Tirofiban hydrochloride - Generic Drug Details

What are the generic sources for tirofiban hydrochloride and what is the scope of freedom to operate?

Tirofiban hydrochloride is the generic ingredient in two branded drugs marketed by Medicure and Gland Pharma Ltd, and is included in three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Tirofiban hydrochloride has five patent family members in five countries.

There are four drug master file entries for tirofiban hydrochloride. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for tirofiban hydrochloride

International Patents:	5
US Patents:	1
Tradenames:	2
Applicants:	2
NDAs:	3
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	49
Patent Applications:	2,240
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tirofiban hydrochloride
DailyMed Link:	tirofiban hydrochloride at DailyMed

Recent Clinical Trials for tirofiban hydrochloride

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

Sponsor	Phase
Beijing Tiantan Hospital	Phase 4
GrandPharma (China) Co., Ltd.	Phase 4
Beijing Healthunion Cardio-Cerebrovascular Disease Prevention and Treatment Foundation	Phase 4

See all tirofiban hydrochloride clinical trials

Generic filers with tentative approvals for TIROFIBAN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for tirofiban hydrochloride

Drug Class	Platelet Aggregation Inhibitor
Physiological Effect	Decreased Platelet Aggregation

Paragraph IV (Patent) Challenges for TIROFIBAN HYDROCHLORIDE

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 tirofiban hydrochloride

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	SOLUTION;INTRAVENOUS	020913-001	May 14, 1998		DISCN	No	No
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-003	Apr 20, 2000	AP	RX	Yes	Yes
Gland Pharma Ltd	TIROFIBAN HYDROCHLORIDE	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	206888-001	Apr 8, 2021	AP	RX	No	No
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	INJECTABLE;INJECTION	020912-001	May 14, 1998		DISCN	No	No

Expired US Patents for tirofiban hydrochloride

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	SOLUTION;INJECTION	020912-002	Aug 31, 2016
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020912-001	May 14, 1998
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-003	Apr 20, 2000

International Patents for tirofiban hydrochloride

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	03092767
European Patent Office	1503753	METHODE PERMETTANT D'INHIBER L'AGREGATION PLAQUETTAIRE (A METHOD FOR INHIBITING PLATELET AGGREGATION)
Japan	2005532306
Canada	2483929	METHODE PERMETTANT D'INHIBER L'AGREGATION PLAQUETTAIRE (A METHOD FOR INHIBITING PLATELET AGGREGATION)
Australia	2003234596	A METHOD FOR INHIBITING PLATELET AGGREGATION

Supplementary Protection Certificates for tirofiban hydrochloride

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
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