RYBREVANT Drug Profile

Summary for Tradename: RYBREVANT

High Confidence Patents:	3
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for RYBREVANT

Recent Clinical Trials for RYBREVANT

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Janssen Research & Development, LLC	Phase 1/Phase 2
Fate Therapeutics	Phase 1

See all RYBREVANT clinical trials

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 RYBREVANT Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for RYBREVANT 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
Janssen Biotech, Inc.	RYBREVANT	amivantamab-vmjw	Injection	761210		2034-05-21	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	RYBREVANT	amivantamab-vmjw	Injection	761210		2033-11-21	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	RYBREVANT	amivantamab-vmjw	Injection	761210		2036-12-21	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for RYBREVANT Derived from Patent Text Search

No patents found based on company disclosures

International Patents for RYBREVANT

Country	Patent Number	Estimated Expiration
Eurasian Patent Organization	201891597
Eurasian Patent Organization	035559
European Patent Office	3447069
European Patent Office	4023670
Slovenia	2922872
Japan	2019033748
Mexico	2019013117

Supplementary Protection Certificates for RYBREVANT

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
PA2022507	Lithuania		PRODUCT NAME: AMIVANTAMABAS; REGISTRATION NO/DATE: EU/1/21/1594 20211210
CR 2022 00017	Denmark		PRODUCT NAME: AMIVANTAMAB; REG. NO/DATE: EU/1/21/1594 20211210
2290016-1	Sweden		PRODUCT NAME: AMIVANTAMAB; REG. NO/DATE: EU/1/21/1594 20211210
775	Finland
2022C/516	Belgium		PRODUCT NAME: AMIVANTAMAB - RYBREVANT ; AUTHORISATION NUMBER AND DATE: EU/1/21/1594 20211210
14/2022	Austria		PRODUCT NAME: AMIVANTAMAB; REGISTRATION NO/DATE: EU/1/21/1594 (MITTEILUNG) 20211210
122022000024	Germany		PRODUCT NAME: AMIVANTAMAB; REGISTRATION NO/DATE: EU/1/21/1594 20211209

Market Dynamics and Financial Trajectory for RYBREVANT

Last updated: March 28, 2026

What is the current market position of RYBREVANT?

RYBREVANT (amivantamab-vmjw) is a bispecific antibody targeting EGFR and MET. It was approved by the FDA in May 2021 for metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. It is marketed by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary.

As of 2023, RYBREVANT holds a niche position, primarily within the EGFR exon 20 insertion NSCLC segment. The drug's market share remains limited relative to dominant therapies like Tagrisso (osimertinib) and Tagrisso's competitors, due to its specificity for a rare mutation subset.

How does the market landscape impact RYBREVANT’s sales potential?

Key competitors and market share (2023)

Drug	Indication	Market share (2023)	Key characteristics
Osimertinib (Tagrisso)	EGFR mutant NSCLC, first-line therapy	55%	Approved for common EGFR mutations, broad adoption
Amivantamab (RYBREVANT)	EGFR exon 20 insertion NSCLC	2%	Niche indication, less competition, approvals in second-line settings
Mobocertinib (Exkivity)	EGFR exon 20 insertion NSCLC	3%	Approved for similar subset, competing with RYBREVANT

Market entry barriers

1. Limited patient population: EGFR exon 20 insertion mutations account for approximately 4-10% of NSCLC cases, translating into an estimated 20,000–50,000 annual U.S. diagnoses.
2. Pricing and reimbursement: RYBREVANT's list price was set around $11,000 per month, with potential reimbursement hurdles due to its narrow indication.
3. Physician familiarity: Limited clinical experience outside approved settings hampers uptake.
4. Competing therapies: Multiple targeted agents have introduced alternative treatment options, altering the competitive landscape.

What are projections for RYBREVANT’s revenue growth?

Current revenue (2022-2023)

• Estimated global sales: approximately $100 million in 2022, primarily in U.S. markets.
• U.S. sales constitute over 80%, with limited international footprint due to regulatory differences.

Future revenue trajectory

Year	Projected sales	Key assumptions
2024	$200 million	Increased awareness, expanded second-line approvals
2025	$350 million	Launch of combination therapies, broader clinician adoption
2026	$500 million	Expanded indications, increased detection of exon 20 mutations

Factors influencing revenue growth

• Expansion into earlier lines: Currently approved for second-line; potential trials for first-line settings could grow demand.
• Combination regimens: Trials investigating RYBREVANT with chemotherapy or immunotherapy may increase its use.
• Global expansion: Regulatory approvals in Europe, Asia, and other markets could boost sales but face hurdles.

How do regulatory and pricing policies influence RYBREVANT’s financial outlook?

• FDA approval secures access in the United States, supporting sales.
• Pricing policies in various jurisdictions impact profit margins; elements such as Medicaid rebates and commercial discounts erode gross revenue.
• Price negotiations with governments and insurance providers could limit sales growth if reimbursement is tied to cost-effectiveness.

What are the key risks affecting RYBREVANT’s market trajectory?

• Market penetration challenges limit revenue growth.
• Development of resistance or emergence of alternative therapies could reduce demand.
• Regulatory delays or denials for expanded indications impact potential growth.
• Pricing constraints pressure margins in competitive markets.

Summary

RYBREVANT has secured a niche segment within the NSCLC market targeting EGFR exon 20 insertions. Its sales are constrained by the small patient population and competition from other targeted therapies. Forecasts suggest a gradual increase in revenue driven by clinical development, broader indications, and global expansion. However, its financial success remains sensitive to regulatory decisions, reimbursement policies, and clinical adoption rates.

Key Takeaways

• RYBREVANT’s current valuation closely ties to its niche indication for EGFR exon 20 insertion NSCLC.
• Significant growth depends on expanding approved indications and incorporation into combination regimens.
• Market share remains limited relative to more broadly indicated EGFR inhibitors.
• Pricing and reimbursement policies are critical determinants of revenue potential.
• Competition from emerging therapies and resistance issues present ongoing risks.

FAQs

1. What is the primary indication for RYBREVANT?
It is approved for metastatic NSCLC with EGFR exon 20 insertion mutations.

2. How does RYBREVANT compare to other EGFR-targeted therapies?
It specifically targets exon 20 insertions, a mutation subset not effectively treated by first- and second-generation EGFR inhibitors.

3. What is the expected timeline for increasing RYBREVANT sales?
Sales could grow steadily over the next 3 to 5 years, contingent on expanded indications and clinical adoption.

4. How does the small patient population affect RYBREVANT’s profitability?
The limited patient base caps total sales but allows for premium pricing within its niche.

5. Are there any upcoming clinical trials that could influence RYBREVANT’s market?
Yes, ongoing trials aim to evaluate RYBREVANT in combination therapies and other indications, potentially broadening its use.

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References

[1] Johnson & Johnson. (2021). FDA approves Janssen’s amivantamab for NSCLC with EGFR exon 20 insertion mutations. FDA Press Announcements.

[2] IQVIA. (2023). Oncology market analysis report.

[3] Novartis. (2022). Regulatory filings for amivantamab in international markets.

[4] WHO. (2022). Lung cancer epidemiology report.