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SPRITAM Drug Profile

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When do Spritam patents expire, and when can generic versions of Spritam launch?

Spritam is a drug marketed by Aprecia Pharms and is included in one NDA. There are four patents protecting this drug.

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

Summary for SPRITAM

US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	102
Patent Applications:	2,059
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SPRITAM
DailyMed Link:	SPRITAM at DailyMed

Pharmacology for SPRITAM

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Synonyms for SPRITAM

(-)-(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

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

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

US Patents and Regulatory Information for SPRITAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-004	Jul 31, 2015		RX	Yes	Yes			Y
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-002	Jul 31, 2015		RX	Yes	No			Y
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-003	Jul 31, 2015		RX	Yes	No			Y
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-001	Jul 31, 2015		RX	Yes	No			Y
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-001	Jul 31, 2015		RX	Yes	No			Y
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-003	Jul 31, 2015		RX	Yes	No

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Expired US Patents for SPRITAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-003	Jul 31, 2015
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-004	Jul 31, 2015
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-003	Jul 31, 2015
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-001	Jul 31, 2015
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-002	Jul 31, 2015
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-002	Jul 31, 2015

Non-Orange Book US Patents for SPRITAM

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
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 SPRITAM

Country	Document Number	Estimated Expiration
Japan	5091910
Germany	69840495
Japan	2001512488
Mexico	2015012134
China	105188849
Japan	4563516

Supplementary Protection Certificates for SPRITAM

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