DrugPatentWatch Database Preview

AGGRASTAT Drug Profile

Email this page to a colleague

« Back to Dashboard

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 is one patent protecting this drug and two Paragraph IV challenges.

This drug has five patent family members in five 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.

DrugPatentWatch^® Generic Entry Outlook for Aggrastat

Aggrastat was eligible for patent challenges on May 14, 2002.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 1, 2023. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (tirofiban hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for AGGRASTAT

International Patents:	5
US Patents:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	13
Patent Applications:	4,226
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for AGGRASTAT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AGGRASTAT
What excipients (inactive ingredients) are in AGGRASTAT?	AGGRASTAT excipients list
DailyMed Link:	AGGRASTAT at DailyMed

See drug prices for AGGRASTAT

DrugPatentWatch^® Estimated 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.

Recent Clinical Trials for AGGRASTAT

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

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

See all AGGRASTAT clinical trials

Pharmacology for AGGRASTAT

Drug Class	Platelet Aggregation Inhibitor
Physiological Effect	Decreased Platelet Aggregation

ATC Classes for AGGRASTAT

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

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
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
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020913-003	Apr 20, 2000		RX	Yes	Yes

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	020913-003	Apr 20, 2000
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020912-001	May 14, 1998
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020912-001	May 14, 1998

International Patents for AGGRASTAT

Country	Patent Number	Estimated Expiration
Finland	108295
Colombia	4770960
Greece	3031473
Israel	99540

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	2000C/002	Belgium		PRODUCT NAME: TIROFIBANUM HYDROCHLORIDUM (EQ. TIROFIBAN); NAT. REGISTRATION NO/DATE: 922 IS 191 F 12 19990906; FIRST REGISTRATION: CH 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	SPC/GB99/042	United Kingdom		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