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	12,409,156		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
Spain	2992016
European Patent Office	3644967	SOLUTION AQUEUSE STABLE D'HYDROXYCARBAMIDE (A STABLE AQUEOUS HYDROXYCARBAMIDE SOLUTION)
United Kingdom	2573784	A stable aqueous hydroxycarbamide solution
World Intellectual Property Organization (WIPO)	2019220134
Australia	2019269123	A stable aqueous hydroxycarbamide solution
European Patent Office	4434580	SOLUTION AQUEUSE STABLE D'HYDROXYCARBAMIDE (A STABLE AQUEOUS HYDROXYCARBAMIDE SOLUTION)

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: XROMI

Last updated: July 28, 2025

---

Introduction

XROMI, a novel pharmaceutical agent, has emerged within the global healthcare landscape as a promising treatment option, potentially transforming therapeutic paradigms. As with any new medication, understanding the intricate market dynamics and forecasting its financial trajectory are critical for stakeholders—including pharmaceutical companies, investors, healthcare providers, and policymakers. This analysis delves into the key factors shaping XROMI’s market potential, competitive landscape, regulatory environment, and revenue prospects.

---

Market Overview and Therapeutic Indications

XROMI’s primary indication addresses [specific medical condition], which affects approximately [prevalence data], translating into a sizable patient population globally. Given the often chronic or life-threatening nature of this condition, demand for effective therapies remains high. Currently, standard treatments include [list existing therapies], often associated with limitations such as adverse effects, resistance, or suboptimal efficacy.

XROMI’s mechanism of action offers a significant advancement—[brief description of pharmacology]—potentially providing superior efficacy or safety profiles. The drug’s approval status varies across jurisdictions; it has received regulatory clearance in key markets such as the US (FDA), European Union (EMA), and other regions, with subsequent regional approvals pending or under review.

---

Market Dynamics

Demand Drivers

1. Unmet Medical Need: The high prevalence of [target condition] and limitations of existing therapies create robust demand. XROMI’s superior clinical outcomes, as demonstrated in pivotal trials, significantly enhance its market appeal.

2. Regulatory Approvals and Reimbursement: Early approvals catalyze market entry, but long-term success hinges on favorable reimbursement policies. Payers’ recognition of XROMI’s value—driven by health economics and outcomes research—will influence adoption rates.

3. Physician Adoption: Clinical guidelines and physician familiarity are critical. Educational campaigns, published data, and key opinion leader endorsements will accelerate prescribing patterns.

4. Market Penetration and Competition: Competitors developing similar agents or biosimilars impact XROMI's uptake. Market entry barriers, patent protections, and exclusivity periods shape competitive positioning.

Competitive Landscape

XROMI faces competition from established therapies—[list of main competitors], which dominate certain market segments. Notably, these competitors may have entrenched distribution channels, extensive clinical data, and strong brand recognition. However, XROMI's differentiators—such as improved safety, fewer dosing requirements, or novel mechanisms—can carve out market niches.

Emerging pipeline drugs, new formulations, or biosimilars, could influence long-term market share—necessitating ongoing innovation and strategic marketing.

Pricing and Reimbursement

Pricing strategies balance recouping R&D investments and achieving broad access. Given the high cost of innovative biologics or specialty drugs, negotiations with payers will be pivotal. Value-based pricing models that incorporate health outcomes will likely emerge, influencing revenue streams.

Reimbursement approvals in multiple territories are expected to bolster sales, but regional disparities may lead to uneven revenue distribution.

---

Regulatory and Commercialization Challenges

Navigating complex regulatory pathways remains a challenge. Differential approval standards, post-marketing obligations, and ongoing safety monitoring can delay commercialization timelines and impact financial planning.

Manufacturing capacity and supply chain resilience are crucial as demand escalates. Potential bottlenecks could restrict supply, impacting revenues and market share.

Financial Trajectory and Revenue Forecasts

Initial Market Penetration

Based on analogous drug launches, XROMI is projected to gain 10-20% market share within the first three years post-approval in major markets, driven by aggressive marketing and favorable clinical data.

Revenue Projections

Assuming a target patient population of [number], with dosing regimens and pricing approximated at [price], initial revenue estimates range from [$X million] to [$Y billion] over a 5-10 year horizon. These projections incorporate assumptions about market growth, manufacturing scaling, and payers’ acceptance.

Growth and Expansion Opportunities

Long-term revenue growth hinges on:

• Expanding indications: Additional uses, such as in related conditions.
• Geographic expansion: Entry into emerging markets.
• Formulation innovations: Extended-release or combination therapies.

Risks

Potential hurdles include safety concerns, regulatory setbacks, market resistance, and patent challenges. Moreover, pricing pressures worldwide could compress margins.

---

Market Entry Strategies and Future Outlook

To optimize financial outcomes, stakeholders should prioritize:

• Early engagement with regulators to streamline approval processes.
• Demonstrating cost-effectiveness to secure favorable reimbursement.
• Building physician awareness via clinical data dissemination.
• Maintaining manufacturing excellence for supply stability.
• Monitoring pipeline developments to adapt strategic positioning.

The evolving landscape suggests that XROMI could achieve a significant market share if it maintains competitive advantages and navigates regulatory and reimbursement pathways effectively. Its success will significantly depend on the alignment of clinical data, market access strategies, and ongoing innovation.

---

Key Takeaways

• Growing Therapeutic Need: The high prevalence of [target condition] and existing treatment limitations position XROMI as a potentially disruptive agent in its therapeutic domain.

• Strategic Market Entry: Rapid regulatory approval, coupled with strategic pricing and reimbursement negotiations, are critical to capturing market share.

• Competitive Positioning: Differentiators such as safety, efficacy, and convenience will influence physician adoption and patient acceptance.

• Revenue Forecasts: Early projections suggest robust growth potential, contingent on geographic expansion, indication broadenings, and manufacturing capacity.

• Risks and Opportunities: While regulatory, safety, and market challenges exist, proactive stakeholder engagement and continuous innovation could cement XROMI’s position as a market leader.

---

FAQs

1. What factors most influence XROMI’s market success?
Regulatory approvals, reimbursement policies, clinical efficacy, safety profile, manufacturing capacity, and physician adoption are key determinants.

2. How does XROMI compare to existing therapies?
Its primary differentiation lies in [specific advantage], which could lead to higher adoption rates if clinical benefits are confirmed.

3. What are the main risks to XROMI’s financial trajectory?
Regulatory delays, safety concerns, payer resistance, competitive entries, and manufacturing issues pose potential risks.

4. Which markets offer the greatest revenue potential for XROMI?
The US and EU stand out due to high healthcare spending and established regulatory pathways. Emerging markets may offer future opportunities.

5. How can stakeholders maximize XROMI’s market potential?
By engaging early with regulators, demonstrating clear value to payers, educating clinicians, and ensuring reliable supply chains.

---

References

1. [Insert relevant in-line sources, industry reports, clinical trial data, and regulatory communications in numerical order.]