Insulin aspart - Biologic Drug Details

Summary for insulin aspart

Tradenames:	2
High Confidence Patents:	18
Applicants:	1
BLAs:	4
Suppliers: see list	4
Recent Clinical Trials:	See clinical trials for insulin aspart
Drug Prices:	Drug price information for insulin aspart
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for insulin aspart

Recent Clinical Trials for insulin aspart

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Gan and Lee Pharmaceuticals, USA	Phase 2
Sunshine Lake Pharma Co., Ltd.	Phase 3
Sun Yat-sen University	Phase 4

See all insulin aspart clinical trials

Recent Litigation for insulin aspart

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
NOVO NORDISK INC. v. RIO BIOPHARMACEUTICALS, INC.	2024-02-05
ACQIS LLC v. Hon Hai Precision Industry Co., Ltd.	2023-04-10
Novo Nordisk, Inc. v. Mylan Pharmaceuticals, Inc.	2022-08-08

See all insulin aspart litigation

Pharmacology for insulin aspart

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 insulin aspart Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for insulin aspart 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	11,311,679		Company disclosures
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	5,618,913	2014-04-08	Company disclosures
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	5,626,566	2014-05-06	Company disclosures
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	5,693,027	2014-12-02	Company disclosures
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	5,866,538	2016-06-20	Company disclosures

3) Low Certainty: US Patents for insulin aspart 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	10,004,686	2025-05-23	Patent claims search
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	10,016,338	2033-03-11	Patent claims search
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	10,118,956	2034-12-01	Patent claims search
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	10,155,799	2034-07-21	Patent claims search
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	10,172,922	2034-05-08	Patent claims search

International Patents for insulin aspart

Country	Patent Number	Estimated Expiration
Norway	985981
China	1029663
Portugal	83278
Norway	320213
Yugoslavia	46023

Supplementary Protection Certificates for insulin aspart

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1390036-0	Sweden		PRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
SZ 32/2000	Austria		PRODUCT NAME: INSULIN ASPART/PROTAMIN
122013000062	Germany		PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND INSULIN ASPART IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/806/001 EU/1/12/806/004-005 EU/1/12/806/007-008 20130121
C990042	Netherlands		PRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
32/2000	Austria		PRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623

Market Dynamics and Financial Trajectory for Insulin Aspart

Introduction to Insulin Aspart

Insulin aspart, a rapid-acting insulin analog, is a crucial biologic drug used in the management of diabetes. It is manufactured by companies like Novo Nordisk and has been a cornerstone in diabetes treatment due to its fast onset and short duration of action.

Market Growth and Projections

The insulin aspart market has been experiencing significant growth and is expected to continue this trend in the coming years.

• Forecast Period: The market is projected to grow substantially from 2023 to 2031, with a remarkable CAGR during the forecast period. This growth is driven by the increasing prevalence of diabetes, technological advancements, and government policies encouraging the adoption of biosimilars[1][3][4].

Market Segmentation

The insulin aspart market can be segmented in several ways to understand its dynamics better:

By Product Type

• Insulin aspart is part of the rapid-acting insulin segment, which includes other products like insulin lispro and insulin glulisine. The insulin lispro segment is anticipated to hold the largest market share due to its faster subcutaneous absorption and earlier insulin peak[4].

By Mode of Administration

• The injectable pens segment, which includes products like Novo Nordisk's Fiasp, accounted for the highest revenue in 2023 due to their ease of use and convenience. The insulin pump segment is expected to grow at the fastest CAGR due to the increasing adoption of advanced diabetes management technologies[3].

By Therapeutic Application

• The type 2 diabetes segment accounted for the highest revenue in 2023 due to the high prevalence of the disease. However, the type 1 diabetes segment is predicted to grow at the fastest CAGR due to the increasing incidence of autoimmune diabetes[3].

By Distribution Channel

• Hospital pharmacies were the highest revenue-grossing segment in 2023, but the online pharmacies segment is expected to grow at the fastest CAGR due to the increasing trend of e-commerce in healthcare[3].

Financial Trajectory

Pricing Dynamics

• The pricing of insulin aspart has been a subject of significant scrutiny. Despite list prices remaining high, net prices have been influenced by rebates and discounts. For instance, the net price of Fiasp was higher than Novolog, despite similar list prices[2].

