	2022-08-24	Terminated 2024-05-17	—

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

API Supply Chain7 active DMFs

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

MSN LABORATORIES PRIVATE LTDBARICITINIB

DMF 353402020

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDBARICITINIB

DMF 360302021

APITORIA PHARMA PRIVATE LTDBARICITINIB

DMF 365982021

WISDOM PHARMACEUTICAL CO LTDBARICITINIB

DMF 367322022

NANJING LIBRAVO PHARMACEUTICAL CO LTDBARICITINIB

DMF 372442022

ZAKLADY FARMACEUTYCZNE POLPHARMA SABARICITINIB

DMF 395622024

TONGSHENG PHARMACEUTICAL (JINGMEN) CO LTDBARICITINIB INTERMEDIATE 1

DMF 433062025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 2, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 1MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 22, 2024

No patent or exclusivity listings for this strength.

#002 — 2MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 22, 2024