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).

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 6 NDCs

Highest NADAC/Unit

$11.94

per ea

Lowest NADAC/Unit

$4.18

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00245057001ISOTRETINOIN 10 MG CAPSULE	$11.94	EA	Generic	—	2026-01-21
68308057030ISOTRETINOIN 10 MG CAPSULE	$11.94	EA	Generic	—	2026-01-21
00245057101ISOTRETINOIN 20 MG CAPSULE	$5.97	EA	Generic	—	2026-06-17
68308057130ISOTRETINOIN 20 MG CAPSULE	$5.97	EA	Generic	—	2026-06-17
00245057301ISOTRETINOIN 30 MG CAPSULE	$4.18	EA	Generic	—	2026-06-17
68308057330ISOTRETINOIN 30 MG CAPSULE	$4.18	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 3 NDCs (3 FSS)

Lowest Price

$81.53

Highest Price

$181.16

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00245-0570-01ISOTRETINOIN (EQV-ABSORICA) 10MG CAP	$88.86	FSS	The Davinci Company, LLC	06/30/2029
00245-0571-01ISOTRETINOIN (EQV-ABSORICA) 20MG CAP	$81.53	FSS	The Davinci Company, LLC	06/30/2029
00245-0573-01ISOTRETINOIN (EQV-ABSORICA) 30MG CAP	$181.16	FSS	The Davinci Company, LLC	06/30/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

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