Romiplostim - Biologic Drug Details

Summary for romiplostim

Tradenames:	1
High Confidence Patents:	4
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for romiplostim
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for romiplostim

Recent Clinical Trials for romiplostim

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Peking University People's Hospital	Phase 2
Institute of Hematology & Blood Diseases Hospital	N/A
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	Phase 3

See all romiplostim clinical trials

Recent Litigation for romiplostim

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.	2018-04-30

See all romiplostim litigation

Pharmacology for romiplostim

Mechanism of Action	Thrombopoietin Receptor Agonists
Physiological Effect	Increased Megakaryocyte Maturation Increased Platelet Production
Established Pharmacologic Class	Thrombopoietin Receptor Agonist

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 romiplostim Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Amgen Inc.	NPLATE	romiplostim	For Injection	125268		2018-10-23	Company disclosures
Amgen Inc.	NPLATE	romiplostim	For Injection	125268		2018-10-23	Company disclosures
Amgen Inc.	NPLATE	romiplostim	For Injection	125268		2018-10-23	Company disclosures
Amgen Inc.	NPLATE	romiplostim	For Injection	125268		2018-10-23	Company disclosures

3) Low Certainty: US Patents for romiplostim 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
Amgen Inc.	NPLATE	romiplostim	For Injection	125268		2033-03-11	Patent claims search
Amgen Inc.	NPLATE	romiplostim	For Injection	125268		2034-11-21	Patent claims search
Amgen Inc.	NPLATE	romiplostim	For Injection	125268		2039-02-26	Patent claims search
Amgen Inc.	NPLATE	romiplostim	For Injection	125268		2031-04-20	Patent claims search

International Patents for romiplostim

Country	Patent Number	Estimated Expiration
Hungary	P0104327
Australia	5943201
Japan	2003533187
Slovakia	4962001

Supplementary Protection Certificates for romiplostim

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SZ 25/2009	Austria		PRODUCT NAME: ROMIPLOSTIM
SPC/GB09/035	United Kingdom		PRODUCT NAME: ROMIPLOSTIM; REGISTERED: UK EU/1/08/497/001 20090206; UK EU/1/08/497/002 20090206
C 2009 009	Romania		PRODUCT NAME: NPLATE-ROMIPLOSTIM; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/497/001, RO EU/1/08/497/002; DATE OF NATIONAL AUTHORISATION: 20090204; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/08/497/001, EMEA EU/1/08/497/002; DATE OF FIRST AUTHORISATION IN EEA: 20090204
91598	Luxembourg		PRODUCT NAME: ROMIPLOSTIM (NPLATE - ROMIPLOSTIM); AUTHORISATION NUMBER AND DATE: EU/1/08/497/001-002 20090206

Market Dynamics and Financial Trajectory for the Biologic Drug: Romiplostim

Introduction

Romiplostim, marketed under the brand name Nplate, is a thrombopoietin receptor agonist used in the treatment of immune thrombocytopenia (ITP), a condition characterized by low platelet counts. This article delves into the market dynamics and financial trajectory of romiplostim, highlighting its current market status, growth prospects, and the factors influencing its financial performance.

Global Market Size and Growth

The global romiplostim market is projected to experience significant growth over the next few years. As of 2024, the market size is estimated to be in the billions, with a forecasted expansion to USD 1.8 billion by 2031, driven by the increasing prevalence of thrombocytopenia and other related conditions[4].

Regional Market Growth

The market growth of romiplostim varies across different regions:

• North America: This region holds the largest market share, with over 40% of the global revenue. It is expected to grow at a compound annual growth rate (CAGR) of 4.2% from 2024 to 2031, driven by rising environmental awareness, government incentives, and technological advancements[1].
• Europe: Europe accounts for over 30% of the global market and is expected to grow at a CAGR of 4.5% during the same period. Factors such as increasing infrastructure developments and industry cooperation are anticipated to fuel this growth[1].
• Asia Pacific: This region is expected to experience the highest growth rate, with a CAGR of 8% from 2024 to 2031, driven by lifestyle changes and rising urbanization[1].
• South America and Middle East & Africa: These regions are also expected to see significant growth, with CAGRs of 5.4% and 5.7%, respectively, driven by the increasing use of romiplostim in various therapies[1].

