FIASP Drug Profile

Summary for Tradename: FIASP

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for FIASP
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FIASP

See drug prices for FIASP

Recent Litigation for FIASP

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-11-10
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-05-12
Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc.	2018-05-31

See all FIASP litigation

Pharmacology for FIASP

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 FIASP Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for FIASP 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.	FIASP	insulin aspart	Injection	208751		2026-07-17	Company disclosures
Novo Nordisk Inc.	FIASP	insulin aspart	Injection	208751		2037-11-17	Company disclosures
Novo Nordisk Inc.	FIASP	insulin aspart	Injection	208751		2037-02-24	Company disclosures
Novo Nordisk Inc.	FIASP	insulin aspart	Injection	208751		2039-01-17	Company disclosures
Novo Nordisk Inc.	FIASP	insulin aspart	Injection	208751		2025-01-21	Company disclosures

3) Low Certainty: US Patents for FIASP 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.	FIASP	insulin aspart	Injection	208751		2025-05-23	Patent claims search
Novo Nordisk Inc.	FIASP	insulin aspart	Injection	208751		2033-03-11	Patent claims search
Novo Nordisk Inc.	FIASP	insulin aspart	Injection	208751		2034-12-01	Patent claims search
Novo Nordisk Inc.	FIASP	insulin aspart	Injection	208751		2034-07-21	Patent claims search
Novo Nordisk Inc.	FIASP	insulin aspart	Injection	208751		2034-05-08	Patent claims search

International Patents for FIASP

Country	Patent Number	Estimated Expiration
European Patent Office	1843809
Germany	602005017182
Poland	1909870
Russian Federation	2318541
World Intellectual Property Organization (WIPO)	2006076921

Supplementary Protection Certificates for FIASP

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SZ 41/2005	Austria		PRODUCT NAME: NOVOMIX 70 - SUSPENSION, ENTHALTEND LÖSLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHÄLTNIS 70:30
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
40/2005	Austria		PRODUCT NAME: NOVOMIX 50 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 50:50; REGISTRATION NO/DATE: EU/1/00/142/011 - EU/1/00/142/016 20051005
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 the Biologic Drug: FIASP

Introduction to Biologics and Their Market Growth

Biologics have become a significant segment of the pharmaceutical market, exhibiting substantial growth over the past few years. They now represent 42% of the total medicines market, up from 30% in 2014, with their revenue increasing by 70% in the last five years to reach $232 billion[3].

Overview of FIASP

FIASP, a faster-acting insulin aspart, is a biologic drug manufactured by Novo Nordisk. It is part of the insulin class, which is a critical segment within the biologics market, particularly in the diabetes therapy area.

Market Position and Pricing Dynamics

List Price vs. Net Price

Despite being priced at near-list-price parity with its precursor NovoLog, FIASP maintains a premium net price. The list price of FIASP is $34.75, closely matching NovoLog's list price of $35.08, but its net price is higher at $17.36 compared to NovoLog's $10.74[4].

Market Share and Competition

The entry of FIASP into the market has not significantly altered the market share dynamics in favor of the new product. Instead, it has maintained a premium pricing strategy, which is a common approach in the biologic market to capture and protect franchise revenue. However, this strategy is under pressure due to the increasing competition from biosimilars and other follow-on biologics[3].

Financial Trajectory

Spending Trends

Between 2018 and 2022, the average annual total Part D spending per Medicare enrollee taking FIASP or NovoLog increased by 11% from $3,002 to $3,323. This indicates a steady demand for these insulin products despite the introduction of newer alternatives[5].

Out-of-Pocket Spending

During the same period, the average annual out-of-pocket spending per enrollee decreased by 28% from $168 to $121. This reduction is likely due to changes in insurance coverage and pricing negotiations, which have become more prevalent in the pharmaceutical market[5].

Impact of Regulatory Changes

Inflation Reduction Act (IRA)

The U.S. Inflation Reduction Act (IRA), signed into law in August 2022, has significant implications for drug pricing and delivery innovation. For drugs like FIASP, which are part of the insulin market, the IRA could lead to negotiated prices and potentially impact revenue. For instance, the IRA includes provisions for Medicare to negotiate prices for certain high-cost drugs, which could affect the net revenue of FIASP and similar products[2].

