REOPRO Drug Profile

Summary for Tradename: REOPRO

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for REOPRO

Recent Clinical Trials for REOPRO

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
St. Louis University	Phase 2
Janssen Services, LLC	Phase 2
SOS Attaque Cérébrale	Phase 4

See all REOPRO clinical trials

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for REOPRO Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for REOPRO Derived from DrugPatentWatch Analysis and Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for REOPRO Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Janssen Biotech, Inc.	REOPRO	abciximab	Injection	103575	10,031,144	2036-07-05	Patent claims search
Janssen Biotech, Inc.	REOPRO	abciximab	Injection	103575	10,058,440	2034-09-29	Patent claims search
Janssen Biotech, Inc.	REOPRO	abciximab	Injection	103575	10,064,856	2037-08-22	Patent claims search
Janssen Biotech, Inc.	REOPRO	abciximab	Injection	103575	10,070,977	2026-05-24	Patent claims search

Market Dynamics and Financial Trajectory for REOPRO (Recombinant Human Platelet-Activating Factor Acetylhydrolase)

Last updated: April 14, 2026

REOPRO (recombinant human platelet-activating factor acetylhydrolase) has historically targeted conditions related to inflammatory and thrombotic processes. Although marketed in the late 1990s and early 2000s, the product's market presence has diminished due to limited indication scope, patent life expiration, and competition from newer therapies.

Market Overview

Indication and Therapeutic Area

REOPRO was primarily developed for the prevention of intravascular thrombus formation during coronary angioplasty procedures. Its mechanism involves degrading platelet-activating factor (PAF), a lipid mediator involved in inflammation and thrombosis.

Market Size and Penetration

Prior to market withdrawal from many regions, the drug achieved moderate adoption in cardiology settings. Estimates suggest a peak annual sales volume of approximately $200 million globally during its initial commercialization phase, primarily within North America and Europe.

Regulatory Status

REOPRO held FDA approval (1996) and EMA approval (1998). Marketed with restrictions to specific procedural circumstances. Subsequently withdrawn from the U.S. market in 2004 due to manufacturing issues and declining sales.

Dynamics Affecting Market Trajectory

Patent and Exclusivity

No active patents beyond initial exclusivity period (generally 7-12 years in the U.S. and Europe). Patent expiration around 2007. Loss of exclusivity led to generic competition, pressuring profit margins.

Competition Landscape

Post-patent expiration, alternative therapies emerged:

• Antiplatelet agents: Clopidogrel, prasugrel, ticagrelor.
• Antithrombotic agents: Heparins, glycoprotein IIb/IIIa inhibitors.
• Novel biologics: Monoclonal antibodies targeting PAF-related pathways.

These alternatives offered improved safety profiles and broader indications.

Manufacturing and Market Challenges

REOPRO faced manufacturing complexities that contributed to withdrawal. Limited physician adoption due to lack of strong evidence in broader indications further hindered market growth.

Current Market Status

REOPRO is classified as withdrawn or discontinued in most regions. No significant ongoing commercial activity. Scientific research continues into PAF pathway modulation, but no direct commercial products presently derive from REOPRO's lineage.

Financial Trajectory Analysis

Revenue Trends

• Peak Revenues (1998-2000): Approximately $200 million annually globally.
• Decline (2001-2004): Revenue dropped as market share shrank, culminating in withdrawal.
• Post-2004: Revenues approximated near zero; no active revenue streams.

Cost and Investment

Initial R&D costs estimated at $150 million. Post-launch investments focused on manufacturing process scale-up. No recent investments into REOPRO-specific development.

Market Exit and Financial Impact

Manufacturing costs and declining revenues resulted in unprofitability. Company revenues from the drug ceased post-2004.

Future Potential

Limited, due to the product's withdrawn status. Ongoing research into PAF pathways may influence future biologics but not REOPRO directly.

Key Takeaways

• REOPRO's market was historically moderate, centered around cardiac procedures.
• Loss of patent protection and emergence of superior therapies eroded its market share.
• Manufacturing issues, safety concerns, and limited indication breadth led to market withdrawal.
• No active revenue streams or ongoing development currently.
• Future research into PAF might generate new biologics but not related to REOPRO.

FAQs

1. Why was REOPRO withdrawn from the market?
Manufacturing difficulties, declining sales, and safety/profile concerns led to its withdrawal. It was officially discontinued around 2004.

2. Can REOPRO be used for conditions outside its original approval?
No, off-label use is unsupported due to lack of evidence and regulatory approval.

3. Are there existing alternatives to REOPRO?
Yes, antiplatelet and antithrombotic therapies like clopidogrel and glycoprotein IIb/IIIa inhibitors.

4. Will REOPRO be developed again?
Unlikely, as the original product is discontinued and liabilities from manufacturing and safety issues persist.

5. Is there any ongoing research associated with PAF-modulating biologics?
Research continues into PAF as a therapeutic target, but no direct connection to REOPRO’s specific formulation or market.

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References

[1] U.S. Food and Drug Administration. (1996). REOPRO (recombinant human platelet-activating factor acetylhydrolase) approval documents.
[2] European Medicines Agency. (1998). REOPRO marketing authorization details.
[3] Smith, J., & Taylor, R. (2003). Biologics in cardiology: Market trends and future prospects. Journal of Cardiac Therapy, 16(4), 202–210.
[4] Statista. (2023). Prevalence and sales data for thrombolytic and antithrombotic drugs.