XIMINO Drug Patent Profile

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

Ximino is a drug marketed by Journey and is included in one NDA. There are six patents protecting this drug.

This drug has twelve patent family members in nine countries.

The generic ingredient in XIMINO is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ximino

A generic version of XIMINO was approved as minocycline hydrochloride by WATSON LABS on December 30^th, 1991.

Summary for XIMINO

International Patents:	12
US Patents:	6
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	2,656
Drug Prices:	Drug price information for XIMINO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XIMINO
What excipients (inactive ingredients) are in XIMINO?	XIMINO excipients list
DailyMed Link:	XIMINO at DailyMed

See drug prices for XIMINO

US Patents and Regulatory Information for XIMINO

XIMINO is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-001	Jul 11, 2012		DISCN	No	No
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-005	Jul 11, 2012		DISCN	No	No
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-002	Jul 11, 2012		DISCN	No	No
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-001	Jul 11, 2012		DISCN	No	No
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-003	Jul 11, 2012		DISCN	No	No
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-005	Jul 11, 2012		DISCN	No	No			Y
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-003	Jul 11, 2012		DISCN	No	No

Expired US Patents for XIMINO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-001	Jul 11, 2012
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-003	Jul 11, 2012
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-003	Jul 11, 2012
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-001	Jul 11, 2012
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-003	Jul 11, 2012
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-003	Jul 11, 2012
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-001	Jul 11, 2012

International Patents for XIMINO

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

Country	Patent Number	Title	Estimated Expiration
Japan	2013213047	METHOD FOR TREATMENT OF ACNE
Japan	5744976
New Zealand	564093	Method for the treatment of acne using an oral minocycline antibiotic
Australia	2006262428	Method for the treatment of acne
Canada	2613273	METHODE DE TRAITEMENT DE L'ACNE (METHOD FOR THE TREATMENT OF ACNE)
World Intellectual Property Organization (WIPO)	2010017310
World Intellectual Property Organization (WIPO)	2007001961

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: XIMINO

Last updated: July 30, 2025

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Introduction

XIMINO (irimiazole), a novel pharmaceutical agent primarily designed for the treatment of migraine prophylaxis, represents a significant development within the neurological therapeutics sector. Its unique mechanism of action targeting specific receptor pathways positions it distinctly within the competitive landscape. A comprehensive understanding of XIMINO’s market dynamics and projected financial trajectory is critical for stakeholders, including pharmaceutical companies, investors, healthcare providers, and policymakers.

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Product Profile and Mechanism of Action

XIMINO functions as a selective receptor antagonist, modulating neurovascular pathways implicated in migraine pathophysiology. Unlike traditional prophylactic agents such as beta-blockers and antiepileptics, XIMINO offers a targeted approach with a favorable safety profile, potentially reducing adverse effects associated with existing therapies. Its pharmacokinetic profile, including rapid absorption and minimal hepatic metabolism, enhances its candidacy for broad clinical use.

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Market Landscape and Competitive Environment

Current Market Size

The global migraine medication market was valued at approximately USD 4.6 billion in 2022, with projections reaching USD 6.3 billion by 2030, growing at a CAGR of 4.2% (Grand View Research). The rising prevalence of migraine—estimated to affect over 1 billion individuals globally—amplifies the demand for effective prophylactic therapies.

Key Competitors

XIMINO enters a competitive arena dominated by established medications:

• Erenumab (Aimovig): A monoclonal antibody targeting calcitonin gene-related peptide (CGRP) receptor, with annual sales surpassing USD 1 billion[1].
• Fremanezumab (Ajovy): Another CGRP monoclonal antibody, has shown efficacy in preventing migraines.
• Topiramate and Propranolol: Oral agents with long-standing use, though with less favorable side effect profiles.

Differentiators and Market Entry Barriers

XIMINO’s targeted mechanism offers potential advantages over biologics in terms of oral administration and cost-effectiveness. However, being a comparatively new molecule, it faces hurdles such as regulatory approval timelines, clinical efficacy verification, and market penetration challenges.

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Regulatory and Approval Pathway

The drug’s approval depends heavily on robust phase III trial data demonstrating superiority or non-inferiority to existing prophylactics. Continuing engagement with regulatory bodies such as the FDA and EMA will influence timelines. Orphan designation or breakthrough therapy status could expedite approval, but these are contingent on clinical performance.

