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OBETICHOLIC ACID

ANDA

OBETICHOLIC ACID | A214862 | APOTEX INC

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Intercept Pharmaceuticals, Inc. et al v. Apotex Inc. et al 1:2020cv01105 4 patentsANDA 214862obeticholic acid	D. Del.	2020-08-21	Terminated 2023-02-24	—

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

API Supply Chain11 active DMFs1 inactive

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

DR REDDYS LABORATORIES LTDOBETICHOLIC ACID

DMF 319772018

MSN LIFE SCIENCES PRIVATE LTDOBETICHOLIC ACID

DMF 336102019

INDUSTRIALE CHIMICA SRLOBETICHOLIC ACID

DMF 337762019

OPTIMUS DRUGS PRIVATE LTDOBETICHOLIC ACID

DMF 339602019

HETERO LABS LTDOBETICHOLIC ACID

DMF 342822019

ALEMBIC PHARMACEUTICALS LTDOBETICHOLIC ACID

DMF 343332019

BIOPHORE INDIA PHARMACEUTICALS PVT LTDOBETICHOLIC ACID

DMF 344132019

SOLARA ACTIVE PHARMA SCIENCES LTDOBETICHOLIC ACID

DMF 345612020

CHANGZHOU PHARMACEUTICAL FACTORYOBETICHOLIC ACID

DMF 373552022

MOEHS IBERICA SLOBETICHOLIC ACID

DMF 382212023

KAIFENG PHARMACEUTICAL (GROUP) CO LTDOBETICHOLIC ACID

DMF 383482023

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDInactiveOBETICHOLIC ACID

DMF 362922021

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 16, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 30, 2023

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 30, 2023