Viewing data from:

KEPPRA XR

NDA

LEVETIRACETAM | N022285 | UCB INC

2 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

Today

7858122

Sep. 17, 2028

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

184 trials from ClinicalTrials.gov — 2 recruiting, 143 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)NCT01666080	N/A	Recruiting	Masonic Cancer Center, University of Minnesota	30	2012-08 → 2027-06
Seizure Treatment in Glioma NCT03048084	Phase 4	Recruiting	Leiden University Medical Center	120	2018-02-01 → 2028-07-01
Levetiracetam in Chronic Neuropathic Pain Following Spinal Cord Injury NCT00252954	Phase 4	Completed	Danish Pain Research Center	36	2005-11 → 2008-12
Bioequivalency Study of Levetiracetam 1g Tablets Under Fed Conditions NCT00827320	N/A	Completed	Roxane Laboratories	26	2007-06 → 2007-06
Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures NCT01954121	Phase 3	Completed	UCB Pharma SA	436	2013-09 → 2015-09
Determine Effects of Adjunctive Levetiracetam on Sleep Architecture in Adults With Partial Onset Epilepsy.NCT00245713	Phase 4	Completed	UCB Pharma	40	2003-03 → 2004-11
Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures NCT00615615	Phase 3	Completed	UCB Pharma	216	1999-09 → 2003-03
Bioequivalency Study of Levetiracetam 1g Under Fasted Conditions NCT00826722	N/A	Completed	Roxane Laboratories	30	2007-06 → 2007-06
Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method NCT00160615	Phase 3	Completed	UCB Japan Co. Ltd.	154	2001-09-12 → 2007-01-17
A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy NCT00631150	Phase 4	Completed	UCB Pharma	35	2003-03 → 2004-07

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$13.51

per ea

Lowest NADAC/Unit

$9.04

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
50474059966KEPPRA XR 750 MG TABLET	$13.51	EA	Brand	$0.2409	2026-06-17
50474059866KEPPRA XR 500 MG TABLET	$9.04	EA	Brand	$0.1681	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 | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$382.81

Highest Price

$755.90

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
50474-0598-66KEPPRA 500MG EXTENDED RELEASE TAB	$503.40	FSS	UCB, Inc.	09/14/2030
50474-0598-66KEPPRA 500MG EXTENDED RELEASE TAB	$382.81	Big4	UCB, Inc.	09/14/2030
50474-0599-66KEPPRA 750MG EXTENDED RELEASE TAB	$755.90	FSS	UCB, Inc.	09/14/2030
50474-0599-66KEPPRA 750MG EXTENDED RELEASE TAB	$580.86	Big4	UCB, Inc.	09/14/2030

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

Medicare Part D Spending

CMS annual spending data for Keppra XR (2024)

Total Spending

$25.0M

Total Claims

13,615

Beneficiaries

1,993

Avg Cost/Unit

$10.38

Spending Trend

$25.5M(2019)→$26.7M(2020)→$25.4M(2021)→$26.3M(2022)→$26.7M(2023)→$25.0M(2024)

YoY Change:-1.8%

5yr CAGR:+4.3%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain30 active DMFs18 inactive

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

DIVIS LABORATORIES LTDLEVETIRACETAM

DMF 168942003

DR REDDYS LABORATORIES LTDLEVETIRACETAM

DMF 169662003

HETERO LABS LTDLEVETIRACETAM (FORM 1)

DMF 177382004

NEULAND LABORATORIES LTDLEVETIRACETAM USP

DMF 177992004

LUPIN LTDLEVETIRACETAM USP

DMF 190802005

APITORIA PHARMA PRIVATE LTDLEVETIRACETAM USP

DMF 193872006

ORBION PHARMACEUTICALS PRIVATE LTDLEVETIRACETAM

DMF 197472006

SUN PHARMACEUTICAL INDUSTRIES LTDLEVETIRACETAM USP

DMF 214142008

ESTEVE QUIMICA SALEVETIRACETAM INJECTABLE GRADE/NON-STERILE

DMF 218372008

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDLEVETIRACETAM USP (PROCESS II)

DMF 238532010

JUBILANT BIOSYS LTDLEVETIRACETAM USP

DMF 242002010

SRINI PHARMACEUTICALS PRIVATE LTDLEVETIRACETAM USP

DMF 247572011

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDLEVETIRACETAM

DMF 250052011

AMOLI ORGANICS PVT LTDLEVETIRACETAM USP [ROUTE CODE - LVS]

DMF 257622012

SOLARA ACTIVE PHARMA SCIENCES LTDLEVETIRACETAM USP

DMF 265002012

SMS PHARMACEUTICALS LTDLEVETIRACETAM USP

DMF 284312014

DIVIS LABORATORIES LTDLEVETIRACETAM (PROCESS B)

