NEUMEGA Drug Profile

Summary for Tradename: NEUMEGA

High Confidence Patents:	6
Applicants:	1
BLAs:	1

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 NEUMEGA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Wyeth Pharmaceuticals Inc.	NEUMEGA	oprelvekin	For Injection	103694	5,215,895	2010-06-01	Company disclosures
Wyeth Pharmaceuticals Inc.	NEUMEGA	oprelvekin	For Injection	103694	5,270,181	2011-02-06	Company disclosures
Wyeth Pharmaceuticals Inc.	NEUMEGA	oprelvekin	For Injection	103694	5,371,193	2011-12-06	Company disclosures

3) Low Certainty: US Patents for NEUMEGA 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
Wyeth Pharmaceuticals Inc.	NEUMEGA	oprelvekin	For Injection	103694	10,053,498	2034-11-21	Patent claims search
Wyeth Pharmaceuticals Inc.	NEUMEGA	oprelvekin	For Injection	103694	10,117,943	2039-02-26	Patent claims search
Wyeth Pharmaceuticals Inc.	NEUMEGA	oprelvekin	For Injection	103694	10,195,188	2036-06-13	Patent claims search

International Patents for NEUMEGA

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	9213955
Mexico	9203439
Mexico	9203295

NEUMEGA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: Neumega

Introduction

Neumega, also known as oprelvekin, is a biologic drug used to stimulate the production of platelets, particularly in patients undergoing chemotherapy. To understand the market dynamics and financial trajectory of Neumega, we need to delve into several key aspects, including market trends, competition, pricing, and the broader biologics market.

Biologics Market Overview

Biologics have become a significant segment of the pharmaceutical market, accounting for 42% of total medicines spending as of 2019, up from 30% in 2014[4].

Neumega's Role in the Market

Neumega is used to treat thrombocytopenia, a condition characterized by low platelet counts. It falls under the category of supportive care biologics, which are crucial in managing side effects of chemotherapy.

Market Exclusivity and Competition

Unlike small molecules, biologics have complex market exclusivity dynamics. The introduction of biosimilars has significantly altered the competitive landscape. For instance, in the supportive care segment, biosimilars like those for filgrastim and pegfilgrastim have led to substantial price erosion and market share shifts[1].

Pricing and Cost Savings

The pricing of biologic drugs, including Neumega, is influenced by the entry of biosimilars. For example, biosimilars of pegfilgrastim have reduced the average sales price (ASP) by 56% compared to the reference product, highlighting the potential for cost savings in the biologics market[1].

Financial Performance of Similar Biologics

To gauge the financial trajectory of Neumega, we can look at similar biologics. For instance, Amgen's Neulasta (pegfilgrastim), a drug in the same supportive care category, has seen significant market dynamics. As of Q3 2024, the biosimilar share of the pegfilgrastim market was 84%, indicating a highly competitive market with substantial price reductions[1].

Impact of Biosimilars on Revenue

The introduction of biosimilars can significantly impact the revenue of original biologic drugs. For example, Amgen's AMGEVITA (adalimumab biosimilar) has seen volume growth but also faces increased competition, leading to lower net selling prices. This trend is likely to affect Neumega if biosimilars are approved and launched[3].

Market Share and Volume Trends

In the supportive care segment, biosimilars have quickly gained market share. For filgrastim, lower-priced biosimilars dominate the market, with Neupogen's market share significantly reduced by the entry of biosimilars like Zarxio and Nivestym[1].

Cost Savings and Reimbursement

The use of biosimilars can lead to substantial cost savings. For instance, the change in reimbursement for Medicare patients receiving pegfilgrastim biosimilars has decreased from $292/year to -$93/year, highlighting the economic benefits of biosimilar adoption[5].

Future Outlook

The future of Neumega and similar biologics will be shaped by the increasing presence of biosimilars. As more biosimilars are approved and launched, the market is likely to see further price erosion and shifts in market share. Companies will need to adapt their pricing strategies and focus on innovation to maintain market presence.

Financial Implications for Manufacturers

Manufacturers of biologic drugs like Neumega face significant financial implications due to biosimilar competition. The reduction in ASP and market share can lead to decreased revenues. For example, Amgen's financial results show that while volume growth can offset some of the price reductions, the overall impact on revenue can be substantial[3].

Strategic Responses

To mitigate the impact of biosimilars, manufacturers may employ various strategies, including:

• Price Adjustments: Lowering the prices of the original biologic to remain competitive.
• Innovation: Investing in new products or indications to diversify revenue streams.
• Market Access: Enhancing patient access through rebates, discounts, and other programs.

Key Takeaways

• Biosimilar Impact: The entry of biosimilars significantly affects the pricing and market share of original biologic drugs.
• Cost Savings: Biosimilars can lead to substantial cost savings for healthcare systems.
• Market Dynamics: The supportive care segment is highly competitive, with biosimilars quickly gaining market share.
• Financial Trajectory: Manufacturers face reduced revenues due to price erosion and market share shifts.
• Strategic Adaptation: Companies must adapt their strategies to remain competitive in a biosimilar-dominated market.

FAQs

What is Neumega used for?

Neumega, or oprelvekin, is used to stimulate the production of platelets in patients undergoing chemotherapy, particularly those with thrombocytopenia.

How do biosimilars affect the market for biologic drugs like Neumega?

Biosimilars lead to significant price erosion and market share shifts, reducing the average sales price (ASP) of the original biologic drug and increasing competition.

What are the financial implications for manufacturers of biologic drugs facing biosimilar competition?

Manufacturers face reduced revenues due to lower ASPs and decreased market share, necessitating strategic adaptations such as price adjustments and innovation.

Can biosimilars lead to cost savings?

Yes, the adoption of biosimilars can lead to substantial cost savings for healthcare systems, as seen in the case of pegfilgrastim biosimilars.

How do market exclusivity dynamics differ between small molecules and biologics?

Market exclusivity dynamics for biologics are more complex and subject to biosimilar competition, unlike small molecules which are more consistently subject to generic competition[4].

Sources

1. Samsung Bioepis: Biosimilar Market Dynamics - SAMSUNG BIOEPIS, Q3 2024.
2. Neumora Therapeutics: Neumora Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update.
3. Amgen: AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS.
4. FTC: Biologics Market Dynamics: Setting the Stage for Biosimilars.
5. ASCO: Cost savings of biosimilar pegfilgrastim in a Medicare OCM.