Biosimilar Competition

Biosimilar Market Dynamics

Biosimilars are becoming increasingly important in the biologic market, offering cheaper alternatives to original biologic products. By year-end 2019, 17% of the biologics market was accessible to biosimilars, with biosimilars achieving a 20% share of the market. This trend is expected to continue, with up to 50% of biologic market sales potentially facing biosimilar competition in the future[1].

Impact on FIASP

While FIASP has not yet faced direct biosimilar competition, the broader insulin market is under pressure from biosimilars. For example, biosimilars of insulin products like filgrastim and epoetin alpha have already entered the market, setting a precedent for future competition in the insulin segment[1].

Pipeline and Future Prospects

Biologic Pipeline

The biologic pipeline, particularly in the oncology and autoimmune spaces, continues to grow. However, the diabetes segment, where FIASP is positioned, has fewer candidates in the pipeline compared to oncology. This could mean that while FIASP may face less immediate competition from new biologics, it will still need to contend with the increasing presence of biosimilars and other follow-on biologics[3].

Market Diversification

The biologic market is diversifying, with new biologics launching into various therapy areas. This diversification, combined with the introduction of biosimilars, will lead to a more competitive market. Companies like Novo Nordisk will need to focus on innovation and payer-friendly strategies to maintain market share and revenue[3].

Key Takeaways

• Market Growth: Biologics, including FIASP, are part of a growing market segment with significant revenue growth.
• Pricing Dynamics: FIASP maintains a premium net price despite similar list prices to its predecessor NovoLog.
• Financial Trends: Spending on FIASP has increased, but out-of-pocket costs for patients have decreased.
• Regulatory Impact: The Inflation Reduction Act could impact FIASP's revenue through price negotiations.
• Biosimilar Competition: The insulin market is under pressure from biosimilars, which could affect FIASP's market position in the future.
• Pipeline and Future Prospects: The biologic pipeline is diversifying, but the diabetes segment faces less immediate competition from new biologics.

FAQs

What is FIASP, and how does it differ from NovoLog?

FIASP is a faster-acting insulin aspart manufactured by Novo Nordisk, differing from NovoLog primarily in its faster onset of action. Despite similar list prices, FIASP has a higher net price than NovoLog[4].

How has the Inflation Reduction Act impacted biologic drugs like FIASP?

The IRA allows for Medicare to negotiate prices for certain high-cost drugs, which could potentially reduce the net revenue of biologic drugs like FIASP. This act also highlights the importance of drug delivery innovation in response to regulatory changes[2].

What is the current market share of FIASP compared to other insulin products?

While specific market share figures for FIASP are not detailed, it is known that FIASP has maintained a premium pricing strategy but has not significantly altered the market share dynamics in its favor. The market remains competitive with other insulin products like NovoLog[4].

How does the biosimilar market affect biologic drugs like FIASP?

Biosimilars offer cheaper alternatives to original biologic products, which can erode the revenue of biologics like FIASP. As more biosimilars enter the market, FIASP and similar products will face increased competition and downward pricing pressure[1].

What are the future prospects for the biologic market, particularly for diabetes treatments?

The biologic market is expected to diversify with new launches in various therapy areas. For diabetes treatments, while there are fewer pipeline candidates compared to oncology, the market will remain competitive due to biosimilar entry and the need for payer-friendly innovation strategies[3].

Sources

1. Biologics Market Dynamics: Setting the Stage for Biosimilars - IQVIA, March 2020.
2. The Inflation Reduction Act: Implications for Drug Delivery Innovation - L.E.K. Consulting.
3. Disruption and maturity: The next phase of biologics - IQVIA.
4. Estimated Changes in Insulin Prices and Discounts After Entry of Biosimilars - JAMA Health Forum, June 2023.
5. NovoLog/Fiasp: Medicare Enrollee Use and Spending - ASPE, November 2023.