FYARRO Drug Patent Profile

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

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

This drug has one hundred and fifty patent family members in thirty-two 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:	150
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	1
Patent Applications:	2,713
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 two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aadi	FYARRO	sirolimus	POWDER;INTRAVENOUS	213312-001	Nov 22, 2021		RX	Yes	Yes	12,133,844
Aadi	FYARRO	sirolimus	POWDER;INTRAVENOUS	213312-001	Nov 22, 2021		RX	Yes	Yes	11,497,737		Y
Aadi	FYARRO	sirolimus	POWDER;INTRAVENOUS	213312-001	Nov 22, 2021		RX	Yes	Yes	10,973,806
Aadi	FYARRO	sirolimus	POWDER;INTRAVENOUS	213312-001	Nov 22, 2021		RX	Yes	Yes	12,061,183		Y

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/000273 Rapamune 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/005896 Hyftor 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
New Zealand	711695	Nanoparticle comprising rapamycin and albumin as anticancer agent
South Korea	101943230
South Korea	20150002886	NANOPARTICLE COMPRISING RAPAMYCIN AND ALBUMIN AS ANTICANCER AGENT
South Korea	20180021836

Supplementary Protection Certificates for FYARRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0763039	122008000023	Germany		PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0648494	SPC/GB01/037	United Kingdom		PRODUCT NAME: SIROLIMUS; REGISTERED: CH IKS 55243 20000926; UK EU/1/01/171/001-005 20010313
0763039	08C0018	France		PRODUCT NAME: TEMSIROLIMUS; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039	SPC/GB08/025	United Kingdom		PRODUCT NAME: TEMSIROLIMUS AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/07/424/001 20071119

FYARRO Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for FYARRO

Introduction

FYARRO, a novel prescription medication developed by Aadi Bioscience, has been making significant waves in the treatment of Perivascular Epithelioid Cell Neoplasm (PEComa), a rare and aggressive form of cancer. Here, we delve into the market dynamics and financial trajectory of FYARRO, highlighting its clinical significance, market growth, and financial performance.

Clinical Significance of FYARRO

FYARRO, utilizing an innovative protein-bound particle delivery system, stands out from other mTOR inhibitors. It has demonstrated a marked reduction in cell proliferation, angiogenesis, and glucose uptake, offering a promising treatment option for adults with locally advanced unresectable or metastatic malignant PEComa[1].

Market Growth and Dynamics

The market for FYARRO is experiencing an inflection point as the healthcare industry focuses more on addressing PEComa effectively. Here are some key points:

Increasing Demand

FYARRO has seen robust sales growth, with Q3 2024 sales reaching $7.2 million, a 21% year-over-year increase and a 17% quarter-over-quarter increase. This growth is driven by heightened demand from both new and existing accounts, particularly major oncology centers[2][4].

High Reorder Rate

The high reorder rate, with 90% of accounts placing multiple orders in Q3 2024 and 80% in Q2 2024, underscores the clinical value and acceptance of FYARRO among healthcare providers[2][5].

Competitive Landscape

The market is dynamic, with emerging therapies aiming to challenge the status quo. However, FYARRO's unique delivery system and promising clinical outcomes position it strongly in the competitive landscape. The report from ResearchAndMarkets.com provides a detailed SWOT analysis and competitive undertakings that may influence FYARRO’s market dominance[1].

Financial Performance

Aadi Bioscience's financial results provide insight into the financial trajectory of FYARRO:

Sales Growth

FYARRO sales have shown consistent growth:

• Q4 2023 sales were $6.3 million, representing a 21% year-over-year growth.
• Full-year 2023 sales were $24.4 million, a 60% year-over-year increase[3].
• Q2 2024 sales were $6.2 million, a 15% increase from Q1 2024[4][5].

Operating Expenses and Net Loss

Despite the growth in sales, Aadi Bioscience continues to operate at a net loss:

• Q3 2024 net loss improved to $12.5 million compared to $16.3 million in Q3 2023.
• Q2 2024 net loss decreased to $14.6 million from $18.0 million in Q2 2023[2][5].

Cash Position

The company's cash reserves are significant but have been decreasing:

• As of Q3 2024, the cash position was $62.6 million, expected to fund operations into at least the second half of 2026.
• As of Q2 2024, the cash position was $78.6 million, expected to fund operations into Q4 2025[2][5].

Regulatory Milestones and Developmental Activities

FYARRO's development pathway includes several significant regulatory milestones:

PRECISION1 Trial

The PRECISION1 trial, which is registration-directed for nab-sirolimus in solid tumors with TSC1 or TSC2 inactivating alterations, is on track to complete enrollment. The trial has shown promising interim results, with sustained tumor reductions in a heavily pre-treated population[3].

Phase 2 Trials

Aadi Bioscience is actively enrolling patients in Phase 2 trials for endometrial cancer and neuroendocrine tumors (NETs), further exploring FYARRO’s potential in mTOR-driven cancer targets[3].

Future Outlook

The future of FYARRO looks promising, with several factors contributing to its potential market dominance:

Market Projections

The report from ResearchAndMarkets.com projects significant market growth for FYARRO through 2032, highlighting the drug’s anticipated economic impact and clinical benefits in the treatment of PEComa[1].

Emerging Therapies

While FYARRO is currently a preferred treatment for malignant PEComa, the market remains dynamic with the emergence of alternate treatment options. However, FYARRO’s unique mechanism of action and strong clinical outcomes position it favorably in the competitive landscape[1].

Key Takeaways

• Strong Sales Growth: FYARRO has shown consistent year-over-year and quarter-over-quarter sales growth.
• High Clinical Value: The high reorder rate indicates strong demand and clinical acceptance.
• Financial Stability: Despite operating at a net loss, the company has a significant cash position to fund operations.
• Regulatory and Developmental Milestones: Ongoing trials and regulatory milestones are crucial for FYARRO’s continued growth.
• Market Dominance: FYARRO’s unique delivery system and promising clinical outcomes position it strongly in the market.

FAQs

What is FYARRO used for?

FYARRO is used for the treatment of adults with locally advanced unresectable or metastatic malignant Perivascular Epithelioid Cell Neoplasm (PEComa)[1].

How has FYARRO performed financially?

FYARRO has shown significant sales growth, with Q3 2024 sales reaching $7.2 million, a 21% year-over-year increase. Despite this, Aadi Bioscience operates at a net loss but has a strong cash position to fund operations[2][5].

What are the key regulatory milestones for FYARRO?

The PRECISION1 trial is a significant regulatory milestone, along with ongoing Phase 2 trials for endometrial cancer and neuroendocrine tumors[3].

How does FYARRO compare to other mTOR inhibitors?

FYARRO stands out due to its innovative protein-bound particle delivery system, which reduces cell proliferation, angiogenesis, and glucose uptake more effectively than other mTOR inhibitors[1].

What is the projected market growth for FYARRO?

The market for FYARRO is projected to grow significantly through 2032, driven by its clinical benefits and economic impact in the treatment of PEComa[1].

Sources

1. ResearchAndMarkets.com - "FYARRO Market Size, Forecast, and Market Insight - 2032"[1].
2. Stocktitan.net - "Aadi Bioscience Announces Financial Results for the Third Quarter 2024 and Provides Corporate Update"[2].
3. PR Newswire - "Aadi Bioscience Announces Financial Results for the Fourth Quarter and Full Year 2023 and Provides Corporate Update"[3].
4. Synapse.patsnap.com - "Aadi Bioscience Reports Q2 2024 Financials and Corporate Update"[4].
5. Stocktitan.net - "Aadi Bioscience Announces Financial Results for the Second Quarter 2024"[5].