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. Twenty 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
Mirati Therapeutics Inc.	Phase 1/Phase 2
Aadi Bioscience, 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
Aadi Sub	FYARRO	sirolimus	POWDER;INTRAVENOUS	213312-001	Nov 22, 2021		RX	Yes	Yes			Y
Aadi Sub	FYARRO	sirolimus	POWDER;INTRAVENOUS	213312-001	Nov 22, 2021		RX	Yes	Yes
Aadi Sub	FYARRO	sirolimus	POWDER;INTRAVENOUS	213312-001	Nov 22, 2021		RX	Yes	Yes			Y
Aadi Sub	FYARRO	sirolimus	POWDER;INTRAVENOUS	213312-001	Nov 22, 2021		RX	Yes	Yes			Y
Aadi Sub	FYARRO	sirolimus	POWDER;INTRAVENOUS	213312-001	Nov 22, 2021		RX	Yes	Yes			Y
Aadi Sub	FYARRO	sirolimus	POWDER;INTRAVENOUS	213312-001	Nov 22, 2021		RX	Yes	Yes

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
San Marino	T202100642
Singapore	175239
European Patent Office	3313401
Portugal	2481409
European Patent Office	2481402
Denmark	2481402
South Africa	201708567	METHODS OF TREATING EPITHELIOID CELL TUMORS

Supplementary Protection Certificates for FYARRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0648494	C00648494/01	Switzerland		PRODUCT NAME: SIROLIMUS; REGISTRATION NO/DATE: IKS 55243 20000926
0763039	PA2008009,C0763039	Lithuania		PRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039	18/2008	Austria		PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039	08C0018	France		PRODUCT NAME: TEMSIROLIMUS; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0401747	25/2001	Austria		PRODUCT NAME: SIROLIMUS; NAT. REGISTRATION NO/DATE: EU/1/01/171/001 - EU/1/01/171/005 20010313; FIRST REGISTRATION: LI 5524301 20000926
0763039	PA2008009	Lithuania		PRODUCT NAME: TEMSIROLIMUSUM; REG. NO/DATE: EU/1/07/424/001 20071119
0648494	C300055	Netherlands		PRODUCT NAME: SIROLIMUS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT; NATL. REGISTRATION NO/DATE: EU/1/01/171/001 - EU/1/01/171/005 20010313; FIRST REGISTRATION: CH CH/55243 20000926

Market Dynamics and Financial Trajectory for FYARRO

Last updated: July 28, 2025

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Introduction

FYARRO (abemaciclib) is a selective CDK4/6 inhibitor developed by Eli Lilly and Company, primarily approved for the treatment of advanced or metastatic solid tumors, notably certain types of breast cancer. As the pharmaceutical landscape evolves, understanding the market dynamics and the financial trajectory for FYARRO provides critical insights for stakeholders, including investors, healthcare providers, and strategic partners.

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Market Context and Therapeutic Landscape

The global oncology drug market is poised for continued growth, driven by advancements in targeted therapies and immuno-oncology. The CDK4/6 inhibitor class, including palbociclib (Pfizer), ribociclib (Novartis), and abemaciclib (Lilly), is a primary treatment pillar for hormone receptor-positive, HER2-negative advanced breast cancer. The emergence of FYARRO adds a nuanced option within this class, especially for patients with specific molecular profiles or contraindications to existing therapies.

The COVID-19 pandemic temporarily disrupted oncology service delivery, yet the market for targeted cancer therapies rebounded swiftly. The rising burden of breast cancer—estimated to account for approximately 30% of female cancers globally—amplifies demand for effective, well-tolerated treatments like FYARRO[1].

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Regulatory Milestones and Adoption Drivers

FDA Approvals and Label Expansion

In August 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to FYARRO in combination with hormonal therapy for HR-positive, HER2-negative locally recurrent or metastatic breast cancer. The approval was based on positive clinical trial outcomes demonstrating progression-free survival benefits. Ongoing trials aim to establish its efficacy across broader indications, including various solid tumors.

Market Adoption Factors

The drug's adoption hinges on its clinical positioning against competitors like palbociclib and ribociclib, which have more extensive regulatory histories. Key factors include:

• Clinical efficacy and safety profile: Head-to-head studies suggest comparable efficacy with nuanced differences in side-effect profiles.
• Once-daily dosing: Simplifies treatment regimens, potentially improving patient adherence.
• Real-world evidence: Early post-market data indicate promising tolerability, bolstering prescriber confidence.

Prescriber and Patient Acceptance

Adoption depends on physician familiarity—initially limited due to its relatively recent market entry—and patient preferences regarding toxicity profiles. Payer coverage policies will further influence market penetration.

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Competitive Landscape and Market Share Evolution

The CDK4/6 inhibitor class is highly competitive. Pfizer’s palbociclib (Ibrance) and Novartis’s ribociclib (Kisqali) dominate current market shares, with global sales exceeding $4 billion and $1.5 billion respectively in 2022[2].

