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NDA

LEVETIRACETAM | N204417 | TRIPOINT THERAPEUTICS

2 strengths5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Expired (2)Expiring < 1yr (3)Today

2027

Today

Sep. 3, 2027

Feb. 22, 2026

Oct. 31, 2027

Oct. 31, 2027

Feb. 22, 2026

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

194 trials from ClinicalTrials.gov — 9 recruiting, 2 active, 144 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Clinical Trial Evaluating the Efficacy of AGB101 for Reducing Hippocampal Overactivity in Older Adults NCT06919926	Phase 2	Active	Johns Hopkins University	60	2025-04-17 → 2028-05
Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis NCT05824728	Phase 2	Active	Johns Hopkins University	30	2023-09-28 → 2026-12
Levetiracetam Extended-Release Plus Stupp Protocol for Hypoxic IDH-Wildtype Glioblastoma NCT07758062	Phase 2	Not Yet Recruiting	Tianjin Medical University General Hospital	140	2026-09-01 → 2029-09-01
Prophylactic Anti-Seizure Medication vs No Anti-Seizure Medication for Patients With Primary Motor Cortex Brain Metastases NCT07130786	Phase 2	Recruiting	Ayal A. Aizer, MD	150	2025-12-23 → 2030-02
Levetiracetam for Persons at Risk for Alzheimer's Disease NCT07477431	Phase 2	Recruiting	Sunnybrook Health Sciences Centre	40	2025-10-23 → 2028-02
Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)NCT06907173	Phase 3	Recruiting	University of Virginia	770	2026-03-06 → 2029-12
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 → 2028-06
High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly NCT06345495	Phase 2	Recruiting	M.D. Anderson Cancer Center	30	2024-10-01 → 2029-01-01
Investigating the Effect of a Single-dose of Levetiracetam on Brain Function, Chemistry and Cognitive Performance in Psychosis Risk NCT06224530	N/A	Recruiting	King's College London	69	2024-07-19 → 2026-08-30
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures NCT05610085	Phase 2	Recruiting	University of California, San Diego	133	2023-03-24 → 2027-12-31

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

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 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

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

2 letters from Drugs@FDA

Date	Submission	Document
Mar 13, 2024	SUPPL -9	View Letter (PDF)
Dec 21, 2020	SUPPL -4	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1GM

RLD

5 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 20, 2018

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8163306	Sep 3, 2027	—	—	Yes	—	—
8425938	Feb 22, 2026	—	—	Yes	—	—
8431156	Oct 31, 2027	—	—	Yes	—	—
8470367	Oct 31, 2027	—	—	Yes	—	—
8535717	Feb 22, 2026	—	—	Yes	—	—

#002 — 1.5GM

RLD

5 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 20, 2018