XROMI Drug Patent Profile

When do Xromi patents expire, and when can generic versions of Xromi launch?

Xromi is a drug marketed by Nova Labs Ltd and is included in one NDA. There is one patent protecting this drug.

This drug has nine patent family members in seven countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Xromi

A generic version of XROMI was approved as hydroxyurea by BARR on October 16^th, 1998.

Summary for XROMI

International Patents:	9
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	3,425
Drug Prices:	Drug price information for XROMI
What excipients (inactive ingredients) are in XROMI?	XROMI excipients list
DailyMed Link:	XROMI at DailyMed

See drug prices for XROMI

Pharmacology for XROMI

Drug Class

Antimetabolite

US Patents and Regulatory Information for XROMI

XROMI is protected by one 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
Nova Labs Ltd	XROMI	hydroxyurea	SOLUTION;ORAL	216593-001	Apr 4, 2024		RX	Yes	Yes			Y
Nova Labs Ltd	XROMI	hydroxyurea	SOLUTION;ORAL	216593-001	Apr 4, 2024		RX	Yes	Yes
Nova Labs Ltd	XROMI	hydroxyurea	SOLUTION;ORAL	216593-001	Apr 4, 2024		RX	Yes	Yes

International Patents for XROMI

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2019220134
Australia	2019269123	A stable aqueous hydroxycarbamide solution
United Kingdom	201808013
United Kingdom	2573784	A stable aqueous hydroxycarbamide solution
Spain	2992016
European Patent Office	4434580	SOLUTION AQUEUSE STABLE D'HYDROXYCARBAMIDE (A STABLE AQUEOUS HYDROXYCARBAMIDE SOLUTION)

XROMI Market Analysis and Financial Projection

Last updated: April 25, 2026

Market dynamics and financial trajectory for XROMI

XROMI’s market and financial trajectory cannot be produced from verifiable sources with the information available in this session.

What is XROMI’s commercial footprint?

No market size, sales, approvals, launch geography, or payer/price data for XROMI is present here in a way that supports a complete, accurate market-dynamics and financial-trajectory analysis.

How does XROMI perform across geographies and channels?

No jurisdiction-level or channel-level evidence (e.g., US OTC vs Rx mix, EU market access, tender dynamics, hospital vs retail distribution) is available here to map penetration, uptake, or channel shifts.

What are the drivers and constraints shaping XROMI demand?

No documented demand drivers (label expansions, guideline inclusion, competitor displacement, acquisition of new indications, manufacturing supply stability) or constraints (safety communications, formulary exclusions, reimbursement denials, inventory issues) are available here.

What does XROMI’s financial trajectory show over time?

No audited or reliably reported financial trail (manufacturer net sales, wholesaler sell-through, gross-to-net bridges, rebates/discounts, segment reporting, quarterly trend) is available here to establish trajectory.

How do competitor dynamics affect XROMI economics?

No competitor set (ATC/class alternatives), class pricing levels, or documented switching/rebates data is available here to quantify competitive pressure.

What does the IP position imply for forward sales durability?

No patent or regulatory exclusivity timeline for XROMI is available here to connect IP milestones to revenue durability, generic entry risk, or settlement events.

Key Takeaways

• A complete market dynamics and financial trajectory for XROMI requires verifiable market and financial data that is not present in this session.
• No defensible statements on sales performance, uptake, geography, pricing, competitive impact, or IP-linked revenue durability can be produced without those sources.

FAQs

1. Is XROMI approved and where?
2. What are XROMI’s reported sales and growth rate?
3. Who are XROMI’s key competitors and how do they price?
4. What payer and formulary dynamics govern XROMI uptake?
5. What is XROMI’s patent and exclusivity timeline for revenue durability?

References

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