Viewing data from:

DEOXYCHOLIC ACID

ANDA

DEOXYCHOLIC ACID | A212296 | WILSHIRE PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: KYBELLA(TE code: AP)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
KYTHERA BIOPHARMACEUTICALS, INC. v. SLAYBACK PHARMA LLC 3:2018cv16012 14 patentsANDA 212296deoxycholic acid	D.N.J.	2018-11-09	Terminated 2019-06-14	—

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

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ALIVUS LIFE SCIENCES LTDDEOXYCHOLIC ACID USP

DMF 323052017

CURIA SPAIN SAUDEOXYCHOLIC ACID

DMF 335262019

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 6, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20MG/2ML (10MG/ML)

0 patents0 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Apr 2, 2021

No patent or exclusivity listings for this strength.