DMF 301852016

HETERO LABS LTDLEVETIRACETAM (FORM-1), PROCESS-II

DMF 306262016

MSN LIFE SCIENCES PRIVATE LTDLEVETIRACETAM USP

DMF 336082019

AURORE LIFE SCIENCES PRIVATE LTDLEVETIRACETAM USP

DMF 340972019

INNOVARE LABS PRIVATE LTDLEVETIRACETAM USP

DMF 345932020

AURORE LIFE SCIENCES PRIVATE LTDLEVETIRACETAM FORM-I USP

DMF 352722020

CHIERON ACTIVE INGREDIENTS PRIVATE LTDLEVETIRACETAM

DMF 353162020

EMNAR PHARMA PRIVATE LTDLEVETIRACETAM USP

DMF 354412020

SHAOXING JINGXIN PHARMACEUTICALS CO LTDLEVETIRACETAM

DMF 356292021

IOL CHEMICALS AND PHARMACEUTICALS LTDLEVETIRACETAM USP

DMF 363742021

GRANULES INDIA LTDLEVETIRACETAM USP

DMF 377752022

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDLEVETIRACETAM, USP (PROCESS VII)

DMF 378522022

VASUDHA PHARMA CHEM LTDLEVETIRACETAM USP

DMF 381302023

RUI LABORATORIES PRIVATE LIMITEDLEVETIRACETAM USP

DMF 412452025

ESTEVE QUIMICA SAInactiveLEVETIRACETAM

DMF 173272004

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveLEVETIRACETAM

DMF 190332005

RANBAXY LABORATORIES LTDInactiveLEVETIRACETAM

DMF 190512005

HIKAL LTDInactiveLEVETIRACETAM API

DMF 191042006

CAMBREX CHARLES CITY INCInactiveLEVETIRACETAM

DMF 197382006

SIGNA SA DE CVInactiveLEVETIRACETAM USP

DMF 204122007

ALEMBIC PHARMACEUTICALS LTDInactiveLevetiracetam

DMF 211222007

MYLAN LABORATORIES LTDInactiveLEVETIRACETAM USP

DMF 212012007

WANBURY LTDInactiveLEVETIRACETAM

DMF 217432008

ZACH SYSTEM SPAInactiveLEVETIRACETAM

DMF 217472008

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDInactiveLEVETIRACETAM USP

DMF 222352008

AMOLI ORGANICS PVT LTDInactiveLEVETIRACETAM

DMF 235852010

SECOND PHARMA CO LTDInactiveLEVETIRACETAM

DMF 251202011

WATERSTONE PHARMACEUTICALS (HUBEI) CO LTDInactiveLEVETIRACETAM

DMF 261942012

CTX LIFE SCIENCES PVT LTDInactiveLEVETIRACETAM

DMF 274582013

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDInactiveLEVETIRACETAM USP (PROCESS V)

DMF 301192015

WANBURY LTDInactiveLEVETIRACETAM

DMF 311492016

ZHEJIANG JIANGBEI PHARMACEUTICAL CO LTDInactiveLEVETIRACETAM

DMF 342222019

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

Approval Letters

20 letters from Drugs@FDA

Date	Submission	Document
Mar 13, 2024	SUPPL -36	View Letter (PDF)
Aug 18, 2023	SUPPL -34	View Letter (PDF)
Oct 1, 2020	SUPPL -29	View Letter (PDF)
Oct 24, 2019	SUPPL -28	View Letter (PDF)
Oct 30, 2017	SUPPL -26	View Letter (PDF)
Apr 27, 2017	SUPPL -25	View Letter (PDF)
Oct 28, 2016	SUPPL -23	View Letter (PDF)
Apr 8, 2016	SUPPL -22	View Letter (PDF)
Mar 12, 2015	SUPPL -17	View Letter (PDF)
Aug 11, 2014	SUPPL -20	View Letter (PDF)
Aug 4, 2014	SUPPL -18	View Letter (PDF)
Mar 11, 2014	SUPPL -16	View Letter (PDF)
Mar 11, 2014	SUPPL -19	View Letter (PDF)
Jul 26, 2013	SUPPL -13	View Letter (PDF)
Jul 26, 2013	SUPPL -15	View Letter (PDF)
Aug 12, 2011	SUPPL -14	View Letter (PDF)
May 4, 2009	SUPPL -7	View Letter (PDF)
May 4, 2009	SUPPL -2	View Letter (PDF)
Feb 18, 2009	SUPPL -1	View Letter (PDF)
Sep 16, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MG

RLDAB

1 patent0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 12, 2008

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7858122	Sep 17, 2028	—	—	Yes	—	—

#002 — 750MG

RLDAB

1 patent0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Feb 12, 2009