INTEGRILIN Drug Patent Profile

When do Integrilin patents expire, and what generic alternatives are available?

Integrilin is a drug marketed by Msd Sub Merck and is included in one NDA.

The generic ingredient in INTEGRILIN is eptifibatide. There are fifteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the eptifibatide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Integrilin

A generic version of INTEGRILIN was approved as eptifibatide by TEVA PHARMS USA on June 12^th, 2015.

Summary for INTEGRILIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	16
Patent Applications:	6,271
Drug Prices:	Drug price information for INTEGRILIN
What excipients (inactive ingredients) are in INTEGRILIN?	INTEGRILIN excipients list
DailyMed Link:	INTEGRILIN at DailyMed

See drug prices for INTEGRILIN

Recent Clinical Trials for INTEGRILIN

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

Sponsor	Phase
Baylor College of Medicine	Phase 1/Phase 2
Sisse R. Ostrowski, MD PhD DMSc	Phase 2
University of Alabama at Birmingham	Phase 2

See all INTEGRILIN clinical trials

Paragraph IV (Patent) Challenges for INTEGRILIN

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 INTEGRILIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-001	May 18, 1998		DISCN	Yes	No
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-002	May 18, 1998		DISCN	Yes	No

Expired US Patents for INTEGRILIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-002	May 18, 1998	5,686,570
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-001	May 18, 1998	5,686,570
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-001	May 18, 1998	5,756,451
Msd Sub Merck	INTEGRILIN	eptifibatide	INJECTABLE;INJECTION	020718-001	May 18, 1998	5,968,902

EU/EMA Drug Approvals for INTEGRILIN

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

International Patents for INTEGRILIN

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

Country	Patent Number	Title	Estimated Expiration
Austria	146969
Australia	6036990
Australia	636159
Canada	2059124	INHIBITEURS D'AGREGATION DE PLAQUETTES (PLATELET AGGREGATION INHIBITORS)

Supplementary Protection Certificates for INTEGRILIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0477295	SPC/GB99/046	United Kingdom		PRODUCT NAME: EPTIFIBATIDE OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: CH 54054 19970227; CH 54050 19970227; UK EU/1/99/109/001 19990701; UK EU/1/99/109/002 19990701
0477295	C990043	Netherlands		PRODUCT NAME: EPTIFIBATIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NAT. REGISTRATION NO/DATE: EU/1/99/109/001 - EU/1/99/109/002 19990701; FIRST REGISTRATION: CH 54050, 54054 19970227
0477295	51/1999	Austria		PRODUCT NAME: EPTIFIBATID ODER PHARMAZEUTISCH ANNEHMBARE SALZE HIEVON; NAT. REGISTRATION NO/DATE: EU/1/99/109/001 EU/1/99/109/002 19990701; FIRST REGISTRATION: LI 54050 UND 54054 19970227

Last updated: June 26, 2026

INTEGRILIN Market Dynamics and Financial Trajectory: Sales Trend, Share Shifts, Exclusivity, and Generic/Biosimilar Pressure

INTEGRILIN (eptifibatide) is an established inpatient antiplatelet used for acute coronary syndromes and PCI in hospital settings. Commercial trajectory is shaped by (1) hospital formulary behavior and protocol standardization around bivalirudin versus GP IIb/IIIa inhibitors, (2) the timing and depth of exclusivity/patent coverage for eptifibatide and its manufacturing process, and (3) persistent exposure to low-cost generic competition once chemical and formulation protections lapsed. Net sales have remained supportable primarily through institutional demand, guideline-driven use in selected workflows, and contracting dynamics with large distributors and IDNs rather than sustained premium pricing.

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What is INTEGRILIN’s current market position and who competes with it?

Competitive set (functional class):

• Other GP IIb/IIIa inhibitors:
  • abciximab (ReoPro, Centocor)
  • tirofiban (Aggrastat, late 1990s approvals)
• Direct competitor with material substitution behavior:
  • bivalirudin (Angiomax)

How the competitive dynamic works in hospitals:

• GP IIb/IIIa inhibitors are typically deployed in acute catheterization workflows where rapid platelet inhibition is needed, often in specific PCI and ACS pathways.
• Over time, many centers shifted toward bivalirudin (with heparin/other adjuncts) to reduce bleeding and simplify infusion protocols, especially as evidence accumulated that bleeding outcomes were improved in broader populations.
• Within GP IIb/IIIa inhibitors, product switching tends to track contract pricing, formulary preference, and inventory logistics, since efficacy differences between agents are narrower than the economic delta at scale for procurement organizations.

Buyer behavior that drives share:

• Group purchasing organizations (GPOs) and IDNs negotiate class contracts where a single agent can be favored.
• Tender cycles and rebate structures can shift volume quickly once a generic is available or when a rival’s acquisition/contracting strategy improves.

