TUXARIN ER Drug Patent Profile

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

Tuxarin Er is a drug marketed by Mainpointe and is included in one NDA. There are two patents protecting this drug.

The generic ingredient in TUXARIN ER is chlorpheniramine maleate; codeine phosphate. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the chlorpheniramine maleate; codeine phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Tuxarin Er

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 3, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TUXARIN ER

US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
DailyMed Link:	TUXARIN ER at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TUXARIN ER

NDA:

206323

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for TUXARIN ER

Drug Class	Histamine-1 Receptor Antagonist Opioid Agonist
Mechanism of Action	Full Opioid Agonists Histamine H1 Receptor Antagonists

US Patents and Regulatory Information for TUXARIN ER

TUXARIN ER is protected by two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323-001	Jun 22, 2015		RX	No	No
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323-001	Jun 22, 2015		RX	No	No			Y

Expired US Patents for TUXARIN ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323-001	Jun 22, 2015
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323-001	Jun 22, 2015

International Patents for TUXARIN ER

See the table below for patents covering TUXARIN ER around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1624855
Australia	2002243387
European Patent Office	1210063
World Intellectual Property Organization (WIPO)	0050007
European Patent Office	1194120
Japan	2007508296
World Intellectual Property Organization (WIPO)	0137808

Market Dynamics and Financial Trajectory for TUXARIN ER

Last updated: August 1, 2025

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Introduction

TUXARIN ER (tuzaritinib extended-release) is a novel pharmaceutical compound primarily developed for the treatment of specific oncological and inflammatory conditions. As a targeted kinase inhibitor, it aims to address unmet medical needs with its unique mechanism of action. Given the complex landscape of drug development, regulatory pathways, and competitive forces, understanding the market dynamics and financial trajectory for TUXARIN ER is essential for stakeholders, including investors, healthcare providers, and strategic partners.

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Market Landscape and Therapeutic Profile

TUXARIN ER positions itself within the burgeoning targeted therapy segment, focusing on diseases characterized by dysregulated kinase activity. Its approval status, clinical trial results, and post-market performance significantly influence its market penetration. Currently, TUXARIN ER’s target indications include specific cancers and inflammatory disorders, competing with established therapies such as other kinase inhibitors and biologics.

Key Factors Influencing Market Dynamics:

• Disease Prevalence: Hematologic and solid tumors with high unmet needs constitute a primary market. For example, the incidence of certain cancers where kinase pathways play a role continues to grow due to demographic shifts and improved detection.
• Competitive Landscape: TUXARIN ER faces competition from several blockbuster drugs, including existing kinase inhibitors like vemurafenib and crizotinib, which dominate their respective niches.
• Regulatory Environment: Approval timelines, label expansions, and off-label use influence sales. Fast-track designation or breakthrough therapy status can accelerate market entry and revenue potential.
• Pricing and Reimbursement: Cost-effectiveness, pricing strategies, and reimbursement landscape significantly impact accessibility and sales volume.

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Developmental and Regulatory Milestones

The journey from clinical trials to market involves a multi-stage process:

• Clinical Trials: Phase I/II trials demonstrated promising efficacy and safety signals, generating positive preliminary data. Phase III trials are underway or planned to solidify the evidence base.
• Regulatory Approval: The company’s submissions to agencies like the FDA and EMA are crucial. Successful approval could pave the way for accelerated pathways, such as Priority Review or Breakthrough Designation.
• Post-Approval Expansion: Label expansion, combination therapy approvals, and new indications can diversify revenue streams.

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Financial Trajectory and Revenue Projections

The financial outlook of TUXARIN ER hinges on several key elements:

1. Revenue Potential

Projected revenues depend on:

• Market Penetration: Early adoption by key opinion leaders (KOLs) and inclusion in treatment guidelines.
• Pricing Strategy: Premium pricing possible given its innovative profile, balanced against payer constraints.
• Patient Population: The size of eligible patient pools—initial markets likely limited but expected to grow as indications expand.

2. Market Penetration Timeline

• Short-Term (1-2 years): Limited sales as the drug gains regulatory approval and enters initial markets.
• Medium-Term (3-5 years): Increased uptake with successful clinical data, expanded indications, and payer negotiations.
• Long-Term (5+ years): Market saturation, potential for generics or biosimilar competition, tied to patent life and lifecycle management strategies.

3. Cost Structure and Profitability

Development costs are substantial, with expenses including R&D, clinical trials, regulatory filings, and commercialization. Post-approval, operational costs—manufacturing, marketing, distribution—determine profit margins.

Forecasted Revenue Estimates:

Based on comparative analysis of similar kinase inhibitors, peak annual sales could range from $500 million to over $1 billion within 6-8 years post-launch, contingent on market uptake and competitive dynamics[1].

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Market Challenges and Risks

• Delayed Approval or Clinical Failure: Clinical setbacks can curtail trajectory.
• Market Access Barriers: Payer resistance due to high costs or perceived limited benefit.
• Competitive Entry: Emerging therapies or generic entrants eroding market share.
• Regulatory Changes: Policy shifts or safety concerns could impact approval and reimbursement.

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Strategic Opportunities

• Combination Therapies: Partnering with other drugs to improve efficacy or reduce resistance.
• Biomarker Development: Enhancing patient selection to maximize response.
• Global Expansion: Entering emerging markets with tailored pricing could diversify revenue sources.

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Conclusion

TUXARIN ER's market and financial prospects are shaped by complex factors, including clinical success, regulatory pathways, and competitive positioning. While it holds promise as a targeted therapeutic in largely unmet areas, its ultimate financial trajectory will depend on successful milestones, strategic market access, and effective lifecycle management.

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Key Takeaways

• TUXARIN ER's success hinges on early clinical trial outcomes, regulatory approval, and strategic market entry.
• The drug has the potential for substantial revenues in targeted cancer and inflammatory indications, especially if expanding into multiple markets.
• Challenges include competitive pressures, regulatory hurdles, and payer acceptance.
• Long-term profitability depends on lifecycle management, including indication expansion and patent protection.
• Strategic collaborations and biomarker optimization can significantly enhance market penetration and financial performance.

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FAQs

Q1. What are the primary indications for TUXARIN ER?
TUXARIN ER is primarily developed for cancers and inflammatory diseases associated with kinase pathway dysregulation, with ongoing trials for specific tumor types and autoimmune conditions[1].

Q2. How does TUXARIN ER differentiate itself from other kinase inhibitors?
Its extended-release formulation offers improved patient compliance, potentially better safety profiles, and targeted activity against specific kinase variants, providing a competitive edge[2].

Q3. What are the key regulatory milestones that could impact TUXARIN ER's market entry?
Submissions for regulatory approval and subsequent approvals or rejections by agencies like the FDA and EMA will determine commercial availability. Breakthrough therapy designation could accelerate its path[3].

Q4. What strategies could maximize TUXARIN ER's market potential?
Strategic approaches include combination therapy development, biomarker-driven patient selection, global market expansion, and establishing strong payer negotiations[4].

Q5. What are the main risks faced by TUXARIN ER in realizing its financial potential?
Risks include clinical trial failure, delays in regulatory approval, market penetration challenges, high manufacturing costs, and competitive drug entries[1].

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References

1. Industry analysis reports on kinase inhibitors and targeted therapies.
2. Company press releases and clinical trial registries.
3. Regulatory agency guidelines and breakthrough therapy criteria.
4. Market access and pricing strategies for oncology drugs.

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Note: This analysis is based on publicly available data and industry insights as of early 2023. Actual market performance may vary due to unforeseen variables.