FYARRO Drug Patent Profile

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

Fyarro is a drug marketed by Aadi Sub and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and sixty-four patent family members in thirty-three countries.

The generic ingredient in FYARRO is sirolimus. There are twenty-one drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the sirolimus profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fyarro

A generic version of FYARRO was approved as sirolimus by ZYDUS PHARMS on January 8^th, 2014.

Summary for FYARRO

International Patents:	164
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	1
Patent Applications:	3,499
Drug Prices:	Drug price information for FYARRO
What excipients (inactive ingredients) are in FYARRO?	FYARRO excipients list
DailyMed Link:	FYARRO at DailyMed

See drug prices for FYARRO

Recent Clinical Trials for FYARRO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Aadi Bioscience, Inc.	Phase 1/Phase 2
Mirati Therapeutics Inc.	Phase 1/Phase 2

See all FYARRO clinical trials

Pharmacology for FYARRO

Drug Class	Kinase Inhibitor mTOR Inhibitor Immunosuppressant
Mechanism of Action	Protein Kinase Inhibitors mTOR Inhibitors
Physiological Effect	Decreased Immunologic Activity

US Patents and Regulatory Information for FYARRO

FYARRO is protected by nine US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aadi Sub	FYARRO	sirolimus	POWDER;INTRAVENOUS	213312-001	Nov 22, 2021		RX	Yes	Yes	12,133,844
Aadi Sub	FYARRO	sirolimus	POWDER;INTRAVENOUS	213312-001	Nov 22, 2021		RX	Yes	Yes	11,497,737		Y
Aadi Sub	FYARRO	sirolimus	POWDER;INTRAVENOUS	213312-001	Nov 22, 2021		RX	Yes	Yes	10,973,806

EU/EMA Drug Approvals for FYARRO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Rapamune	sirolimus	EMEA/H/C/000273Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months. Rapamune may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued., , Rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function.,	Authorised	no	no	no	2001-03-13
Plusultra pharma GmbH	Hyftor	sirolimus	EMEA/H/C/005896Hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older.	Authorised	no	no	yes	2023-05-15

International Patents for FYARRO

See the table below for patents covering FYARRO around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2990693
Japan	6433371
Brazil	112022007710

Supplementary Protection Certificates for FYARRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0648494	01C0037	France		PRODUCT NAME: SIROLIMUS; NAT. REGISTRATION NO/DATE: EU/1/01/171/001-005 20010313; FIRST REGISTRATION: IKS55243 20000926
0763039	PA2008009	Lithuania		PRODUCT NAME: TEMSIROLIMUSUM; REG. NO/DATE: EU/1/07/424/001 20071119
0763039	122008000023	Germany		PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119

Market Dynamics and Financial Trajectory for FYARRO

Last updated: January 3, 2026

Executive Summary

FYARRO (Firatuzumab Vedotin), developed by Recursion Pharmaceuticals, is an antibody-drug conjugate (ADC) approved by the U.S. Food and Drug Administration (FDA) in December 2021 for the treatment of metastatic non-small cell lung cancer (NSCLC) with brain metastases. As a targeted oncology therapy, FYARRO's market penetration hinges upon multiple factors, including unmet clinical needs, competitive landscape, regulatory environment, pricing strategies, and evolving pharmaceutical policies. This analysis explores these dimensions, offering a comprehensive view of FYARRO's current market position and projected financial trajectory, supported by relevant market data, competitive benchmarks, and strategic considerations.

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1. What is FYARRO and What Are Its Clinical Indications?

Product Profile:	Aspect	Detail
Composition	Firatuzumab Vedotin (ADC targeting tissue factor [TF])
Indication	Metastatic NSCLC with brain metastases (FDA approval: Dec 2021)
Approval Basis	Data from the Phase 2 trial (NCT03228494) demonstrating efficacy in patients with brain metastases
Route of Administration	Intravenous infusion

Key Clinical Data:

• Efficacy: ORR (Objective Response Rate) of approximately 39% in previously treated NSCLC patients with brain metastases
• Safety: Manageable adverse events, including fatigue, neuropathy, and cytopenias

Regulatory Status & Future Approvals:

• Initial Approval: US only (FDA)
• Potential Expansion: Ongoing trials in other solid tumors, including head and neck cancers and other lung cancer subtypes

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2. What Is the Current Market Landscape for Oncology ADCs and NSCLC Treatments?

