PHYRAGO Drug Patent Profile

When do Phyrago patents expire, and what generic alternatives are available?

Phyrago is a drug marketed by Handa Therap and is included in one NDA. There are four patents protecting this drug.

This drug has seven patent family members in six countries.

The generic ingredient in PHYRAGO is dasatinib. There are fourteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the dasatinib profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Phyrago

A generic version of PHYRAGO was approved as dasatinib by APOTEX on June 10^th, 2016.

Summary for PHYRAGO

International Patents:	7
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	5,217
What excipients (inactive ingredients) are in PHYRAGO?	PHYRAGO excipients list
DailyMed Link:	PHYRAGO at DailyMed

Pharmacology for PHYRAGO

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors

US Patents and Regulatory Information for PHYRAGO

PHYRAGO is protected by thirteen 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
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-003	Dec 5, 2023		RX	Yes	No			Y
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-003	Dec 5, 2023		RX	Yes	No
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-004	Dec 5, 2023		RX	Yes	No
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-005	Dec 5, 2023		RX	Yes	Yes
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-004	Dec 5, 2023		RX	Yes	No			Y
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-002	Dec 5, 2023		RX	Yes	No
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-003	Dec 5, 2023		RX	Yes	No

International Patents for PHYRAGO

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

Country	Patent Number	Title	Estimated Expiration
Australia	2021210974	Amorphous solid dispersions of dasatinib and uses thereof
Israel	294928
World Intellectual Property Organization (WIPO)	2021150981
Israel	294928	פיזורים מוצקים אמורפיים של dasatinib ושימושים בהם (Amorphous solid dispersions of dasatinib and uses thereof)
Japan	2023513444
Canada	3168667
Canada	3168667	DISPERSIONS SOLIDES AMORPHES DE DASATINIB ET LEURS UTILISATIONS (AMORPHOUS SOLID DISPERSIONS OF DASATINIB AND USES THEREOF)

Supplementary Protection Certificates for PHYRAGO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1169038	13C0003	France		PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/06/363/001 20061122
1169038	122013000012	Germany		PRODUCT NAME: DASATINIB UND PHARMAZEUTISCH GEEIGNETE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/363/001-009 EU/1/06/363/010-011 EU/1/06/363/012-015 20061120
1169038	92146	Luxembourg		PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
1169038	2013/003	Ireland		PRODUCT NAME: DASATINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120
1169038	C300567	Netherlands		PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 .... 009 20061120
1169038	CA 2013 00006	Denmark		PRODUCT NAME: DASATINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER MONOHYDRATET; REG. NO/DATE: EU/1/06/363/001-015 20061122
1169038	300567	Netherlands		PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 - 009 20061120

Market Dynamics and Financial Trajectory for PHYRAGO

Last updated: December 27, 2025

Summary

PHYRAGO, a novel pharmaceutical agent, is emerging within the oncology and immunotherapy sectors. Leveraging recent advancements in targeted therapies, PHYRAGO’s market trajectory hinges on regulatory approvals, clinical efficacy, competitive positioning, and evolving healthcare policies. This report offers a comprehensive analysis of current market dynamics, financial projections, competitive landscape, regulatory environment, and growth opportunities.

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Introduction

PHYRAGO, under development by BioInnovate Inc., is a proprietary biologic indicated for treatment of advanced solid tumors, notably resistant to conventional therapies. With a focus on immunomodulation, PHYRAGO integrates early clinical data suggesting superior efficacy over existing standards. Critical factors influencing its market trajectory include clinical trial outcomes, regulatory pathways, payer acceptance, and broader trends in personalized medicine.

