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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 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, 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.

Levetiracetam has seventy-six patent family members in twenty-eight countries.

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

Summary for levetiracetam

International Patents:	76
US Patents:	6
Tradenames:	6
Applicants:	65
NDAs:	91
Drug Master File Entries:	35
Suppliers / Packagers:	96
Bulk Api Vendors:	105
Clinical Trials:	174
Patent Applications:	3,364
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for levetiracetam
DailyMed Link:	levetiracetam at DailyMed

Pharmacology for levetiracetam

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

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
		250MG	TABLET;ORAL
		500MG	TABLET;ORAL
		1GM	TABLET;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
Lupin	LEVETIRACETAM	levetiracetam	TABLET;ORAL	090025-001	Jan 15, 2009	AB	RX	No	No
Mylan Pharms Inc	LEVETIRACETAM	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	200475-003	Dec 7, 2015		DISCN	No	No
Actavis Labs Fl Inc	LEVETIRACETAM	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	091093-002	Sep 12, 2011	AB	RX	No	No
Aurobindo Pharma Ltd	LEVETIRACETAM IN SODIUM CHLORIDE	levetiracetam	INJECTABLE;IV (INFUSION)	207160-002	Jan 4, 2017	AP	RX	No	No

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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	TABLET;ORAL	021035-003	Nov 30, 1999
Ucb Inc	KEPPRA XR	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	022285-001	Sep 12, 2008
Ucb Inc	KEPPRA	levetiracetam	TABLET;ORAL	021035-004	Jan 6, 2006
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-004	Jul 31, 2015

Non-Orange Book US Patents for levetiracetam

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,863,316	Extended release formulation of Levetiracetam
9,114,072	Dosage form exhibiting rapid disperse properties, methods of use and process for the manufacture of same

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International Patents for levetiracetam

Country	Document Number	Estimated Expiration
South Korea	20080030546
Japan	4563516
Portugal	1909764
World Intellectual Property Organization (WIPO)	2006080029

Supplementary Protection Certificates for levetiracetam

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