APIDRA Drug Profile

Summary for Tradename: APIDRA

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

See drug prices for APIDRA

Recent Clinical Trials for APIDRA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Medical University of Warsaw	Phase 4
Massachusetts General Hospital	Phase 2/Phase 3
Boston University	Phase 2/Phase 3

See all APIDRA clinical trials

Recent Litigation for APIDRA

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
SANOFI-AVENTIS U.S. LLC v. MERCK SHARP & DOHME CORP.	2017-08-08

See all APIDRA litigation

Pharmacology for APIDRA

Ingredient-type	Insulin
Established Pharmacologic Class	Insulin Analog

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 APIDRA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for APIDRA Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629	6,221,633	2017-06-20	Company disclosures

3) Low Certainty: US Patents for APIDRA 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
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629	10,004,686	2025-05-23	Patent claims search
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629	10,016,338	2033-03-11	Patent claims search
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629	10,155,799	2034-07-21	Patent claims search

International Patents for APIDRA

Country	Patent Number	Estimated Expiration
Turkey	199801144
Canada	2235443
Germany	122004000049

Supplementary Protection Certificates for APIDRA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
05C0009	France		PRODUCT NAME: INSULINE GLULISINE; REGISTRATION NO/DATE: EU/1/04/285/001 20040929
132005901285503	Italy		PRODUCT NAME: INSULINA GLULISINE(APIDRA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/04/285/001-020, 20040927
300170	Netherlands		PRODUCT NAME: INSULINE-GLULISINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/04/285/002 20040928

APIDRA Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for the Biologic Drug: Apidra

Introduction

Apidra, also known as insulin glargine, is a rapid-acting insulin analog used in the management of diabetes mellitus. To understand the market dynamics and financial trajectory of Apidra, it is crucial to delve into the broader biologics market, the impact of biosimilars, and specific factors influencing Apidra's market position.

Biologics Market Overview

The biologics market has been experiencing significant growth, driven by factors such as the rising prevalence of chronic diseases, technological advancements, and increasing adoption of biosimilars. By 2023, the biologics market size had reached USD 349.6 billion and is projected to grow to USD 699.5 billion by 2032, with a CAGR of 7.8% during 2024-2032[3].

Market Share and Competition

Biologics now represent a substantial share of the pharmaceutical market, accounting for 42% of total medicine spending, up from 30% in 2014. This shift is largely due to the high value and extended market exclusivity periods of biologic drugs compared to small molecules[4].

Biosimilar Competition

Biosimilars, which are biologic products that are highly similar to an already approved biologic drug, are increasingly impacting the market. By the end of 2019, 17% of the biologics market was accessible to biosimilars, with biosimilars achieving a 20% share of this accessible market[4].

Apidra and Biosimilar Competition

Apidra, being an insulin analog, faces competition from biosimilars. The original biologic, Lantus (also insulin glargine), has seen significant biosimilar competition. For instance, Sanofi announced a 78% list price reduction for Lantus in 2024, a move likely influenced by the presence of biosimilars in the market[2].

Financial Trajectory

Historical Sales

Apidra, as part of the broader insulin market, has seen substantial sales over the years. However, the financial trajectory of Apidra is heavily influenced by the introduction of biosimilars and changes in pricing strategies.

Pricing Strategies

Sanofi, the manufacturer of Apidra, has implemented pricing principles that include transparency, clinical value, and economic considerations. The company has committed to limiting price increases and has reported significant decreases in net prices due to discounts, rebates, and fees. For example, in 2023, Sanofi experienced a 15.7% decrease in its average aggregated net price, largely due to dynamics within its insulin portfolio[2].

Impact of Biosimilars

The entry of biosimilars into the insulin market has led to increased competition, which can drive down prices and affect the financial performance of original biologics like Apidra. The dramatic growth of biosimilars, with a year-on-year growth rate of around 60%, indicates a significant shift in market dynamics that could impact Apidra's sales and revenue[1].

Market Exclusivity and Patent Dynamics

Biologic drugs, including Apidra, have complex patent landscapes that involve multiple patents and timelines. This complexity makes it challenging to predict exact patent expiry dates, but it is clear that the loss of exclusivity (LOE) for key biologics is a significant factor in the market. The LOE for high-value biologics like Humira, Enbrel, and Remicade has opened up opportunities for biosimilars, which in turn affects the market position of drugs like Apidra[1].

Regional Market Impact

The Asia-Pacific region, with its large patient population and growing healthcare infrastructure, is a significant driver of the biologics market. Emerging economies like China and India are increasing their demand for biologics, including insulin analogs like Apidra. However, the presence of biosimilars in these regions can also impact the sales and revenue of original biologics[3].

Patient Affordability and Access

Sanofi's pricing principles emphasize patient affordability and access. The company provides various forms of assistance, including financial support and insurance investigations, to improve the affordability of its medications. These efforts are crucial in maintaining market share in a competitive environment where biosimilars are increasingly available[5].

Future Outlook

The future outlook for Apidra is influenced by several factors:

• Biosimilar Competition: The continued growth of biosimilars will likely drive down prices and increase competition.
• Pricing Strategies: Sanofi's commitment to transparent and patient-centric pricing will be key in maintaining market share.
• Regulatory Environment: Favorable regulatory policies and approvals of new indications can support the market position of Apidra.
• Technological Advancements: Continuous advancements in drug delivery systems and biotechnology can enhance the value proposition of Apidra and other biologics[3].

Key Takeaways

• The biologics market, including Apidra, is experiencing significant growth driven by chronic diseases and technological advancements.
• Biosimilar competition is a major factor influencing the financial trajectory of Apidra.
• Pricing strategies and patient affordability initiatives are crucial for maintaining market share.
• Regional market dynamics, particularly in the Asia-Pacific region, play a significant role in the demand for biologics.
• The future outlook is shaped by biosimilar competition, pricing strategies, regulatory environments, and technological advancements.

FAQs

What is Apidra and how is it used?

Apidra is a rapid-acting insulin analog used in the management of diabetes mellitus. It is administered via injection to help control blood sugar levels.

How does biosimilar competition affect Apidra?

Biosimilar competition drives down prices and increases market competition, which can impact the sales and revenue of Apidra. The presence of biosimilars forces original biologic manufacturers to adjust their pricing strategies.

What are Sanofi's pricing principles for Apidra?

Sanofi's pricing principles include transparency, clinical value, and economic considerations. The company commits to limiting price increases and provides various forms of patient assistance to improve affordability.

How does the Asia-Pacific region impact the market for Apidra?

The Asia-Pacific region, with its large patient population and growing healthcare infrastructure, increases demand for biologics like Apidra. However, the presence of biosimilars in this region also affects the market dynamics.

What is the future outlook for Apidra in the biologics market?

The future outlook for Apidra is influenced by biosimilar competition, pricing strategies, regulatory environments, and technological advancements. The market is expected to continue growing, but Apidra's financial trajectory will depend on how it navigates these factors.

Sources

1. The Impact of Biosimilar Competition in Europe - European Commission, December 2020.
2. Sanofi Comment on Maryland Prescription Drug Affordability Board - Sanofi, May 10, 2024.
3. Biologics Market Size to Reach USD 699.5 Billion by 2032 - IMARC Group, August 8, 2024.
4. Biologics Market Dynamics: Setting the Stage for Biosimilars - FTC, March 9, 2020.
5. Sanofi 2024 Pricing Principles Report - Sanofi, 2024.