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ISOTRETINOIN

ANDA

ISOTRETINOIN | A205063 | ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

6 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ABSORICA(TE code: AB2)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
CIPHER PHARMACEUTICALS, INC. et al v. WATSON LABORATORIES, INC.-FLORIDA et al 1:2013cv06502 1 patentANDA 205063isotretinoin	D.N.J.	2013-10-29	Terminated 2015-10-30	—

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

Medicare Part D Spending

CMS annual spending data for Isotretinoin (2023)

Total Spending

$1.4M

Total Claims

4,912

Beneficiaries

2,097

Avg Cost/Unit

$6.46

Spending Trend

$78K(2019)→$327K(2020)→$622K(2021)→$951K(2022)→$1.4M(2023)

YoY Change:-6.5%

5yr CAGR:+3.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain8 active DMFs2 inactive

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

OLON SPAISOTRETINOIN

DMF 74851988

JIANGXI HENGXIANG PHARMCEUTICAL TECHNOLOGY CO LTDISOTRETINOIN (NON-STERILE BULK FORM)

DMF 191912005

HAS HEALTHCARE ADVANCED SYNTHESIS SAISOTRETINOIN

DMF 199182006

CHONGQING HUAPONT PHARMACEUTICAL CO LTDISOTRETINOIN

DMF 216532008

BIOPHORE INDIA PHARMACEUTICALS PVT LTDISOTRETINOIN

DMF 274842013

SUN PHARMACEUTICAL INDUSTRIES LTDISOTRETINOIN USP

DMF 325172018

CHONGQING HUAPONT PHARMACEUTICAL CO LTDISOTRETINOIN

DMF 345102020

HETERO DRUGS LTDISOTRETINOIN

DMF 368572022

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveISOTRETINOIN USP (NON-STERILE BULK)

DMF 151692000

IPCA LABORATORIES LTDInactiveISOTRETINOIN USP

DMF 226162009

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

Products (6)

Sort:

#001 — 10MG

AB2

0 patents0 exclusivities▴