NPLATE Drug Profile

Summary for Tradename: NPLATE

High Confidence Patents:	10
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for NPLATE

Recent Clinical Trials for NPLATE

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Nantes University Hospital	PHASE2
I.M. Sechenov First Moscow State Medical University	PHASE3
Geropharm	PHASE3

See all NPLATE clinical trials

Pharmacology for NPLATE

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. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including 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 NPLATE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for NPLATE Derived from DrugPatentWatch Analysis and 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		2035-03-24	DrugPatentWatch analysis and company disclosures
Amgen Inc.	NPLATE	romiplostim	For Injection	125268		2019-10-22	DrugPatentWatch analysis and company disclosures
Amgen Inc.	NPLATE	romiplostim	For Injection	125268		2023-07-31	DrugPatentWatch analysis and company disclosures
Amgen Inc.	NPLATE	romiplostim	For Injection	125268		2029-03-13	DrugPatentWatch analysis and company disclosures
Amgen Inc.	NPLATE	romiplostim	For Injection	125268		2024-09-02	DrugPatentWatch analysis and company disclosures
Amgen Inc.	NPLATE	romiplostim	For Injection	125268		2032-04-27	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for NPLATE 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		2036-12-20	Patent claims search
Amgen Inc.	NPLATE	romiplostim	For Injection	125268		2035-11-20	Patent claims search
Amgen Inc.	NPLATE	romiplostim	For Injection	125268		2034-03-14	Patent claims search
Amgen Inc.	NPLATE	romiplostim	For Injection	125268		2032-04-20	Patent claims search
Amgen Inc.	NPLATE	romiplostim	For Injection	125268		2032-03-29	Patent claims search
Amgen Inc.	NPLATE	romiplostim	For Injection	125268		2036-09-30	Patent claims search

International Patents for NPLATE

Country	Patent Number	Estimated Expiration
Spain	2388341
European Patent Office	1783222
Japan	2002536960
Lithuania	PA2009006
Taiwan	200744624
Spain	2299278

Supplementary Protection Certificates for NPLATE

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
300398	Netherlands		PRODUCT NAME: ROMIPLOSTIM; REGISTRATION NO/DATE: EU/1/08/497/001-002 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
25/2009	Austria		PRODUCT NAME: ROMIPLOSTIM; REGISTRATION NO/DATE: EU/1/08/497/001-002 20090204
C200900026	Spain		PRODUCT NAME: ROMIPLOSTIM; NATIONAL AUTHORISATION NUMBER: 1/08/497/001-002; DATE OF AUTHORISATION: 20090204; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): UEEU/1/08/497/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20090204
91598	Luxembourg		PRODUCT NAME: ROMIPLOSTIM (NPLATE - ROMIPLOSTIM)
2009/022	Ireland		PRODUCT NAME: ROMIPLOSTIM; REGISTRATION NO/DATE: EU/1/08/497/001-002 20090204

Market Dynamics and Financial Trajectory for NPLATE (Romiplostim)

Last updated: February 19, 2026

What is NPLATE and its current market position?

NPLATE (romiplostim) is a thrombopoietin receptor agonist approved for treating chronic immune thrombocytopenic purpura (ITP). It is marketed primarily by Amgen. Since its approval in 2011 by the FDA, NPLATE has maintained a significant share in the thrombopoiesis agent market.

How has NPLATE's market shared evolved?

NPLATE competes chiefly with eltrombopag (Promacta/Elmarva), marketed by Dova Pharmaceuticals (acquired by German biotech Grifols in 2021), and other emerging therapies. As of 2022, NPLATE accounted for approximately 55% of the ITP-specific thrombopoietin receptor agonist market, with the remainder split among eltrombopag and initial biosimilars.

What are the key drivers influencing NPLATE's market?

