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SPRITAM Drug Profile

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Which patents cover Spritam, and what generic alternatives are available?

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

This drug has seventeen patent family members in nine countries.

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

US ANDA Litigation and Generic Entry Outlook for Spritam

A generic version of SPRITAM was approved as levetiracetam by MYLAN on January 28^th, 2020.

Summary for SPRITAM

International Patents:	17
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	111
Patent Applications:	2,341
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SPRITAM
DailyMed Link:	SPRITAM at DailyMed

See drug prices for SPRITAM

Pharmacology for SPRITAM

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Synonyms for SPRITAM

(-)-(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

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

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

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	207958-003	Jul 31, 2015		RX	Yes	No
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-004	Jul 31, 2015		RX	Yes	Yes
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-001	Jul 31, 2015		RX	Yes	No
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	207958-002	Jul 31, 2015		RX	Yes	No			Y

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	207958-004	Jul 31, 2015
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-001	Jul 31, 2015
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-003	Jul 31, 2015
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-002	Jul 31, 2015
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-003	Jul 31, 2015
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-001	Jul 31, 2015

International Patents for SPRITAM

Country	Patent Number	Estimated Expiration
Japan	2018162276
Canada	2906029
Australia	2017202752
European Patent Office	3431141
Japan	6170234
European Patent Office	2968994

Supplementary Protection Certificates for SPRITAM

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