Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Harvard Business School
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Last Updated: December 15, 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 freedom to operate?

Levetiracetam is the generic ingredient in seven branded drugs marketed by Ucb Inc, 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, X Gen Pharms, Gland Pharma Ltd, Hq Speciality Pharma, 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, Sparc, Actavis Elizabeth, Actavis Labs Fl Inc, Anchen Pharms, 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, Aprecia 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, and Zydus Pharms Usa Inc, and is included in ninety-three 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 ninety patent family members in thirty countries.

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

Drug Prices for LEVETIRACETAM

See drug prices for LEVETIRACETAM

Drug Sales Revenue Trends for LEVETIRACETAM

See drug sales revenues for LEVETIRACETAM

Recent Clinical Trials for LEVETIRACETAM

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

SponsorPhase
Walter Reed National Military Medical CenterPhase 2
Beth Israel Deaconess Medical CenterPhase 2
Elizabeth ThielePhase 3

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

Generic filers with tentative approvals for LEVETIRACETAM
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial500MGTABLET;ORAL
  Start Trial  Start Trial1GMTABLET;ORAL
  Start Trial  Start Trial750MGTABLET;ORAL

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

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
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
Anda Repository LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 204511-002 Feb 23, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Anchen Pharms LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 091360-001 Oct 4, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Fosun Pharma LEVETIRACETAM levetiracetam TABLET;ORAL 077324-002 Jan 15, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare LEVETIRACETAM levetiracetam TABLET;ORAL 090843-002 Feb 14, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Ucb Inc KEPPRA levetiracetam TABLET;ORAL 021035-004 Jan 6, 2006 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sagent Pharms LEVETIRACETAM levetiracetam INJECTABLE;INTRAVENOUS 091627-001 Jun 26, 2013 AP RX No No   Start Trial   Start Trial   Start Trial
Actavis Elizabeth LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 091557-002 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

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

Supplementary Protection Certificates for LEVETIRACETAM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0162036 2000C/032 Belgium   Start Trial PRODUCT NAME: LEVETIRACETAM; NAT. REGISTRATION NO/DATE: EU/1/00/146/001 20000929; FIRST REGISTRATION: CH 55297 20000329
0162036 C300028 Netherlands   Start Trial 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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Serving leading biopharmaceutical companies globally:

Merck
Moodys
Dow
Harvard Business School
Colorcon
Boehringer Ingelheim

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.