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 six patents protecting this drug.

This drug has nine patent family members in six countries.

The generic ingredient in PHYRAGO is dasatinib. There are fourteen drug master file entries for this compound. Sixteen 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:	9
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	1,548
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 twenty 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	216099-002	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	216099-003	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
Canada	3168667	DISPERSIONS SOLIDES AMORPHES DE DASATINIB ET LEURS UTILISATIONS (AMORPHOUS SOLID DISPERSIONS OF DASATINIB AND USES THEREOF)
European Patent Office	4093379	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	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

Last updated: May 30, 2026

PHYRAGO (Phyrag o?) market dynamics and financial trajectory: sales trend, exclusivity, and generic/biosimilar risk

Executive summary: PHYRAGO’s market trajectory cannot be quantified from the available information because the drug’s active ingredient, dosage form, regulatory status (FDA/EMA or other), and US/EP patent terms are not identified. Without those identifiers, no defensible assessment of Orange Book listings, exclusivity timelines, patent-expiration-driven revenue exposure, or generic/rep licensing risk can be produced.

No market dynamics or financial trajectory figures can be generated reliably without the drug’s confirmed identity.

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What is PHYRAGO and what markets does it serve?

Featured snippet answer: Market dynamics depend on the confirmed active ingredient and approved indication(s). PHYRAGO cannot be mapped to a specific FDA/EMA product record from the provided prompt.

Which regulatory markets matter for launch economics

• US (FDA): drives exclusivity, Paragraph IV risk, and generic conversion.
• EU (EMA + national launches): drives parallel pricing, reference pricing, and tender outcomes.
• UK (MHRA) and select emerging markets: drives local exclusivity and reimbursement constraints.

What product identifiers determine revenue

Revenue modeling requires, at minimum:

• active ingredient and salt
• dosage form (tablet, capsule, solution, injection, etc.)
• strength(s)
• NDC (US) or marketing authorization number (EU)
• indication(s) (oncology, CNS, cardiometabolic, etc.)

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What patents protect PHYRAGO and how strong is the patent estate?

Featured snippet answer: Patent estate strength is undefined without the active ingredient and the jurisdictional filing family.

What to check to measure freedom-to-operate (FTO) for generics

• Composition-of-matter patents
• formulation patents (coatings, particle size, polymorphs, solid-state forms)
• method-of-use patents tied to specific dosing or patient subgroups
• manufacturing process patents (crystallization, purification, impurity control)
• pediatric exclusivity and marketing exclusivity interaction (where applicable)

How patent strength translates to sales durability

• Broad composition claims increase generic entry delay.
• Method-of-use claims can slow “label carve-out” entry.
• Formulation/process claims can preserve premium pricing by restricting AB switching.

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When does PHYRAGO lose exclusivity and when are generic entry windows?

Featured snippet answer: Exclusivity and patent loss dates cannot be calculated without the approved product identity and patent list.

Exclusivity categories that change financial trajectory

• US non-patent exclusivity (New Chemical Entity, New Molecular Entity, orphan drug, etc.)
• patent-term expiration (composition, formulation, method-of-use)
• pediatric exclusivity extension
• market exclusivity triggered by FDA approvals (if applicable)

Paragraph IV challenge implications

• A first Paragraph IV filer can force a settlement with “launch-at-risk” pricing pressure.
• Multiple challenges can compress the time window before generic erosion.

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What is the Orange Book status of PHYRAGO?

Featured snippet answer: Orange Book status cannot be provided without the US NDC and active ingredient confirmation.

What an Orange Book record typically shows

• Listed patents by type (drug substance, drug product, method-of-use)
• patent expiration dates
• submission and patent listing history
• exclusivity codes (where present)

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What generic entry risks exist for PHYRAGO?

Featured snippet answer: Generic entry risk cannot be assessed without the drug’s patent and exclusivity profile.

Risk signals used in deal and litigation underwriting

• close-in patent expirations relative to current sales
• number of unexpired method-of-use patents
• formulation/polymorph coverage depth
• history of Paragraph IV filings in that therapeutic class
• evidence of label complexity and dosing specificity (which raises “carve-out” barriers)

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What patent litigation affects PHYRAGO and what settlement scenarios are likely?

Featured snippet answer: Litigation posture cannot be assessed without the product’s patent list and any known case docket details.

Typical settlement structures that reshape revenue

• delayed generic launch date with payment terms
• covenant not to sue tied to specific formulations or manufacturing
• “at-risk” launch dates absent infringement findings
• label carve-outs to avoid method-of-use claims

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How does PHYRAGO compare with competing drugs in pricing and market access?

Featured snippet answer: Comparative market dynamics require:

• therapeutic class and MoA
• key competitors (same indication, same line of therapy)
• reimbursement status by geography
• price bands after any tender or HTA action

Price erosion drivers

• formulary placement and step edits
• biosimilar/generic competition timing
• procurement tenders (especially in EU and UK)
• patient cost-sharing changes

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What FDA approval pathway did PHYRAGO use, and how does that affect revenue?

Featured snippet answer: FDA pathway cannot be determined from the provided prompt.

Pathway effects on commercial ramp

• accelerated approval can drive faster uptake but can increase post-market risk
• standard approval can support longer-term label stability
• orphan designation (if applicable) can add exclusivity and pricing support

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Which companies are likely commercial competitors for PHYRAGO?

Featured snippet answer: Company-level competitive mapping requires confirmed active ingredient and therapeutic indication.

What “competitor set” means in underwriting

• originator and authorized generics (if any)
• generic incumbents with established manufacturing capacity
• biosimilar candidates (only relevant if PHYRAGO is biologic)
• specialty pharma with distribution advantages

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What does PHYRAGO’s sales trajectory look like: ramp, peak, and erosion?

Featured snippet answer: A sales trajectory cannot be produced without access to the confirmed product’s commercial data.

Sales-shape framework used for trajectory modeling

• initial adoption curve: formulary penetration and prescriber awareness
• peak year drivers: label expansion, higher dose usage, geographic expansion
• erosion: first generic entry, settlement-triggered launch timing, tender-driven price cuts

Metrics needed to quantify trajectory

• annual net sales and prescription counts
• gross-to-net trends (rebates, discounts)
• geographic mix
• payer mix and segment-level utilization

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Key Takeaways

• PHYRAGO’s market dynamics and financial trajectory cannot be quantified from the provided prompt because the drug’s verified identity (active ingredient, dosage form, jurisdictional approvals) is missing.
• No defensible patent, Orange Book status, exclusivity, litigation, generic risk, or competitive revenue pressure can be produced without that identity.

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FAQs

1. How do I determine the correct Orange Book record for a drug if the brand name is ambiguous?
2. What are the most common patent categories that block generic entry for branded small molecules?
3. How do settlement agreements typically affect the timing of generic launch-at-risk?
4. Which reimbursement mechanisms most reliably predict revenue erosion after generic entry?
5. What indicators suggest a product is likely to face multiple Paragraph IV challenges?

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References

No sources cited because PHYRAGO’s verified drug identity (active ingredient and authorized product listing) is not provided in the prompt.