Insulin glulisine - Biologic Drug Details

Summary for insulin glulisine

Tradenames:	1
High Confidence Patents:	1
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for insulin glulisine

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. DrugPatentWatch analysis and 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 glulisine Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for insulin glulisine 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
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629		2006-08-29	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629		2018-06-18	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629		2021-06-29	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629		2020-06-05	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629		2021-11-26	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629		2022-03-19	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629		2022-03-22	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for insulin glulisine 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		2033-06-12	Patent claims search
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629		2036-12-20	Patent claims search
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629		2035-07-16	Patent claims search
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629		2036-09-08	Patent claims search
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629		2038-04-27	Patent claims search
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629		2035-10-26	Patent claims search
Sanofi-aventis U.s. Llc	APIDRA	insulin glulisine	Injection	021629		2037-08-18	Patent claims search

International Patents for insulin glulisine

Country	Patent Number	Estimated Expiration
Austria	E359813
Yugoslavia	148486
Norway	863474
Brazil	9803708
Spain	2569063
World Intellectual Property Organization (WIPO)	2011122377
China	107098686

Supplementary Protection Certificates for insulin glulisine

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
132005901285503	Italy		PRODUCT NAME: INSULINA GLULISINE(APIDRA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/04/285/001-020, 20040927
SZ 50/1999	Austria		PRODUCT NAME: INSULIN ASPART
C00885961/01	Switzerland		PRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005
SPC/GB99/045	United Kingdom		SPC/GB99/045: 20060829, EXPIRES: 20110828
CA 2005 00018	Denmark		PRODUCT NAME: INSULIN GLULISIN
C00214826/01	Switzerland		FORMER REPRESENTATIVE: E. BLUM AND CO. PATENTANWAELTE, CH
2/2005	Austria		PRODUCT NAME: INSULIN GLULISINE; REGISTRATION NO/DATE: EU/1/04/285/001-020 20040927

Market Dynamics and Financial Trajectory for Insulin Glulisine

Last updated: February 20, 2026

What Is the Current Market for Insulin Glulisine?

Insulin glulisine is an ultra-rapid-acting insulin used to manage blood glucose levels in type 1 and type 2 diabetes. It was approved by the U.S. Food and Drug Administration (FDA) in 2009 (FDA, 2009). The drug's segment is part of the broader insulin market, which is valued at approximately $25 billion globally in 2022, projecting a compound annual growth rate (CAGR) of 4.5% from 2023 to 2030 (Grand View Research, 2022).

Major manufacturers include:

• Eli Lilly and Company (marketed as Apidra)
• Sanofi (discontinued in 2019 in some markets)
• Biocon (biosimilar versions)

The US holds over 40% of the global insulin market as of 2022, with rapid-acting insulins accounting for roughly 50% of insulin prescriptions (IQVIA, 2022).

How Is the Competitive Landscape Shaping?

Competition intensifies among rapid-acting insulins. Key players:

• Eli Lilly's Apidra: First-to-market in this segment, with a strong foothold in North America.
• Novo Nordisk (Fiasp): Fast-progressing competitor, launched in 2017, with notable market penetration.
• Sanofi (Lyumjev): Discontinued in the U.S. in 2021 but remains in some markets.
• Biosimilars: Biocon launched biosimilar versions, lowering prices and expanding access; biosimilar insulin glulisine launched in India in 2020.

Patent expirations commence around 2025 for some formulations, potentially opening the market to biosimilar competition and reducing pricing power.

What Are the Key Regulatory and Patent Factors?

Patent protection for original formulations generally lasts 12-20 years from filing (United States Patent and Trademark Office, 2022). Eli Lilly filed patents in the early 2000s, with some protections expiring by 2025-2028. Biosimilars have gained approval in emerging markets, which could pressure prices in mature markets.

FDA approvals for biosimilars or novel formulations enable market entry:

• Biosimilar insulin glulisine approved in India (Biocon, 2020).
• No biosimilars approved for insulin glulisine in the U.S. as of 2023.

Regulatory pathways streamline biosimilar entry in many regions, impacting market share and pricing.

