Viewing data from:

ABSORICA

NDA

ISOTRETINOIN | N021951 | SUN PHARMACEUTICAL INDUSTRIES INC

6 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases 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	—
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).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Absorica (2023)

Total Spending

$76K

Total Claims

Beneficiaries

Avg Cost/Unit

$38.82

Spending Trend

$257K(2019)→$235K(2020)→$164K(2021)→$93K(2022)→$76K(2023)

YoY Change:-5.7%

5yr CAGR:+0.9%

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.

Approval Letters

19 letters from Drugs@FDA

Date	Submission	Document
Feb 10, 2026	SUPPL -28	View Letter (PDF)
Jul 2, 2024	SUPPL -16	View Letter (PDF)
Jul 19, 2023	SUPPL -23	View Letter (PDF)
Mar 27, 2023	SUPPL -22	View Letter (PDF)
Oct 7, 2022	SUPPL -21	View Letter (PDF)
Oct 13, 2021	SUPPL -18	View Letter (PDF)
Dec 10, 2020	SUPPL -17	View Letter (PDF)
Jan 28, 2020	SUPPL -15	View Letter (PDF)
Nov 12, 2019	SUPPL -13	View Letter (PDF)
Sep 13, 2018	SUPPL -14	View Letter (PDF)
May 3, 2018	SUPPL -11	View Letter (PDF)
Apr 24, 2018	SUPPL -12	View Letter (PDF)
Jun 20, 2017	SUPPL -10	View Letter (PDF)
Jul 12, 2016	SUPPL -8	View Letter (PDF)
Feb 5, 2016	SUPPL -7	View Letter (PDF)
Sep 8, 2015	SUPPL -5	View Letter (PDF)
Aug 19, 2014	SUPPL -3	View Letter (PDF)
Jul 31, 2014	SUPPL -1	View Letter (PDF)
May 30, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#001 — 10MG

RLDAB2

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: May 25, 2012

No patent or exclusivity listings for this strength.

#002 — 20MG

RLDAB2

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 25, 2012

#003 — 30MG

RLDAB2

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 25, 2012

#004 — 40MG

RLDAB2

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 25, 2012

#005 — 25MG

RLDAB2

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 15, 2014

#006 — 35MG

RLDAB2

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 15, 2014