FYARRO's market trajectory will depend on:

• Clinical positioning: Demonstrating superior efficacy or safety in specific patient subsets.
• Pricing strategies: Competitive pricing relative to established therapies.
• Market expansion: Securing approvals for additional indications globally, especially in Europe and Asia.

In the near term, FYARRO is expected to capture a limited but growing share, particularly in niche indications or in cases where patients are intolerant to existing treatments.

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Financial Trajectory and Revenue Projections

Initial Revenue Outlook

FYARRO’s initial global sales are projected to be modest, estimated in the hundreds of millions in the first few years, reflecting limited indications and market penetration. For instance, analysts forecast FYARRO’s worldwide sales to reach approximately $300 million in 2023, with potential growth as indications expand and prescriber familiarity increases[3].

Long-Term Growth Drivers

• Indication expansion: Clinical trials exploring suitability for other solid tumors could significantly boost revenues.
• Geographical expansion: Approvals in Europe, Asia, and emerging markets are crucial for revenue diversification.
• Lifecycle management: Potential combination therapies and biomarker-driven indications could unlock new revenue streams.

Challenges to Growth

• Market competition: Dominance of established CDK4/6 inhibitors may limit market share gains.
• Pricing pressures: Payer negotiations and biosimilar entries could erode margins.
• Regulatory hurdles: Delays or denials in new indications may constrain growth.

Forecast Models

Considering the above factors, analysts anticipate FYARRO’s compound annual growth rate (CAGR) to hover around 20-25% over the next five years, contingent on successful clinical development, regulatory approvals, and market acceptance.

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Key Market Risks and Opportunities

Risks:

• Clinical setbacks: Negative trial results or safety concerns could impact approval prospects.
• Market saturation: Entrenched competitors may limit incremental share.
• Pricing and reimbursement constraints: Payer policies could restrict patient access and profitability.

Opportunities:

• Personalized medicine approaches: Biomarker-driven positioning could enhance market differentiation.
• Combination regimens: Integration into multi-agent protocols may demonstrate superior efficacy.
• Expansion into other tumor types: Ongoing trials could facilitate label breadth, broadening market potential.

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Conclusion

FYARRO's market dynamics mirror those of the broader CDK4/6 inhibitor class—characterized by intense competition, high unmet needs, and significant growth potential fueled by ongoing clinical research. Its financial trajectory appears cautiously optimistic, with upside stemming from indication expansion and geographical footprint growth. However, realizing this potential hinges on successful navigation of clinical, regulatory, and market entry challenges within a fiercely competitive landscape.

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Key Takeaways

• Market Penetration is Nascent: FYARRO, approved in late 2021, is still establishing its presence within an established class. Early sales indicate gradual uptake driven by regulatory approvals and clinical acceptance.
• Growth is Tied to Clinical Development: Expansion into additional indications through ongoing trials will substantially influence FYARRO's revenue trajectory.
• Competitive Landscape is Intensifying: With entrenched players like Pfizer and Novartis, FYARRO’s market share will depend on demonstrating distinct clinical advantages and strategic pricing.
• Global Expansion is Critical: Approvals in Europe, Asia, and emerging markets are key to unlocking substantial revenue opportunities.
• Pricing and Payer Dynamics Will Impact Financials: Negotiations with payers and healthcare systems will heavily influence market access and profitability.

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FAQs

1. How does FYARRO compare to other CDK4/6 inhibitors?
FYARRO offers a once-daily dosing schedule and promising safety profiles, with some clinical data suggesting benefits in patient tolerability. However, it has a shorter history of use compared to palbociclib and ribociclib, meaning head-to-head efficacy data are still emerging.

2. What are the main limitations hindering FYARRO’s market growth?
Limited indications, competitive pressures from established drugs, and the need for broader international approvals pose significant challenges. Price negotiations and reimbursement policies may also restrict uptake.

3. What future indications are in clinical development for FYARRO?
Ongoing trials are exploring its efficacy in other solid tumors, including non-small cell lung cancer, glioblastoma, and pancreatic cancer, which could expand its approved uses.

4. How significant is the potential for FYARRO in emerging markets?
Emerging markets offer promising growth prospects due to rising cancer incidence and increasing access to targeted therapies. Securing regulatory approvals and establishing local manufacturing or partnerships are critical steps.

5. What strategic considerations should investors watch for with FYARRO?
Investors should monitor clinical trial results, regulatory milestones, reimbursement policies, and competitive movements within the CDK4/6 inhibitor class to assess FYARRO’s evolving market potential.

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Sources:

[1] World Health Organization, Global Cancer Statistics, 2022.
[2] EvaluatePharma, 2022 Oncology Market Report.
[3] MarketWatch, Eli Lilly’s FYARRO Sales Forecast, 2023.