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AGGRASTAT Drug Profile

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Which patents cover Aggrastat, and when can generic versions of Aggrastat launch?

Aggrastat is a drug marketed by Medicure and is included in two NDAs. There are two patents protecting this drug.

This drug has twelve patent family members in six countries.

The generic ingredient in AGGRASTAT is tirofiban hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tirofiban hydrochloride profile page.

Summary for AGGRASTAT

International Patents:	12
US Patents:	2
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	56
Clinical Trials:	12
Patent Applications:	3,812
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for AGGRASTAT
Prior Art and Litigation Support	Order Prior Art and Litigation support for AGGRASTAT
DailyMed Link:	AGGRASTAT at DailyMed

Generic Entry Opportunity Date for AGGRASTAT

NDA:

020913

Dosage:

INJECTABLE;INJECTION

NDA:

020912

Dosage:

INJECTABLE;INJECTION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for AGGRASTAT

Drug Class	Platelet Aggregation Inhibitor
Physiological Effect	Decreased Platelet Aggregation

Synonyms for AGGRASTAT

(2S)-2-(butane-1-sulfonamido)-3-{4-[4-(piperidin-4-yl)butoxy]phenyl}propanoic acid

(2S)-2-(butylsulfonylamino)-3-[4-(4-piperidin-4-ylbutoxy)phenyl]propanoic acid

(2S)-2-(BUTYLSULFONYLAMINO)-3-[4-[4-(4-PIPERIDYL)BUTOXY]PHENYL]PROPANOIC ACID

(2S)-2-(Butylsulfonylamino)-3-{4-[4-(4-piperidyl)butoxy}phenyl propanoic acid

(S)-2-(butylsulfonamido)-3-(4-(4-(piperidin-4-yl)butoxy)phenyl)propanoic acid

140430-EP2277565A2

140430-EP2277566A2

140430-EP2277567A1

140430-EP2277568A2

140430-EP2277569A2

140430-EP2277570A2

140430-EP2292280A1

142373-60-2 (hydrochloride)

144494-65-5

151065-53-1

494T655

AB1009554

AC1L1U7O

AC1Q6VFB

AGG

Agrastat (TN)

AK546550

AKOS015894972

AN-31474

API0005653

AS-35267

AX8154227

BCP06642

BDBM50004058

BIDD:GT0363

BRD-K37872686-311-01-6

C07965

C22H36N2O5S

CHEBI:9605

CHEMBL916

COKMIXFXJJXBQG-NRFANRHFSA-N

CS-2829

D08607

DB00775

DTXSID20162730

EBD44261

FT-0773940

GGX234SI5H

GTPL6586

HSDB 7323

HY-17369B

J-524973

KB-269052

KS-00000H6G

L-700,462

L-700462

L-Tyrosine, N-(butylsulfonyl)-O-(4-(4-piperidinyl)butyl)-

L700462;MK383

LS-173214

MK-383

MolPort-006-167-632

N-(Butylsulfonyl)-O-(4-(4-piperidyl)butyl)-L-tyrosine

N-(butylsulfonyl)-O-(4-piperidin-4-ylbutyl)-L-tyrosine

N-(BUTYLSULFONYL)-O-[4-(4-PIPERIDINYL)BUTYL]-L-TYROSINE

n-(butylsulfonyl)-o-[4-(piperidin-4-yl)butyl]-l-tyrosine

N-(n-butanesulfonyl)-O-(4-(4-piperidinyl)-butyl)-(s)-tyrosine

NCGC00263584-02

RL01804

s3085

SC-96683

SCHEMBL3685

tirofiban

Tirofiban (INN)

Tirofiban [BAN:INN]

Tirofiban [INN:BAN]

tirofiban hydrochloride (monohydrate)

Tirofiban, >=98.5% (HPLC)

tirofibanum

UNII-GGX234SI5H

ZINC3806104

US Patents and Regulatory Information for AGGRASTAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020913-002	May 17, 2002		RX	Yes	No
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020913-001	May 14, 1998		DISCN	No	No
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020912-001	May 14, 1998		DISCN	No	No

Expired US Patents for AGGRASTAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INJECTION	020912-002	Aug 31, 2016
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020913-001	May 14, 1998
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020913-003	Apr 20, 2000

International Patents for AGGRASTAT

Country	Patent Number	Estimated Expiration
European Patent Office	1068172
United Kingdom	9809793
Japan	2005532306

Supplementary Protection Certificates for AGGRASTAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0478363	48/1999	Austria		PRODUCT NAME: TIROFIBAN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: 1-23140 UND 1-23141 19990714; FIRST REGISTRATION: LI IKS-NR 54761 19980528
0478363	C990040	Netherlands		PRODUCT NAME: TIROFIBAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF EEN HYDRAAT, IN HET BIJZONDER TIROFIBANHY- DROCHLORIDE MONOHYDRAAT; NATL REGISTRATION NO/DATE: RVG 23380-1 19990707; FIRST REGISTRATION: DE 42618.00.00-01 19980630
0478363	2000C/002	Belgium		PRODUCT NAME: TIROFIBANUM HYDROCHLORIDUM (EQ. TIROFIBAN); NAT. REGISTRATION NO/DATE: 922 IS 191 F 12 19990906; FIRST REGISTRATION: CH 54761 19980528