Cost Impact and Economic Benefits

Romiplostim offers significant economic benefits compared to other treatments for ITP, such as intravenous immunoglobulin (IVIg). A study in Québec, Canada, found that the average annual drug acquisition costs for romiplostim were $48,024, compared to $98,868 for IVIg. Additionally, romiplostim resulted in lower costs for drug preparation and administration, as well as less time lost from work, leading to an average annual cost savings of almost $54,000 per patient[2].

Mechanism of Action and Clinical Use

Romiplostim works by stimulating the thrombopoietin receptor, leading to increased megakaryocyte maturation and platelet production. It is used to treat adults with chronic ITP and children who have had ITP for at least six months and are at least one year old, reducing the risk of bleeding by increasing platelet counts[5].

Market Competition and Challenges

The romiplostim market faces competition from other approved products for ITP and emerging therapies. The original biologic company, Amgen, must compete with generic and biosimilar manufacturers. Factors such as doctors’ perceptions, patent extensions, and pricing strategies can influence the market expansion[4].

Patent Landscape and Future Outlook

The patents for Nplate (romiplostim) are set to expire in various years up to 2039, depending on the country and specific patent claims. This opens up opportunities for biosimilar entrants, which could significantly impact the market dynamics in the future[5].

Financial Performance and Forecast

The financial performance of romiplostim is closely tied to its market growth and competitive landscape. With an expected market size of USD 1.8 billion by 2031, the drug is a significant contributor to Amgen's overall financial performance. Incremental healthcare spending and extensive research in the treatment of ITP are expected to expand the market size, enabling drug manufacturers to penetrate deeper into the market[3].

Industry Cooperation and Policy Development

The growth of the romiplostim market is also influenced by industry cooperation, consumer trends, government laws, and technological breakthroughs. Collaboration between public and commercial sectors can expedite market investment, R&D efforts, and policy development, further driving market growth[1].

Key Takeaways

• The global romiplostim market is projected to reach USD 1.8 billion by 2031.
• Regional growth rates vary, with Asia Pacific expected to grow the fastest.
• Romiplostim offers significant cost savings compared to IVIg.
• The drug's mechanism of action involves stimulating the thrombopoietin receptor.
• Market competition and patent expirations will shape the future market landscape.
• Industry cooperation and policy development are crucial for market growth.

FAQs

What is romiplostim used for?

Romiplostim is used to treat adults with chronic immune thrombocytopenia (ITP) and children who have had ITP for at least six months and are at least one year old, to reduce the risk of bleeding by increasing platelet counts.

How does romiplostim compare to IVIg in terms of cost?

Romiplostim is significantly cheaper than IVIg, with average annual drug acquisition costs of $48,024 compared to $98,868 for IVIg, resulting in an average annual cost savings of almost $54,000 per patient[2].

What is the expected market size of romiplostim by 2031?

The global romiplostim market is expected to reach USD 1.8 billion by 2031[4].

Which region is expected to grow the fastest in the romiplostim market?

The Asia Pacific region is expected to grow the fastest, with a CAGR of 8% from 2024 to 2031[1].

When do the patents for Nplate (romiplostim) expire?

The patents for Nplate (romiplostim) are set to expire in various years up to 2039, depending on the country and specific patent claims[5].

Sources

1. Cognitive Market Research: Romiplostim Market Report 2024 (Global Edition)
2. PubMed: Comparative net cost impact of the utilization of romiplostim and IVIg
3. Business Wire: Nplate (Romiplostim) Romiplate Drug Insight and Market Forecast
4. PharmiWeb: Romiplostim Market Is Projected To Succeed In USD 1.8 billion By 2031
5. Drug Patent Watch: When will the NPLATE patents expire, and when will biosimilar entrants emerge?