LUCENTIS Drug Profile

Summary for Tradename: LUCENTIS

High Confidence Patents:	9
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for LUCENTIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LUCENTIS

Recent Clinical Trials for LUCENTIS

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Hoffmann-La Roche	Phase 3
Ocugen	Phase 1
Sinocelltech Ltd.	Phase 3

See all LUCENTIS clinical trials

Recent Litigation for LUCENTIS

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Novartis Pharma AG v. Regeneron Pharmaceuticals, Inc.	2023-01-05
Janssen Biotech, Inc. v. Amgen Inc.	2022-11-29
Apple Inc. v. Masimo Corporation	2022-10-20

See all LUCENTIS litigation

PTAB Litigation

Petitioner	Date
Regeneron Pharmaceuticals, Inc. et al.	2021-04-16
Regeneron Pharmaceuticals, Inc.	2020-07-16
Regeneron Pharmaceuticals, Inc. et al.	2020-07-16

See all LUCENTIS litigation

Pharmacology for LUCENTIS

Mechanism of Action	Vascular Endothelial Growth Factor Inhibitors
Established Pharmacologic Class	Vascular Endothelial Growth Factor Inhibitor

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 LUCENTIS Derived from Brand-Side Litigation

These patents were obtained from brand-side disclosures in response to biosimilar applications

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Patent Expiration
Genentech, Inc.	LUCENTIS	ranibizumab	Injection	125156	October 13, 2016	8,574,869	2028-07-08
Genentech, Inc.	LUCENTIS	ranibizumab	Injection	125156	June 30, 2006	6,921,659	2023-10-17
Genentech, Inc.	LUCENTIS	ranibizumab	Injection	125156	October 13, 2016	10,112,994	2035-11-05

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

No patents found based on company disclosures

3) Low Certainty: US Patents for LUCENTIS 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
Genentech, Inc.	LUCENTIS	ranibizumab	Injection	125156	10,004,788	2032-05-15	Patent claims search
Genentech, Inc.	LUCENTIS	ranibizumab	Injection	125156	10,016,338	2033-03-11	Patent claims search
Genentech, Inc.	LUCENTIS	ranibizumab	Injection	125156	10,016,434	2033-08-12	Patent claims search

Market Dynamics and Financial Trajectory for the Biologic Drug: Lucentis

Introduction

Lucentis, a biologic drug developed by Genentech (a member of the Roche Group) and Novartis, has been a cornerstone in the treatment of retinopathies, including age-related macular degeneration (AMD) and diabetic macular edema. Here, we delve into the market dynamics and financial trajectory of Lucentis, highlighting its impact, competition, and future outlook.

Historical Success and Market Impact

Lucentis was approved by the FDA in 2006 and quickly became a blockbuster drug, generating billions of dollars in revenue. It revolutionized the treatment of AMD and other retinal diseases, offering significant improvements in patient outcomes[3].

Market Share and Competition

As of Q3 2023, Lucentis faces increasing competition from biosimilars. Two biosimilars, Byooviz and Cimerli, have been launched, collectively capturing a 34% market share. Despite this, Lucentis remains a dominant player, though its market share has been eroded by these newer entrants[1].

Price Trends

The average sales price (ASP) of Lucentis and its biosimilars has seen a significant decline. As of Q1 2024, the average ASP of all Lucentis products is $1,003, down 23% from the reference product's ASP at the time of the first biosimilar launch. The average ASP for biosimilars alone is $1,062, a decrease of 18%[1].

Financial Performance

Revenue

Lucentis has been a significant contributor to the revenues of both Novartis and Roche. However, recent financial reports indicate a decline in sales due to increased competition from biosimilars and other biologics. For instance, Novartis reported a 24% decline in Lucentis sales in Q4 2023 compared to the previous year[2].

Profitability

The profitability of Lucentis is also affected by the rising competition. While it remains a profitable drug, the erosion of market share and price reductions have impacted its overall contribution to the companies' bottom lines. Roche's financial reports for 2022 showed a stable but slightly declining revenue from Lucentis, reflecting the broader market trends[5].

Therapeutic Landscape

Age-Related Macular Degeneration (AMD)

The AMD drugs market, where Lucentis is a key player, is expected to grow at a CAGR of 10.7% from 2024 to 2029, reaching $17.37 billion by 2029. This growth is driven by the increasing prevalence of AMD and the introduction of new treatments, including biosimilars and other biologics like Eylea and Vabysmo[4].

Emerging Competitors

Eylea, developed by Regeneron Pharmaceuticals, has surpassed Lucentis in sales, generating $9.4 billion in revenue in 2021. Other drugs like Vabysmo and Syfovre are also gaining traction, further diversifying the treatment options for AMD and other retinal diseases[3][4].

Regulatory Environment

The approval of biosimilars has significantly altered the regulatory landscape for biologic drugs like Lucentis. The FDA has approved multiple biosimilars across various therapeutic areas, including ophthalmology, which has increased competition and driven price reductions[1].

Future Outlook

Market Growth

Despite the challenges posed by biosimilars, the overall market for AMD and retinal disease treatments is expected to grow. Lucentis, while facing increased competition, will likely remain a significant player due to its established brand and clinical efficacy.

Innovation and Adaptation

To maintain market share, companies like Novartis and Roche are focusing on innovation and adaptation. This includes developing new formulations, expanding into other therapeutic areas, and leveraging biosimilar strategies to stay competitive.

Key Takeaways

• Lucentis has been a groundbreaking treatment for retinal diseases but faces increasing competition from biosimilars.
• The market share and ASP of Lucentis have declined due to biosimilar entries.
• The AMD drugs market is expected to grow significantly, driven by new treatments and increasing prevalence.
• Companies must innovate and adapt to maintain market share in a competitive landscape.

FAQs

What is Lucentis used for?

Lucentis is used for the treatment of age-related macular degeneration (AMD), diabetic macular edema, and other retinal diseases.

How has the market share of Lucentis been affected by biosimilars?

As of Q3 2023, two biosimilars have launched, capturing a combined market share of 34%, which has eroded Lucentis's market dominance.

What is the current average sales price (ASP) of Lucentis and its biosimilars?

As of Q1 2024, the average ASP of all Lucentis products is $1,003, down 23% from the reference product's ASP at the time of the first biosimilar launch. The average ASP for biosimilars alone is $1,062, a decrease of 18%.

How is the AMD drugs market expected to grow?

The AMD drugs market is expected to grow at a CAGR of 10.7% from 2024 to 2029, reaching $17.37 billion by 2029.

What are some of the emerging competitors to Lucentis?

Eylea, Vabysmo, and Syfovre are some of the emerging competitors in the AMD treatment market.

Sources

1. Samsung Bioepis, "Biosimilar Market Report Q1 2024".
2. Novartis, "Novartis Financial Results Q4 2023 – English".
3. Medical Affairs Specialist, "Therapeutic Areas Transformed by Biologics: Part 2".
4. MarketsandMarkets, "Age-related Macular Degeneration (AMD) Drugs Market worth ...".
5. Roche, "Finance Report 2022 | Roche".