LEVEMIR Drug Profile

Summary for Tradename: LEVEMIR

High Confidence Patents:	14
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for LEVEMIR
Recent Clinical Trials:	See clinical trials for LEVEMIR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEVEMIR

See drug prices for LEVEMIR

Recent Clinical Trials for LEVEMIR

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Novo Nordisk A/S	Phase 1
Hennepin Healthcare Research Institute	N/A
Minneapolis Medical Research Foundation	N/A

See all LEVEMIR clinical trials

Recent Litigation for LEVEMIR

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
NOVO NORDISK INC. v. RIO BIOPHARMACEUTICALS, INC.	2024-01-19
NOVO NORDISK INC. v. DR. REDDY'S LABORATORIES, LTD.	2023-11-08
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-11-10

See all LEVEMIR litigation

Pharmacology for LEVEMIR

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 LEVEMIR Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for LEVEMIR 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.	LEVEMIR	insulin detemir	Injection	021536		2026-07-17	Company disclosures
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536		2037-11-17	Company disclosures
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536		2037-02-24	Company disclosures
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536		2039-01-17	Company disclosures
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536		2025-01-21	Company disclosures
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536		2008-02-10	Company disclosures

3) Low Certainty: US Patents for LEVEMIR 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.	LEVEMIR	insulin detemir	Injection	021536		2033-03-11	Patent claims search
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536		2032-04-18	Patent claims search
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536		2031-06-02	Patent claims search
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536		2035-07-15	Patent claims search
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536		2035-07-15	Patent claims search
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536		2029-01-28	Patent claims search

International Patents for LEVEMIR

Country	Patent Number	Estimated Expiration
Denmark	1909870
Denmark	411686
European Patent Office	1003581
Norway	985981
Norway	320213
Spain	2276112

Supplementary Protection Certificates for LEVEMIR

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
28/2004	Austria		PRODUCT NAME: INSULIN-DETEMIR UND PHARMAZEUTISCH ANNEHMBARE ZN-SALZE DAVON; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: LI 56370 56371 56372 20031110
122004000035	Germany		PRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601 FIRST REGISTRATION: LIECHTENSTEIN 5637001 5637101 5637201 20031110
2004/015	Ireland		PRODUCT NAME: INSULIN DETEMIR; NAT REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION NO/DATE: CH 56370 56371 56372 20031110; PAEDIATRIC INVESTIGATION PLAN: P/0172/2014
PA2004005	Lithuania		PRODUCT NAME: INSULIN DETEMIR; REGISTRATION NO/DATE: EU/1/04/278/001, EU/1/04/278/002, EU/1/04/278/003, EU/1/04/278/004, EU/1/04/278/005, EU/1/04/278/006, EU/1/04/278/007, EU/1/04/278/008, EU/1/04/278/00 20040601
91101	Luxembourg		91101, EXPIRES: 20190601
SPC/GB04/036	United Kingdom		PRODUCT NAME: INSULIN DETEMIR, NEB29- TETRADECANOYL- DES(B30) HUMAN INSULIN; NATL REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: CH 56370, 56311, 56372 20031110

Market Dynamics and Financial Trajectory for the Biologic Drug: Levemir

Introduction

Levemir, a long-acting insulin analog developed by Novo Nordisk, has been a crucial medication for many diabetes patients, particularly young people and pregnant women. However, recent announcements have significantly impacted its market dynamics and financial trajectory.

Price Cuts and Market Response

In 2023, Novo Nordisk, along with other major insulin manufacturers like Eli Lilly and Sanofi, implemented substantial price cuts on several insulin products. For Levemir, the list price was reduced by 65%, bringing the cost down to $107.85 for a vial and $161.77 for a FlexPen[3][4].

This move was praised by insulin users and advocates, as it provided financial relief in a market where insulin prices had been a significant burden. However, this positive development was short-lived.

Discontinuation Announcement

Despite the price cuts, Novo Nordisk announced in November 2023 that it would discontinue Levemir in the U.S. market by the end of 2024. The FlexPen version would be discontinued even sooner, in April 2024[1][4].

Reasons for Discontinuation

The decision to discontinue Levemir was attributed to several factors, including global manufacturing constraints and the limited availability of the drug due to its exclusion from many insurance formularies. Pharmacy managers and insurers have increasingly favored newer, more expensive insulin formulations and biosimilars, which are cheaper generic versions of branded insulins[1][4].

Impact on Patients

The discontinuation of Levemir has significant implications for the approximately 200,000 patients in the U.S. who currently rely on this medication. Patients will need to transition to alternative insulins, which may not be as effective or convenient for their specific needs. The alternative insulin offered by Novo Nordisk is significantly more expensive, exacerbating the financial burden on patients[1][4].

