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:	4,824
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;INJECTION	020912-002	Aug 31, 2016	6,136,794
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INJECTION	020912-002	Aug 31, 2016	5,972,967
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-001	May 14, 1998	5,292,756
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020912-001	May 14, 1998	5,972,967
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	5,658,929

International Patents for AGGRASTAT

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

Country	Patent Number	Title	Estimated Expiration
Austria	150454
Australia	655436
Australia	8478291
Canada	2052073	ANTAGONISTES DES RECEPTEURS DE LA FIBRINOGENE A BASE DE SULFAMIDES (SULFONAMIDE FIBRINOGEN RECEPTOR ANTAGONISTS)
China	1038748
China	1069971

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	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	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

AGGRASTAT (tirofiban) market dynamics and financial trajectory: exclusivity, generic/biosimilar risk, and revenue outlook

Last updated: July 29, 2026

AGGRASTAT is a brand of tirofiban hydrochloride, an intravenous GPIIb/IIIa inhibitor used as an antiplatelet in acute coronary syndromes and percutaneous coronary intervention settings. In the current US and major EU markets, the core financial story is a mature, largely genericized product with limited incremental growth levers. Brand revenue has been structurally pressured by generic entry and loss of US brand exclusivity, shifting the competitive field toward low-cost injectables and hospital formulary dynamics tied to dosing, supply, and acquisition contracts.

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What is AGGRASTAT (tirofiban) and how is it used clinically?

AGGRASTAT (tirofiban HCl) is a small-molecule antiplatelet delivered as an IV infusion. It is used to reduce thrombotic complications in patients with acute coronary syndrome who are managed with coronary angiography and possible PCI, and in procedural contexts to prevent platelet aggregation mediated by GPIIb/IIIa.

Key clinical use cases that drive demand

• Acute coronary syndromes (UA/NSTEMI), especially where invasive management is planned.
• PCI support where rapid platelet inhibition is needed.

Where tirofiban fits vs substitutes

• Competitive class dynamics vs other IV antiplatelets and adjuncts used in ACS/PCI pathways (institution- and guideline-driven).
• Substitution is less about comparative efficacy marketing and more about protocol fit, supply reliability, and contract pricing.

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What patents protect AGGRASTAT (tirofiban) and how strong is the patent estate?

AGGRASTAT’s market trajectory is dominated by the reality that tirofiban as an active pharmaceutical ingredient is no longer protected as a brand-new molecule, and the competitive landscape is concentrated on generics of tirofiban rather than new, long-dated monopoly rights. As a result, the patent estate does not appear to function as a continuing economic moat in the way it would for modern biologics or late-life small molecules.

Patent estate pattern typical for mature IV injectables

• Early composition-of-matter coverage is historically relied upon for brand lead time.
• Later protections (method of use, formulation, or device-specific delivery) typically contribute only if they map cleanly to current labeling and are not readily designed around.
• For mature injectables, generic manufacturers often pursue ANDA entries that avoid narrow formulation or dosing claims.

Financial impact: Once generic supply is established, brand revenue follows a steep multi-year decline. Remaining brand usage is usually tied to legacy contracts, controlled distribution, or specific formulary preferences, which typically erode over time.

(No patent list is provided here because the required Orange Book and patent-document level detail for AGGRASTAT is not included in the available input.)

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When does AGGRASTAT lose exclusivity and what generic entry risks exist for tirofiban?

For a mature IV injectable like tirofiban, “exclusivity” is less a single date and more a sequence:

• Loss of brand exclusivity and conversion to generic-led purchasing.
• Timing of ANDA approvals across dosage strengths and packaging formats.
• Any residual exclusivity tied to specific labeling or formulation changes, if present, is typically shorter and smaller in economic effect than the initial molecule exclusivity.

Generic entry risk profile

• High: Classically, tirofiban has an established generic ecosystem.
• Commercially decisive: pricing pressure from multiple ANDA entrants makes “brand retention” difficult without differentiated supply or contracting advantages.

Financial impact: the probability of continued meaningful share for AGGRASTAT is low in markets where contracting consolidates around lowest acquisition cost and consistent supply performance.

(No exclusivity dates are provided because the required dataset of Orange Book exclusivity and patent terms for the exact AGGRASTAT NDC(s) is not included in the available input.)

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What is the Orange Book status of AGGRASTAT (tirofiban)?

AGGRASTAT’s current economics are consistent with a product that is:

• Not protected by long-lasting, molecule-level exclusivity in major markets.
• Operates in a competitive environment with generic equivalents available.

However, an Orange Book status line item (including patent numbers, expiration dates, and listed exclusivities by NDC) is not included in the available input, and an accurate, citation-backed Orange Book breakdown cannot be generated from the provided information.

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How many companies manufacture tirofiban generics and what does that do to pricing?

In mature IV antiplatelet injectables, generic competition typically creates:

• Multiple ANDA suppliers with overlapping labeling.
• Rapid price convergence toward the lowest sustainable acquisition cost.
• Contract-driven substitution at hospital group level.

Market structure effects

• More than one approved generic usually accelerates the decline in brand net price.
• A shift toward supply-chain reliability and pricing consistency becomes more important than clinical differentiation.

Where pricing pressure shows up in financials

• Brand gross margin compresses as net price falls.
• Brand unit volumes may hold briefly but generally decline as formularies standardize.
• Profitability becomes contingent on contract-specific pricing, co-pay dynamics (if any), and continued tender inclusion.

(No company roster or market share figures are provided because the required current supplier list and market data are not included in the available input.)

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What is the financial trajectory of AGGRASTAT (tirofiban) over the past 5 to 10 years?

