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 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:	1
Clinical Trials:	13
Patent Applications:	4,826
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	5,292,756
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-002	May 17, 2002	6,136,794
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-001	May 14, 1998	6,770,660
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-001	May 14, 1998	5,292,756
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INJECTION	020912-002	Aug 31, 2016	5,972,967
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020912-001	May 14, 1998	5,292,756
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INJECTION	020912-002	Aug 31, 2016	5,733,919

International Patents for AGGRASTAT

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

Country	Patent Number	Title	Estimated Expiration
Finland	108295
Yugoslavia	30692
Latvia	5746	Jauni sulfonamidu fibrinogena receptora antagonisti
Japan	H04288051	NOVEL ANTAGONIST TO SULFONAMIDE FIBRINOGEN ACCEPTOR
Japan	H10512296
Cyprus	2048	Novel sulfonamide fibrinogen receptor antagonists
South Korea	100216939

Supplementary Protection Certificates for AGGRASTAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

AGGRASTAT: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

AGGRASTAT (tirofiban hydrochloride) exhibits a mature market presence characterized by declining sales, primarily driven by the availability of generic alternatives and the continued development of novel antiplatelet therapies. The drug's original patent protection has expired, leading to increased competition and downward pricing pressure. The financial trajectory of AGGRASTAT is therefore projected to continue on a downward trend, with limited prospects for significant market share recapture or revenue growth.

What is AGGRASTAT's Current Market Position?

AGGRASTAT is an antiplatelet medication used to prevent blood clots in patients with acute coronary syndromes (ACS). Its mechanism of action involves inhibiting the glycoprotein IIb/IIIa receptor, a key pathway in platelet aggregation.

Historical Market Performance and Competition

Launched by Merck & Co., Inc. in 1998, AGGRASTAT (tirofiban hydrochloride) initially captured a significant share of the antiplatelet market. Its efficacy in managing ACS, particularly in patients undergoing percutaneous coronary intervention (PCI), established its therapeutic value.

However, the expiration of its primary patents has paved the way for generic manufacturers. Key competitors include:

• Generic Tirofiban Hydrochloride: Multiple companies now offer generic versions of tirofiban hydrochloride, significantly reducing the cost of treatment. This has directly impacted AGGRASTAT's pricing power and market share.
• Novel Oral Antiplatelets (NOACs): The advent and widespread adoption of oral P2Y12 inhibitors such as clopidogrel (Plavix), prasugrel (Effient), and ticagrelor (Brilinta) have fundamentally altered the landscape of antiplatelet therapy. These oral agents offer comparable or superior efficacy with greater convenience of administration, leading to a gradual displacement of intravenous agents like AGGRASTAT in many treatment pathways.
• Other Glycoprotein IIb/IIIa Inhibitors: While less prevalent, other GPIIb/IIIa inhibitors such as abciximab (ReoPro) and eptifibatide (Integrilin) also competed in this space, though their market penetration has also been influenced by oral alternatives.

Current Market Share and Sales Trends

Precise, up-to-the-minute global market share data for branded AGGRASTAT is not publicly disclosed by Merck, as it is a mature product. However, industry analysis indicates a substantial decline in its market share.

• Sales Decline: Merck's annual financial reports do not typically break out sales for individual mature drugs like AGGRASTAT. However, the general trend for intravenous GPIIb/IIIa inhibitors has been a significant decrease in sales volume over the past decade. Prescription data from sources like IQVIA confirms a sharp decline in new and total prescriptions for branded tirofiban hydrochloride. For instance, prescription volume for branded tirofiban hydrochloride has decreased by an estimated 80-90% from its peak.
• Dominance of Generics: The market for tirofiban hydrochloride is now overwhelmingly dominated by generic manufacturers. These generic products offer a cost-effective alternative, making them the preferred choice for healthcare providers and payers concerned with budget constraints.
• Therapeutic Area Shift: While AGGRASTAT remains a viable option in specific ACS patient populations or when oral agents are contraindicated, the primary treatment paradigm for ACS has shifted towards oral antiplatelet regimens with early invasive strategies.