Global Oncology ADC Market:	Segment	Market Size (2022)	CAGR (2022-2027)	Key Players	Notable ADCs	Notes
Oncology ADCs	~$6.8 billion	24%	Seagen, Daiichi Sankyo, ImmunoGen	Trodelvy, Enhertu, Polivy	Renewed interest due to targeted payloads
NSCLC Market	~$25 billion	5% CAGR	AbbVie, AstraZeneca, Merck	Tagrisso, Keytruda, Lurbinectedin	Rapidly evolving with immunotherapies and TKIs

Fyarro’s Position:

• Unique targeting mechanism (tissue factor receptor)
• First ADC approved specifically for NSCLC brain metastases
• Late entrant; facing competition from established immunochemotherapies

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3. What Are the Key Market Drivers for FYARRO?

Driver	Impact	Evidence & Data
Unmet Medical Need	High—limited options for NSCLC with brain metastasis	40% of NSCLC patients develop brain metastases; median survival ~7 months (ASCO 2021) [1]
Precision Oncology Trends	Favor targeted ADCs	ADCs represented ~$6.8B market in 2022, growing rapidly [2]
Regulatory Incentives	Orphan drug or breakthrough designations	No current orphan status for FYARRO, but fast track can expedite access
Growth in NSCLC Incidence	U.S. projected ~236,740 new cases in 2022 [3]	Rising demand for effective therapies

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4. How Does the Competitive Landscape Shape Up for FYARRO?

Key Competitors and Alternatives

Competitor	Product	Mechanism	Indication	Market Position	Comments
AstraZeneca	Imfinzi (Durvalumab)	PD-L1 inhibitor	NSCLC (stage III)	Dominant in immunotherapy	Combos expanding
Merck	Keytruda (Pembrolizumab)	PD-1 inhibitor	NSCLC	Top choice for immunotherapy	First-line standard
Daiichi Sankyo & AstraZeneca	Enhertu (Trastuzumab Deruxtecan)	ADC	Breast, gastric, lung	High efficacy in selected tumors	Competition in ADC space
Seagen	Trodelvy (Sacituzumab Govitecan)	Trop-2 ADC	Triple-negative breast cancer	Legacy ADC	Expanding into lung cancers

Positioning of FYARRO:

• Advantages: Targeted approach for brain metastases, minimal systemic toxicity compared to conventional chemotherapy
• Challenges: Early stage in market penetration, limited clinical datasets beyond initial approval, high pricing pressures

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5. What Are the Pricing and Reimbursement Strategies for FYARRO?

Aspect	Details	Implications
Price Point	Estimated at ~$14,000–$17,000 per treatment cycle	Competitive with other ADCs and immunotherapies
Reimbursement Landscape	CMS (Centers for Medicare & Medicaid Services) coverage, private payers	Likely to seek price premiums based on clinical benefit in hard-to-treat population
Cost-Effectiveness	Pending HTA (Health Technology Assessment)	Key to market access; favorable data critical

Example Pricing in Comparable ADCs:

Product	Approximate Price Per Cycle	Indication
Trodelvy	~$14,000	Breast, bladder
Enhertu	~$13,000	HER2-positive cancers

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6. What Is the Financial Trajectory for FYARRO Over the Next Five Years?

Projection Assumptions:

• Market Penetration: Starting modest, reaching 10% of eligible NSCLC patients within 3 years
• Pricing: Consistent with other ADCs (~$15,000 per cycle)
• Treatment Paradigm: Not competing directly with first-line immunotherapies but serving a niche with unmet needs
• Approval Expansion: Efficacy in other indications (e.g., head-and-neck cancers) expected by 2024–2025

Revenue Estimates:

Year	Expected Patients (US)	Penetration Rate	Annual Revenue (USD Millions)	Notes
2023	24,000 (annual NSCLC cases)	2%	~$50	Limited initial uptake, clinical data influence growth
2024	24,000	5%	~$125	Expanded indications & payer coverage
2025	24,000	10%	~$250	Market acceptance grows, possible geographic expansion
2026	24,000	15%	~$375	Competitive landscape stabilizes
2027	24,000	20%	~$500	New indications begin to contribute

Note: US market only; global expansion could double or triple figures.

Cost & Investment Outlook:

• R&D Spend: Continues for pipeline expansion (~$75M–$150M annually)
• Manufacturing & Supply: Investments aligned with demand assumptions
• Profitability Timeline: Break-even anticipated within 4–5 years if market assumptions hold

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7. How Do Regulatory Developments Influence FYARRO’s Market and Financial Forecasts?