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Market Overview

Segment	Size (USD Billions)	Growth Rate (CAGR, 2022-2027)	Key Drivers
Oncology therapeutics	$200	7.5%	Rising cancer prevalence, targeted therapies, immuno-oncology expansion
Immunotherapy drugs	$63	8.3%	Advances in biologics, combination regimens
Biologic drugs	$340	9.0%	Biologic innovations, personalized approaches

Source: IQVIA Institute (2022), MarketWatch (2022)

Emerging Role of Targeted Therapies

The oncology therapeutics market is increasingly dominated by biologics—accounting for approximately 50% of all cancer drug sales—and PHYRAGO aims to capitalize on this shift through its immune-modulatory profile.

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Market Dynamics

1. Regulatory Environment

• FDA and EMA Approvals: PHYRAGO’s pivotal Phase III trial results are under review, with potential FDA breakthrough designation pending further data.
• Pathways: Accelerated approval routes are accessible given the drug’s orphan designation and high unmet need.
• Patent Exclusivity & Lifecycle: Patent filings extend until 2035, providing a protected market window.

2. Scientific & Clinical Efficacy

• Clinical Trial Data: Phase III results show a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) for advanced melanoma and lung cancer.
• Safety Profile: With adverse events comparable or lower than current standards, PHYRAGO demonstrates strong safety tolerability.

3. Competitive Landscape

Competitor	Drug Name	Mechanism	Market Share (2022)	Differentiators
Regeneron/BeiGene	Libtayo	PD-1 inhibitor	15%	Well-established efficacy, combination potential
Merck	Keytruda	PD-1 inhibitor	25%	Market leader, broad indications
Novartis	Kymriah	CAR-T therapy	5%	Personalized cell therapy
BioInnovate	PHYRAGO	Immunomodulator (candidate)	Pending approval	Novel mechanism, potential for combination strategies

4. Reimbursement and Market Access

• Pricing Strategies: Biologics pricing varies by indication, usually in the $70k–$150k per treatment course.
• Payer Landscape: Reimbursement negotiations focus on demonstrating cost-effectiveness, especially with surrogate endpoints like PFS.

5. Healthcare Policy Trends

• Value-based Pricing: Increasing emphasis on outcomes-based reimbursement models.
• Access to Innovation: Policies supporting expedited review processes accelerate market entry.

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Financial Trajectory

1. Revenue Projections

Year	Sales (USD Billions)	Assumptions
2023	$0.2	Approved initially for a select indication, limited uptake
2024	$0.8	Expanded indication approvals, early adoption in key markets
2025	$2.1	Broader market penetration, implementation of combination therapies
2026	$3.5	Global expansion, regulatory approvals in Europe/Asia
2027	$4.7	Market saturation, increase in repeat prescriptions

Note: Assumes successful regulatory approval and positive clinical outcomes.

2. Cost Structure

Cost Element	Estimated Percentage of Revenue
R&D expenditures	25–30%
Manufacturing & supply chain	15–20%
Marketing & sales	10–15%
Regulatory & compliance	5–7%
Overhead & administration	8–10%

3. Profitability Outlook

Projected EBITDA margins could reach 25–30% by 2026, contingent on manufacturing optimization and market penetration.

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Comparative Analysis of Market Entry Strategies

Strategy	Pros	Cons
Direct Commercial Launch	Full control over branding and pricing	High upfront costs, risk of slow adoption
Strategic Licensing or Partnerships	Shared risk, access to established channels	Lower margins, dependency on partners
Accelerated Approval & Market Entry	Faster revenue generation	Higher risk if clinical data is uncertain

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Opportunities & Challenges

Opportunities

• Expansion into rare and orphan indications.
• Synergistic use with existing immunotherapy agents.
• Adoption of biosimilars post patent expiry.

Challenges

• Navigating complex regulatory pathways.
• Price negotiations and payer pushback.
• Competition from established biologics with entrenched market positions.
• Potential safety concerns emerging from post-marketing data.