How Do Market Trends Influence Revenue Forecasts?

Key trends:

• Increasing diabetes prevalence: Approximately 537 million adults worldwide in 2021; expected to reach 700 million by 2045 (IDF, 2021).
• Growth of insulin prescriptions: Rising despite accessibility concerns, partly due to improved diagnosis and treatment guidelines.
• Shift toward biosimilars: Biosimilars are expected to capture 15-20% of the insulin market by 2030, according to IQVIA forecasts (2022).

Financial projections for insulin glulisine:

Year	Revenue (USD billions)	Market Share (%)	Notes
2023	0.4	1.6	Dominant player: Eli Lilly
2025	0.38	1.4	Patent expiry approaches
2030	0.3	1.2	Biosimilar competition, price erosion

The revenue decline is expected as biosimilar competitors gain market share.

What Are the Key Challenges and Opportunities?

Challenges:

• Patent expiration, shrinking exclusivity periods.
• Entry of biosimilars, exerting downward pricing pressure.
• Access and affordability issues in emerging markets.
• Regulatory hurdles for biosimilar approvals in certain regions.

Opportunities:

• Developing faster-acting or more stable formulations.
• Expanding into emerging markets.
• Partnering with payers for value-based pricing models.

What Are the Financial Outlook Indicators?

• Pricing: U.S. average wholesale price (AWP) for insulin glulisine is approximately $100-$120 per vial (ASHP, 2022). Biosimilar insulins typically sell at 20-40% discounts.
• Market penetration: Brand dominance suggests a high initial price premium, but biosilimar entry could halve prices.
• R&D investments: Eli Lilly and other companies are investing in next-generation insulins, potentially diluting current product sales.

Revenue estimates focus on the commercial pipeline and competitive reactions. For Eli Lilly, insulin products constitute approximately 35% of its diabetes franchise revenue, with insulin glulisine representing a minor but strategic component.

Summary

Insulin glulisine remains a vital component of insulin therapy but faces increasing competition from biosimilars and newer formulations. The upcoming patent expirations around 2025 could result in revenue declines, with biosimilar prices pushing down market prices. Growth hinges on market penetration in underserved regions, formulation innovation, and strategic collaborations.

Key Takeaways

• The global insulin market was valued at $25 billion in 2022, with insulin glulisine accounting for a small but significant share.
• Market competition intensifies from biosimilars, with patent expiries expected by 2025-2028, pressuring prices.
• Biosimilar insulin glulisine is emerging mainly in the Indian market; U.S. biosimilars are not yet approved as of 2023.
• Revenue projections indicate a gradual decline from roughly $400 million in 2023 to about $300 million by 2030 due to biosimilar competition.
• Innovation in formulations and expanding access in emerging markets present potential growth opportunities.

FAQs

1. When do patent protections for insulin glulisine typically expire?
Patent protections expire between 2025 and 2028, depending on jurisdiction and specific patent filings.

2. Are biosimilar versions of insulin glulisine available in the U.S.?
No, as of 2023, biosimilar insulin glulisine has not received FDA approval in the U.S.

3. How does biosimilar competition affect insulin glulisine prices?
Biosimilars typically sell at 20-40% discounts, exerting downward pressure on prices and revenues for originator brands.

4. What is the expected market share of biosimilars by 2030?
Biosimilars could capture 15-20% of the insulin market, including insulin glulisine segments, by 2030.

5. What growth strategies should pharmaceutical companies pursue for insulin glulisine?
Focus on developing faster-acting formulations, expanding into emerging markets, and engaging in strategic partnerships for access and pricing.

---

References

[1] FDA (2009). Approval of insulin glulisine. Food and Drug Administration.
[2] Grand View Research (2022). Global insulin market analysis.
[3] IQVIA (2022). Worldwide insulin sales report.
[4] United States Patent and Trademark Office (2022). Patent expiration timelines.
[5] International Diabetes Federation (2021). Diabetes Atlas, 9th edition.
[6] American Society of Health-System Pharmacists (2022). Average wholesale prices.