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How large is the INTEGRILIN market and what demand drivers sustain volume?

Core demand drivers:

• Inpatient use in PCI and acute coronary syndrome (ACS) pathways.
• Continued reliance in settings where clinicians prefer GP IIb/IIIa intensification over alternative anticoagulant/antiplatelet regimens for defined subpopulations.
• Stability tied to national cath lab volumes and ACS incidence, but offset by workflow substitution to bivalirudin and institutional protocol changes.

Practical market sizing mechanics:

• The market is concentrated in large hospitals where cath labs run at scale.
• Demand is less “dispensing-optimized” (retail) and more “protocol-optimized” (inpatient drug choice per case).
• As a result, market growth is slower than drugs driven by broader outpatient utilization, and it is more vulnerable to guideline and protocol shifts.

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What do prescribing and guideline trends do to INTEGRILIN volumes?

Directional impact:

• GP IIb/IIIa inhibitors have seen long-run substitution pressure from bivalirudin in many PCI/ACS workflows due to bleeding tradeoffs and regimen convenience.
• Even when used, adoption can be “selective” rather than routine, limiting peak sales.

Hospital formulary reality:

• Formularies often keep at least one GP IIb/IIIa option as a backstop for high-risk cases, but may reduce share for each member depending on contract terms and local clinical champions.

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When did exclusivity end for INTEGRILIN, and when do generic launches become feasible?

Feasibility timeline framework:
Generic availability is driven by the expiration of:

1. composition-of-matter patents on eptifibatide, and/or
2. formulation and manufacturing process patents, and
3. any regulatory exclusivities that apply to the approved drug product.

Once those are cleared, generics can launch via abbreviated pathways (typical for small molecules after patent expiry), subject to bioequivalence and labeling comparability.

Commercial implication:

• For products like INTEGRILIN, the moment generic competition becomes viable is typically when pricing compresses, margins fall, and procurement shifts to the lowest-cost supplier that meets supply assurance requirements.

(Note: the exact exclusivity end-date depends on the Orange Book patent expiry calendar for the specific NDA product and listed patents; a complete, accurate date-by-date timeline requires that Orange Book listing data be provided.)

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What patents protect INTEGRILIN and how does the patent estate affect pricing?

INTEGRILIN’s patent estate historically covers several layers:

• Active ingredient claims (eptifibatide itself)
• Formulation claims (stability, composition, and delivery system attributes for IV administration)
• Manufacturing/process claims (synthetic route steps, purification, intermediates, or critical process parameters)

How these claims affect competition:

• If composition-of-matter protections expire first, generic entrants may launch quickly for standard dosage forms.
• If formulation or process patents remain, companies may delay entry or launch only products that “design around” remaining claims, sometimes limiting the earliest entry and preserving a higher price band temporarily.

(A complete, accurate count of patents and their expiry dates requires the specific Orange Book patent list for INTEGRILIN’s NDA and the associated assignees.)

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What is the Orange Book status of INTEGRILIN and what does it imply for generic entry risks?

Orange Book status determines whether generic applicants can rely on “patent certifications” that trigger litigation and whether entry is blocked by unexpired patents. Key elements include:

• Patent listing types (drug substance, drug product, method-of-use)
• Patent expiry dates
• Whether the listed patents have triggered Paragraph IV litigation

Generic entry risk channels:

• Patent infringement risk if a generic’s product falls within an unexpired claim scope.
• Delays if the NDA holder wins or if a settlement includes “authorized generic” or non-compete style entry windows.

(A full Orange Book map cannot be produced without the NDA-specific listed patent numbers and expiries.)

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What INTEGRILIN patent litigation and Paragraph IV challenges have occurred?

GP IIb/IIIa inhibitor generics commonly face a mix of:

• Paragraph IV certifications against drug product and process patents
• One or more settlements that govern timing for full commercialization
• Injunction or “stay” effects while litigation proceeds

Litigation outcome impact on the market:

• If a generic is enjoined or settles with delayed entry, the incumbent can preserve sales for longer and often maintains better contracting leverage.
• If multiple generics enter without long delays, pricing compresses and the market concentrates around the fastest-to-volume and strongest-supply bidders.

(A complete litigation history with case numbers and settlement dates requires the underlying court dockets tied to INTEGRILIN’s specific NDA and patent list.)

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How do settlement agreements typically affect INTEGRILIN’s financial trajectory post-generic entry?

When settlements are reached, they typically influence:

• Earliest launch date for generic products
• Whether the NDA holder supplies product during a carve-out period
• Authorized generic arrangements
• Exclusivity windows for specific strengths, pack sizes, or label versions

Financial trajectory effects:

• Revenue typically declines nonlinearly around settlement launch windows.
• The incumbent’s share can drop sharply at launch, then stabilize if supply constraints limit competition or if contracts shift gradually.

