NOVOLOG Drug Profile

Summary for Tradename: NOVOLOG

High Confidence Patents:	18
Applicants:	1
BLAs:	3
Drug Prices:	Drug price information for NOVOLOG
Recent Clinical Trials:	See clinical trials for NOVOLOG
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NOVOLOG

See drug prices for NOVOLOG

Recent Clinical Trials for NOVOLOG

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Amphastar Pharmaceuticals, Inc.	Phase 2/Phase 3
The Cleveland Clinic	Phase 4
Boston Medical Center	Phase 3

See all NOVOLOG clinical trials

Recent Litigation for NOVOLOG

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
NOVO NORDISK INC. v. RIO BIOPHARMACEUTICALS, INC.	2024-01-19
NOVO NORDISK INC. v. DR. REDDY'S LABORATORIES, LTD.	2023-11-08
SANOFI-AVENTIS U.S. LLC v. MYLAN N.V.	2017-10-24

See all NOVOLOG litigation

Pharmacology for NOVOLOG

Established Pharmacologic Class	Insulin Analog
Chemical Structure	Insulin

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 NOVOLOG Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for NOVOLOG Derived from 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.	NOVOLOG	insulin aspart	Injection	020986		2025-01-21	Company disclosures
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986		2014-04-08	Company disclosures
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986		2014-05-06	Company disclosures
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986		2014-12-02	Company disclosures

3) Low Certainty: US Patents for NOVOLOG 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.	NOVOLOG	insulin aspart	Injection	020986		2025-05-23	Patent claims search
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986		2033-03-11	Patent claims search
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986		2034-12-01	Patent claims search
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986		2034-07-21	Patent claims search

International Patents for NOVOLOG

Country	Patent Number	Estimated Expiration
Czechoslovakia	8606310
Finland	102182
Hungary	P0202575
Ireland	66138

Supplementary Protection Certificates for NOVOLOG

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
41/2005	Austria		PRODUCT NAME: NOVOMIX 70 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 70:30; REGISTRATION NO/DATE: EU/1/00/142/017 - EU/1/00/142/022 20051005
132000900885237	Italy		AUTHORISATION NUMBER(S) AND DATE(S): (VEDI NOTE), 20000801;- - -, 20181206
C990042	Netherlands		PRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
SPC/GB00/027	United Kingdom		PRODUCT NAME: INSULIN ASPART AND PROTAMINE (NOVOMIX 30); REGISTERED: CH 55414 01 20000623; CH 55415 02 20000623; CH 55416 02 20000623; UK EU/1/00/142/001-008 20000801

Market Dynamics and Financial Trajectory for Novolog and the Biologics Market

Introduction to Biologics and Novolog

Biologics, including drugs like Novolog, are revolutionizing the treatment of various chronic and acute diseases. Novolog, a rapid-acting insulin analog developed by Novo Nordisk, is a key player in the diabetes management market.

Global Biologics Market Overview

The global biologics market is experiencing significant growth, driven by increasing demand for targeted and effective treatments for chronic diseases such as cancer, neurological disorders, genetic diseases, and autoimmune diseases.

• Market Size and Growth: The global biologics market was valued at USD 511.04 billion in 2024 and is projected to reach USD 1,374.51 billion by 2033, growing at a CAGR of 10.4% during the forecast period[1].
• Regional Dominance: North America holds the largest revenue share of 46% in 2023, due to high prevalence of chronic diseases, favorable reimbursement policies, and significant investments in R&D[1].

Novolog and the Diabetes Market

Price Adjustments and Affordability

Novo Nordisk has taken significant steps to make insulin products, including Novolog, more affordable.

• Price Reductions: Starting January 1, 2024, Novo Nordisk is lowering the list prices of several insulin products, including Novolog, by up to 75%. This move aims to reduce the burden of out-of-pocket costs for patients with diabetes[3].

Market Impact

The price adjustments are part of a broader strategy to address patient affordability and market dynamics.

• Patient Affordability: By reducing list prices, Novo Nordisk aims to make insulin more accessible, reflecting the company's commitment to ensuring patients can afford their medications[3].
• Market Dynamics: These price reductions also reflect the company's response to evolving policy changes and market pressures, ensuring a sustainable path forward for both patients and the company[3].

Financial Performance of Novo Nordisk

Revenue and Sales Growth

Novo Nordisk has seen robust financial performance, driven by strong sales of its biologic products, including insulin.

