Oprelvekin - Biologic Drug Details

Summary for oprelvekin

Tradenames:	1
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 oprelvekin Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for oprelvekin 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
Wyeth Pharmaceuticals Inc.	NEUMEGA	oprelvekin	For Injection	103694	6,066,317	2009-11-22	Company disclosures

3) Low Certainty: US Patents for oprelvekin 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
Wyeth Pharmaceuticals Inc.	NEUMEGA	oprelvekin	For Injection	103694	10,383,876	2031-04-05	Patent claims search

International Patents for oprelvekin

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	9213955
Mexico	9203439
Mexico	9203295
Greece	3035627

Oprelvekin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: Oprelvekin

Introduction to Oprelvekin

Oprelvekin, also known as recombinant interleukin-11 (IL-11), is a thrombopoietic growth factor that stimulates the proliferation of hematopoietic stem cells. It was developed and launched by Genetics Institute (now part of Wyeth, which is a subsidiary of Pfizer) and is marketed under the brand name Neumega. Oprelvekin is primarily used to prevent severe thrombocytopenia and reduce the need for platelet transfusions in patients undergoing myelosuppressive chemotherapy for non-myeloid malignancies[2][4].

FDA Approval and Clinical Use

Oprelvekin received FDA approval in November 1997 for its primary indication. Clinical studies have shown its effectiveness in reducing thrombocytopenia in oncologic patients treated with myelosuppressive chemotherapeutic drugs, significantly decreasing the need for platelet transfusions[4].

Market Drivers

Increasing Demand for Chemotherapy-Induced Thrombocytopenia Therapeutics

The global chemotherapy-induced thrombocytopenia therapeutics market, which includes oprelvekin, is driven by advancements in chemotherapy and cancer therapies. As more patients undergo chemotherapy, the demand for thrombocytopenia therapeutics is expected to rise, fueling market growth. This market is estimated to be valued at US$ 1,531.3 million in 2023 and is expected to exhibit a CAGR of 5% during the forecast period from 2023 to 2030[1].

Technological Advancements and Research

Continuous technological advancements and increased research and development activities in biologic therapies are key drivers for the market. Companies like Amgen, Inc., Novartis AG, and Pfizer Inc. are actively involved in developing and improving thrombocytopenia therapeutics, including oprelvekin[1].

Financial Performance

Historical Sales

In fiscal 2000, sales of oprelvekin for Genetics Institute were US$ 34 million. Analysts estimated that this figure would remain around US$ 30-34 million in the subsequent years, 2001 and 2002[2].

Market Share and Competition

Oprelvekin competes in a market dominated by several major pharmaceutical companies. North America holds a significant market share, with companies like Genetics Institute (now part of Pfizer) and other key players such as Amgen, Inc., Novartis AG, and Swedish Orphan Biovitrum AB playing crucial roles. The market share distribution and competitive landscape indicate a robust but competitive environment for oprelvekin[1].

Regional Analysis

North America

North America is estimated to hold a dominant position in the global chemotherapy-induced thrombocytopenia therapeutics market, with a market share of 43.2% in 2023. Initiatives such as the U.S. government's Persistent Poverty Initiative, aimed at reducing the cumulative effects of persistent poverty on cancer outcomes, are expected to drive significant growth in this region[1].

Global Expansion

Oprelvekin is also being developed and marketed in other regions. For instance, Wyeth-Ayerst holds the license for Europe, Africa, Latin America, and Asia (excluding Japan), while in Japan, it is being developed by Genetics Institute and Yamanouchi. This global expansion strategy helps in increasing the market reach and revenue potential for oprelvekin[2].

Side Effects and Safety Considerations

While oprelvekin is effective in reducing thrombocytopenia, it also has potential side effects. For example, it can increase fibrinogen levels and von-Willebrand-factor (vWf) activity, which may contribute to the development of stroke, although a precise association is not yet established[4].

Future Outlook

Market Growth Projections

The chemotherapy-induced thrombocytopenia therapeutics market, including oprelvekin, is expected to grow significantly over the forecast period. With a projected CAGR of 5% from 2023 to 2030, the market is anticipated to reach US$ 2,154.6 million by 2030[1].

Emerging Trends and Opportunities

The biologics market, of which oprelvekin is a part, is driven by emerging trends such as the development of advanced drug delivery systems, increasing adoption of biosimilars, and strong pipeline of biologic drugs. These trends are expected to continue driving the market forward, providing opportunities for growth and innovation in the thrombocytopenia therapeutics segment[3].

Key Takeaways

• Market Value and Growth: The global chemotherapy-induced thrombocytopenia therapeutics market, including oprelvekin, is valued at US$ 1,531.3 million in 2023 and is expected to grow at a CAGR of 5% until 2030.
• Regional Dominance: North America holds a significant market share, driven by initiatives and advancements in cancer therapies.
• Financial Performance: Oprelvekin has shown steady sales figures, with historical sales around US$ 34 million in fiscal 2000.
• Safety and Side Effects: While effective, oprelvekin has potential side effects that need careful monitoring.
• Future Outlook: The market is expected to grow, driven by technological advancements and increasing demand for biologic therapies.

FAQs

What is oprelvekin used for?

Oprelvekin is used to prevent severe thrombocytopenia and reduce the need for platelet transfusions in patients undergoing myelosuppressive chemotherapy for non-myeloid malignancies.

Who developed and markets oprelvekin?

Oprelvekin was developed by Genetics Institute and is marketed under the brand name Neumega. Genetics Institute is now part of Pfizer.

What are the potential side effects of oprelvekin?

Oprelvekin can increase fibrinogen levels and von-Willebrand-factor (vWf) activity, which may contribute to the development of stroke, although a precise association is not yet established.

What is the current market value of the chemotherapy-induced thrombocytopenia therapeutics market?

The global chemotherapy-induced thrombocytopenia therapeutics market is estimated to be valued at US$ 1,531.3 million in 2023.

What is the projected growth rate for the chemotherapy-induced thrombocytopenia therapeutics market?

The market is expected to exhibit a CAGR of 5% during the forecast period from 2023 to 2030.

Sources

1. Coherent Market Insights - Chemotherapy Induced Thrombocytopenia Therapeutics Market
2. PubMed - Oprelvekin. Genetics Institute
3. Biospace - Biologics Market Size to Reach USD 699.5 Billion by 2032
4. Wikipedia - Oprelvekin