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Last Updated: April 10, 2020

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LEVETIRACETAM Drug Profile


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When do Levetiracetam patents expire, and what generic alternatives are available?

Levetiracetam is a drug marketed by Akorn, Am Regent, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hainan Poly Pharm, Hikma Farmaceutica, Hospira Inc, Jubilant Generics, Micro Labs, Mylan Labs Ltd, Sagent Pharms, Sun Pharm Inds Ltd, Xgen Pharms, Aci Healthcare Ltd, Actavis Mid Atlantic, Amneal Pharms, Anda Repository, Apotex Inc, Breckenridge, Hetero Labs Ltd Iii, Hi-tech Pharmacal, Lannett Co Inc, Lupin Ltd, Orit Labs Llc, Pharm Assoc, Taro, Tris Pharma Inc, Wockhardt Bio Ag, Actavis Elizabeth, Actavis Labs Fl Inc, Anchen Pharms, Apotex, Dexcel Pharma, Eci Pharms Llc, Hisun Pharm Hangzhou, Lotus Pharm Co Ltd, Mylan Pharms Inc, Pharmadax Inc, Prinston Inc, Rouses Point Pharms, Sandoz, Sun Pharm, Sun Pharm Industries, Teva Pharms, Torrent Pharms Ltd, Virtus Pharms, Accord Hlthcare, Acic Pharms, Aurobindo Pharma, Breckenridge Pharm, Chartwell Rx, Dr Reddys Labs Ltd, Fosun Pharma, Invagen Pharms, Lupin, Mylan, Orchid Hlthcare, Oxford Pharms, Secan Pharms, Torrent Pharms, Vintage Pharms, Watson Labs Inc, Wockhardt, Zydus Pharms Usa Inc, Gland Pharma Ltd, and Hq Speciality Pharma. and is included in eighty-seven NDAs.

The generic ingredient in LEVETIRACETAM is levetiracetam. There are thirty-five drug master file entries for this compound. Seventy-eight suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.

US ANDA Litigation and Generic Entry Outlook for Levetiracetam

A generic version of LEVETIRACETAM was approved as levetiracetam by MYLAN on November 4th, 2008.

  Start Trial

Drug patent expirations by year for LEVETIRACETAM
Drug Prices for LEVETIRACETAM

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Drug Sales Revenue Trends for LEVETIRACETAM

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Recent Clinical Trials for LEVETIRACETAM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Walter Reed National Military Medical CenterPhase 2
Lady Hardinge Medical CollegePhase 2/Phase 3
Beth Israel Deaconess Medical CenterPhase 2

See all LEVETIRACETAM clinical trials

Recent Litigation for LEVETIRACETAM

Identify potential future generic entrants

District Court Litigation
Case NameDate
PAR PHARMACEUTICAL, INC. v. UCB, INC.2011-03-23
Aventis Pharmaceuticals Inc. v. Barr Laboratories Inc.2006-05-02
In re: '318 Patent Infringement Litigation2005-06-03

