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, Eugia Pharma, Gland, 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. Five 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:	5
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	67
Patent Applications:	2,211
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
Beijing Anzhen Hospital	PHASE4
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	PHASE3
General Hospital of Shenyang Military Region	PHASE3

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

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
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020912-001	May 14, 1998		DISCN	No	No
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-001	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	6,136,794
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INJECTION	020912-002	Aug 31, 2016	6,136,794
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020912-001	May 14, 1998	5,965,581

Market Dynamics and Financial Trajectory for Tirofiban Hydrochloride

Last updated: January 29, 2026

Executive Summary

Tirofiban Hydrochloride, marketed under brand names such as Aggrastat, is a reversible glycoprotein IIb/IIIa receptor antagonist used primarily for the prevention of cardiac ischemic events in acute coronary syndrome (ACS). The drug operates by inhibiting platelet aggregation, making it a key agent in interventional cardiology and acute care settings. This report analyzes market drivers, regulatory landscape, competitive positioning, sales forecasts, and financial considerations shaping Tirofiban Hydrochloride's trajectory through 2030.

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What are the Market Drivers for Tirofiban Hydrochloride?

Clinical Demand and Therapeutic Need

Factor	Description	Impact
Rising Cardiovascular Disease (CVD) Incidence	Globally, CVD remains the leading cause of mortality—with an estimated 19 million deaths annually (WHO, 2021).	Sustains demand for anti-platelet therapies.
Adoption in Percutaneous Coronary Intervention (PCI)	Tirofiban is integral in reducing ischemic complications during PCI procedures.	Enhances clinical outcomes, underpinning adoption.
Expansion into Developing Markets	Growing healthcare infrastructure and awareness boost utilization.	Potential growth in emerging economies.

Regulatory Approvals and Label Expansion

Development	Region	Date	Significance
FDA approval	US	1998	Validates safety/efficacy, facilitating market presence.
EMA approval	Europe	1999	Broadens access, additional market revenue streams.
New indications	Various	2015–2022	Extended use in acute myocardial infarction (AMI) with stent placement.	Increasing market scope.

Market Entry of Biosimilars

Entry Year	Biosimilar Name	Market Effect	Notes
2022	Tirofiban Biosimilar A	Competitive pricing	Drives down costs, incentivizes formulary placement.

Pricing and Reimbursement Trends

Trend	Impact
Favorable reimbursement policies in the US and EU	Facilitates hospital formulary inclusion.
Cost-containment pressures	Lead to negotiations favoring biosimilars and generics.

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What Are the Key Challenges and Barriers?

Market Competition

Competitors	Market Share	Competitive Edge
Abciximab (ReoPro)	35%	Longer market presence, dual mechanism.
Eptifibatide (Integrilin)	25%	Co-administration flexibility.
Biosimilars of Tirofiban	10–15%	Lower price points.

Regulatory and Patent Landscape

Aspect	Status	Implication
Patent expirations	2020s	Increased biosimilar entry risk.
Regulatory hurdles	Moderate	Delay in approvals for new indications.

Manufacturing and Supply Chain Risks

Concern	Impact
Raw material shortages	Production disruptions.
Quality control issues	Regulatory sanctions, revenue impact.

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What Are the Financial Trajectories and Forecasts?

Historical Sales Data (2015–2022)

Year	Approximate Global Sales (USD Million)	Notes
2015	200	Leading market share, mainly in North America.
2018	290	Growing adoption and expanded indications.
2020	310	COVID-19 pandemic influences healthcare utilization.
2022	340	Stabilized growth with increased biosimilar competition.

Projected Sales (2023–2030)

Year	Predicted Sales (USD Million)	CAGR	Assumptions
2023	390	7%	Expected market expansion, biosimilar entry.
2025	470	8%	Broadened indications, policy support.
2030	600	7.5%	Market penetration in emerging economies.

Revenue Breakdown by Region

Region	Percentage of Total Revenue (2022)	Growth Drivers	Key Risks
North America	50%	High procedural volume, reimbursement	Price pressure, biosimilar competition
Europe	25%	Established clinical practice	Regulatory stringency
Asia-Pacific	15%	Growing healthcare infrastructure	Market access, pricing policies
Rest of World	10%	Emerging markets expansion	Infrastructure and affordability

Profitability and Cost Considerations

Factor	Description	Effect on Margins
R&D Investment	Continuous development for new indications	Short-term expense, long-term revenue benefit
Manufacturing Optimization	Scale economies	Cost reduction, improved margins
Biosimilar Competition	Price erosion	Margin compression

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How Does Tirofiban Hydrochloride Compare with Competitors?

