TIROFIBAN HYDROCHLORIDE - Generic Drug Details

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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, Eugia Pharma, Gland Pharma Ltd, and Nexus, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for tirofiban hydrochloride. Four suppliers are listed for this compound.

Summary for TIROFIBAN HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	5
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	54
Patent Applications:	2,138
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TIROFIBAN HYDROCHLORIDE
What excipients (inactive ingredients) are in TIROFIBAN HYDROCHLORIDE?	TIROFIBAN HYDROCHLORIDE excipients list
DailyMed Link:	TIROFIBAN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for TIROFIBAN HYDROCHLORIDE

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

Sponsor	Phase
The First Affiliated Hospital of University of Science and Technology of China	Phase 3
Pharmaron (Chengdu) Clinical Services Co., Ltd.	Phase 3
Peking Union Medical College Hospital	Phase 3

See all TIROFIBAN HYDROCHLORIDE clinical trials

Pharmacology for TIROFIBAN HYDROCHLORIDE

Drug Class	Platelet Aggregation Inhibitor
Physiological Effect	Decreased Platelet Aggregation

Anatomical Therapeutic Chemical (ATC) Classes for TIROFIBAN HYDROCHLORIDE

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

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

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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
Eugia Pharma	TIROFIBAN HYDROCHLORIDE	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	216379-002	May 1, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-002	May 17, 2002	AP	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nexus	TIROFIBAN HYDROCHLORIDE	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	213947-001	Feb 7, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-001	May 14, 1998		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 TIROFIBAN HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INJECTION	020912-002	Aug 31, 2016	⤷ Sign Up	⤷ Sign Up
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-003	Apr 20, 2000	⤷ Sign Up	⤷ Sign Up
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-002	May 17, 2002	⤷ Sign Up	⤷ Sign Up
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-002	May 17, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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