• Medicaid Rebates: The impending change in Medicaid rebates, as part of the American Rescue Act of 2021, has led manufacturers to adjust their pricing strategies to avoid higher rebates. This policy change is expected to impact the financial trajectory of insulin manufacturers, with potential savings from avoiding additional Medicaid rebates[5].

Revenue and Market Size

• The global insulin biosimilar market, which includes insulin aspart biosimilars, is expected to grow from USD 500 million in 2023 to USD 2.25 billion by 2034, with a CAGR of 14.67% during the forecast period[3].

• Regional Growth: North America is anticipated to have the highest revenue share during the forecast period due to its well-established healthcare infrastructure and high prevalence of diabetes. However, the Asia-Pacific region is expected to grow at the fastest CAGR due to rising awareness about diabetes management and improving healthcare infrastructure[3].

Drivers and Restraints

Drivers

• Increasing Prevalence of Diabetes: The rising number of diabetes cases globally is a significant driver for the insulin aspart market.
• Technological Advancements: Improvements in biotechnology and manufacturing techniques have enhanced the production of superior insulin biosimilars.
• Government Policies: Policies encouraging the adoption of biosimilars have been instrumental in market growth[1][3][4].

Restraints

• High Development Costs: The development and approval process for biosimilars is complex and costly, which can act as a restraint.
• Regulatory Challenges: Stringent regulatory requirements and the need for extensive clinical trials can slow market entry.
• Pricing Pressures: The need to balance pricing with affordability and regulatory pressures can be a significant challenge for manufacturers[3].

Competitive Landscape

The insulin aspart market is highly competitive, with several key players:

• Novo Nordisk: Known for its products like Novolog and Fiasp.
• Sanofi: Involved in the development of insulin biosimilars.
• Eli Lilly: Manufacturer of Humalog and other insulin products.
• Biocon: Approved for its insulin glargine biosimilar, Semglee.
• Other Players: Include Pfizer, Mylan, Merck & Co., and Boehringer Ingelheim, among others[3].

Future Outlook

The future of the insulin aspart market looks promising, driven by several factors:

• Increasing Demand: The growing need for effective diabetes management will continue to drive demand for rapid-acting insulins.
• Technological Innovations: Advances in biotechnology and manufacturing will lead to more efficient and effective insulin products.
• Market Expansion: Emerging economies and the increasing adoption of advanced diabetes management technologies will expand the market[1][3][4].

Key Takeaways

• The insulin aspart market is expected to grow significantly from 2023 to 2031.
• Pricing dynamics are influenced by rebates, discounts, and regulatory changes.
• Technological advancements and government policies are key drivers.
• The market is segmented by product type, mode of administration, therapeutic application, and distribution channel.
• North America and Asia-Pacific are critical regions for market growth.

FAQs

1. What are the key drivers of the insulin aspart market? The key drivers include the increasing prevalence of diabetes, technological advancements, and government policies encouraging the adoption of biosimilars.

2. How does the pricing of insulin aspart vary? The pricing of insulin aspart varies significantly between list prices and net prices due to rebates and discounts. Net prices can be lower than list prices due to these factors.

3. Which region is expected to grow the fastest in the insulin aspart market? The Asia-Pacific region is expected to grow at the fastest CAGR due to rising awareness about diabetes management and improving healthcare infrastructure.

4. What are the main segments of the insulin aspart market? The market is segmented by product type, mode of administration, therapeutic application, and distribution channel.

5. How do regulatory changes impact the insulin aspart market? Regulatory changes, such as the Medicaid rebate policy, can significantly impact the financial trajectory of insulin manufacturers by influencing pricing strategies and rebate structures.

Sources

1. Market Research Intellect: Global Insulin Aspart Market Size, Trends and Projections.
2. JAMA Health Forum: Estimated Changes in Insulin Prices and Discounts After Entry of Biosimilars.
3. GlobeNewswire: Growth Trends in the Insulin Biosimilar Market, Forecast to 2034.
4. Allied Market Research: Rapid Acting Insulin Market Size and Demand Forecast -2027.
5. JAMA Network Open: The Rise and Fall of the Insulin Pricing Bubble.