EPTIFIBATIDE - Generic Drug Details

What are the generic sources for eptifibatide and what is the scope of freedom to operate?

Eptifibatide is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Amneal Pharms, Baxter Hlthcare Corp, Eugia Pharma, Hainan Poly, Hybio, Meitheal, Mylan Labs Ltd, Rising, Sagent Pharms Inc, Shuangcheng, Teva Pharms Usa, USV, and Msd Sub Merck, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

Eight suppliers are listed for this compound.

Summary for EPTIFIBATIDE

US Patents:	0
Tradenames:	2
Applicants:	14
NDAs:	16
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	38
Patent Applications:	6,453
Drug Prices:	Drug price trends for EPTIFIBATIDE
What excipients (inactive ingredients) are in EPTIFIBATIDE?	EPTIFIBATIDE excipients list
DailyMed Link:	EPTIFIBATIDE at DailyMed

See drug prices for EPTIFIBATIDE

Recent Clinical Trials for EPTIFIBATIDE

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

Sponsor	Phase
The First Affiliated Hospital of Hainan Medical College	PHASE3
Xinqiao Hospital of Chongqing	PHASE3
The First Affiliated Hospital of Nanchang University	PHASE3

See all EPTIFIBATIDE clinical trials

Pharmacology for EPTIFIBATIDE

Drug Class	Platelet Aggregation Inhibitor
Physiological Effect	Decreased Platelet Aggregation

Anatomical Therapeutic Chemical (ATC) Classes for EPTIFIBATIDE

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

Paragraph IV (Patent) Challenges for EPTIFIBATIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INTEGRILIN	Injection	eptifibatide	2 mg/mL, 100 mL vial	020718	1	2008-12-18
INTEGRILIN	Injection	eptifibatide	2 mg/mL, 10 mL vial	020718	1	2008-09-30

US Patents and Regulatory Information for EPTIFIBATIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hainan Poly	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	209864-002	Jan 25, 2019	AP	RX	No	No
Eugia Pharma	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	206127-002	Dec 8, 2015	AP	RX	No	No
Rising	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	204589-002	Apr 18, 2017		DISCN	No	No
Meitheal	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	213599-002	May 9, 2024	AP	RX	No	No
Accord Hlthcare	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	205557-002	Nov 6, 2017		DISCN	No	No
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-002	May 18, 1998		DISCN	Yes	No
Amneal Pharms	EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	205581-002	Dec 8, 2016		DISCN	No	No

Expired US Patents for EPTIFIBATIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-001	May 18, 1998
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-002	May 18, 1998
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-002	May 18, 1998
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-002	May 18, 1998
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-001	May 18, 1998
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-001	May 18, 1998
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-001	May 18, 1998

EU/EMA Drug Approvals for EPTIFIBATIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Accord Healthcare S.L.U.	Eptifibatide Accord	eptifibatide	EMEA/H/C/004104Eptifibatide Accord is intended for use with acetylsalicylic acid and unfractionated heparin.Eptifibatide Accord is indicated for the prevention of early myocardial infarction in adults presenting with unstable angina or non-Q-wave myocardial infarction, with the last episode of chest pain occurring within 24 hours and with electrocardiogram (ECG) changes and/or elevated cardiac enzymes.Patients most likely to benefit from Eptifibatide Accord treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early PTCA (Percutaneous Transluminal Coronary Angioplasty).	Authorised	yes	no	no	2016-01-11
GlaxoSmithKline (Ireland) Limited	Integrilin	eptifibatide	EMEA/H/C/000230Integrilin is intended for use with acetylsalicylic acid and unfractionated heparin.Integrilin is indicated for the prevention of early myocardial infarction in patients presenting with unstable angina or non-Q-wave myocardial infarction with the last episode of chest pain occurring within 24 hours and with ECG changes and / or elevated cardiac enzymes.Patients most likely to benefit from Integrilin treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early percutaneous transluminal coronary angioplasty (PTCA).	Authorised	no	no	no	1999-07-01

Last updated: July 26, 2026

EPTIFIBATIDE market dynamics and financial trajectory (2025 outlook)

Executive summary: Eptifibatide (Integrilin, IV glycoprotein IIb/IIIa inhibitor) is a mature, low-growth hospital-only product with declining demand from guideline and practice shifts toward alternative antiplatelet strategies and newer procedural pathways. Commercial revenue remains concentrated in acute-care geographies where branded access persists and generics are not fully suppressing price. The financial trajectory is characterized by: (1) shrinking addressable use in ACS/PCI as monotherapy and P2Y12-centered regimens expanded, (2) aggressive price compression where generic competition is present, and (3) episodic stability driven by large tertiary hospital tender cycles rather than sustained volume growth.

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Is eptifibatide still selling in 2025 and how fast is demand declining?

Featured snippet: Demand for eptifibatide is largely hospital/tender-driven and has trended down versus earlier years due to utilization erosion in ACS and PCI as care pathways shifted.

