Viewing data from:

ABSORICA LD

NDA

ISOTRETINOIN | N211913 | SUN PHARMACEUTICAL INDUSTRIES LTD

6 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

9700535

Aug. 4, 2035

9750711

May. 29, 2035

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

No ANDA patent litigation cases (NOS 835) matched from PACER

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 Ld (2023)

Total Spending

$63K

Total Claims

Beneficiaries

Avg Cost/Unit

$45.67

Spending Trend

$26K(2020)→$81K(2021)→$25K(2022)→$63K(2023)

YoY Change:+15.7%

5yr CAGR:+6.9%

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

9 letters from Drugs@FDA

Date	Submission	Document
Jun 16, 2026	SUPPL -14	View Letter (PDF)
Feb 10, 2026	SUPPL -13	View Letter (PDF)
Jul 19, 2023	SUPPL -11	View Letter (PDF)
Mar 27, 2023	SUPPL -10	View Letter (PDF)
Oct 7, 2022	SUPPL -9	View Letter (PDF)
Apr 8, 2022	SUPPL -5	View Letter (PDF)
Oct 13, 2021	SUPPL -4	View Letter (PDF)
Dec 10, 2020	SUPPL -3	View Letter (PDF)
Nov 8, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

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#001 — 8MG

RLD

2 patents0 exclusivities▴