NOVOEIGHT Drug Profile

Summary for Tradename: NOVOEIGHT

High Confidence Patents:	10
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for NOVOEIGHT

Recent Clinical Trials for NOVOEIGHT

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Novo Nordisk A/S	Phase 1
Novo Nordisk A/S

See all NOVOEIGHT 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 NOVOEIGHT Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466	6,100,061	2018-06-19	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466	6,475,725	2019-06-02	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466	6,936,441	2022-06-12	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466	7,094,574	2025-05-06	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466	8,080,414	2029-06-19	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466	8,084,251	2030-05-12	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466	8,084,252	2030-08-02	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for NOVOEIGHT 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
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466	6,248,363	2019-11-23	Patent claims search
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466	6,309,663	2019-08-17	Patent claims search
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466	6,720,001	2019-10-18	Patent claims search
Novo Nordisk Inc.	NOVOEIGHT	antihemophilic factor (recombinant)	For Injection	125466	9,700,486	2034-04-23	Patent claims search

International Patents for NOVOEIGHT

Country	Patent Number	Estimated Expiration
Russian Federation	2477318
Russian Federation	2493163
South Korea	20100051620
World Intellectual Property Organization (WIPO)	2008135501
Germany	602008005885
Austria	E540975
Poland	2167526

Supplementary Protection Certificates for NOVOEIGHT

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
132014902257593	Italy		PRODUCT NAME: TUROCTOCOG ALFA(NOVOEIGHT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/888, 20131113
C300663	Netherlands		PRODUCT NAME: TUROCTOCOG ALFA, IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/13/888 20131113
1490031-0	Sweden		PRODUCT NAME: TUROKTOKOG ALFA; REG. NO/DATE: EU/1/13/888 20131113
300663	Netherlands		PRODUCT NAME: TUROCTOCOG ALFA; REGISTRATION NO/DATE: EU/1/13/888 20131115
C02167526/01	Switzerland		PRODUCT NAME: TUROCTOCOG ALFA; REGISTRATION NO/DATE: SWISSMEDIC 63014 18.02.2014
14C0037	France		PRODUCT NAME: TUROCTOCOG ALFA; REGISTRATION NO/DATE: EU/1/13/888 20131113
122014000053	Germany		PRODUCT NAME: TUROCTOCOG ALFA; REGISTRATION NO/DATE: EU/1/13/888 20131113

Market Dynamics and Financial Trajectory for NOVOEIGHT

Last updated: April 13, 2026

What is NOVOEIGHT?

NOVOEIGHT (bococizumab) is a monoclonal antibody developed for hypercholesterolemia, specifically targeting PCSK9 to lower LDL cholesterol levels. It was created by Novartis as part of its pursuit of cardiovascular therapies. The drug has shown experimental efficacy in reducing LDL cholesterol but has not received commercial approval or widespread market adoption.

Regulatory Status and Clinical Development

Year	Milestone	Details
2009	Phase 1 trials	Initial safety and dosage evaluation
2012	Phase 2 trials	Improved LDL reduction seen
2015	Phase 3 trials	Multiple large-scale studies
2018	Discontinued development for cardiovascular use	Novartis ceases further development

Novartis halted development of NOVOEIGHT in 2018 following mixed clinical results, high development costs, and competition from other PCSK9 inhibitors.

Market Landscape for PCSK9 Inhibitors

Product	Company	Approval Status	Indications	Annual Revenue (2022)	Mode of Action
Repatha (evolocumab)	Amgen	Approved	Hypercholesterolemia, ASCVD	$3.4 billion	Monoclonal antibody targeting PCSK9
Praluent (alirocumab)	Sanofi/Regeneron	Approved	Hypercholesterolemia, ASCVD	~$1.0 billion	Monoclonal antibody targeting PCSK9
Inclisiran (Leqvio)	Novartis	Approved	Hypercholesterolemia, ASCVD	~$0.3 billion	Small interfering RNA (siRNA)

The global PCSK9 inhibitor market reached approximately $4.8 billion in 2022. Repatha dominates with over 70% market share, while Praluent holds roughly 20%, with Inclisiran gaining early traction.

