MYTESI Drug Patent Profile

Which patents cover Mytesi, and when can generic versions of Mytesi launch?

Mytesi is a drug marketed by Napo Pharms Inc and is included in one NDA. There are two patents protecting this drug.

This drug has twenty-eight patent family members in twenty-two countries.

The generic ingredient in MYTESI is crofelemer. One supplier is listed for this compound. Additional details are available on the crofelemer profile page.

DrugPatentWatch^® Generic Entry Outlook for Mytesi

Mytesi was eligible for patent challenges on December 31, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 31, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for MYTESI

International Patents:	28
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Drug Prices:	Drug price information for MYTESI
What excipients (inactive ingredients) are in MYTESI?	MYTESI excipients list
DailyMed Link:	MYTESI at DailyMed

See drug prices for MYTESI

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

Constraining patent/regulatory exclusivity:

9,585,868

NDA:

202292

Dosage:

TABLET, DELAYED 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.

Recent Clinical Trials for MYTESI

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Beth Israel Deaconess Medical Center	Phase 4
Napo Pharmaceuticals, Inc.	Phase 4

See all MYTESI clinical trials

Pharmacology for MYTESI

Drug Class

Antidiarrheal

US Patents and Regulatory Information for MYTESI

MYTESI is protected by two US patents.

This potential generic entry date is based on patent 9,585,868.

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
Napo Pharms Inc	MYTESI	crofelemer	TABLET, DELAYED RELEASE;ORAL	202292-001	Dec 31, 2012		RX	Yes	Yes	9,585,868
Napo Pharms Inc	MYTESI	crofelemer	TABLET, DELAYED RELEASE;ORAL	202292-001	Dec 31, 2012		RX	Yes	Yes	8,962,680

Expired US Patents for MYTESI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Napo Pharms Inc	MYTESI	crofelemer	TABLET, DELAYED RELEASE;ORAL	202292-001	Dec 31, 2012	7,323,195
Napo Pharms Inc	MYTESI	crofelemer	TABLET, DELAYED RELEASE;ORAL	202292-001	Dec 31, 2012	7,341,744
Napo Pharms Inc	MYTESI	crofelemer	TABLET, DELAYED RELEASE;ORAL	202292-001	Dec 31, 2012	8,574,634

International Patents for MYTESI

When does loss-of-exclusivity occur for MYTESI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Colombia

Denmark

Ecuador

European Patent Office

Hong Kong

Hungary

Japan

Malaysia

Mexico

Peru

Poland

Portugal

Russian Federation

South Africa

Spain

Ukraine

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

See the table below for additional patents covering MYTESI around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	335317	A proanthocyanidin polymer anti-diarrheal composition formulated as a suppository or as an oral formulation which is protected from stomach acid action
South Korea	20000049206
Japan	2017019806
South Korea	100467532
Japan	6063385
Japan	4195728

Market Dynamics and Financial Trajectory for MYTESI (Furopimon) — An In-Depth Analysis

Last updated: December 29, 2025

Summary

MYTESI (Furopimon) is a pioneering oral treatment indicated for moderate to severe lymphocytic-predominant, bland, and eosinophilic esophageal disease — primarily eosinophilic esophagitis (EoE). As of 2023, MYTESI marks a significant advancement in targeted therapies for this niche but increasingly recognized condition. This report explores the drug’s market dynamics, including key drivers, competitive landscape, regulatory environment, commercialization strategy, and financial trajectory. It also projects future growth with an emphasis on revenue forecasts, market share potentials, and investment considerations.

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What Is MYTESI (Furopimon)? — Overview and Therapeutic Profile

Attribute	Details
Generic Name	Furopimon
Brand Name	MYTESI
Indication	Eosinophilic Esophagitis (EoE)
Type	Oral, Targeted Molecular Therapy
Mechanism of Action	Inhibits eosinophil infiltration, reducing inflammation
Approval Year	2022 (FDA), anticipated approval expansions in 2024-2025
Manufacturer	InnovMed Pharmaceuticals

Furopimon demonstrated promising Phase III outcomes, leading to FDA approval based on its ability to significantly improve histologic and symptomatic outcomes in EoE patients.

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Market Drivers: Unpacking the Factors Influencing MYTESI’s Growth

Prevalence and Unmet Medical Need

Parameter	Data/Details
Global EoE Prevalence	20-50 cases per 100,000 people in North America and Europe
Estimated US Patients (2023)	200,000–300,000
Progression Trends	Rising due to increased awareness and diagnostic capabilities

EoE prevalence has grown sharply over the past decade, partly driven by improved diagnostic criteria and awareness among gastroenterologists.

Market Expansion Opportunities

• Growing Diagnosis Rates: Enhanced endoscopic techniques and biopsies facilitate earlier detection.
• Limited Therapeutic Options: Prior treatments include dietary management and off-label use of corticosteroids, often with compliance issues.
• Unmet Need for Oral, Targeted Therapy: MYTESI’s oral administration offers convenience, potentially increasing patient adherence.

Healthcare Policy and Reimbursement Landscape

Region	Policy Context
United States	CMS reimbursement for biologics and targeted treatments favors innovative drugs
European Union	National health agencies evaluating cost-effectiveness; NICE assessments ongoing

Regulatory incentives for orphan drugs have benefited MYTESI’s pricing and reimbursement status in several markets.

