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Last Updated: November 22, 2019

DrugPatentWatch Database Preview

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 and two Paragraph IV challenges.

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.

Drug patent expirations by year for AGGRASTAT
Drug Prices for AGGRASTAT

See drug prices for AGGRASTAT

Generic Entry Opportunity Date for AGGRASTAT
Generic Entry Dates for AGGRASTAT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
INJECTABLE;INJECTION
Generic Entry Dates for AGGRASTAT*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for AGGRASTAT

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

SponsorPhase
David HasanPhase 1/Phase 2
University Hospital Inselspital, BernePhase 4
Second Hospital of Jilin UniversityPhase 4

See all AGGRASTAT clinical trials

Recent Litigation for AGGRASTAT

Identify potential future generic entrants

District Court Litigation
Case NameDate
MEDICURE INTERNATIONAL, INC. v. GLAND PHARMA LTD.2018-11-16

See all AGGRASTAT litigation

Pharmacology for AGGRASTAT
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
Paragraph IV (Patent) Challenges for AGGRASTAT
Tradename Dosage Ingredient NDA Submissiondate
AGGRASTAT INJECTABLE;INJECTION tirofiban hydrochloride 020913 2019-08-29
AGGRASTAT INJECTABLE;INJECTION tirofiban hydrochloride 020913 2018-10-03

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   Start Trial   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020913-001 May 14, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020912-001 May 14, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020913-001 May 14, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020913-002 May 17, 2002 RX Yes 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 AGGRASTAT

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

Supplementary Protection Certificates for AGGRASTAT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0478363 C990040 Netherlands   Start Trial 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   Start Trial PRODUCT NAME: TIROFIBANUM HYDROCHLORIDUM (EQ. TIROFIBAN); NAT. REGISTRATION NO/DATE: 922 IS 191 F 12 19990906; FIRST REGISTRATION: CH 54761 19980528
0478363 48/1999 Austria   Start Trial 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 SPC/GB99/042 United Kingdom   Start Trial PRODUCT NAME: TIROFIBAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE HYDROCHLORIDE; REGISTERED: LI 54761 19980528; CH 54761 19980528; DE 42618.00.00 19980630; DE 42618.00.01 19980630; DE 42620.00.00 19980630; DE 42620.00.01 19980630; UK PL 00025/0375 19990715; UK PL 00025/0376 19990715
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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