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AGGRASTAT Drug Profile

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.

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:	4,103
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for AGGRASTAT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AGGRASTAT
DailyMed Link:	AGGRASTAT at DailyMed

Drug patent expirations by year for AGGRASTAT

Generic Entry Opportunity Date for AGGRASTAT

Generic Entry Dates for AGGRASTAT^: Start Trial* Constraining patent/regulatory exclusivity: Start Trial NDA: 020913 Dosage: INJECTABLE;INJECTION
Generic Entry Dates for AGGRASTAT^: Start Trial* Constraining patent/regulatory exclusivity: Start Trial 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.

Recent Clinical Trials for AGGRASTAT

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

Sponsor	Phase
David Hasan	Phase 1/Phase 2
University Hospital Inselspital, Berne	Phase 4
Second Hospital of Jilin University	Phase 4

See all AGGRASTAT clinical trials

Recent Litigation for AGGRASTAT

Identify potential future generic entrants

District Court Litigation

Case Name	Date
MEDICURE INTERNATIONAL, INC. v. GLAND PHARMA LTD.	2018-11-16

See all AGGRASTAT litigation

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

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

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Glossary

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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

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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

International Patents for AGGRASTAT

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Country	Patent Number	Estimated Expiration
Australia	2003234596	Start Trial
United Kingdom	9809793	Start Trial
World Intellectual Property Organization (WIPO)	9938827	Start Trial
Australia	740941	Start Trial
Canada	2318215	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for AGGRASTAT

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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