Viewing data from:

ISOTRETINOIN

ANDA

ISOTRETINOIN | A212333 | UPSHER SMITH LABORATORIES LLC

3 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
GALEPHAR PHARMACEUTICAL RESEARCH, INC. et al v. UPSHER-SMITH LABORATORIES, LLC 2:2019cv02546 5 patentsANDA 212333isotretinoin	D.N.J.	2019-01-30	Terminated 2020-09-04	—

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

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.

Approval Letters

1 letter from Drugs@FDA

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

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 10MG

AB2

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Sep 21, 2021

No patent or exclusivity listings for this strength.

#002 — 20MG

AB2

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Sep 21, 2021

#003 — 30MG

AB2

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Sep 21, 2021