(Settlement details are NDA- and case-specific and require case documents tied to INTEGRILIN.)

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What dosing forms and labeling elements drive INTEGRILIN revenue exposure?

For hospital-only injectables, revenue exposure tends to be dominated by:

• Dosage strength availability
• Pack/kit format and distribution model (direct-to-hospital logistics vs distributor coverage)
• Labeling inclusion for specific PCI/ACS indications that map to protocol use

Because inpatient drug choice is protocol driven, small label changes can shift adoption only if they align with local guideline pathways. Still, label breadth can matter for payer and clinical pathway coverage.

(A complete revenue mapping by strength and label requires the product’s specific formulation and strength presentation details from labeling and/or claims datasets.)

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How does INTEGRILIN compare with bivalirudin and other GP IIb/IIIa inhibitors on commercial outcomes?

Commercial comparison logic:

• Bivalirudin has often faced stronger adoption due to bleeding profile and ease of use, which can translate into larger share in many PCI protocols.
• Abciximab and tirofiban compete on local preference, evidence interpretation, and contracting.

Relative market impacts commonly observed in practice:

• When bivalirudin is preferred by protocol, GP IIb/IIIa inhibitor sales can plateau or decline even as cath volumes grow.
• When GP IIb/IIIa inhibitors are kept as a secondary option, sales can persist through “high-risk” utilization but lose broad share.

(Quantitative sales comparisons require pulling unit/sales data across these products, which is not provided here.)

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What manufacturing and supply-chain barriers shape INTEGRILIN pricing and availability?

In sterile injectables, supply matters as much as legal market access:

• Sterile manufacturing capacity and validation lead times
• Quality system compliance and batch release reliability
• Distribution contracting that favors suppliers with high fill-rate history

When supply is stable, generics can erode incumbent pricing quickly. When supply is constrained, pricing can stay higher and market share can be fragmented across fewer suppliers.

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What financial trajectory should investors expect from INTEGRILIN given its competitive structure?

Base-case trajectory pattern (typical for mature hospital injectables facing generic entry):

• Revenue holds first through institutional loyalty and procurement inertia.
• A step-down occurs around generic launch windows tied to patent expiry and litigation outcomes.
• Subsequent declines slow as the market stabilizes among a few low-cost suppliers and contracts re-optimize.

Why trajectory differs from retail drugs:

• Inpatient purchasing has fewer product substitutions per patient cycle than outpatient dispensing has per prescription.
• However, once contracts switch, volume follows quickly because the cath lab ordering process is streamlined.

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Key tables: Market dynamics and exclusivity drivers for INTEGRILIN

Market forces checklist

Driver	Mechanism	Likely effect on INTEGRILIN revenue
Protocol shift to bivalirudin	Reduced routine GP IIb/IIIa use in PCI/ACS pathways	Downward pressure on volume
Hospital contracting	GPO/IDN tenders select lowest-cost, reliable suppliers	Margin compression, share swings
Patent expiry	Enables generic entry	Step-down in pricing and sales
Litigation timing	Delays entry when Paragraph IV challenges succeed or settle	Temporary revenue protection
Sterile supply reliability	Quality failures constrain supply, limit competition	Can stabilize pricing if competitors are constrained

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Key Takeaways

• INTEGRILIN’s market is hospital-protocol driven, where GP IIb/IIIa inhibitor use can be reduced by substitution toward bivalirudin and driven by IDN contracting cycles.
• The financial trajectory is most sensitive to legal entry timing (patent expiry, Paragraph IV litigation, and settlements) because pricing typically compresses quickly after generic availability.
• Long-run share is shaped less by outpatient brand demand and more by procurement and cath lab protocol standardization.

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FAQs

1) What is INTEGRILIN used for in hospital cath lab workflows?
It is an IV GP IIb/IIIa inhibitor used in ACS and PCI contexts per approved labeling and protocol selection.

2) Does INTEGRILIN face substitution from bivalirudin at the formulary level?
Yes. Many hospitals shift routine PCI/ACS workflows toward bivalirudin, leaving GP IIb/IIIa inhibitors as a more selective option.

3) What are the main risk factors for generic entry timing for INTEGRILIN?
Remaining drug substance, drug product, and process patents; plus Paragraph IV litigation and settlement terms.

4) What drives pricing after generic launch for hospital injectables like INTEGRILIN?
Low-cost procurement via tenders, contracting structure, and supply reliability rather than patient-level switching.

5) How do sterile manufacturing constraints affect competitive outcomes for INTEGRILIN generics?
Batch release timelines, sterility validation, and supply continuity can limit the speed and breadth of competitive entry, affecting price erosion pace.

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References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (U.S. FDA database).
2. FDA. eDRUG and labeling repository for INTEGRILIN (eptifibatide) NDA product. (U.S. FDA database).