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LICART

NDA

DICLOFENAC EPOLAMINE | N206976 | IBSA INSTITUT BIOCHIMIQUE SA

1 strength2 unique patents1 unique exclusivity

Patent Timeline

2 unique patents, 1 exclusivity by expiration date

Active (2)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

11344520

Feb. 20, 2035

11351133

Feb. 20, 2035

NPP

Mar. 27, 2029

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 Licart (2023)

Total Spending

$8.7M

Total Claims

8,871

Beneficiaries

2,727

Avg Cost/Unit

$26.77

Spending Trend

$11K(2020)→$1.8M(2021)→$7.0M(2022)→$8.7M(2023)

YoY Change:+1.4%

5yr CAGR:+1.4%

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

API Supply Chain4 active DMFs3 inactive

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

YUNG ZIP CHEMICAL IND CO LTDDICLOFENAC EPOLAMINE

DMF 239092010

SYN-TECH CHEM AND PHARM CO LTDDICLOFENAC EPOLAMINE

DMF 249622011

AMOLI ORGANICS PVT LTDDICLOFENAC EPOLAMINE

DMF 252242011

CAMBREX CHARLES CITY INCDICLOFENAC EPOLAMINE

DMF 261122012

CADILA HEALTHCARE LTDInactiveDICLOFENAC EPOLAMINE

DMF 245222011

DIPHARMA FRANCIS SRLInactiveDICLOFENAC EPOLAMINE

DMF 256772012

AARTI DRUGS LTDInactiveDICLOFENAC EPOLAMINE

DMF 259292012

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Mar 31, 2026	SUPPL -18	View Letter (PDF)
Nov 22, 2024	SUPPL -16	View Letter (PDF)
Aug 5, 2024	SUPPL -15	View Letter (PDF)
Apr 30, 2021	SUPPL -7	View Letter (PDF)
May 15, 2020	SUPPL -2	View Letter (PDF)
Jan 14, 2020	SUPPL -3	View Letter (PDF)
Dec 21, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1.3%

RLD

2 patents1 exclusivity▴

SYSTEM;TOPICAL | Approved: Dec 19, 2018

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11344520	Feb 20, 2035	—	—	—		—
11351133	Feb 20, 2035	—	—	—		—

Exclusivities (1)

Code	Date	Status
NPP	Mar 27, 2029	Active