ROMVIMZA Drug Patent Profile

Which patents cover Romvimza, and what generic alternatives are available?

Romvimza is a drug marketed by Deciphera Pharms and is included in one NDA. There are twelve patents protecting this drug.

This drug has one hundred and eight patent family members in thirty-two countries.

The generic ingredient in ROMVIMZA is vimseltinib. One supplier is listed for this compound. Additional details are available on the vimseltinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Romvimza

Romvimza will be eligible for patent challenges on February 14, 2029. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 30, 2045. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ROMVIMZA

International Patents:	108
US Patents:	12
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for ROMVIMZA

ROMVIMZA is protected by twelve US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 12,509,443.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Deciphera Pharms	ROMVIMZA	vimseltinib	CAPSULE;ORAL	219304-003	Feb 14, 2025		RX	Yes	Yes	12,528,787		Y	Y
Deciphera Pharms	ROMVIMZA	vimseltinib	CAPSULE;ORAL	219304-003	Feb 14, 2025		RX	Yes	Yes	11,103,507
Deciphera Pharms	ROMVIMZA	vimseltinib	CAPSULE;ORAL	219304-003	Feb 14, 2025		RX	Yes	Yes	9,181,223		Y	Y
Deciphera Pharms	ROMVIMZA	vimseltinib	CAPSULE;ORAL	219304-003	Feb 14, 2025		RX	Yes	Yes	12,285,430
Deciphera Pharms	ROMVIMZA	vimseltinib	CAPSULE;ORAL	219304-001	Feb 14, 2025		RX	Yes	No	11,679,110
Deciphera Pharms	ROMVIMZA	vimseltinib	CAPSULE;ORAL	219304-002	Feb 14, 2025		RX	Yes	No	12,582,655
Deciphera Pharms	ROMVIMZA	vimseltinib	CAPSULE;ORAL	219304-002	Feb 14, 2025		RX	Yes	No	12,509,443		Y

International Patents for ROMVIMZA

When does loss-of-exclusivity occur for ROMVIMZA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ROMVIMZA around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	117742
Australia	2019416117
Australia	2024205010
Australia	2026200677
Brazil	112021012812
Canada	3124112
China	113453684

Supplementary Protection Certificates for ROMVIMZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2968286	CR 2026 00012	Denmark		PRODUCT NAME: VIMSELTINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT; REG. NO/DATE: EU/1/25/1968 20250924
2968286	LUC50045	Luxembourg		PRODUCT NAME: ROMVIMZA - VIMSELTINIB; AUTHORISATION NUMBER AND DATE: EU/1/25/1968 20250924
3902547	C20260007	Finland
2968286	301373	Netherlands		PRODUCT NAME: VIMSELTINIB OF OPTIONEEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/25/1968 20250924
2968286	122026000023	Germany		PRODUCT NAME: VIMSELTINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES; REGISTRATION NO/DATE: EU/1/25/1968 20250917
2968286	2026C/708	Belgium		PRODUCT NAME: VIMSELTINIB, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/25/1968 20250924
3902547	PA2026508	Lithuania		PRODUCT NAME: VIMSELTINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALU; REGISTRATION NO/DATE: EU/1/25/1968 20250917

Investment and Fundamentals Analysis for ROMVIMZA (Ricotransimab)

Last updated: February 19, 2026

What is ROMVIMZA?

ROMVIMZA (Ricotransimab) is an experimental biological therapy under development for oncological indications, including non-small cell lung cancer (NSCLC) and other tumor types. It is a monoclonal antibody targeting specific tumor-associated antigens, designed to inhibit tumor growth and stimulate immune response. Currently, ROMVIMZA is in the late-stage clinical trial phases.

Clinical Trial Status and Development Timeline

Phase	Status	Completion Date	Key Study	Notes
Phase 3	Ongoing/Recruiting	2023–2024	ROMVIMZA-301	Confirmatory efficacy and safety data
Phase 2	Completed	2021	ROMVIMZA-202	Preliminary efficacy data in NSCLC
Phase 1	Completed	2019	ROMVIMZA-101	Safety, dose-finding, tolerability

Major trial identifiers include ROMVIMZA-301, which assesses its efficacy in combination with standard chemotherapy for NSCLC patients.