What clinical uses drive eptifibatide demand

Eptifibatide is used to inhibit platelet aggregation via the GP IIb/IIIa receptor, with principal indications in:

• ACS/UA/NSTEMI settings where PCI is planned or occurring (commonly with heparin and aspirin).
• PCI to reduce ischemic complications in selected high-risk patients.

Demand is sensitive to:

• PCI volumes (overall procedure volume is stable to modestly growing in many markets, but use of IIb/IIIa agents is lower).
• Guideline adherence and cath-lab protocols.
• Availability of alternative agents (short-acting IV antiplatelets, upstream potent P2Y12 use, and institutional formulary preferences).

Practice and guideline dynamics affecting utilization

Key drivers behind utilization pressure:

• Higher baseline potency upstream: more patients receive potent P2Y12 inhibitors before and during PCI workflows, reducing incremental benefit perceived from GP IIb/IIIa inhibitors.
• Risk stratification tightening: hospitals apply more selective criteria for IIb/IIIa use to limit bleeding risk and simplify post-procedure antithrombotic regimens.
• Bleeding management constraints: shorter infusion protocols and reduced use where bleeding risk is high.

Where demand has held up better

• High-volume cath centers with entrenched IV GP IIb/IIIa protocols.
• Tender markets that still support branded supply or limited generic penetration.
• Periods when procedural volumes spike (seasonal variations in cath throughput in some regions).

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How do competition and generic pressure affect Integrilin pricing and margins?

Featured snippet: Price compression and tender-led contracting drive margin pressure more than volume growth. Branded eptifibatide faces direct cost pressure where approved generics are available and formularies shift.

Generic substitution mechanics in hospital procurement

Hospitals typically contract eptifibatide through:

• National and regional purchasing organizations.
• Framework agreements with volume commitments.
• Tender bids that favor lowest-cost equivalent supply.

When a generic product gains traction, pricing declines generally outpace any offset from incremental prescribing.

Margin implications

• Branded manufacturer margins compress after sustained formulary inclusion of generics.
• Switching cycles are multi-quarter because switching requires protocol changes, inventory management, and staff retraining.
• Product lifecycle maturity means no meaningful cost-offsets from new indications or delivery system differentiation (eptifibatide is a standardized IV infusion therapy).

Tender cycle timing that moves revenue

• Revenue is often lumpy: hospital renewals and tender awards can swing quarterly shipments.
• Brand resilience depends on contract grandfathering and supplier performance metrics.

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What product mix and procurement cycles shape eptifibatide’s financial trajectory?

Featured snippet: Financial trajectory is driven by hospital contract cycles and the proportion of patients treated in cath-lab pathways where IIb/IIIa inhibitors remain part of protocol.

Key demand determinants

• Hospital cath-lab utilization: higher PCI volume increases opportunity.
• Use rate within PCI/ACS pathways: a lower IIb/IIIa share reduces the addressable use.
• Patient selection: high-risk cohorts and procedure complexity affect the proportion treated.
• Inventory management: lead times and shelf-life constraints affect purchasing timing.

Revenue shape

• Declining baseline from reduced prescribing.
• Quarterly variability from tender renewals and hospital stocking decisions.
• Limited upside because eptifibatide does not capture new therapeutic segments at scale.

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What are the major revenue risks for eptifibatide: guideline drift, bleeding, or competition?

Featured snippet: Competition and guideline drift are the dominant, recurring risks; bleeding risk is a utilization lever that can accelerate de-emphasis during restrictive protocols.

1) Guideline drift and protocol substitution

Risks:

• continued movement to alternative antiplatelet approaches where IIb/IIIa is used less often.
• protocol simplification reducing infusion steps.

Impact:

• structural demand downshift.
• reduced peak utilization during unstable periods, because fewer patients qualify.

2) Generic competition and tender repricing

Risks:

• expanding generic footprint in key geographies.
• price erosion through multi-source contracting.

Impact:

• gross margin compression.
• revenue decline even where volume is stable.

3) Safety-related utilization constraints

Risks:

• bleeding risk management leads to stricter eligibility.
• staff and institutional policies respond to adverse event trends and internal audits.

Impact:

• “eligible population” shrinks.
• length of infusion and concomitant anticoagulant/antiplatelet regimen adjustments can reduce use.

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How does eptifibatide compare with other GP IIb/IIIa inhibitors on market dynamics?

Featured snippet: The GP IIb/IIIa class is broadly mature and exposed to similar guideline-driven utilization decreases; differentiation is mainly about availability, pricing, and protocol fit.

Comparables

• Abciximab (class member with different profile and usage pattern).
• Tirofiban (class member with different dosing/protocol fit).
• Eptifibatide competes for a subset of ACS/PCI patients within hospital formularies.

Competitive effects

• If a hospital standardizes on another IIb/IIIa agent, it can reduce eptifibatide usage quickly through formulary substitution.
• If the class share declines overall, all members face volume pressure.

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What regulatory status and supply access issues affect eptifibatide commercialization?

Featured snippet: Eptifibatide’s regulatory positioning is mature; supply and contract continuity dominate near-term commercialization rather than new regulatory approvals.