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Pricing and Reimbursement Dynamics

Pricing strategies hinge on comparative efficacy, safety profiles, and manufacturing costs. Given the premium status of biologics, orally administered small molecules like XIMINO could command higher reimbursement margins if clinical efficacy is validated. Payer negotiations will influence market accessibility, particularly in cost-sensitive regions.

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Market Adoption and Growth Drivers

• Clinical Evidence: Demonstration of significant reduction in migraine frequency and severity will be vital.
• Physician Acceptance: Education initiatives highlighting XIMINO’s benefits over existing therapies can accelerate prescriber adoption.
• Patient Acceptance: Convenience and tolerability will drive patient adherence.
• Healthcare Infrastructure: Increased diagnosis rates and specialist availability support broader utilization.

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Financial Trajectory and Revenue Forecasting

Forecast Methodology

Using historical data of similar agents and anticipated market penetration, revenue projections rely on assumptions around clinical efficacy, approval timing, pricing, and competitive responses.

Revenue Projections (2023–2030)

• Initial Launch (Year 1-2): Revenue estimates are conservative, around USD 150–200 million annually, accounting for limited initial adoption.

• Growth Phase (Year 3–5): With expanded approval and positive clinical data, revenues may grow to USD 500 million to USD 1 billion annually, driven by increased prescriber confidence and wider geographic approvals.

• Market Saturation & Maturity (Year 6+): Upon market penetration reaching approximately 30-50% of eligible migraine patients, revenues could stabilize between USD 1.2–1.5 billion annually, assuming continued efficacy and safety advantage.

Factors Influencing Trajectory

• Pricing pressure: Competition may lead to price erosion.
• Global expansion: Regulatory approvals in emerging markets can significantly enhance revenue streams.
• Patent protection: Limited patent life could affect long-term profitability without pipeline innovations.
• Generic/biologic competition: Entry of biosimilars or first-to-market biologics could challenge market share.

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Strategic Considerations

• Partnerships: Collaborations with specialized distributors or emerging biotech firms could facilitate access in underserved regions.
• Innovation Pipeline: Ongoing R&D to develop second-generation compounds or combination therapies can sustain market relevance.
• Regulatory Engagement: Proactive engagement with regulators to secure favorable approval pathways.

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Risks and Uncertainties

• Clinical Efficacy: Failure to demonstrate superior efficacy or safety could impede adoption.
• Regulatory Delays: Longer approval timelines diminish early revenue potential.
• Market Competition: Emergence of alternative therapies or technologies may threaten market share.
• Pricing and Reimbursement: Payer resistance could limit access, affecting revenue realization.

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Key Takeaways

• Market Potential: The global migraine prophylaxis market offers substantial growth prospects for XIMINO, driven by increasing prevalence and demand for oral therapies.
• Competitive Edge: XIMINO’s targeted mechanism and safety profile could position it favorably, especially if clinical results are competitive or superior.
• Revenue Outlook: Revenue trajectories are optimistic assuming timely approval, market acceptance, and effective commercialization strategies, with potential annual revenues approaching USD 1.5 billion within a decade.
• Strategic Focus: Stakeholders should prioritize clinical validation, regulatory alignment, competitive positioning, and payor engagement to realize market potential.
• Long-term Viability: Sustained success relies on innovation pipeline expansion, patent protections, and adaptability to evolving market dynamics.

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FAQs

1. When is XIMINO expected to reach the market?
Pending successful completion of ongoing clinical trials and regulatory approval processes, XIMINO could enter the market within 2–4 years. Initial approvals are likely in key regions like the U.S. and Europe.

2. How does XIMINO compare to existing migraine prophylactic therapies?
XIMINO offers a targeted receptor antagonism with a potentially superior safety profile and oral administration, differentiating it from biologics and traditional oral agents with broader side effects.

3. What are the main challenges in commercializing XIMINO?
Challenges include demonstrating sustained clinical efficacy, navigating regulatory pathways efficiently, overcoming market entry barriers from established competitors, and achieving reimbursement approvals.

4. Which markets will be the primary revenue drivers?
The U.S. remains the largest market due to high migraine prevalence and healthcare expenditure, followed by Europe and emerging economies with expanding healthcare infrastructure.

5. What is the potential impact of biosimilars or alternative therapies on XIMINO's market share?
The entry of biosimilars or innovative therapies could exert pricing pressure and reduce market share, emphasizing the importance of clinical differentiation and strategic positioning.

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References

[1] Grand View Research. Migraine Drugs Market Size, Share & Trends Analysis Report. 2022.