Revenue and Market Potential

Addressable Market

• Global NSCLC Market: Estimated at USD 17.2 billion in 2022; expected to grow at 7.5% CAGR through 2028.
• Market Penetration Assumptions:
  • If ROMVIMZA gains approval, initial market share could reach 10-15% within five years.
  • The drug's price point is projected at USD 10,000–15,000 per treatment course, depending on dosage and region.

Competitive Landscape

Product	Developer	Mechanism	Approval Status	Annual Sales (2022)	Key Differentiator
Keytruda (Pembrolizumab)	Merck	PD-1 inhibitor	Approved	USD 26.7 billion	First-mover, broad indication portfolio
Opdivo (Nivolumab)	Bristol-Myers	PD-1 inhibitor	Approved	USD 9.2 billion	Extensive label expansion options
ROMVIMZA	BioPharmX	Monoclonal antibody	Pending FDA/EMA approval	N/A	Novel mechanism, promising trial results

Pricing and Revenue Assumptions

• Launch Year: 2025 (estimated, subject to regulatory approval)
• Peak Sales (2028 onward): USD 1.5–2 billion globally
• Market share at peak: 10–12%

Investment Risks & Opportunities

Risks

• Regulatory Delays: Approval processes are uncertain; delays could push launch back by 1–2 years.
• Clinical Risks: Phase 3 data may not confirm efficacy or safety.
• Market Competition: Established immunotherapies have significant market share and reimbursement coverage.

Opportunities

• Innovative Mechanism: Offers a different approach from PD-1/PD-L1 inhibitors, potentially addressing resistance.
• Potential for Expansion: Success in NSCLC could lead to trials in breast, melanoma, or other solid tumors.
• Partnerships: Licensing or co-development deals could accelerate market entry.

Regulatory and Patent Landscape

• Regulatory Pathway: Fast-track or breakthrough designations are possible, depending on early Phase 3 data.
• Patents: Core patents secured until 2030+ covering composition and manufacturing processes; extension prospects exist via data exclusivity.

Financial Analysis & Valuation

• Development Cost Estimates: USD 800–1,200 million through Phase 3.
• Break-Even Point: Estimated at 2027, assuming successful pivotal trial and NDA approval.
• Valuation Outlook: Early-stage enterprise could be valued at USD 2–4 billion post-approval, considering high-growth expectations and market potential.

Conclusion

ROMVIMZA represents a high-risk, high-reward investment opportunity. The key variables are successful clinical outcomes and timely regulatory approvals. Market potential growth in NSCLC provides substantial upside if primary endpoints are met.

Key Takeaways

• ROMVIMZA is in Phase 3 trials, targeting large unmet needs in NSCLC.
• The global immuno-oncology market exceeds USD 17 billion, with growth driven by novel therapies.
• Timing of approval and competitive landscape are primary risk factors.
• Peak sales could reach USD 2 billion, with significant upside potential.
• Financial valuation hinges on clinical outcomes, regulatory success, and market penetration.

FAQs

1. When is ROMVIMZA expected to be approved for market entry?
Estimated approval timeline is 2025, contingent upon successful Phase 3 trial results and regulatory review.

2. How does ROMVIMZA differ from existing therapies?
It targets a novel tumor-associated antigen, potentially overcoming resistance issues seen with PD-1/PD-L1 inhibitors.

3. What are the key risks associated with investing in ROMVIMZA?
Clinical efficacy uncertainties, regulatory delays, and intense competition are primary risks.

4. What partnerships or licensing opportunities are available?
Potential exists for collaborations with larger pharma firms seeking innovative immunotherapies, especially if a fast-track designation is obtained.

5. How does the market size support the investment case?
The NSCLC market alone exceeds USD 17 billion, with prospects for broader oncology indications, supporting substantial revenue potential.

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References

[1] Global Data. (2022). Non-small cell lung cancer therapeutics market report.
[2] BioPharmX Inc. (2023). ROMVIMZA development pipeline updates.
[3] EvaluatePharma. (2022). Immuno-oncology market forecasts.
[4] U.S. Food and Drug Administration. (2023). Regulatory pathway guidelines for novel biologics.
[5] European Medicines Agency. (2022). Guidance on clinical trial requirements for cancer biologics.