Viewing data from:

KEPPRA

NDA

LEVETIRACETAM | N021035 | UCB INC

4 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)TodayPED (+6 mo)

2027

2028

2029

2030

2031

2032

Today

8802142

Dec. 7, 2031

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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Lachman Consulting Services, Inc. FDA-2026-P-5876 Lachman Consulting Services, Inc. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Levetiracetam Powder for Oral Solution in strengths of 250 mg, 500 mg, 750 mg, 1000 mg, and 1500 mg per sachet suitable for submiss	Suitability	2026-05-21	Open	Lachman Consulting Services

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pharmacokinetic and Placental Transfer of Levetiracetam NCT04117425	N/A	Completed	Assistance Publique - Hôpitaux de Paris	14	2022-04-20 → 2023-08-16

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

Medicare Part D Spending

CMS annual spending data for Levetiracetam* (2023)

Total Spending

$171.5M

Total Claims

4,449,740

Beneficiaries

766,583

Avg Cost/Unit

$0.33

Spending Trend

$77.7M(2019)→$254K(2019)→$136.2M(2019)→$14.2M(2019)→$7K(2020)→$77.8M(2020)→$15.1M(2020)→$148.3M(2020)→$75.2M(2021)→$15.4M(2021)→$172.5M(2021)→$1K(2021)→$1K(2022)→$76.7M(2022)→$16.5M(2022)→$174.4M(2022)→$76.3M(2023)→$1K(2023)→$171.5M(2023)→$15.8M(2023)

YoY Change:-4.5%

5yr CAGR:+3.7%

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

API Supply Chain29 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 PHARMOVA 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

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

33 letters from Drugs@FDA

Date	Submission	Document
Mar 13, 2024	SUPPL -115	View Letter (PDF)
Sep 1, 2023	SUPPL -113	View Letter (PDF)
Aug 18, 2023	SUPPL -112	View Letter (PDF)
Oct 1, 2020	SUPPL -104	View Letter (PDF)
Oct 24, 2019	SUPPL -102	View Letter (PDF)
Oct 30, 2017	SUPPL -100	View Letter (PDF)
Apr 27, 2017	SUPPL -99	View Letter (PDF)
Oct 28, 2016	SUPPL -96	View Letter (PDF)
Mar 12, 2015	SUPPL -93	View Letter (PDF)
Aug 11, 2014	SUPPL -94	View Letter (PDF)
Mar 11, 2014	SUPPL -91	View Letter (PDF)
Jul 26, 2013	SUPPL -89	View Letter (PDF)
Dec 21, 2011	SUPPL -74	View Letter (PDF)
Dec 21, 2011	SUPPL -85	View Letter (PDF)
Dec 21, 2011	SUPPL -52	View Letter (PDF)
Dec 21, 2011	SUPPL -73	View Letter (PDF)
Dec 21, 2011	SUPPL -83	View Letter (PDF)
Aug 12, 2011	SUPPL -90	View Letter (PDF)
May 4, 2009	SUPPL -80	View Letter (PDF)
May 4, 2009	SUPPL -78	View Letter (PDF)
Sep 25, 2007	SUPPL -62	View Letter (PDF)
Mar 23, 2007	SUPPL -57	View Letter (PDF)
Aug 18, 2006	SUPPL -50	View Letter (PDF)
Aug 18, 2006	SUPPL -54	View Letter (PDF)
Jan 30, 2006	SUPPL -38	View Letter (PDF)
Jan 20, 2006	SUPPL -48	View Letter (PDF)
Jun 23, 2005	SUPPL -40	View Letter (PDF)
Oct 29, 2004	SUPPL -33	View Letter (PDF)
Oct 29, 2004	SUPPL -32	View Letter (PDF)
Sep 9, 2003	SUPPL -30	View Letter (PDF)
May 22, 2002	SUPPL -19	View Letter (PDF)
May 22, 2002	SUPPL -13	View Letter (PDF)
Nov 30, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 250MG

RLDAB

1 patent0 exclusivities▴

TABLET;ORAL | Approved: Nov 30, 1999

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8802142	Jun 7, 2031PED: Dec 7, 2031	PED	—	Yes	—	—

#002 — 500MG

RLDAB

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Nov 30, 1999

#003 — 750MG

RLDAB

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Nov 30, 1999

#004 — 1GM

RLDAB

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Jan 6, 2006