AGGRASTAT Drug Patent 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 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. Two suppliers are listed for this compound. Additional details are available on the tirofiban hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aggrastat

A generic version of AGGRASTAT was approved as tirofiban hydrochloride by GLAND PHARMA LTD on April 8^th, 2021.

Summary for AGGRASTAT

International Patents:	5
US Patents:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	13
Patent Applications:	5,386
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

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

Anatomical Therapeutic Chemical (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	Strength	NDA	ANDAs Submitted	Submissiondate
AGGRASTAT	Injection	tirofiban hydrochloride	5 mg/100 mL	020913	1	2019-08-29
AGGRASTAT	Injection	tirofiban hydrochloride	12.5 mg/250 mL	020913	1	2018-10-03

US Patents and Regulatory Information for AGGRASTAT

AGGRASTAT is protected by one US patents.

Patents protecting 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	020912-001	May 14, 1998		DISCN	No	No
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-003	Apr 20, 2000	AP	RX	Yes	Yes
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INJECTION	020912-002	Aug 31, 2016		RX	Yes	Yes
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-002	May 17, 2002		RX	Yes	No
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-001	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;INTRAVENOUS	020913-002	May 17, 2002
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INJECTION	020912-002	Aug 31, 2016
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-001	May 14, 1998
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020912-001	May 14, 1998
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-003	Apr 20, 2000
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-003	Apr 20, 2000

International Patents for AGGRASTAT

See the table below for patents covering AGGRASTAT around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2483929	METHODE PERMETTANT D'INHIBER L'AGREGATION PLAQUETTAIRE (A METHOD FOR INHIBITING PLATELET AGGREGATION)
Russian Federation	2116296	SULFONAMIDE DERIVATIVES, PHARMACEUTICAL COMPOSITION BASED ON THEREOF, METHOD OF INHIBITION OF FIBRIN EFFECT AND A METHOD OF TREATMENT OF MAMMALIAN WITH THROMBOSIS
China	1200676
Singapore	63636	Novel sulfonamide fibrinogen receptor antagonists
Australia	740941
Slovakia	282353

Supplementary Protection Certificates for AGGRASTAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
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