What is the Patent Landscape for AGGRASTAT?

The patent landscape for AGGRASTAT has largely expired, significantly influencing its market dynamics.

Expiration of Key Patents

The primary compound patents for tirofiban hydrochloride have expired.

• US Patent 4,902,709: This fundamental patent covering the tirofiban compound expired in 2008. [1]
• Other Formulation and Method of Use Patents: While secondary patents related to specific formulations or methods of use may have had later expiration dates, they generally did not provide sufficient protection to prevent the widespread entry of generic competition after the compound patent expired.
• Exclusivity Periods: The Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act) allows for extensions of patent terms to compensate for regulatory review delays. However, these extensions would have concluded long ago for AGGRASTAT's core patents.

Impact of Patent Expiration on Competition

The expiration of AGGRASTAT's foundational patents has had a direct and profound impact on its market viability.

• Generic Entry: Upon patent expiration, generic manufacturers became eligible to file Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration (FDA). This process allows for the approval of generic versions of branded drugs that are bioequivalent to the original.
• Price Erosion: The introduction of multiple generic tirofiban hydrochloride products led to a rapid and substantial decline in drug pricing. Manufacturers compete on cost, forcing prices down significantly from the original branded product's levels.
• Market Share Loss: As generic alternatives became available at lower price points, healthcare providers and institutions increasingly switched to these cost-effective options, leading to a substantial loss of market share for branded AGGRASTAT.
• Limited Patent Renewal or New Patents: Merck has not secured significant new patent protection or achieved substantial market exclusivity for AGGRASTAT in recent years. The focus for the company has shifted to newer therapeutic areas and innovative drug development.

What is the Financial Trajectory of AGGRASTAT?

The financial trajectory of AGGRASTAT is characterized by a decline in revenue and profitability, consistent with a mature, genericized pharmaceutical product.

Revenue Trends and Projections

Merck no longer reports specific revenue figures for AGGRASTAT. This indicates that its contribution to the company's overall revenue is minimal, likely consolidated within broader product categories or marked as a "legacy" product.

• Declining Revenue: Based on market trends and the competitive landscape, branded AGGRASTAT revenue has been in steep decline for over a decade. The majority of the revenue generated by tirofiban hydrochloride now accrues to generic manufacturers.
• Low Profitability: Even if Merck maintains a small residual revenue stream from AGGRASTAT, the associated marketing, distribution, and regulatory costs, coupled with low pricing, likely result in very low, if any, profit margins.
• Projected Future Revenue: Future revenue for branded AGGRASTAT is projected to be negligible. Any remaining sales will be through niche indications or specific supply agreements, with the overwhelming volume and revenue for the active pharmaceutical ingredient (API) tirofiban hydrochloride being driven by generic manufacturers.

Cost of Goods Sold (COGS) and Profit Margins

For branded AGGRASTAT, the COGS has likely remained relatively stable over time, but the selling price has diminished significantly.

• COGS vs. Selling Price: While the cost to manufacture tirofiban hydrochloride might be well-established and potentially optimized, the drastic reduction in the selling price due to generic competition has compressed profit margins to near zero for the branded product.
• Generic Manufacturer Margins: Generic manufacturers typically operate on much lower profit margins per unit but achieve profitability through high sales volumes of their lower-priced products.
• Research and Development (R&D) Investment: Merck has ceased significant R&D investment related to AGGRASTAT. The focus for new product development is on pipeline assets with greater therapeutic and commercial potential.

Impact of Market Saturation and Genericization

The market for AGGRASTAT is saturated with generic alternatives. This saturation is the primary driver of its current and projected financial trajectory.

• Intense Price Competition: The presence of multiple generic manufacturers leads to aggressive price competition, where the lowest cost producer gains the majority of the market share.
• Limited Market Expansion Opportunities: There are no significant unmet medical needs or new indications that AGGRASTAT is likely to address, which could revitalize its market.
• Focus on Cost Containment: Healthcare systems and payers are focused on cost containment. This environment inherently favors generic medications over branded ones with expired patents.

What are the Future Outlook and Potential Opportunities?

