LANTUS Drug Profile

Summary for Tradename: LANTUS

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

See drug prices for LANTUS

Recent Clinical Trials for LANTUS

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Basrah	N/A
Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social	Phase 4
National Polytechnic Institute, Mexico	Phase 4

See all LANTUS clinical trials

Recent Litigation for LANTUS

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
United States v. Pobre	2019-07-22

See all LANTUS litigation

PTAB Litigation

Petitioner	Date
Mylan Pharmaceuticals Inc., et al.	2017-06-05

See all LANTUS litigation

Pharmacology for LANTUS

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 LANTUS Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for LANTUS 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	LANTUS	insulin glargine	Injection	021081	5,370,629	2012-02-21	Company disclosures
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	5,509,905	2013-04-23	Company disclosures
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	5,656,722	2014-08-12	Company disclosures

3) Low Certainty: US Patents for LANTUS 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	LANTUS	insulin glargine	Injection	021081	10,004,686	2025-05-23	Patent claims search
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	10,016,338	2033-03-11	Patent claims search
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	10,029,011	2029-11-13	Patent claims search
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	10,092,513	2033-04-03	Patent claims search
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	10,117,909	2028-10-17	Patent claims search

International Patents for LANTUS

Country	Patent Number	Estimated Expiration
Germany	59300890
Hong Kong	1006171
Japan	H02218696
Germany	3837825
World Intellectual Property Organization (WIPO)	9316740

Supplementary Protection Certificates for LANTUS

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00C0023	France		PRODUCT NAME: INSULIN GLARGINE; NAT. REGISTRATION NO/DATE: EU/0/00/134/001 20000609; FIRST REGISTRATION: EU/1/00/134/001 20000609
C300019	Netherlands		PRODUCT NAME: INSULINE GLARGINE,DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH GESCHIKT ZOUT; REGISTRATION NO/DATE: EU/1/00/134/001 - 007 20000609
10075022	Germany		PRODUCT NAME: INSULIN GLARGIN (LANTUS ); REGISTRATION NO/DATE: EU/1/00/134/001-007 20000609
300883	Netherlands		PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REGISTRATION NO/DATE: EU/1/16/1157 20170113
0091020-8 0090020-9	Sweden		PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 20000609

Market Dynamics and Financial Trajectory for the Biologic Drug: Lantus

Introduction to Lantus

Lantus, a long-acting insulin glargine, has been a cornerstone in the treatment of diabetes since its introduction by Sanofi. It has maintained a significant market presence despite the emergence of biosimilar competitors.

Market Share and Competition

Despite the entry of biosimilars like Semglee and Rezvoglar, Lantus continues to dominate the insulin market. As of recent analyses, Lantus retains a majority of the total market volume (78%) and new drug starts (54%)[1].

Biosimilar Competition

Semglee, an interchangeable biosimilar to Lantus, has seen modest uptake since its launch in 2021. It has gained a Medicare market share of only 6%, up from 3% initially. In the commercial space, Semglee has a higher share of new-to-brand starts at 24%, but this is still below its peak of 35% in early 2022[1].

Price Dynamics

The pricing strategy has been a critical factor in Lantus's market retention. Although Semglee's wholesale acquisition cost is slightly lower than Lantus ($269 vs $292 for a standard pack size), the difference is not significant enough to sway market share drastically. However, Sanofi's announcement to reduce Lantus's list price by 78% starting January 2024, along with a $35 cap on out-of-pocket costs for patients with commercial insurance, is expected to further solidify its market position[1][5].

Financial Performance

Revenue Trends

Lantus has been a significant contributor to Sanofi's revenue. However, recent trends show a decline in sales. In the fourth quarter of 2022, Lantus sales decreased by 27.6% in the U.S., reflecting lower volumes at significantly lower prices. For the full year 2022, Lantus sales declined by 14.4%[4].

