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Generated: October 22, 2018

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Levetiracetam - Generic Drug Details

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What are the generic drug sources for levetiracetam and what is the scope of levetiracetam freedom to operate?

Levetiracetam is the generic ingredient in six branded drugs marketed by Ucb Inc, Akorn, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hainan Poly Pharm, Hikma Farmaceutica, Hospira Inc, Jubilant Generics, Luitpold, Mylan Labs Ltd, Sagent Pharms, Sun Pharm Inds Ltd, X Gen Pharms, Gland Pharma Ltd, Hq Speciality Pharma, Aci Healthcare Ltd, Actavis Mid Atlantic, Amneal Pharms, Apotex Inc, Breckenridge Pharm, Hetero Labs Ltd Iii, Hi-tech Pharmacal, Lannett Co Inc, Lupin Ltd, Orit Labs Llc, Pharm Assoc, Taro, Tolmar, Tris Pharma Inc, Wockhardt Bio Ag, Actavis Elizabeth, Actavis Labs Fl Inc, Anchen Pharms, Dexcel Pharma, Eci Pharms Llc, Intellipharmaceutics, Lotus Pharm Co Ltd, Mylan Pharms Inc, Pharmadax Inc, Pharmtak Inc, Prinston Inc, Rouses Point Pharms, Sandoz, Sun Pharm Industries, Sun Pharma Global, Teva Pharms, Torrent Pharms Ltd, Virtus Pharms, Aprecia Pharms, Accord Hlthcare, Acic Pharms, Ajanta Pharma, Aurobindo Pharma, Dr Reddys Labs Ltd, Fosun Pharma, Invagen Pharms, Lupin, Mylan, Orchid Hlthcare, Oxford Pharms, Secan Pharms, Torrent Pharms, Vintage Pharms, Watson Labs Inc, Wockhardt, and Zydus Pharms Usa Inc, and is included in ninety-one NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are thirty-five drug master file entries for levetiracetam. Ninety-seven suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for levetiracetam
Synonyms for levetiracetam
(-)-(S)-alpha-Ethyl-2-oxo-1-pyrrolidineacetamide
(-)-Levetiracetam
(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, A-ETHYL-2-OXO-, (AS)-
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
AC1NR4PY
ACT02712
AJ-26885
AK-72955
AKOS015841981
ALBB-027275
AM20070676
ANW-41693
BC208262
BDBM50422542
BIDD:GT0242
BR-72955
C07841
CCG-100928
CHEBI:6437
CHEMBL1286
CJ-24357
CPD000466303
CS-1854
CTK3J2270
D00709
D01XRM
D0E1XL
DB01202
DTXSID9023207
E Keppra
E keppra (TN)
Elepsia XR
Etiracetam levo-isomer
etiracetam, S-isomer
FT-0082600
FT-0602577
GTPL6826
HE290875
HMS2051D07
HMS2089L20
HMS2235I18
HMS3262H11
HPHUVLMMVZITSG-LURJTMIESA-N
HSDB 7528
HY-B0106
KB-53189
Keppra
Keppra (TN)
Keppra XR
Keppra, Keppra XR),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, >=98% (HPLC)
Levetiracetam, analytical standard
Levetiracetam, European Pharmacopoeia (EP) Reference Standard
Levetiracetam, United States Pharmacopeia (USP) Reference Standard
Levetiracetame
Levetiracetamum
Levetiracetamum [INN-Latin]
Levetiractam
Levetriacetam
Levipil
Leviteracetam
Levitiracetam, pharmaceutical secondary standard; traceable to USP, PhEu
Levroxa
LP00835
LS-137054
LS41261
M-2814
matever
MCULE-5120797917
MFCD03265610
MLS000759403
MLS001424069
MLS006010215
MolPort-003-848-377
NC00178
NCGC00186028-01
NCGC00261520-01
NSC-760119
NSC760119
Pharmakon1600-01502265
Q-201292
RP23251
RTC-063977
RTECS VJ0000000
s1356
SAM001246539
SBB070161
SC-15831
SCHEMBL118843
SIB-S1
SMR000466303
Spritam
ST2408279
STL388027
TL8000131
Torleva
Tox21_500835
UCB 22059
UCB L-059
ucb L059
ucb L060
UCB-22059
UCB-L 059
UCB-L059
UNII-230447L0GL component HPHUVLMMVZITSG-LURJTMIESA-N
UNII-44YRR34555
ZINC1547851
Tentative approvals for LEVETIRACETAM
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial500MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial1GMTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial750MGTABLET;ORAL

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
Hi-tech Pharmacal LEVETIRACETAM levetiracetam SOLUTION;ORAL 090601-001 Feb 28, 2012 AA RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Accord Hlthcare LEVETIRACETAM levetiracetam TABLET;ORAL 090843-003 Feb 14, 2011 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Aurobindo Pharma Ltd LEVETIRACETAM levetiracetam SOLUTION;ORAL 079063-001 Jan 15, 2009 AA RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Aprecia Pharms SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958-004 Jul 31, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Vintage Pharms LEVETIRACETAM levetiracetam TABLET;ORAL 091491-001 Dec 14, 2010 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Watson Labs Inc LEVETIRACETAM levetiracetam TABLET;ORAL 078797-002 Jan 15, 2009 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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Expired US Patents for levetiracetam

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Aprecia Pharms SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958-002 Jul 31, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Aprecia Pharms SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958-001 Jul 31, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Ucb Inc KEPPRA levetiracetam INJECTABLE;IV (INFUSION) 021872-001 Jul 31, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-003 Nov 30, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-004 Jan 6, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-002 Nov 30, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for levetiracetam

Supplementary Protection Certificates for levetiracetam

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00028 Netherlands ➤ Try a Free Trial PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929
00C/032 Belgium ➤ Try a Free Trial PRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Baxter
Colorcon
Farmers Insurance
Cantor Fitzgerald
Johnson and Johnson
QuintilesIMS
Merck
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.