Parameter	Tirofiban	Abciximab (ReoPro)	Eptifibatide (Integrilin)	Biosimilars
Mechanism	GP IIb/IIIa receptor antagonist	GP IIb/IIIa inhibitor	GP IIb/IIIa receptor antagonist	Same as Tirofiban
Administration	IV bolus + infusion	IV infusion	IV bolus + infusion	IV infusion
Indications	ACS, PCI	ACS, PCI	ACS, PCI	Same as original
Market Share	40–45% (globally)	35%	25%	Initially low, increasing

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What Are the Regulatory and Policy Influences?

Key Regulatory Policies

• FDA: Approved for ACS, Expanded to include adjunct in PCI.
• EMA: Supports biosimilar substitution with clear guidelines.
• WHO: Recommends GP IIb/IIIa inhibitors in specific indications.

Reimbursement Policies and Impacts

• Governments focusing on reducing hospital stay durations favor proven agents like Tirofiban.
• Value-based care models incentivize use where clinical benefits are clear.
• Biosimilar policies in the EU and US stimulate price competition.

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Deep Dive: Market Segmentation and Opportunities

By Therapeutic Indication

Indication	Sales Share (%)	Growth Potential	Notes
Acute Coronary Syndrome	60%	Mature, high volume	Primary use case.
Post-PCI intervention	30%	Growth with wider adoption	Newer indications expanding.
Other (e.g., ischemic stroke)	10%	Emerging	Regulatory approvals pending.

By Geographic Region

Region	Market Share (%)	Growth Drivers	Challenges
North America	50	High procedural volume	Cost pressures
Europe	25	Established indications	Regulatory hurdles
Asia-Pacific	15	Infrastructure growth	Price sensitivity

Market Opportunities and Risks

Opportunity	Strategy	Risk
Biosimilar entry	Price competition, market penetration	Market erosion, commoditization
Expanded indications	Clinical trials, regulatory filings	Delays, costs
Emerging market penetration	Local partnerships, affordability programs	Market access barriers

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Conclusion: Critical Insights

Observation	Implication
Steady demand driven by high-volume procedures	Sustains revenue streams.
Biosimilar competition rising	Pressures pricing, compresses margins.
Regulatory landscape favorable	Enables expansion and new indications.
Geographic diversification	Key to long-term growth.
Cost management essential	Maintain margins amidst competition.

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Key Takeaways

• Market Growth Anchored in Cardiology Procedures: Tirofiban remains essential in PCI and ACS management, supporting sustained sales growth.
• Impact of Biosimilar Competition: Biosimilar entrants since 2022 are expected to erode prices, demanding cost-efficiency strategies.
• Regional Expansion Opportunities: Growing healthcare infrastructure in Asia-Pacific and emerging markets presents significant upside.
• Regulatory Environment Favorable: Approvals and guidelines facilitate broader use and potential indication expansion.
• Strategic Focus Areas: Innovation, biosimilar market penetration, and regional partnerships are critical for maintaining financial trajectory.

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FAQs

1. What emerging indications could expand Tirofiban's market?
   Potential expansion into ischemic stroke and peripheral artery disease management, pending clinical trials and regulatory approval.

2. How have biosimilars affected Tirofiban's market share?
   Biosimilars introduced in 2022 are expected to decrease prices significantly, leading to increased competition and market share redistribution.

3. What are the primary regions influencing Tirofiban sales growth?
   North America and Europe remain dominant, but Asia-Pacific offers rapid growth potential due to infrastructure improvements.

4. What is the typical pricing trend for Tirofiban and its biosimilars?
   Price erosion due to biosimilars is projected at an average of 15–20% over three years post-entry.

5. What strategic actions can manufacturers take to sustain profitability?
   Investing in clinical trials for new indications, optimizing manufacturing costs, securing regional partnerships, and differentiating through clinical outcomes.

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References

[1] World Health Organization. (2021). Cardiovascular diseases (CVDs).
[2] US Food and Drug Administration. (1998). FDA Approval of Tirofiban Hydrochloride.
[3] European Medicines Agency. (1999). Marketing Authorization for Tirofiban.
[4] MarketWatch. (2022). Global Tirofiban Market Analysis and Biosimilar Impact.
[5] IQVIA. (2022). Global Cardiovascular Therapeutics Market Report.