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Key Comparisons: PHYRAGO versus Market Leaders

Feature	PHYRAGO	Keytruda	Libtayo
Mechanism	Immunomodulator	PD-1 inhibitor	PD-1 inhibitor
Indications	Multiple solid tumors	Broad, including melanoma, NSCLC	Cutaneous squamous cell carcinoma
Market share (2022)	Pending	25%	15%
Clinical Advantage	Novel immune pathway	Extensive approval, experience	Competitive efficacy, fewer side effects
Regulatory status	Under review (as of 2023)	Fully approved	Approved

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Deep Dive: Regulatory and Policy Impact

Regulatory Trends

• The FDA’s Oncology Center of Excellence prioritizes accelerated pathways, benefiting drugs like PHYRAGO.
• The European Medicines Agency (EMA) has adopted adaptive licensing, potentially expediting access in Europe.

Healthcare Policy Considerations

• Value-Based Care: Outcomes-based reimbursement models could benefit innovative biologics demonstrating superior efficacy.
• Global Access & Equity: Governments are emphasizing pricing reforms to ensure affordability, especially in emerging markets.

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Forecasting Future Market Trajectory

Timeline	Key Events	Expected Market Impact
2023	Regulatory submission, initial approval in the US	Narrow initial market, limited revenue
2024	Expanded indication approvals, early-market adoption	Rapid revenue growth, increased clinical use
2025–2026	Global expansion, combination therapy strategies	Stabilization of revenues, market share consolidation
2027 and beyond	Post-patent period, biosimilar development	Potential price erosion, focus on differentiation

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Conclusion and Strategic Recommendations

• Short-term: Prioritize FDA approval, prepare for payer negotiations, and establish manufacturing scalability.
• Medium-term: Expand indication portfolio, explore combination therapies, and adapt to evolving policies.
• Long-term: Invest in biosimilar development, explore emerging markets, and incorporate precision medicine strategies to maintain competitive advantage.

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Key Takeaways

• PHYRAGO’s success depends heavily on securing regulatory approval based on compelling clinical efficacy data.
• The biologic market for oncology therapies is expanding at a CAGR of ~9%, with PHYRAGO positioned for growth through differentiation.
• Reimbursement, pricing, and healthcare policies favor innovative treatments that demonstrate tangible patient outcomes.
• Competition from established PD-1 inhibitors necessitates strategic differentiation, possibly via unique mechanisms or combination protocols.
• Forecasted revenues indicate a trajectory toward several billion dollars annually post-2024, assuming successful market penetration.

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FAQs

Q1: What clinical data supports PHYRAGO’s efficacy?
A1: Phase III trial results demonstrate statistically significant improvements in overall survival and progression-free survival across multiple tumor types, with a favorable safety profile, positioning the drug for approval.

Q2: How does PHYRAGO differentiate itself from existing biologics?
A2: PHYRAGO targets a novel immune pathway, potentially offering superior efficacy in resistant tumors and fewer side effects compared to current PD-1 inhibitors.

Q3: What are the main regulatory hurdles for PHYRAGO?
A3: The primary hurdles involve demonstrating consistent clinical benefit, safety, and navigating accelerated approval pathways, especially as competing products are well-established.

Q4: How does the competitive landscape impact PHYRAGO’s market potential?
A4: Competition from established therapies like Keytruda and Libtayo may slow market penetration unless PHYRAGO demonstrates clear clinical advantages or cost-effectiveness.

Q5: What strategic options should BioInnovate consider for maximizing commercial success?
A5: Options include forming strategic partnerships, pursuing global regulatory pathways, investing in biosimilar development post-patent expiry, and expanding indications through adaptive clinical trials.

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References

1. IQVIA Institute. "2022 Global Oncology Market Report." IQVIA, 2022.
2. MarketWatch. "Biologics in Oncology: Market Trends and Outlook." 2022.
3. FDA & EMA regulatory guidance documents (2023).
4. BioInnovate Inc. Clinical Trial Data Releases, 2023.

Note: Figures and projections are based on current available data as of early 2023 and are subject to change with market developments.