BASAGLAR Drug Profile

Summary for Tradename: BASAGLAR

High Confidence Patents:	16
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for BASAGLAR
Recent Clinical Trials:	See clinical trials for BASAGLAR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BASAGLAR

See drug prices for BASAGLAR

Recent Clinical Trials for BASAGLAR

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Eli Lilly and Company	Phase 3
Baqai Institute of Diabetology and Endocrinology	PHASE4
Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders	PHASE4

See all BASAGLAR clinical trials

Recent Litigation for BASAGLAR

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
MERCK SHARP & DOHME LLC v. SUN PHARMACEUTICAL INDUSTRIES LTD.	2025-02-24
Merck Sharp & Dohme Corp. v. Actavis Laboratories FL, Inc.	2020-01-17
MERCK SHARP & DOHME CORP. v. ACTAVIS LABORATORIES FL, INC.	2020-01-16

See all BASAGLAR litigation

PTAB Litigation

Petitioner	Date
Pfizer Inc.	2019-05-02
Mylan Pharmaceuticals Inc. et al.	2018-09-10
Mylan Pharmaceuticals Inc., et al.	2017-06-05

See all BASAGLAR litigation

Pharmacology for BASAGLAR

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. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including 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 BASAGLAR Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for BASAGLAR 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
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	5,618,913	2006-08-29	DrugPatentWatch analysis and company disclosures
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	5,656,722	2014-09-12	DrugPatentWatch analysis and company disclosures
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	7,476,652	2025-03-25	DrugPatentWatch analysis and company disclosures
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	7,713,930	2028-12-04	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for BASAGLAR 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
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	10,004,686	2033-06-12	Patent claims search
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	10,016,338	2036-12-20	Patent claims search
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	10,029,011	2030-11-11	Patent claims search
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	10,092,513	2034-04-01	Patent claims search

International Patents for BASAGLAR

Country	Patent Number	Estimated Expiration
Argentina	241801
Austria	E113061
Australia	593274
Australia	6206686

Supplementary Protection Certificates for BASAGLAR

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SPC/GB00/022	United Kingdom		PRODUCT NAME: INSULIN GLARGINE (LANTUS) OPTIONALLY IN THE FORM OF ESTERS THEREOF OR PHYSIOLOGICALLY TOLERATED SALTS THEREOF.; REGISTERED: UK EU/1/00/134/001 20000609; UK EU/1/00/134/002 20000609; UK EU/1/00/134/003 20000609; UK EU/1/00/134/004 20000609; UK EU/1/00/134/005 20000609; UK EU/1/00/134/006 20000609; UK EU/1/00/134/007 20000609
C990042	Netherlands		PRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
10075022	Germany		PRODUCT NAME: INSULIN GLARGIN (LANTUS ); REGISTRATION NO/DATE: EU/1/00/134/001-007 20000609
CR 2017 00020	Denmark		PRODUCT NAME: INSULIN GLARGINE/LIXISENATID; REG. NO/DATE: EU/1/16/1157/001-004 20170113

Market Dynamics and Financial Trajectory of BASAGLAR

Last updated: April 9, 2026

What Is BASAGLAR?

BASAGLAR is a basal insulin glargine analog developed by Lilly and previously marketed under its own brand, now marketed as a biosimilar version of Sanofi’s Lantus. It is used to manage blood glucose levels in adults and children with diabetes mellitus.

Market Position and Competition

Market Size
The global basal insulin market was valued at approximately USD 25 billion in 2022, with expectations to grow at a CAGR of 8-10% through 2030 [1].

Major Competitors

• Sanofi Lantus (Sanofi)
• Novo Nordisk Tresiba (Insulin degludec)
• Eli Lilly's own Trurrep (biosimilar insulin glargine)

Pricing and Reimbursement
Biosimilar insulins like BASAGLAR are priced roughly 20-30% lower than originators. In the U.S., pricing for BASAGLAR ranges around USD 97 per pen, compared to USD 150+ for Lantus. Reimbursement policies vary by country, impacting adoption rates.

Market Share Trends
BASAGLAR launched in 2016, capturing a fragment of the basal insulin segment. Its market share has fluctuated between 5-10% in the U.S., with rises in Europe and emerging markets. Transitioning prescriber confidence remains ongoing.

