Viewing data from:

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	N.D. W. Va.	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

48 trials from ClinicalTrials.gov, 38 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy and Safety of Fluvastatin or Valsartan and Their Combination in Dyslipidemic Patients With Hypertension and Endothelial Dysfunction NCT00171327	Phase 4	Completed	Novartis	213	2004-07 → 2005-09
Fluvastatin Versus Hepatitis C Virus NCT00441493	N/A	Completed	Bader, Ted, M.D.	32	2006-09 → 2007-09
An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia NCT03510884	Phase 3	Completed	Sanofi	153	2018-05-31 → 2022-08-05
Preventive Arterial Wall Phenotype and Low-dose Fluvastatin/Valsartan Combination NCT03393377	N/A	Completed	University Medical Centre Ljubljana	20	2014-09 → 2017-06
A 12 Week Study of MK0653A in Patients Who Have Been Hospitalized for a Possible Heart Problem (0653A-808)NCT00132717	Phase 3	Completed	Organon and Co	450	2005-01-01 → 2007-06-01
Statin Recapture Therapy Before Coronary Artery Bypass Grafting NCT01715714	Phase 4	Completed	University of Cologne	2,630	2012-11-07 → 2020-09-27
Investigation of the Steady State Pharmacokinetics of Tacrolimus, Mycophenolate Mofetil and Fluvastatin After Renal Transplantation NCT00223015	Phase 4	Completed	University Hospital Schleswig-Holstein	15	2004-05 → 2005-04
Investigation of the Steady State Pharmacokinetics of Sirolimus, Mycophenolat Mofetil and Fluvastatin After Renal Transplantation NCT00223028	Phase 4	Completed	University Hospital Schleswig-Holstein	15	2005-04 → 2005-07
A Study of LY3015014 in Participants With High Cholesterol NCT01890967	Phase 2	Completed	Eli Lilly and Company	527	2013-06 → 2014-06
Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients NCT00674297	Phase 2	Completed	Hospital for Special Surgery, New York	41	2008-05 → 2013-02

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs (1 brand, 2 generic)

Highest NADAC/Unit

$13.06

per ea

Lowest NADAC/Unit

$2.36

per ea

Brand NDCs

Generic NDCs

Avg Brand: $13.06

Avg Generic: $2.36

82% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
66758021131LESCOL XL 80 MG TABLET	$13.06	EA	Brand	$2.36	2026-02-18
00781801701FLUVASTATIN ER 80 MG TABLET	$2.36	EA	Generic	—	2026-06-17
00781801731FLUVASTATIN ER 80 MG TABLET	$2.36	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

$23.65

Highest Price

$260.05

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00781-8017-01FLUVASTATIN NA 80MG TAB,SA	$62.69	FSS	Sandoz, Inc.	08/14/2028
00781-8017-31FLUVASTATIN NA 80MG TAB,SA	$23.65	FSS	Sandoz, Inc.	08/14/2028
66758-0211-31LESCOL XL 80MG TAB	$260.05	FSS	Sandoz, Inc.	08/14/2028

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

Medicare Part D Spending

CMS annual spending data for Lescol XL (2024)

Total Spending

$527K

Total Claims

616

Beneficiaries

165

Avg Cost/Unit

$12.67

Spending Trend

$979K(2019)→$888K(2020)→$962K(2021)→$866K(2022)→$722K(2023)→$527K(2024)

YoY Change:+2.3%

5yr CAGR:+4.5%

Source: CMS Medicare Part D Spending by Drug (2024). 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.