• Sales Growth: In 2023, Novo Nordisk reported a 31% increase in net sales, reaching DKK 232.261 billion. This growth is attributed to strong sales across North America and international operations[5].
• Operating Profit: The company's operating profit grew by 37% to DKK 102.574 billion in 2023, reflecting the success of its product portfolio and strategic investments[5].

Research and Development

Investments in R&D are crucial for the continued growth and innovation in biologics.

• R&D Investments: Novo Nordisk invested heavily in R&D, with costs increasing to 14.0% of sales in 2023. This includes significant advancements in pipeline products such as semaglutide and insulin icodec[5].

Manufacturing and Supply Chain

Production Capacity

To meet the growing demand for biologics, companies are expanding their production capacities.

• Capacity Expansion: Novo Nordisk has invested over DKK 75 billion in 2023 alone to expand its production capacity, aiming to serve millions more patients worldwide[5].

Manufacturing Segments

The biologics market is segmented based on manufacturing processes, with in-house and outsourcing segments showing different growth trajectories.

• In-House vs. Outsourcing: The in-house segment dominated the market with an 85.87% share in 2023, while the outsourcing segment is projected to expand at a CAGR of 10.8% during the forecast period[1].

Disease Categories and Product Segments

Oncology and Hematological Disorders

Biologics are increasingly used in various disease categories, with oncology and hematological disorders showing significant growth.

• Oncology Segment: The oncology segment dominated the biologics industry with a 29.40% share in 2023. The hematological disorder segment is expected to expand at the fastest CAGR of 11.8% during the forecast period[1].

Monoclonal Antibodies and RNAi Therapeutics

• Monoclonal Antibodies: The monoclonal antibodies segment accounted for a 68% share in 2023. Other segments like antisense and RNAi therapeutics are anticipated to expand at a CAGR of 20.7% during the forecast period[1].

Regional Growth and Opportunities

Asia Pacific Region

The Asia Pacific region is emerging as a significant market for biologics.

• CAGR: The Asia Pacific region is projected to expand at a CAGR of 11.2% during the forecast period, driven by growing awareness and unmet medical needs[1].

Challenges and Opportunities

Regulatory and Pricing Pressures

Biologic drug manufacturers face regulatory and pricing pressures that can impact their financial trajectory.

• Regulatory Changes: Companies must navigate evolving policy changes and regulatory requirements, which can influence pricing strategies and market access[3].

Innovation and Pipeline Development

Continuous innovation is crucial for maintaining market leadership.

• Pipeline Development: Novo Nordisk's pipeline includes novel combination therapies and new insulin products, such as insulin icodec, which is pending regulatory approval. These developments are expected to drive future growth[5].

Key Takeaways

• Market Growth: The global biologics market is projected to reach USD 1,374.51 billion by 2033, driven by increasing demand for targeted treatments.
• Price Adjustments: Novo Nordisk's price reductions for insulin products aim to improve patient affordability.
• Financial Performance: Novo Nordisk has seen strong sales growth and significant investments in R&D and production capacity.
• Regional Opportunities: The Asia Pacific region offers substantial growth opportunities for biologics.
• Innovation: Continuous innovation in pipeline products is essential for maintaining market leadership.

FAQs

Q: What is the projected growth rate of the global biologics market? A: The global biologics market is projected to grow at a CAGR of 10.4% from 2024 to 2033[1].

Q: Why is Novo Nordisk reducing the prices of its insulin products? A: Novo Nordisk is reducing the prices to make insulin more affordable for patients and to address the complex pricing system and evolving policy changes[3].

Q: Which region dominates the biologics market? A: North America holds the largest revenue share of 46% in the biologics market, driven by high prevalence of chronic diseases and significant investments in R&D[1].

Q: What are some of the key pipeline products of Novo Nordisk? A: Novo Nordisk's pipeline includes novel combination therapies, semaglutide, and insulin icodec, which is pending regulatory approval[5].

Q: How is the Asia Pacific region contributing to the growth of the biologics market? A: The Asia Pacific region is projected to expand at a CAGR of 11.2% due to growing awareness and unmet medical needs[1].

Sources

1. Biologics Market Size to Hit Around USD 1.37 Trillion By 2033 - Biospace
2. Novolog reported its financial results for the first quarter of 2023 - Novolog
3. Novo Nordisk to lower U.S. prices of several pre-filled insulin pens and vials up to 75% for people living with diabetes in January 2024 - PR Newswire
4. Biological Drugs Market Trends and Forecast 2014 - 2020 - Transparency Market Research
5. Novo Nordisk Annual Report 2023 - Novo Nordisk