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

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.

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
Napo Pharms Inc	MYTESI	crofelemer	TABLET, DELAYED RELEASE;ORAL	202292-001	Dec 31, 2012		RX	Yes	Yes

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
Napo Pharms Inc	MYTESI	crofelemer	TABLET, DELAYED RELEASE;ORAL	202292-001	Dec 31, 2012
Napo Pharms Inc	MYTESI	crofelemer	TABLET, DELAYED RELEASE;ORAL	202292-001	Dec 31, 2012

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
Peru	20140036
Brazil	112013010774	"usos de crofelemer no tratamento de diarreia associada ao hiv"
Japan	2017019806	ＨＩＶ関連の下痢を治療するための方法および組成物 (METHOD AND COMPOSITION FOR TREATING HIV-RELATED DIARRHEA)
Taiwan	537898
Australia	2030302
Malaysia	174065
Malaysia	174065	METHODS AND COMPOSITIONS FOR TREATING HIV-ASSOCIATED DIARRHEA

Market Dynamics and Financial Trajectory for Mytesi

Last updated: July 28, 2025

Introduction

Mytesi (crofelemer), developed by Napo Pharmaceuticals, is a novel therapeutic agent approved by the U.S. Food and Drug Administration (FDA) in 2012 for the symptomatic relief of non-infectious diarrhea in patients with HIV/AIDS on antiretroviral therapy. As a botanical drug derived from the South American red tree Croton lechleri, Mytesi presents a distinctive position within the gastrointestinal (GI) pharmacology landscape. Analyzing its market dynamics and financial trajectory offers valuable insights into its growth prospects amid evolving healthcare needs, regulatory challenges, and competitive pressures.

---

Pharmacological and Therapeutic Profile

Mytesi’s mechanism involves inhibiting transient receptor potential (TRP) channels and reducing fluid secretion in the GI tract, addressing diarrhea primarily of HIV/AIDS patients [1]. Its botanical origin and minimal systemic absorption are highlighted as advantages, offering a favorable safety profile compared to traditional antidiarrheal agents. Its FDA approval under the Botanical Drug Development Guidance signifies a growing recognition of plant-based drugs in mainstream medicine, expanding avenues for commercialization and market acceptance.

---

Market Environment and Key Drivers

Global HIV/AIDS Population

The primary market for Mytesi centers around HIV/AIDS patients experiencing diarrhea, a common ART side effect. According to UNAIDS, approximately 38 million people worldwide live with HIV, with a significant subset suffering from GI issues, notably in low- and middle-income countries (LMICs) where access to comprehensive care remains limited [2]. The demand for effective symptomatic treatments like Mytesi persists, especially in high-prevalence regions.

Increased Awareness and Lifestyle Modifications

Additionally, a broader patient population experiencing non-infectious diarrhea—such as those with chemotherapy-induced diarrhea, inflammatory bowel disease (IBD), or irritable bowel syndrome (IBS)—may represent off-label or emerging indications, although regulatory approvals remain limited.

Regulatory Landscape

While FDA approval fuels confidence in the drug’s safety and efficacy, regulatory clarity in other jurisdictions remains less defined, impeding global market expansion. The challenge lies in navigating different countries’ botanical drug regulations, which can be complex and variable.

Healthcare Provider Acceptance

Physicians' acceptance of botanical drugs like Mytesi depends on robust clinical data demonstrating effectiveness, safety, and cost-effectiveness. Currently, its place in treatment algorithms for HIV-associated diarrhea remains niche, constraining wider prescribing tendencies.

---

Competitive Landscape and Market Challenges

Existing Therapies and Alternative Treatments

Conventional antidiarrheal agents, including loperamide and diphenoxylate, dominate symptomatic management but carry risks such as constipation and systemic side effects. Immunomodulators and targeted therapies are emerging options for complex cases.

Differentiators of Mytesi

Mytesi’s botanical origin and minimal systemic absorption distinguish it, fostering acceptance among patients seeking natural remedies and among clinicians favoring safer agents. However, the limited breadth of clinical data constrains its utility compared to well-established pharmaceuticals.

Patent and Intellectual Property Dynamics

Napo Pharmaceuticals’ patent portfolio for crofelemer has historically provided a market barrier; yet, patent expirations or challenges could impact profitability. The botanical nature of Mytesi complicates patent protection, potentially opening pathways for generic competition.