See all LEVETIRACETAM litigation

Pharmacology for LEVETIRACETAM
Synonyms for LEVETIRACETAM
(-)-(S)-alpha-Ethyl-2-oxo-1-pyrrolidineacetamide
(-)-(S)-alpha-ethyl-2-oxo-1-pyrrolidineacetamide (2S)-2-(2-Oxo-pyrrolidin-1-yl)butanamide
(2S)-(2-Oxopyrrolidin-1-yl)butyramide
(2S)-2-(2-oxidanylidenepyrrolidin-1-yl)butanamide
(2S)-2-(2-oxo-1-pyrrolidinyl)butanamide
(2S)-2-(2-oxopyrrolidin-1-yl)butanamide
(ALPHAS)-ALPHA-ETHYL-2-OXO-1-PYRROLIDINEACETAMIDE
(S)-(-)-alpha-ethyl-2-oxo-1-pyrrolidineacetamide
(S)-2-(2-Oxo-1-pyrrolidinyl)butyramide
(S)-2-(2-OXO-PYRROLIDIN-1-YL)-BUTYRAMIDE
(s)-2-(2-oxopyrrolidin-1-yl) butyramide
(S)-2-(2-Oxopyrrolidin-1-yl)butanamide
(S)-2-(2-oxopyrrolidin-1-yl)butyramide
(S)-alpha-Ethyl-2-oxo-1-pyrrolidineacetamide
(S)-Levetiracetam
1-Pyrrolidineacetamide, alpha-ethyl-2-oxo-, (alphaS)-
1-Pyrrolidineacetamide, alpha-ethyl-2-oxo-, (S)-
102767-28-2
2(S)-(2-OXOPYRROLIDIN-1-YL)BUTYRAMIDE
44YRR34555
767L282
A800616
AB0012613
AB00639945_07
AB00639945_08
AB00639945-06
AB13957
AB2000064
AC-1479
ACT02712
AGB-101
AKOS015841981
ALBB-027275
AM20070676
ANW-41693
BCP11856
BDBM50422542
BIDD:GT0242
BR-72955
C07841
CCG-100928
CHEBI:6437
CHEMBL1286
CPD000466303
CS-1854
CTK3J2270
D00709
DB01202
DTXSID9023207
E Keppra
E keppra (TN)
Elepsia XR
Etiracetam levo-isomer
etiracetam, S-isomer
FT-0082600
FT-0602577
GTPL6826
HMS2051D07
HMS2089L20
HMS2235I18
HMS3262H11
HMS3713P16
HPHUVLMMVZITSG-LURJTMIESA-N
HSDB 7528
HY-B0106
Keppra
Keppra (TN)
Keppra XR
Keppra, Elepsia,Levetiracetam
Keppra;Keppra XR
KS-00000ILW
KS-1176
L-059
L0234
Levesam 500
Levetiracetam (JAN/USAN/INN)
Levetiracetam [INN]
Levetiracetam [USAN:USP:INN:BAN]
Levetiracetam 1.0 mg/ml in Methanol
Levetiracetam In Sodium Chloride
Levetiracetam solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Levetiracetam, >=98% (HPLC)
Levetiracetam, analytical standard
Levetiracetam, European Pharmacopoeia (EP) Reference Standard
Levetiracetam, United States Pharmacopeia (USP) Reference Standard
Levetiracetame
Levetiracetamum
Levetiracetamum [INN-Latin]
Levetiractam
Levipil
Leviteracetam
Levitiracetam, Pharmaceutical Secondary Standard; Certified Reference Material
Levroxa
LP00835
LS-137054
LS41261
M-2814
matever
MCULE-5120797917
MFCD03265610
MLS000759403
MLS001424069
MLS006010215
N03AX14
NC00178
NCGC00186028-01
NCGC00261520-01
NSC-760119
NSC760119
Pharmakon1600-01502265
Q-201292
RTC-063977
s1356
SAM001246539
SC-15831
SCHEMBL118843
SIB-S1
SMR000466303
Spritam
SR-01000759400
SR-01000759400-4
SR-01000759400-5
ST2408279
STL388027
SW197558-3
Torleva
Tox21_500835
UCB 22059
ucb L059
ucb L060
UCB-22059
UCB-L 059
UCB-L059
UNII-230447L0GL component HPHUVLMMVZITSG-LURJTMIESA-N
UNII-44YRR34555
ZINC1547851
Paragraph IV (Patent) Challenges for LEVETIRACETAM
Tradename Dosage Ingredient NDA Submissiondate
KEPPRA XR TABLET, EXTENDED RELEASE;ORAL levetiracetam 022285 2011-01-07
KEPPRA TABLET;ORAL levetiracetam 021035 2007-01-24

US Patents and Regulatory Information for LEVETIRACETAM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Torrent Pharms Ltd LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 091338-001 May 29, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Breckenridge Pharm LEVETIRACETAM levetiracetam TABLET;ORAL 090511-002 Aug 18, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 091261-001 Sep 12, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Actavis Elizabeth LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 091557-001 Sep 12, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
Colorcon
Harvard Business School
Merck
McKinsey
AstraZeneca

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