Aprotinin - Biologic Drug Details

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Summary for aprotinin

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

Recent Clinical Trials for aprotinin

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion	PHASE3
Zagazig University	NA
Children's Cancer Hospital Egypt 57357	Phase 3

See all aprotinin 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:

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.

DrugPatentWatch analysis and brand-side disclosures

These patents were identified from searching 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.

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 aprotinin Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Aprotinin

Last updated: February 15, 2026

Aprotinin is a polypeptide-based serine protease inhibitor primarily used to reduce perioperative bleeding in cardiac surgery. It was historically marketed under the brand name Trasylol, developed by Bayer, and later acquired by FMC Corporation before its market withdrawal. The drug's market dynamics have shifted significantly due to safety concerns and regulatory actions.

What Are the Key Market Factors Affecting Aprotinin?

Historical Market Presence:
Aprotinin gained approval in multiple markets during the 1980s and 1990s for reducing bleeding during high-risk cardiac surgeries. The drug's utilization peaked in the late 1990s and early 2000s.

Safety Concerns and Regulatory Bans:
In 2007, studies raised concerns over increased risks of renal failure, myocardial infarction, stroke, and mortality associated with aprotinin. The subsequent interim and final analyses prompted regulatory agencies like the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) to restrict or suspend its use.

FDA issued a boxed warning and withdrew approval in 2007.
EMA withdrew approval in 2008, classifying aprotinin as non-essential.

Market Withdrawal and Discontinuation:
Following these actions, global sales plummeted. Bayer discontinued Trasylol in 2008, and FMC exited the market in 2014, leaving limited residual use in specific regions or investigational settings.

How Has the Market Evolved Post-Withdrawal?

Current Market Composition:
The market for aprotinin has largely collapsed. Some niche or compounding pharmacies may produce or stock it outside regulatory oversight. Clinical trial pipelines occasionally explore derivatives or similar agents with improved safety profiles but no significant commercial alternatives have emerged.

Emerging Alternatives:
Several antifibrinolytic agents are now preferred, including:

Tranexamic acid (TXA)
Epsilon-aminocaproic acid (EACA)

These drugs have demonstrated efficacy in reducing bleeding with better safety profiles. The shift towards these agents has further diminished aprotinin’s market share.

Legal and Insurance Factors:
Lawsuits related to aprotinin's adverse effects led to costly settlements and increased scrutiny. Many hospitals and clinicians shifted away from its use, influencing procurement and insurance reimbursement policies.

What Is the Financial Trajectory of Aprotium?

Pre-2007 Financials:
Prior to the regulatory issues, aprotinin generated annual global sales estimated at over $250 million (2006 figure). Bayer and FMC reported revenues from Trasylol at their peak, with Bayer accounting for a significant portion.

Post-2007 Decline:
Following safety concerns and withdrawal, sales declined sharply:

Bayer ceased marketing in 2008; reported annual sales dropped below $50 million prior to withdrawal.
FMC exited early, with minimal residual sales post-2014.

Remaining Market and Investigational Use:
Aprotinin's current market value is negligible. Any existing transactions are limited to research, compounding, or unregulated supplies, making the drug a negligible financial asset.

Potential for Resurgence:
Regulatory bans and safety issues are challenging to reverse without clear evidence of improved safety profiles. Investment in derivative development or new formulations faces high regulatory and legal barriers.

What Are the Regulatory and Legal Risks?

Ongoing litigation related to aprotinin’s adverse event profile sustains negative perception.
Reintroduction would require extensive clinical trials to establish safety, delaying market access and increasing costs.
Regulatory agencies maintain strict stances based on existing safety concerns.

Summary of Market and Financial Outlook

Aspect	Status/Forecast	Remarks
Historical Revenue	$250 million (pre-2007)	Peak sales in late 1990s-early 2000s
Current Sales	Negligible	Due to regulatory bans and safety issues
Market Entry Potential	Low	Safety concerns persist; few prospects for re-approval
Alternative Agents	Growing	Tranexamic acid dominates now
Legal and Reputational Risks	High	Litigation and safety record impact potential reintroduction

Key Takeaways

Aprotinin’s market ceased to exist as a pharmaceutical product post-2008 due to safety concerns.
The drug’s peak sales exceeded $250 million annually; current revenues are negligible.
The shift toward safer antifibrinolytics has eliminated significant market share for aprotinin.
Legal liabilities and regulatory restrictions impede re-entry into the market.
Future financial prospects for aprotinin are limited absent significant safety profile improvements.

FAQs

1. Could aprotinin return to the market?
Unlikely without substantial evidence demonstrating safety improvements, regulatory approval, and resolution of legal liabilities.

2. Are any derivatives or new formulations being developed?
Research into safer protease inhibitors continues, but none have reached commercial viability or regulatory approval.

3. How do antifibrinolytics compare financially?
Agents like tranexamic acid are significantly cheaper, safer, and widely used, leading to stable revenue streams and market dominance.

4. What legal liabilities exist for companies involved?
Multiple lawsuits and class actions linked to aprotinin’s adverse event profile have resulted in settlements and increased legal scrutiny.

5. Are hospitals still using aprotinin off-label?
Limited niche use occurs in some regions or specific cases, often outside regulatory approval, but overall utilization is minimal.

References

[1] U.S. Food and Drug Administration. "FDA approves label change to update warning about Trasylol (aprotinin) and kidney failure risk." 2007.
[2] European Medicines Agency. "Chmp recommends suspension of Trasylol (aprotinin)." 2008.
[3] Bayer AG. Annual Reports (1998-2008).
[4] FMC Corporation. Annual Reports (2008-2014).
[5] ClinicalTrials.gov. "Aprotinin in Cardiac Surgery." Data on investigational studies.

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