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LESCOL XL

NDA

FLUVASTATIN SODIUM | N021192 | SANDOZ INC

1 strength0 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Novartis Pharmaceuticals Corporation et al v. Mylan Pharmaceuticals Inc. et al 1:2011cv00015 1 patentfluvastatin sodium	WVND	2011-02-11	Terminated 2011-12-23	—

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 Lescol XL (2023)

Total Spending

$722K

Total Claims

906

Beneficiaries

217

Avg Cost/Unit

$12.38

Spending Trend

$979K(2019)→$888K(2020)→$962K(2021)→$866K(2022)→$722K(2023)

YoY Change:+14.2%

5yr CAGR:+3.7%

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

API Supply Chain6 active DMFs5 inactive

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

BIOCON LTDFLUVASTATIN SODIUM AMORPHOUS

DMF 184932005

BIOCON LTDFLUVASTATIN SODIUM

DMF 187622005

FIS FABBRICA ITALIANA SINTETICI SPAFLUVASTATIN SODIUM HYDRATE USP

DMF 189112005

TAPI NL BVFLUVASTATIN SODIUM

DMF 192962006

PHARMATHEN INDUSTRIAL SAFLUVASTATIN SODIUM AMORPHOUS

DMF 240912010

BIOCON LTDFLUVASTATIN SODIUM

DMF 367352022

CADILA HEALTHCARE LTDInactiveFLUVASTATIN SODIUM

DMF 178792004

USV LTDInactiveFLUVASTATIN SODIUM USP

DMF 205282007

LUPIN LTDInactiveFLUVASTATIN SODIUM (MICRONIZED) USP

DMF 215092008

AUROBINDO PHARMA LTDInactiveFLUVASTATIN SODIUM USP (NON-STERILE DRUG SUBSTANCE)

DMF 236572010

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveFLUVASTATIN SODIUM USP

DMF 259922012

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

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Nov 29, 2023	SUPPL -29	View Letter (PDF)
Sep 28, 2020	SUPPL -31	View Letter (PDF)
Aug 8, 2017	SUPPL -26	View Letter (PDF)
Nov 5, 2012	SUPPL -21	View Letter (PDF)
Feb 28, 2012	SUPPL -19	View Letter (PDF)
Jun 28, 2011	SUPPL -16	View Letter (PDF)
Jun 14, 2007	SUPPL -13	View Letter (PDF)
Apr 13, 2006	SUPPL -11	View Letter (PDF)
Apr 13, 2006	SUPPL -10	View Letter (PDF)
Apr 5, 2006	SUPPL -12	View Letter (PDF)
Jan 11, 2005	SUPPL -8	View Letter (PDF)
Jun 8, 2003	SUPPL -5	View Letter (PDF)
Sep 6, 2002	SUPPL -4	View Letter (PDF)
Oct 6, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 80MG BASE

RLDAB

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 6, 2000

No patent or exclusivity listings for this strength.