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Generated: May 26, 2019

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LEVETIRACETAM - Generic Drug Details

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

Levetiracetam is the generic ingredient in seven 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, Sparc, 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, Aurobindo Pharma, 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, and Zydus Pharms Usa Inc, and is included in ninety-two NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Levetiracetam has eighty-eight patent family members in thirty countries.

There are thirty-five drug master file entries for levetiracetam. Ninety-eight 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
(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
AC1NR4PY
ACT02712
AJ-26885
AKOS015841981
ALBB-027275
AM20070676
ANW-41693
BC208262
BCP11856
BDBM50422542
BIDD:GT0242
BR-72955
C07841
CCG-100928
CHEBI:6437
CHEMBL1286
CJ-24357
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
KB-53189
Keppra
Keppra (TN)
Keppra XR
Keppra;Keppra XR
KS-00000ILW
KS-1176
L-059
L0234
Levesam 500
Levetiracetam (JAN/USAN/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
MolPort-003-848-377
NC00178
NCGC00186028-01
NCGC00261520-01
NSC-760119
NSC760119
Pharmakon1600-01502265
Q-201292
RP23251
RTC-063977
s1356
SAM001246539
SC-15831
SCHEMBL118843
SIB-S1
SMR000466303
Spritam
SR-01000759400
SR-01000759400-4
SR-01000759400-5
ST2408279
STL388027
SW197558-3
TL8000131
Torleva
Tox21_500835
UCB 22059
ucb L059
ucb L060
UCB-22059
UCB-L 059
UCB-L 059; Keppra
UCB-L059
UNII-230447L0GL component HPHUVLMMVZITSG-LURJTMIESA-N
UNII-44YRR34555
ZINC1547851
Generic filers with tentative approvals for LEVETIRACETAM
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up500MGTABLET;ORAL
➤ Sign Up➤ Sign Up1GMTABLET;ORAL
➤ Sign Up➤ Sign Up750MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Amneal Pharms LEVETIRACETAM levetiracetam SOLUTION;ORAL 090992-001 Oct 27, 2009 AA RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Oxford Pharms LEVETIRACETAM levetiracetam TABLET;ORAL 077319-002 Mar 20, 2009 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gland Pharma Ltd LEVETIRACETAM IN SODIUM CHLORIDE levetiracetam INJECTABLE;IV (INFUSION) 206880-001 Oct 25, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Mid Atlantic LEVETIRACETAM levetiracetam SOLUTION;ORAL 078976-001 Jan 15, 2009 AA RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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
Ucb Inc KEPPRA levetiracetam SOLUTION;ORAL 021505-001 Jul 15, 2003 ➤ Sign Up ➤ Sign Up
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-001 Nov 30, 1999 ➤ Sign Up ➤ Sign Up
Aprecia Pharms SPRITAM levetiracetam TABLET, FOR SUSPENSION;ORAL 207958-003 Jul 31, 2015 ➤ Sign Up ➤ Sign Up
Ucb Inc KEPPRA levetiracetam INJECTABLE;IV (INFUSION) 021872-001 Jul 31, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for LEVETIRACETAM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0162036 2000C/032 Belgium ➤ Sign Up PRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329
0162036 C300028 Netherlands ➤ Sign Up PRODUCT NAME: LEVETIRACETAM; REGISTRATION NO/DATE: EU/1/00/146/001 - EU/1/00/146/026 20000929
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Harvard Business School

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