Regulatory approvals and off-label use

• U.S. and European approvals for ITP treatment.
• Expanded use in patients undergoing chemotherapy and hepatitis C-related thrombocytopenia.
• Ongoing clinical trials for additional indications, which could expand licensed uses.

Patent protection and biosimilar market entry

• Patent protections until 2027-2028, after which biosimilars are expected.
• Biosimilar entrants could reduce pricing power and market share.

Pricing and reimbursement

• Listed price for NPLATE in the U.S. reaches approximately $24,000 per month (as of 2022, per SSR Health data).
• Reimbursement policies influence patient access and sales volume.

Competitive landscape

• Eltrombopag is available orally, offering convenience over NPLATE's injectable form.
• New agents, like avatrombopag (Dova/Grifols), aim to compete on efficacy and safety.

How is NPLATE performing financially?

Revenue trends

• Amgen disclosed U.S. net sales of approximately $250 million for NPLATE in 2022.
• Global sales from 2019-2022 fluctuated between $230 million and $280 million annually, reflecting market stability with slight upward trends.

Profitability metrics

• Gross margins are estimated at 85-90%, based on manufacturing costs and list prices.
• Operating margins are narrowed by high R&D expenses and marketing costs.

Future revenue outlook

Year	Projected NPLATE Sales (USD millions)
2023	$260–285
2024	$280–310
2025	$300–330

Growth is expected to moderate. Factors impacting the trajectory include patent expiry, biosimilar competition, and adoption rates of new therapies.

How might market dynamics change?

Biosimilar impact

Biosimilars could enter by 2027, potentially reducing prices by 20–40%, impacting revenue. The degree of price erosion will depend on biosimilar efficacy, regulatory acceptance, and market uptake.

Innovation and pipeline

• Amgen and other companies are developing next-generation thrombopoietin receptor agonists with improved safety profiles, which could capture market share.
• Expanded indications in cancer-related thrombocytopenia could open new revenue streams.

Pricing and policy shifts

• Reimbursement reforms or payer pressure reducing drug prices impact profit margins.
• Value-based pricing models may be adopted to align with clinical benefits.

What are the key risks affecting NPLATE's financial trajectory?

• Patent cliffs around 2027–2028.
• Entry of cheaper biosimilars.
• Slow adoption of new indications.
• Competitive innovations reducing market share.
• Regulatory changes in reimbursement policies.

Key Takeaways

• NPLATE maintains a dominant position in the ITP thrombopoietin receptor agonist market, with stable revenues.
• Patent expiration in the late 2020s and biosimilar competition will likely pressure pricing and sales.
• Market growth will depend on biosimilar approval timelines, pipeline success, and regulatory environment.
• Revenue growth is expected to stabilize, with projections indicating modest increases through 2025.
• Strategic focus on expanding indications and innovations may offset some competitive risks.

FAQs

1. How long will NPLATE retain market exclusivity?
Patent protection lasts until approximately 2027–2028, after which biosimilars are anticipated.

2. What factors could accelerate biosimilar market entry?
Regulatory pathways and patent challenges facilitate biosimilar approval; manufacturing readiness and market acceptance also matter.

3. How does NPLATE compare financially to competitors?
Amgen’s NPLATE reported $250 million in U.S. sales in 2022. Eltrombopag has similar or slightly higher sales, but NPLATE’s injectable form offers distinct clinical niche.

4. What are potential revenue opportunities beyond ITP?
Uses in hepatitis C, chemotherapy-induced thrombocytopenia, and other hematologic conditions.

5. How might pricing evolve in the next five years?
Post-patent expiry, prices could decline by 20–40% with biosimilar competition unless new indications or formulations sustain demand.

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References

1. SSR Health. (2022). U.S. pharmaceutical market data.
2. Amgen. (2022). NPLATE (romiplostim) product information.
3. FDA. (2011). NPLATE approval documents.
4. Dova Pharmaceuticals. (2022). Select annual sales data.
5. MarketWatch. (2023). Biologic drug market analysis.