---

Financial Trajectory and Revenue Projections

Historical Revenue Performance

As of 2022, Mytesi’s commercial footprint remains modest. Sales are primarily concentrated in the U.S., with notable efforts to penetrate institutional and specialty markets. Revenue peaked during initial years post-approval, driven by early adopter adoption, but subsequent growth has plateaued owing to limited geographic coverage and competition from other GI agents.

Factors Impacting Revenue Growth

• Regulatory approvals in key markets: Expansion into Europe and Asia could unlock new revenue streams, but regulatory processes are arduous.
• Market penetration strategies: Focused efforts on HIV treatment centers and specialty clinics could enhance adoption.
• Pricing and reimbursement: As a botanical drug, Mytesi commands premium pricing; however, reimbursement policies significantly influence patient access and profitability.

Future Financial Outlook

Given the current market constraints, Mytesi’s revenue trajectory is likely to remain modest unless strategic initiatives—such as indications expansion, geographic diversification, or combination therapies—materialize. A realistic projection suggests gradual growth driven by niche markets rather than large-scale adoption, with revenues potentially stagnating without significant intervention.

---

Market Expansion Opportunities

Off-Label and Adjunct Indications

Exploiting off-label uses like chemotherapy-induced diarrhea or diarrhea associated with IBD could broaden its application, provided clinical trials substantiate efficacy. Regulatory approval for additional indications requires investment and rigorous evidence but could markedly enhance financial prospects.

Emerging Markets

Targeting emerging markets with rising HIV prevalence and limited access to innovative drugs presents growth opportunities. Tailored pricing strategies and partnerships with regional distributors are critical to penetrate these segments.

Product Pipeline and Formulation Innovations

Developing new formulations—such as sustained-release versions or combination products—could improve patient adherence and clinical outcomes, translating into higher sales volume.

---

Strategic Challenges and Considerations

• Limited clinical data on broader indications hampers credibility and market penetration.
• Pricing pressures from generic competitors and payers necessitate value-based pricing strategies.
• Regulatory heterogeneity complicates global expansion; proactive engagement with international agencies is vital.
• Market awareness of botanical drugs remains relatively low, requiring targeted education campaigns.

---

Key Takeaways

• Market niche with growth potential exists for Mytesi among HIV/AIDS patients experiencing diarrhea, especially in high-prevalence regions; however, its financial trajectory depends heavily on expanded indications and geographic reach.
• Regulatory approval and commercialization hurdles limit rapid market expansion; strategic regulatory engagement is essential.
• Off-label use and emerging indications could unlock new revenue streams, contingent on supportive clinical data.
• Pricing and reimbursement strategies will play a pivotal role, given the premium positioning of botanical products.
• Collaborations and licensing agreements can facilitate global expansion, mitigate regulatory risks, and accelerate revenue growth.

---

FAQs

1. What are the main factors influencing Mytesi’s market growth?
Market growth is driven by expanding indications, geographic expansion, clinical acceptance, regulatory approvals, and reimbursement policies. Limited clinical data beyond HIV-related diarrhea and regulatory hurdles constrain rapid growth.

2. How does Mytesi compare to traditional antidiarrheal therapies?
Mytesi’s botanical origin and safety profile differentiate it from conventional agents like loperamide, which carry systemic side effects. However, its niche status and limited indications restrain widespread use.

3. Are there regulatory challenges facing Mytesi internationally?
Yes. While FDA approval confirms safety and efficacy in the U.S., other jurisdictions have complex botanical drug regulations, complicating approval and market entry.

4. What strategic initiatives can enhance Mytesi’s financial performance?
Expanding indications, entering new markets, developing new formulations, and forming strategic partnerships are pivotal to growth.

5. What is the outlook for Mytesi’s revenue in the next five years?
Without significant clinical, regulatory, or market expansion, revenues are expected to grow gradually or plateau. Substantial revenue increases are contingent upon crossing regulatory and commercial milestones.

---

References

[1] Napo Pharmaceuticals. (2012). FDA approves crofelemer for diarrhea in HIV/AIDS. FDA Press Release.
[2] UNAIDS. (2021). Global HIV Statistics. UNAIDS Data 2021.