FDA and label-driven utilization

In the US, prescribing follows label and hospital protocol alignment with labeled populations. For mature products, utilization is driven more by:

• institutional clinical pathways,
• procurement and stocking,
• pharmacy and therapeutics committee decisions.

Global access

In many markets, commercialization depends on:

• local approval status of innovator and generics,
• import logistics and tender frameworks,
• reimbursement policies for hospital drugs.

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What is the patent and exclusivity posture that shapes future pricing power?

Featured snippet: Pricing power for eptifibatide is constrained by the mature lifecycle and the likelihood that most meaningful exclusivity has already elapsed.

Lifecycle implication for financial trajectory

• Once exclusivity ends, revenue is heavily exposed to generics.
• Future financial trajectory is therefore dominated by generic penetration depth and contract renegotiation behavior.

(Note: A full patent estate mapping is not provided here because the prompt requests market dynamics and financial trajectory, and no specific jurisdictional patent inventory is included in the available input.)

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How sensitive is eptifibatide revenue to ACS/PCI procedure volumes?

Featured snippet: Revenue is correlated with ACS/PCI activity but more elastic to IIb/IIIa utilization share than to absolute procedure growth.

Elasticity framework

• High elasticity to protocol share: small changes in IIb/IIIa adoption rates can materially shift treated patient counts.
• Moderate elasticity to procedure volume: procedure counts can rise, but adoption declines can offset.

Where incremental demand could come from

• targeted adoption in high-risk PCI workflows where hospitals perceive benefit.
• changes in reimbursement or formulary incentives favoring certain suppliers.

These are typically slow-moving and contract-dependent.

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What settlement, litigation, or regulatory enforcement factors can disrupt supply and sales?

Featured snippet: Disruptions are more likely from manufacturing supply constraints or procurement action than from typical lifecycle innovation events, given the maturity of eptifibatide.

Common disruption vectors in mature injectables

• manufacturing capacity constraints for sterile IV products
• batch release timelines
• quality events leading to temporary supply restrictions
• tender re-awards that temporarily shift market share

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Key market scenarios: what generic launch outcomes are most likely?

Featured snippet: The most likely future outcome is continued price compression without meaningful sustained volume recovery for the originator.

Scenario A: gradual generic share increase

• Originator loses share in tender renewals.
• Market volume shifts to lower-cost suppliers.
• Net effect: revenue declines faster than procedure volume growth.

Scenario B: rapid tender repricing in major regions

• Multiple suppliers become co-listed.
• Competitive bidding drives steeper price drops.
• Net effect: originator revenue compresses sharply, margins deteriorate.

Scenario C: branded resilience via contract carve-outs

• Some hospitals continue to buy branded due to supply reliability or protocol standardization.
• Net effect: revenue declines slower than in markets with immediate generic switching.

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Commercial outlook: what does the financial trajectory imply for stakeholders?

Featured snippet: Eptifibatide is better positioned for steady supply and contract execution than for growth-oriented investment; value is concentrated in procurement cycles and cost positioning.

Implications for investors and licensors

• Base-case is declining or low-single-digit market growth with margin pressure.
• Value creation concentrates in:
  • manufacturing efficiency,
  • tender competitiveness,
  • minimizing supply disruptions.

Implications for generics and biosimilar-style strategy (not applicable)

• Unlike biologics, eptifibatide does not have “biosimilar-like” pathways.
• Competitive advantage is operational:
  • sterile manufacturing scale,
  • robust regulatory and quality record,
  • ability to meet tender volume commitments.

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Key Takeaways

• Eptifibatide demand is mature and hospital-protocol driven, with structural utilization pressure as ACS/PCI care pathways shift away from routine GP IIb/IIIa use.
• Financial trajectory is dominated by tender-led price compression and generic substitution, not by volume expansion.
• Revenue sensitivity is higher to IIb/IIIa adoption share within PCI/ACS than to absolute procedure growth.
• Near-term disruption risk is more supply and procurement driven than from regulatory novelty.

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FAQs

1. What hospital formularies most influence eptifibatide purchasing?
   Regional group purchasing organizations and cath-lab therapeutics committees, especially in high-PCI-volume systems.

2. How does eptifibatide utilization differ between NSTEMI and PCI workflows?
   Utilization tends to cluster in high-risk PCI planned/ongoing pathways where clinicians keep GP IIb/IIIa inhibitors within established infusion protocols.

3. What procurement strategy reduces total cost for eptifibatide in hospitals?
   Competitive tendering with multi-source contracting and standardized preparation/administration workflows to reduce waste and dosing variability.

4. Does eptifibatide revenue move more with price or volume?
   Typically more with price and contract share because adoption rates decline gradually while tender repricing can rapidly reset net pricing.

5. What is the biggest barrier to growth for eptifibatide?
   Protocol de-emphasis and guideline-aligned substitution patterns that reduce eligible patient share over time.

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References

(No sources were provided in the prompt, and none are included here.)