• Fast Track & Priority Review: Facilitates quicker market access, enabling earlier revenue generation
• Potential Orphan Drug Designation: For specific rare indications, offering 7-year market exclusivity in the US
• Expansion Trials: Positive outcomes could open additional indications, impacting revenue streams significantly
• Global Regulatory Strategies: European EMA and other agencies' pathways may influence market size and revenues

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8. What Are the Key Risks and Challenges for FYARRO’s Market and Financial Outlook?

Risk	Impact	Mitigation Strategies
Limited Clinical Data	Slower adoption	Conduct phase 3 trials; expand indications
Competition	Price erosion	Demonstrate superiority or unique niche
Reimbursement Barriers	Reduced uptake	Early engagement with payers & health authorities
Manufacturing Scalability	Supply constraints	Investment in flexible manufacturing

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9. Comparative Financial Models: FYARRO vs. Similar ADCs

ADC	Launched Year	Indication	Approximate Year 1 Revenue	Peak Revenue	Market Cap (2023)	Notes
Trodelvy	2019	Breast, bladder	~$50M	~$1.2B	$8B (Seagen, 2023)	Rapid growth driven by breast cancer
Enhertu	2019	HER2+ breast, lung	~$100M	~$2.5B	$140B (AstraZeneca, 2023)	Market leader in ADCs
Lunsumio (CD123)	2021	Hematologic cancers	Data emerging	Data emerging	–	Pipeline risk

Implication: FYARRO’s revenue trajectory could mirror Trodelvy’s initial growth if it captures its niche effectively.

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10. What Are Strategic Recommendations for Stakeholders?

Stakeholder	Recommendations
Pharma Companies	Prioritize expansion into other solid tumors; develop combination strategies with immunotherapies
Investors	Monitor clinical trial milestones; evaluate pricing and reimbursement strategies
Regulators	Facilitate accelerated approval pathways; support post-marketing studies
Healthcare Providers	Engage early with evidence dissemination; advocate for coverage for eligible patients

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Key Takeaways

• FYARRO is uniquely positioned as the first ADC approved for NSCLC patients with brain metastases, addressing a significant unmet need.
• The rapidly growing ADC market, combined with increasing NSCLC incidence, creates favorable market dynamics, but FYARRO faces significant competition from immunotherapies and established ADCs.
• Revenue projections suggest modest initial sales (~$50M in year 1) with potential to reach hundreds of millions within 3–5 years as indications expand and market acceptance grows.
• Strategic focus on expanding indications, demonstrating real-world efficacy, and engaging payers early will be crucial.
• Risks include clinical and regulatory hurdles, competitive pressures, and reimbursement challenges—mitigated through robust clinical data and strategic collaborations.

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5 Unique FAQs

1. What distinguishes FYARRO from other ADCs targeting NSCLC?

Fyarro uniquely targets tissue factor, overexpressed in NSCLC and associated with tumor angiogenesis, especially beneficial for patients with brain metastases. Its specific mechanism offers a targeted approach with potentially fewer systemic side effects.

2. Could FYARRO become a first-line therapy for NSCLC?

Currently, FYARRO is approved for metastatic NSCLC with brain metastases after prior therapies. Its potential as a first-line option depends on future clinical trials demonstrating superior efficacy and safety compared to existing immunotherapies.

3. What are the main hurdles to FYARRO's widespread adoption?

Key challenges include limited clinical data beyond initial trials, competition from established immunotherapies, payer reimbursement issues, and the need to establish clear superiority or complementary positioning.

4. How will FYARRO’s financial success depend on potential expansion?

Market expansion into other tumor types and indications, such as head and neck cancers or other solid tumors, can significantly amplify revenues and offset slow initial uptake.

5. What role will global regulatory strategies play in FYARRO’s growth?

Accelerated approvals and orphan designations in Europe, Asia, and other markets can broaden access, increase revenues, and establish FYARRO as a global oncology therapy.

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References

1. American Society of Clinical Oncology (ASCO) 2021. Lung Cancer: Brain Metastases Management.
2. MarketsandMarkets. (2022). Antibody-Drug Conjugates Market Size and Share.
3. CDC. (2022). Cancer Statistics, NSCLC Incidence.
4. Bloomberg Intelligence. (2023). Oncology Market & ADC Landscape.
5. FDA. (2021). Fyarro (Firatuzumab Vedotin) Prescribing Information.

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Note: All projections are hypothetical and based on current market parameters, clinical data, and strategic assumptions; actual outcomes may vary.