FRINDOVYX Drug Patent Profile

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

Frindovyx is a drug marketed by Avyxa Holdings and is included in one NDA. There are two patents protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in FRINDOVYX is cyclophosphamide. There are nineteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the cyclophosphamide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Frindovyx

A generic version of FRINDOVYX was approved as cyclophosphamide by BAXTER HLTHCARE on May 21^st, 2008.

Summary for FRINDOVYX

International Patents:	1
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	5,878
What excipients (inactive ingredients) are in FRINDOVYX?	FRINDOVYX excipients list
DailyMed Link:	FRINDOVYX at DailyMed

US Patents and Regulatory Information for FRINDOVYX

FRINDOVYX is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avyxa Holdings	FRINDOVYX	cyclophosphamide	SOLUTION;INTRAVENOUS	210852-002	Jun 7, 2023		RX	Yes	Yes	10,849,916		Y
Avyxa Holdings	FRINDOVYX	cyclophosphamide	SOLUTION;INTRAVENOUS	210852-003	Jun 7, 2023		RX	Yes	Yes	10,849,916		Y
Avyxa Holdings	FRINDOVYX	cyclophosphamide	SOLUTION;INTRAVENOUS	210852-002	Jun 7, 2023		RX	Yes	Yes	11,382,923		Y
Avyxa Holdings	FRINDOVYX	cyclophosphamide	SOLUTION;INTRAVENOUS	210852-003	Jun 7, 2023		RX	Yes	Yes	11,382,923		Y

International Patents for FRINDOVYX

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016005962

FRINDOVYX market dynamics and financial trajectory: exclusivity, competitor risks, and revenue outlook

Last updated: June 25, 2026

FRINDOVYX is not identifiable from available public domain identifiers in the patent-and-regulatory naming conventions used for US/EU drug tracking. No reliable FDA “Orange Book” or EMA marketing authorization record can be tied to the name “FRINDOVYX,” and no defensible patent estate, exclusivity schedule, commercialization milestones, or revenue metrics can be produced without risking fabrication.

Because sufficient verifiable inputs do not exist, a complete and accurate market dynamics and financial trajectory analysis cannot be generated.

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

No defensible FRINDOVYX patent estate can be mapped to a specific active ingredient, sponsor, or dosage form based on the drug name provided.

Which companies hold FRINDOVYX patents and in which jurisdictions?

No jurisdictional or assignee mapping is possible for FRINDOVYX without an identifiable active ingredient and application/market authorization link.

How many formulation, method-of-use, and manufacturing patents cover FRINDOVYX?

No counts can be computed without an identifiable patent family and relevant Orange Book/EP register references.

When does FRINDOVYX lose exclusivity and what are the key FDA timing events?

No FDA regulatory record can be tied to FRINDOVYX, so launch and exclusivity windows (NCE, 5-year, pediatric, MAH/ANDA/BLA gating dates) cannot be stated.

When do relevant Orange Book patents expire for FRINDOVYX?

No Orange Book listing can be attributed to FRINDOVYX.

What pediatric exclusivity and 180-day exclusivity risks exist for FRINDOVYX?

No FDA exclusivity triggers can be verified for FRINDOVYX.

What patent litigation affects FRINDOVYX and what settlements are on the record?

No FRINDOVYX-specific litigation docket can be produced without an identifiable active ingredient/patent list.

Which generics or biosimilars are challenging FRINDOVYX via Paragraph IV?

No Paragraph IV notice attribution can be established.

What does FRINDOVYX’s enforcement history imply for generic launch timing?

No enforcement history can be verified.

What is the Orange Book status of FRINDOVYX and where is it marketed?

No market authorization record can be confirmed for FRINDOVYX in the US or EU.

Is FRINDOVYX listed as an NDA, ANDA reference, or BLA?

No pathway assignment can be verified.

What dosage forms and strengths exist for FRINDOVYX?

No product presentation can be confirmed.

How does FRINDOVYX compare with competing therapies and what substitution risks exist?

No competitor set can be defined without knowing the active ingredient, target indication, mechanism, and approved dosing.

Which branded and generic alternatives compete with FRINDOVYX?

No alternatives can be identified.

How sensitive is FRINDOVYX demand to formulary placement and rebate dynamics?

No demand sensitivity can be quantified without sales history and payer coverage data.

What generic entry risks exist for FRINDOVYX and what are the manufacturing/IP barriers?

No generic entry scenario can be structured without identifying the FDA reference product, patent expiry dates, and enforceable claims.

What barriers do formulation patents pose for generic substitution of FRINDOVYX?

No formulation barrier analysis can be performed.

What CMC/IP constraints could delay generic approval for FRINDOVYX?

No manufacturing process patents or regulatory chemistry details can be tied to FRINDOVYX.

What are FRINDOVYX commercialization metrics and financial trajectory indicators?

No verified financial trajectory can be computed because FRINDOVYX lacks an identifiable public commercialization profile in standard financial disclosures.

What are estimated and reported revenues for FRINDOVYX?

No revenue data can be stated.

What are sales drivers and adoption metrics for FRINDOVYX?

No adoption metrics can be verified.

What cost and margin profile does FRINDOVYX likely have?

No cost basis can be inferred without product and payer structure.

---

Key Takeaways

• FRINDOVYX cannot be matched to a verifiable FDA/EMA product record or an identifiable active ingredient using the name provided, so no defensible patent, exclusivity, litigation, Orange Book, or financial trajectory analysis can be produced.
• Market dynamics depend on the exact indication, mechanism, formulation, and sponsor, none of which can be confirmed for FRINDOVYX from available records tied to the provided name.

FAQs

1. How can I verify FRINDOVYX’s FDA reference product status (NDA/ANDA/BLA) from public databases?
2. Which datasets are used to map a drug name to its Orange Book patent list and exclusivity dates?
3. How do Paragraph IV challenges change expected generic launch timing and 180-day exclusivity for a brand?
4. What indicators best predict peak sales trajectory for a specialty pharma launch?
5. How do formulation and method-of-use patents typically delay generic substitution for oral small molecules?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US FDA.
2. FDA Purple Book: Lists of Licensed Biological Products, Including Biosimilar and Interchangeable Products. US FDA.
3. FDA Drug Approvals and Databases. US FDA.
4. EMA European Medicines Register. European Medicines Agency.

DrugChatter Q&A for FRINDOVYX

Frindovyx vs cyclophosphamide?