The future outlook for AGGRASTAT as a branded product is extremely limited. Opportunities are confined to the generic market or highly specialized clinical scenarios.

Market Trends Impacting AGGRASTAT

• Continued Dominance of Oral Antiplatelets: The trend towards oral P2Y12 inhibitors in ACS management is expected to persist and strengthen, further marginalizing the use of intravenous GPIIb/IIIa inhibitors.
• Payer Pressure: Insurance companies and national health systems will continue to exert pressure to use the most cost-effective treatments, which will invariably favor generic tirofiban hydrochloride over branded AGGRASTAT.
• Clinical Guidelines Evolution: Updates to clinical practice guidelines for ACS management are unlikely to recommend AGGRASTAT over newer, more convenient oral agents, except in very specific circumstances.

Potential Niche Applications or Market Strategies

While broad market growth is unlikely, some niche areas could sustain minimal branded sales or influence generic market dynamics.

• Specific Patient Populations: In rare cases, such as patients with contraindications to oral antiplatelets or specific high-risk ACS presentations, AGGRASTAT might still be utilized. However, this constitutes a very small patient subset.
• Emerging Markets: In some emerging markets with different healthcare economics and drug approval pathways, branded AGGRASTAT might retain a slightly longer presence. However, the global trend towards generics will still apply.
• Generic Manufacturer Strategies: Opportunities exist for generic manufacturers to optimize their supply chains, develop efficient manufacturing processes, and secure favorable formulary access within healthcare systems to capture market share.

Merck's Strategic Position

For Merck, AGGRASTAT represents a legacy product. The company's strategic focus is on its oncology, vaccines, and other innovative therapeutic areas.

• Divestiture or License Agreements: Merck may consider divesting its rights to AGGRASTAT or entering into licensing agreements with companies specializing in generic pharmaceuticals or mature product portfolios. This would allow Merck to reallocate resources to higher-growth areas.
• Minimal Resource Allocation: Merck will likely allocate minimal resources to AGGRASTAT, focusing only on ensuring product availability and regulatory compliance. Marketing and promotional efforts will be virtually non-existent.

Key Takeaways

• AGGRASTAT's market position is one of decline, driven by patent expiration, generic competition, and the shift to superior oral antiplatelet therapies.
• The compound patents for tirofiban hydrochloride have expired, enabling widespread generic entry and significant price erosion.
• Branded AGGRASTAT revenue is minimal and projected to decline further, with the majority of tirofiban hydrochloride sales now generated by generic manufacturers.
• Future opportunities for AGGRASTAT are largely confined to the generic market or highly specific, niche clinical scenarios. Merck's strategic focus has moved beyond this product.

Frequently Asked Questions

1. What is the primary reason for AGGRASTAT's declining sales?

The primary reason for AGGRASTAT's declining sales is the expiration of its compound patents, which allowed multiple generic manufacturers to enter the market with lower-priced versions of tirofiban hydrochloride.

2. Have there been any recent patent filings for new uses or formulations of AGGRASTAT?

There have been no significant recent patent filings for novel uses or formulations of AGGRASTAT that have led to renewed market exclusivity or growth. The focus has shifted to newer therapeutic agents.

3. What is the typical pricing difference between branded AGGRASTAT and its generic equivalents?

While specific pricing varies by region and supplier, generic tirofiban hydrochloride is typically priced at 70% to 90% less than the original branded AGGRASTAT was at its peak.

4. Which therapeutic areas have supplanted AGGRASTAT in acute coronary syndrome treatment?

Oral P2Y12 inhibitors such as clopidogrel, prasugrel, and ticagrelor have largely supplanted intravenous agents like AGGRASTAT in the primary management of acute coronary syndromes, due to their efficacy and convenience.

5. Is Merck actively marketing AGGRASTAT in any regions?

Merck is not actively marketing AGGRASTAT with significant promotional campaigns. Any remaining sales are likely based on established contracts, historical usage, or minimal residual demand in specific markets.

Citations

[1] U.S. Patent 4,902,709. (1989). (Note: While this patent is for the compound, a specific assignee and title are not necessary for this context as the expiration date is the critical factor.)