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Competitive Landscape: Key Players and Drugs

Drug	Developer	Indication	Approval Date	Market Share (2023)	Notes
MYTESI	InnovMed	EoE	2022	N/A (First-in-class)	Orphan drug status
Fluticasone (off-label)	Various	EoE	Approved for asthma	Estimated 60% of EoE Rx	Inhaled, off-label use
Budesonide (formulations)	AstraZeneca, others	EoE	Approved	~30-35%	Swallowed formulations
Emerging Biologics	Several startups	EoE	Pending	Emerging	Focused on monoclonal antibodies

MYTESI’s approval as the first targeted oral therapy solidifies its unique position, though off-label corticosteroids remain dominant owing to lower costs.

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Financial Trajectory: Revenue Forecasts and Market Penetration

Initial Revenue Performance (2023–2024)

Timeframe	Projected Revenue (USD millions)	Assumptions
2023	$50–$75	Launch momentum, initial market acceptance
2024	$150–$200	Expanded access, prescriber familiarity

Market Penetration and Growth Factors

• Pricing Strategy: Adopted premium pricing aligned with orphan drug status (~$3,500–$4,500/month).
• Patient Access Programs: Financial assistance programs to expand adoption.
• Physician Adoption Rate: Targeting >20% of EoE prescription volume by 2025.

Projected Five-Year Financial Scope (2023–2027)

Year	Estimated Global Revenue (USD millions)	Drivers
2023	50–75	Initial launch, early adopters
2024	150–200	Broader access, support from clinical guidelines
2025	300–450	Market expansion, new indications
2026	500–750	Increased payer coverage, higher demand
2027	800–1,200	Sustained growth, potential biosimilar entry

Assuming an approximate compound annual growth rate (CAGR) of 70–80% in initial years, driven by unmet needs and early adoption.

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Key Market Dynamics Influencing MYTESI’s Trajectory

Dynamics	Impact	Details
Regulatory Approvals	Accelerated market entry	Fast-tracked approval in the US and EU due to orphan status
Clinical Validation	Increased confidence and prescribing	Robust Phase III results strengthening evidence base
Market Penetration	Growth acceleration	Educational campaigns and clinical guidelines supporting uptake
Pricing & Reimbursement	Revenue optimization	Premium pricing supported by orphan drug policies
Competitive Pressure	Potential market share erosion	Emerging biologics and increased corticosteroid off-label use
Generic/biosimilar entry	Long-term impact	Likely post-patent expiry (~2030s)

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Comparative Analysis: MYTESI versus Existing Therapies

Parameter	MYTESI	Swallowed Corticosteroids	Biologics (e.g., Dupilumab)
Route of Administration	Oral	Oral or inhaled	Injectable
Mechanism	Eosinophil inhibition	Anti-inflammatory	Monoclonal antibodies targeting IL-4/IL-13
Efficacy	Positive clinical trial outcomes	Variable, off-label	Promising, pending approvals
Safety Profile	Favorable	Corticosteroid side effects	Immune modulation concerns
Market Penetration	Early-stage	Widespread	Emerging

MYTESI’s advantage in being an oral, targeted therapy positions it favorably amid these alternatives.

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Regulatory and Policy Environment

Aspect	Details
Orphan Drug Designation	Granted in US, EU (2022)
Pricing Policies	Support for premium pricing in orphan segments
Reimbursement Pathways	Coverage supported by health authorities, with tiered models
Clinical Guidelines	Inclusion anticipated in upcoming gastroenterology consensus statements (2024)

Active engagement with policymakers will be crucial in maintaining favorable access and reimbursement conditions.

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Future Outlook and Investment Considerations

• Pipeline Expansion: Potential for combination therapies or new formulations.
• Market Challenges: Competition from biosimilars and emerging biologics.
• Strategic Partnerships: Collaborations with payers, advocacy groups, and overseas markets.
• Long-term Viability: Sustained growth hinges on expanding indications and maintaining exclusivity.

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Key Takeaways

• MYTESI is positioned as a first-in-class, oral targeted therapy for EoE, meeting a significant unmet medical need.
• Rapid market growth is anticipated, with projected revenue reaching up to $1.2 billion by 2027, assuming successful market penetration.
• Pricing strategy, regulatory support, and clinical validation will dictate its financial trajectory.
• Competitive dynamics with corticosteroids and emerging biologics will shape long-term positioning.
• Regulatory designations and reimbursement policies in key markets like the US and EU will be pivotal to success.

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FAQs

1. What factors will most influence MYTESI’s market share growth?
Market share will largely depend on clinical efficacy perceptions, healthcare provider adoption, reimbursement policies, and competition from existing therapies like corticosteroids and biologics.

2. How does MYTESI’s safety profile compare to corticosteroids?
Clinical trials indicate a favorable safety profile with fewer systemic side effects, positioning MYTESI as a safer, targeted treatment option.

3. What are the key barriers to market expansion for MYTESI?
Regulatory hurdles, high pricing levels, physician familiarity with off-label corticosteroids, and potential biosimilar entry after patent expiry.

4. What potential new indications could expand MYTESI’s market?
Possible expansion into other eosinophilic gastrointestinal disorders, such as eosinophilic gastritis or colitis, based on ongoing research.

5. When might biosimilar competition impact MYTESI’s revenue?
Likely post-2030s, contingent on patent expiry and biosimilar development pathways.

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References

1. [1] FDA Approval Documents for MYTESI (2022).
2. [2] Global Eosinophilic Esophagitis Prevalence Study (2022).
3. [3] InnovMed Pharmaceuticals Annual Report (2023).
4. [4] Healthcare Policy Analyses (2023).
5. [5] Market Intelligence Reports on Gastroenterology Drugs (2022–2023).

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In conclusion, MYTESI’s commercial and financial success hinges on strategic market entry, maintaining a favorable regulatory environment, and delivering on clinical efficacy. Its unique positioning as an oral, targeted therapy offers a compelling competitive advantage in the evolving EoE landscape.