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.

The generic ingredient in AGGRASTAT is tirofiban hydrochloride. There are four drug master file entries for this compound. Five 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

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	13
Patent Applications:	4,377
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

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

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	AP	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	6,770,660
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INJECTION	020912-002	Aug 31, 2016	5,733,919
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-002	May 17, 2002	5,658,929
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-003	Apr 20, 2000	6,770,660
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-001	May 14, 1998	5,880,136
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-002	May 17, 2002	5,978,698
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-003	Apr 20, 2000	5,292,756

International Patents for AGGRASTAT

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

Country	Patent Number	Title	Estimated Expiration
Bulgaria	102405
World Intellectual Property Organization (WIPO)	9715328
Canada	2483929	METHODE PERMETTANT D'INHIBER L'AGREGATION PLAQUETTAIRE (A METHOD FOR INHIBITING PLATELET AGGREGATION)
Algeria	2110	Compositions pour inhiber l'agégation des plaquettes.
Japan	2002501936
Bulgaria	63623
Norway	981869

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	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	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

AGGRASTAT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AGGRASTAT

Introduction

AGGRASTAT, also known as tirofiban hydrochloride, is a potent antiplatelet drug used in the management of acute coronary syndrome (ACS), including unstable angina and non-ST elevation myocardial infarction. Here, we delve into the market dynamics and financial trajectory of AGGRASTAT, highlighting its clinical significance, market performance, and financial trends.

Clinical Significance of AGGRASTAT

AGGRASTAT is a reversible antagonist of the GP IIb/IIIa receptor, which plays a crucial role in platelet aggregation. Clinical trials have demonstrated its efficacy in reducing cardiac ischemia events when used in combination with heparin and aspirin. For instance, the PRISM-PLUS study showed a 47% risk reduction in myocardial infarction and a 30% risk reduction in refractory ischemia[1].

Market Indications and Usage

AGGRASTAT is indicated for the treatment of acute coronary syndrome, both in patients managed medically and those undergoing percutaneous transluminal coronary angioplasty (PTCA) or atherectomy. Its use is supported by several large-scale clinical studies that have established its safety and efficacy profile[1][4].

Market Performance

Sales Trends

The sales performance of AGGRASTAT has seen fluctuations in recent years. For the year ended December 31, 2023, net AGGRASTAT product sales were $9.7 million, down from $11.7 million in the previous year. This decline is attributed to a decrease in the volume of AGGRASTAT sold and increased pricing competition from generic tirofiban[3].

Competitive Landscape

The market for antiplatelet drugs is highly competitive, with several other GP IIb/IIIa inhibitors and antiplatelet agents available. The presence of generic tirofiban has significantly impacted the sales of AGGRASTAT, as generics often offer a more cost-effective alternative for patients and healthcare providers.

Financial Trajectory

Revenue and Profitability

Medicure Inc., the company behind AGGRASTAT, reported a net loss of $922,000 for the year ended December 31, 2023, compared to a net income of $1.4 million in the previous year. The decline in profitability is largely due to lower net revenue from AGGRASTAT sales and higher selling expenses, partially offset by lower research and development expenses[3].

Cash Flow and Liquidity

Despite the decline in sales, Medicure Inc. has maintained a stable cash position. As of December 31, 2023, the company had unrestricted cash totaling $6.4 million, up from $4.9 million in the previous year. Cash flows from operating activities also improved, totaling $2.1 million for the year ended December 31, 2023[3].

Challenges and Opportunities

Pricing Competition

One of the significant challenges facing AGGRASTAT is the pricing competition from generic alternatives. The decrease in revenue for AGGRASTAT in 2023 highlights the impact of generics on the market share and profitability of branded drugs.

Diversification of Product Portfolio

Medicure Inc. is diversifying its product portfolio to mitigate the impact of declining AGGRASTAT sales. For example, the company's Marley Drug business and other products like ZYPITAMAG have contributed significantly to its revenue, providing alternative revenue streams[3].

Regulatory and Clinical Environment

Clinical Trials and Outcomes

The efficacy and safety of AGGRASTAT have been well-established through several clinical trials. However, the regulatory environment remains stringent, with ongoing monitoring of drug safety and efficacy post-approval. For instance, post-marketing experience has identified additional adverse reactions, including severe allergic reactions and thrombocytopenia[4].

Compliance and Safety

Compliance with regulatory requirements is crucial for maintaining market approval. AGGRASTAT's safety profile, including its bleeding risks and potential for thrombocytopenia, must be carefully managed to ensure patient safety and maintain regulatory approval.

Key Takeaways

• Clinical Efficacy: AGGRASTAT has demonstrated significant clinical benefits in reducing cardiac ischemia events.
• Market Performance: Sales have declined due to competition from generics and pricing pressures.
• Financial Trajectory: Medicure Inc. has reported a net loss in 2023, but maintains a stable cash position.
• Challenges: Pricing competition from generics and regulatory compliance are key challenges.
• Opportunities: Diversification of the product portfolio and strategic investments offer potential for growth.

FAQs

What is AGGRASTAT used for?

AGGRASTAT is used for the treatment of acute coronary syndrome, including unstable angina and non-ST elevation myocardial infarction, often in combination with heparin and aspirin.

How does AGGRASTAT work?

AGGRASTAT is a reversible antagonist of the GP IIb/IIIa receptor, inhibiting platelet aggregation and reducing the risk of cardiac ischemia events.

Why have AGGRASTAT sales declined?

AGGRASTAT sales have declined primarily due to increased competition from generic tirofiban and pricing pressures.

What are the major side effects of AGGRASTAT?

Major side effects include bleeding risks, thrombocytopenia, and potential for severe allergic reactions.

How is Medicure Inc. addressing the decline in AGGRASTAT sales?

Medicure Inc. is diversifying its product portfolio and investing in other revenue-generating products to offset the decline in AGGRASTAT sales.

Sources

1. AGGRASTAT - accessdata.fda.gov
2. 2024 ACC Expert Consensus Decision Pathway on Strategies and ... - jacc.org
3. MEDICURE REPORTS FINANCIAL RESULTS FOR QUARTER AND YEAR ENDED DECEMBER 31, 2023 - medicure.com
4. AGGRASTAT® (tirofiban hydrochloride) injection, for intravenous use - accessdata.fda.gov
5. Cipher - Annual Reports - annualreports.com