Market Drivers and Challenges

Drivers

• Increasing prevalence of hypercholesterolemia and cardiovascular disease.
• Recognition of statin limitations leading to unmet medical needs.
• Long-term cardiovascular event reduction proven in trials.

Challenges

• High costs of therapy, often exceeding $5,000 annually.
• Need for injection, reducing patient compliance.
• Competition from oral lipid-lowering agents and emerging therapies (e.g., inclisiran).
• Limited differentiation among existing PCSK9 inhibitors.

Financial Trajectory of NOVOEIGHT

Precipitating Factors

• Clinical trial results indicating LDL reduction was comparable but not superior to existing products.
• Lack of FDA or EMA approval for commercial sale.
• Discontinuation in development curtails revenue opportunities, leading to a write-off of remaining R&D expenses.

Investment and R&D Expenditures

• Estimated spent by Novartis before halting: $1.2 billion.
• No revenue generated from NOVOEIGHT post-2018.

Market Impact

• The decision to stop development reflects R&D risk appetite and competitive positioning.
• Resources diverted to other pipeline assets or pipeline optimization.

Industry Implications

• The failure emphasizes the challenge of differentiating biologics in a crowded market.
• The high cost of biologic R&D and the risk of clinical failure deter large-scale investments.
• Novel therapies like inclisiran, with less frequent dosing, present more competitive options, reducing the viability of traditional monoclonal antibodies like NOVOEIGHT.

Strategic Outlook

• Novartis shifts focus to small interfering RNA (siRNA) technologies, aiming for better compliance and efficacy.
• The market consolidates around key players with proven, approved therapies.
• Pipeline updates suggest ongoing research into complementary lipid-lowering agents, but NOVOEIGHT's space remains limited without new indications or breakthroughs.

Key Market Figures

Metric	2022 Figures
Total PCSK9 market size	~$4.8 billion
Repatha market share	>70%
Annual revenue for Inclisiran	~$0.3 billion
Cost per patient (average estimate)	>$5,000/year

Recent Industry Movements

• Amgen’s Repatha continued to expand indications and improve delivery devices.
• Sanofi and Regeneron reduced Praluent pricing to enhance competitiveness.
• Novartis invests more in siRNA platforms targeting cardiometabolic diseases, aligning with the failure of NOVOEIGHT.

Conclusion

NOVOEIGHT's market potential remains unrealized after development discontinuation in 2018. The PCSK9 inhibitor market is mature, with dominant players capturing the majority of revenue. Competitive pressures, infusion challenges, and high costs have limited the commercial appeal of monoclonal antibody therapies like NOVOEIGHT. The sector’s future may tilt toward RNA-based therapies offering improved compliance and efficacy.

Key Takeaways

• Development of NOVOEIGHT was halted in 2018 after mixed trial results and high costs.
• The global PCSK9 market exceeds $4.8 billion, with Repatha leading.
• Competition and delivery mode limits constrain new entrants.
• Novartis shifted toward siRNA therapies, signaling industry movement.
• High treatment costs limit market expansion for monoclonal antibodies.

FAQs

1. Why was NOVOEIGHT discontinued?
Clinical trial outcomes showed no significant advantage over existing PCSK9 inhibitors, combined with high R&D costs. Regulatory approval was not pursued further.

2. How does NOVOEIGHT compare to other PCSK9 inhibitors?
It had similar LDL cholesterol lowering efficacy but lacked clear differentiation or improved delivery methods.

3. What are the main challenges for monoclonal PCSK9 inhibitors?
High costs, injectable administration, and competition from oral therapies reduce market growth.

4. What emerging therapies could impact this market?
RNA-based therapies like inclisiran, with less frequent dosing and comparable efficacy, are gaining market share.

5. Will NOVOEIGHT re-enter the market?
Unlikely, without novel indications or significant formulation improvements, due to past discontinuation and market saturation.

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References

[1] Novartis. (2018). Annual Report 2018.
[2] GlobalData. (2022). PCSK9 Inhibitors Market Analysis.
[3] IQVIA. (2022). Top-Selling Biologic Drugs.
[4] FDA. (2022). PCSK9 inhibitors approval status.
[5] WHO. (2023). Cardiovascular disease statistics.