AGGRASTAT’s long-term financial path for most investors and analysts is typically characterized by:

• Early growth tied to introduction and guideline adoption.
• Subsequent decline driven by generic entry and hospital formulary consolidation.
• Stabilization at reduced revenue levels, often with remaining demand in specific institutions, tenders, or legacy contracts.

Typical observable revenue drivers for mature tirofiban brands

• Net price erosion after generics enter.
• Volume changes due to replacement by generics and protocol standardization.
• Tender/batch economics: supply availability and dosing regimen integration into procurement.
• Exclusion risk: removal from formularies can be abrupt after contracting cycles.

Investment and licensing implications

• For any acquirer or licensor, upside generally comes from:
  • Securing distribution or contract preferences.
  • Manufacturing cost advantages or supply differentiation.
  • Narrow specialty niches where branded supply remains preferred.
• Upside is limited by the commodity-like competitive structure once generics dominate.

(No AGGRASTAT-specific revenue numbers are provided because they are not included in the available input.)

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How do hospital formulary decisions affect AGGRASTAT demand and reimbursement?

Formulary mechanics often dominate purchasing in IV ACS/PCI drugs:

• Protocol alignment: institutions standardize IV GPIIb/IIIa selection based on internal pathways and pharmacy committee preferences.
• Acquisition cost: generic pricing typically anchors purchasing decisions.
• Stocking and supply reliability: hospitals avoid items with supply disruptions.
• Switching costs: once switching occurs, repeat brand rebundling is uncommon unless contracts change.

Reimbursement dynamics

For mature injectable generics:

• Reimbursement is typically not a brand-protecting factor.
• The economic battlefield is contracting and hospital pharmacy net acquisition cost.

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How does AGGRASTAT compare with alternatives used in ACS and PCI?

AGGRASTAT competes within a therapeutic workflow rather than a single-drug silo:

• Clinicians select antiplatelet regimens based on ACS risk profile, planned invasive strategy, bleeding risk, and cath lab protocols.
• Where IV GPIIb/IIIa inhibitors remain used, tirofiban generics often substitute for the brand based on procurement economics.
• Any differentiation in outcomes is usually not enough to reverse commodity pricing once a generic is available with the same labeled regimen.

(No head-to-head efficacy or economic model is provided because comparative claims and validated cost-effectiveness sources are not included in the available input.)

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What patent litigation or Paragraph IV challenges affect AGGRASTAT generics?

Paragraph IV ANDA litigation can affect timelines for generic launches and create temporary revenue protection. For AGGRASTAT, there is no litigation docket detail or case list included in the available input, so an accurate, company-and-case-specific section cannot be produced.

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What manufacturing and supply constraints could influence AGGRASTAT availability and financials?

For IV injectables, supply is a key driver of both:

• Hospital trust and contracting retention.
• Short-term revenue stability during shortages.

Typical operational risks for injectable commodity drugs

• API sourcing constraints.
• Sterile manufacturing capacity and batch release timing.
• Regulatory compliance events that can cause temporary withdrawals.

Financial outcomes

• A supply disruption can create temporary pricing lift even for generic-equivalent products.
• Persistent instability typically leads to longer-term formulary substitution to other suppliers.

(No AGGRASTAT or tirofiban specific manufacturing incident data is included in the available input.)

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Key commercial scenarios for AGGRASTAT revenue over the next 3 years

Given a mature, genericized market structure, the forward-looking commercial range is usually driven by procurement and supply:

Scenario 1: Continued generic-led contracting

• Ongoing downward pressure on net price.
• Revenue stabilizes at lower levels.
• Limited ability to grow share absent differentiation.

Scenario 2: Temporary supply gaps among competitors

• Short-term price increases and reinstated tender inclusion.
• Revenue may bounce, but only if supply constraints persist and are resolvable.

Scenario 3: Further formulary tightening by health systems

• Net revenue declines via contracting exclusion.
• Higher risk of sustained volume erosion.

(No forecast model with quantitative assumptions is provided because AGGRASTAT financial baseline metrics and competitor supply data are not included in the available input.)

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Key Takeaways

• AGGRASTAT (tirofiban) is a mature IV antiplatelet exposed to sustained generic price competition.
• The financial trajectory is primarily shaped by generic availability, hospital contracting cycles, and procurement-driven substitution rather than ongoing patent-protected growth.
• Near-term revenue dynamics are most sensitive to supply reliability among tirofiban injectables and health-system formulary consolidation.
• Without a current, cited Orange Book and patent-expiration dataset, the patent-lifecycle narrative cannot be mapped to exact dates or litigation events in a way suitable for high-stakes decisions.

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FAQs

1. Why do hospitals switch from AGGRASTAT to generic tirofiban?
   Net acquisition cost, contract pricing, and standardized ACS/PCI protocols typically outweigh brand differentiation once generics are available.

2. Does AGGRASTAT face biosimilar risk?
   No. Biosimilars apply to biologics; tirofiban is a small-molecule injectable pursued via generic ANDAs.

3. What drives short-term price changes for tirofiban injectables?
   Supplier availability, batch release continuity, and contract tender dynamics.

4. How does tender timing affect AGGRASTAT quarterly revenue?
   Pharmacy contracts and switching cycles can move volume quickly at the start of a new purchasing period.

5. Can AGGRASTAT regain share after generic entry?
   It can only do so in limited cases tied to specific contracts, supply constraints, or institutional preferences; otherwise generic-led purchasing dominates.

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References (APA)

1. No sources were provided in the prompt for AGGRASTAT-specific Orange Book status, litigation, or financials.