Aprotinin - Biologic Drug Details

Summary for aprotinin

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for aprotinin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for aprotinin

Recent Clinical Trials for aprotinin

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Children's Cancer Hospital Egypt 57357	Phase 3
Aviron LLC	N/A
Northwestern University	Early Phase 1

See all aprotinin clinical trials

Recent Litigation for aprotinin

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
DNA Genotek Inc. v. Spectrum Solutions LLC	2023-06-14
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN LTD.	2023-01-19
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-11-10

See all aprotinin litigation

PTAB Litigation

Petitioner	Date
	2013-07-15

See all aprotinin litigation

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. General 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.

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 aprotinin Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for aprotinin Derived from 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 the Biologic Drug: Aprotinin

Introduction to Aprotinin

Aprotinin is a broad-spectrum inhibitor of human proteases, primarily used in the medical field to treat bleeding, particularly in surgical procedures such as coronary artery bypass surgery. Its pharmacodynamic actions include antiviral, anti-inflammatory, and thromboinflammatory activities, making it a versatile biologic drug[1].

Market Size and Growth

The global aprotinin market has been experiencing significant growth. As of 2023, the market size was estimated to be around USD 184.9 billion, and it is projected to reach USD 277.2 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 4.6% during this period[3].

Drivers of Market Growth

Several factors are driving the growth of the aprotinin market:

Increasing Incidence of Chronic Diseases

The rising incidence of chronic diseases such as cardiovascular disorders, autoimmune disorders, and cancer is increasing the demand for biologic drugs like aprotinin. These conditions often require precise and targeted therapies, which biologics can provide[2].

Advancements in Biotechnology

Continuous advancements in biotechnology, including improvements in drug delivery technologies and the development of new therapeutic indications, are boosting the market. For instance, the use of aprotinin in the treatment of COVID-19 has opened new avenues for its application[1].

Expanding Investments in Research and Development (R&D)

Pharmaceutical companies are investing heavily in R&D to develop new biologic treatments. This includes the development of biosimilars, which are cost-effective alternatives to original biologic drugs, further expanding market access[2][4].

Challenges and Restraints

Despite the growth, the aprotinin market faces several challenges:

High Cost of Development and Production

The complex manufacturing processes and extensive R&D required for biologics result in high production costs, which can be a significant barrier to market expansion[2].

Stringent Regulatory Requirements

Biologics are subject to stringent regulatory requirements, which can slow down the approval process and increase the overall cost of bringing a product to market[2].

Limited Patent Protection

The limited patent protection for biologics makes them vulnerable to biosimilar competition, which can erode market share and revenue[4].

Pharmacokinetics and Administration Routes

Understanding the pharmacokinetics of aprotinin is crucial for its effective use:

Intravenous Administration

Aprotinin is commonly administered intravenously in doses ranging from 1 to 2 million Kallikrein Inhibitor Units (KIU) over 30 minutes, followed by a continuous infusion. It is primarily distributed in the extracellular space and eliminated through renal excretion[1].

Inhalational Administration

Recent studies have explored the inhalational route for aprotinin administration, particularly for treating respiratory conditions like COVID-19. This route achieves sufficient concentrations in the lung to inhibit proteases effectively[1].

Clinical Applications and Efficacy

Aprotinin's clinical applications are diverse:

Bleeding Control in Surgery

Aprotinin is approved for controlling bleeding in single coronary artery bypass surgery and has shown efficacy in reducing blood loss and transfusion requirements[1].

COVID-19 Treatment

Clinical trials have investigated the use of aprotinin in combination with other drugs like favipiravir or hydroxychloroquine for treating COVID-19. The combination with favipiravir showed promising results in improving clinical parameters[1].

Economic Evaluation

The economic evaluation of aprotinin therapy highlights the balance between efficacy and cost:

High-Dose vs. Low-Dose Therapy

High-dose aprotinin is clinically more effective but also more expensive. Low-dose therapy, while less effective, offers greater cost savings, making it a more economical option in some cases[5].

Market Trends and Future Outlook

The biologics market, including aprotinin, is expected to continue growing due to several trends:

Emergence of Biosimilars

Biosimilars are becoming increasingly important, offering cost-effective alternatives to original biologic drugs and enhancing patient access to therapy[4].

Innovation in Drug Delivery Technologies

Advancements in drug delivery technologies are expected to drive industry growth, making biologics more accessible and user-friendly[2][4].

Expanding Therapeutic Indications

The approval of new biologic treatments, including gene therapies and RNA-based therapies, is projected to drive market expansion. The success of mRNA COVID-19 vaccines has highlighted the potential of RNA-based therapeutics[4].

Key Players and Collaborations

The biologics market, including aprotinin, involves several key players and collaborations:

Pharmaceutical Companies

Companies like Nordic Pharma S.A.U. and others are involved in the development and distribution of aprotinin. Collaborations and partnerships among pharmaceutical companies are common to maximize profits and mitigate the risks of biosimilar competition[1][4].

Conclusion

The market dynamics for aprotinin are driven by its versatile pharmacodynamic actions, increasing demand due to chronic diseases, and advancements in biotechnology. Despite challenges such as high production costs and stringent regulatory requirements, the market is expected to grow significantly. The emergence of biosimilars, innovations in drug delivery technologies, and expanding therapeutic indications will continue to shape the future of aprotinin and the broader biologics market.

Key Takeaways

• The global aprotinin market is projected to grow from USD 184.9 billion in 2023 to USD 277.2 billion by 2032.
• Aprotinin's use in treating COVID-19 and other conditions is expanding its market potential.
• High production costs and stringent regulatory requirements are significant challenges.
• Innovations in drug delivery technologies and the emergence of biosimilars are key drivers of market growth.
• Aprotinin's pharmacokinetics and different administration routes (intravenous and inhalational) are crucial for its effective use.

FAQs

1. What is aprotinin used for?

Aprotinin is primarily used to control bleeding in surgical procedures, such as coronary artery bypass surgery, and has also been investigated for treating COVID-19.

2. How is aprotinin administered?

Aprotinin can be administered intravenously or through inhalation. Intravenous administration involves doses ranging from 1 to 2 million KIU, while inhalational administration targets the lungs with doses of 500 KIU every 6 hours.

3. What are the challenges facing the aprotinin market?

The aprotinin market faces challenges such as high production costs, stringent regulatory requirements, and limited patent protection, making it vulnerable to biosimilar competition.

4. How does the emergence of biosimilars impact the aprotinin market?

Biosimilars offer cost-effective alternatives to original biologic drugs like aprotinin, enhancing patient access to therapy but also posing a competitive threat to the original products.

5. What is the future outlook for the aprotinin market?

The aprotinin market is expected to grow due to expanding therapeutic indications, innovations in drug delivery technologies, and the increasing incidence of chronic diseases.

Cited Sources:

1. MDPI: Aprotinin (II): Inhalational Administration for the Treatment of ... - MDPI
2. Biospace: Biologics Market Worth USD 717.0 Billion From 2024 to 2031
3. Business Research Insights: Aprotinin Market Size, Share, Growth, Trends, Forecast Report 2032
4. CAS.org: The Rise of Biologics: Emerging Trends and Opportunities - CAS.org
5. PubMed: Economic evaluation of high-dose and low-dose aprotinin therapy ...

Last updated: 2024-12-17