Clinical and Regulatory Landscape

Biosimilar Approvals
The FDA approved BASAGLAR in 2016 based on similarity to Lantus. The FDA’s interchangeability designation is not granted to BASAGLAR, limiting automatic substitution at pharmacy level.

Patent and Patent Challenges
Sanofi held key patents until 2015, after which biosimilars could enter. Patent litigations in key markets delayed biosimilar penetration until late 2010s.

Regulatory Trends
Regulators increasingly accept biosimilars with proven biosimilarity, easing market entry but emphasizing prescribing habits and physician awareness.

Revenue Trends and Financial Performance

Sales Data

• Lilly's revenues from BASAGLAR peaked near USD 600 million globally in 2018.
• Sales declined slightly through 2020-2022 due to increased competition and pricing pressures.

Impact of Biosimilar Competition
BASAGLAR faces challenges from Tresiba and newer biosimilars. While it maintains a foothold, revenue growth has stagnated or declined regionally due to market saturation and preferred physician prescribing patterns.

Profit Margins
Gross margins for BASAGLAR are estimated at approximately 70%, typical for biosimilar insulins. R&D expenses are hidden within Lilly’s broader pharma costs, but specific biosimilar margin metrics are undisclosed.

Future Market and Financial Outlook

Growth Drivers

• Increasing prevalence of diabetes worldwide, estimated to reach 700 million cases by 2045 [2].
• Rising adoption of biosimilars driven by cost savings measures.
• Expansion into emerging markets with growing healthcare infrastructure.

Challenges

• Limited interchangeability status constrains pharmacy-level substitution.
• Healthcare provider and patient hesitation toward biosimilar insulin switching.
• Patent litigations and biosimilar approval delays for competitors may influence timing and market share.

Forecasts

• Sales for BASAGLAR are projected to decline modestly over the next five years, stabilizing around USD 400-500 million globally by 2027.
• Lilly may shift focus toward newer formulations, such as ultra-long-acting insulins, to offset declining revenues.

Strategic Considerations

• Market Penetration: Deeper penetration in Europe and emerging markets remains critical.
• Pricing Strategies: Competitive pricing with broader reimbursement coverage could boost volume.
• Partnerships: Collaboration with healthcare providers to improve physician awareness.
• Innovation: Development of next-generation biosimilars or alternative delivery mechanisms.

Key Takeaways

• BASAGLAR operates in a competitive basal insulin market with limited market share but stable revenue streams.
• Biosimilar dynamics are influenced by regulatory approval, pricing, and physician acceptance.
• Market growth hinges on the global rise in diabetes prevalence and biosimilar adoption policies.
• Revenue has plateaued due to competition; future sales depend on market expansion and acceptance.
• Strategic focus on emerging markets and innovative formulations is vital for sustained profitability.

FAQs

1. How does BASAGLAR compare price-wise with Lantus?
BASAGLAR is approximately 20-30% cheaper per dosing unit, making it an attractive alternative for cost-conscious payers and patients.

2. Will BASAGLAR eventually attain interchangeability status?
Currently, it has not received FDA interchangeability designation, which limits automatic substitution at pharmacies. Future designation depends on additional clinical data and regulatory review.

3. What is the outlook for biosimilar insulin market share?
Biosimilars are expected to capture increasing market share due to cost advantages, but physician and patient acceptance, and formulary policies, influence uptake.

4. How significant is Lilly's revenue from BASAGLAR relative to its total portfolio?
BASAGLAR contributed roughly 2-3% to Lilly’s overall revenue in 2022, reflecting its niche position within the broader diabetes segment.

5. What strategic moves could Lilly make to sustain BASAGLAR revenues?
Expanding into emerging markets, advocating for insulin biosimilar acceptance, and developing next-gen formulations can support growth.

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References

[1] MarketandMarkets. (2023). Basal Insulin Market Forecast.
[2] International Diabetes Federation. (2022). IDF Diabetes Atlas, 10th Ed.
[3] U.S. Food and Drug Administration. (2016). Biosimilar Insulin Approvals.