Financial Performance of Levemir

Historically, Levemir was a substantial revenue generator for Novo Nordisk. In 2022, it generated $649 million in revenue, with over one million users in the United States as recently as 2021. However, its revenue and user base have declined as it has been gradually removed from insurance formularies in favor of cheaper biosimilars[1].

Shift in Novo Nordisk's Focus

Novo Nordisk's decision to discontinue Levemir reflects a broader strategic shift towards more lucrative markets. The company has seen significant success with its GLP-1 weight-loss drugs, such as Wegovy and Ozempic, which have recorded billions in sales. Financial analysts note that insulin is becoming "decreasingly financially important" to Novo Nordisk due to market saturation and competition from biosimilars[4].

Financial Trajectory of Novo Nordisk

Despite the discontinuation of Levemir, Novo Nordisk's overall financial performance remains strong. In the first quarter of 2024, the company reported a 24% increase in sales and a 30% increase in operating profit compared to the same period in 2023. This growth is largely driven by the increased demand for its GLP-1-based diabetes and obesity treatments[5].

Key Financial Highlights

• Net Sales: Increased by 24% to DKK 65,349 million in Q1 2024 compared to Q1 2023[5].
• Operating Profit: Grew by 30% to DKK 31,846 million in Q1 2024[5].
• Net Profit: Rose by 28% to DKK 25,407 million in Q1 2024[5].
• Free Cash Flow: DKK 5.0 billion in Q1 2024, though this represents a significant decline from the previous year[5].

Market Dynamics and Competition

The insulin market is highly competitive, with multiple players offering branded and generic versions of insulin. The rise of biosimilars has further intensified competition, making it challenging for companies like Novo Nordisk to maintain profitability on older insulin products like Levemir.

Biosimilars and Generic Competition

Biosimilars, such as those for glargine, have become increasingly attractive to payers due to their lower costs. This shift has led to a decline in the use of branded insulins like Levemir, as insurers and pharmacy benefit managers prefer cheaper alternatives[1].

Consumer Impact

The discontinuation of Levemir and the broader trend of favoring newer, more expensive insulins over older formulations have significant implications for consumers. It creates a "shell game" where consumers often lose out due to the constant changes in the market and the formularies[4].

Conclusion

The discontinuation of Levemir marks a significant shift in the insulin market, driven by a combination of factors including manufacturing constraints, formulary exclusions, and the strategic focus of Novo Nordisk on more lucrative markets. While this decision may benefit the company financially, it poses challenges for patients who rely on this medication.

Key Takeaways

• Discontinuation of Levemir: Novo Nordisk will stop selling Levemir in the U.S. by the end of 2024.
• Price Cuts: Despite recent price cuts, Levemir's discontinuation reflects broader market dynamics.
• Shift in Focus: Novo Nordisk is focusing more on GLP-1 weight-loss drugs and other lucrative markets.
• Financial Performance: Novo Nordisk's overall financial performance remains strong, driven by other products.
• Market Competition: The rise of biosimilars and generic competition has impacted the profitability of branded insulins.

FAQs

Q: Why is Novo Nordisk discontinuing Levemir?

Novo Nordisk is discontinuing Levemir due to a combination of global manufacturing constraints and the limited availability of the drug on insurance formularies, as well as the company's strategic shift towards more lucrative markets.

Q: What are the implications for patients using Levemir?

Patients will need to transition to alternative insulins, which may be more expensive and not as effective or convenient for their specific needs.

Q: How has the price of Levemir changed recently?

The list price of Levemir was reduced by 65% in 2023, but this price cut did not prevent its discontinuation.

Q: What other products is Novo Nordisk focusing on?

Novo Nordisk is focusing on its GLP-1 weight-loss drugs, such as Wegovy and Ozempic, which have seen significant sales growth.

Q: How has the rise of biosimilars affected the insulin market?

The rise of biosimilars has increased competition in the insulin market, making it challenging for companies to maintain profitability on older branded insulins like Levemir.

Sources

1. Prospect: "Novo Nordisk Discontinues Insulin Medication After Cutting Its Price"
2. Novo Nordisk: "Financial report for the period 1 January 2021 to 31 December 2021"
3. Managed Healthcare Executive: "Novo Nordisk Cuts Price on Several Insulin Products by 75%"
4. USA Today: "Levemir insulin will be discontinued"
5. GlobeNewswire: "Financial report for the period 1 January 2024 to 31 March 2024"