Geographic Performance

The sales performance of Lantus varies by region. In the U.S., Lantus sales have been impacted by competitive pressures and pricing adjustments. In contrast, other regions have shown more stable performance, although overall global sales have been declining due to divestments and lower sales in key markets[4].

Impact of Biosimilars on Financials

Reduced Pricing Power

The entry of biosimilars has forced major insulin manufacturers, including Sanofi, to reduce their list prices significantly. This shift has marked the end of the era of high list prices and high rebates for insulin. For instance, Eli Lilly reported a 50% decline in U.S. revenue for Humalog in the fourth quarter of 2023 compared to the same period in 2022[5].

Operating Income and Margins

Despite the decline in sales, Sanofi's pharmaceutical business operating income (BOI) has shown resilience. In 2022, BOI increased by 17.4% to €11,043 million, driven by improvements in gross margin ratios and moderate growth in SG&A expenses[4].

Market Evolution and Future Outlook

Increased Competition

The insulin market is becoming increasingly competitive with multiple biosimilars in various stages of development. This competition, leveraged by pharmacy benefit managers (PBMs), has led to lower costs for patients. Six additional Lantus biosimilars are in development, and biosimilars for other insulin products like Humalog, NovoLog, and Toujeo are also in the pipeline[5].

Regulatory and Public Scrutiny

The insulin market has been under significant congressional and public scrutiny over pricing. The recent price cuts by major manufacturers are a response to this pressure. These actions indicate a shift towards a more patient-centric pricing strategy[5].

Biologics Market Context

Growth and Maturation

The biologics market, including insulin, has seen significant growth over the past few years. Biologic sales have increased by 70% in the last five years, reaching $232 billion. The top 10 biologic therapies, including those for diabetes, account for 36% of all biologic spending[3].

Therapy Areas

Diabetes, along with autoimmune and oncology therapies, constitutes a major portion of the biologic market, worth over $110 billion. This segment continues to be a key area of focus for pharmaceutical companies[3].

Key Takeaways

• Market Dominance: Lantus continues to dominate the insulin market despite biosimilar competition.
• Price Adjustments: Significant price cuts by Sanofi and other manufacturers have altered the pricing landscape.
• Financial Resilience: Sanofi's pharmaceutical business has maintained strong operating income despite declining Lantus sales.
• Competitive Landscape: The insulin market is becoming more competitive with multiple biosimilars in development.
• Regulatory Pressure: Public and congressional scrutiny has driven manufacturers to adopt more patient-friendly pricing strategies.

FAQs

What is the current market share of Lantus in the insulin market?

Lantus retains a majority of the total market volume (78%) and new drug starts (54%) despite competition from biosimilars[1].

How have biosimilars impacted Lantus sales?

Biosimilars like Semglee have seen modest uptake, but Lantus remains dominant. However, the entry of biosimilars has forced Sanofi to reduce Lantus's list price significantly[1][5].

What are the recent pricing changes for Lantus?

Sanofi has announced a 78% reduction in Lantus's list price starting January 2024, along with a $35 cap on out-of-pocket costs for patients with commercial insurance[1][5].

How has the financial performance of Lantus been in recent years?

Lantus sales have declined, with a 27.6% decrease in the U.S. in the fourth quarter of 2022. However, Sanofi's pharmaceutical business operating income has remained strong[4].

What is the outlook for the insulin market?

The insulin market is becoming more competitive with multiple biosimilars in development. This competition is expected to continue driving down costs for patients[5].

How has regulatory scrutiny impacted the insulin market?

Regulatory and public scrutiny over pricing has led major manufacturers to reduce list prices significantly, marking a shift towards more patient-centric pricing strategies[5].

Sources

1. AJMC: Payer Controls Limiting Semglee Uptake Despite Patient Demand
2. Bloomberg Quint: Company Update Sanofi India
3. IQVIA: Disruption and maturity: The next phase of biologics
4. GlobeNewswire: Press Release Q4 2022 English
5. PCMA: Trends In The US Insulin Market: New Prices, New Players ...