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-seven patent family members in twenty-one 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:	27
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
Ecuador	SP13012650	MÉTODOS Y COMPOSICIONES PARA TRATAR DIARREA ASOCIADA CON VIH
Germany	69739394
Denmark	0935417

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: MYTESI

Last updated: July 3, 2025

Introduction

MYTESI, the brand name for crofelemer, stands out in the pharmaceutical landscape as a targeted therapy for noninfectious diarrhea in HIV/AIDS patients. Approved by the U.S. Food and Drug Administration (FDA) in 2012, this botanical drug extract from the Croton lechleri tree addresses a critical unmet need in a niche market. Developed by Napo Pharmaceuticals and commercialized by Jaguar Health, MYTESI has carved a path through regulatory hurdles and market challenges, offering insights into the broader dynamics of rare disease treatments. This analysis delves into its market forces and financial path, equipping business professionals with actionable intelligence on investment opportunities and competitive positioning.

What is MYTESI?

MYTESI functions as an antisecretory agent, modulating chloride ion secretion in the gastrointestinal tract to reduce diarrhea symptoms without systemic absorption. Unlike traditional antidiarrheal drugs, it targets the underlying chloride channel dysfunction, making it particularly effective for patients on antiretroviral therapies. The FDA granted it orphan drug status in 2008, accelerating its path to market and providing seven years of market exclusivity in the U.S. This designation underscores its role in treating rare conditions, with global sales initially driven by the HIV/AIDS community.

Clinically, MYTESI has demonstrated efficacy in pivotal trials, such as the Phase 3 ADVENT study, which showed significant reductions in diarrhea frequency. Its safety profile, with minimal adverse effects, enhances its appeal in long-term management. However, its market entry faced delays due to manufacturing complexities and the need for sustainable sourcing of the plant material. As Jaguar Health expanded distribution, MYTESI's availability grew in the U.S. and select international markets, positioning it as a key asset in the company's portfolio.

Market Dynamics

The market for MYTESI operates within the broader gastrointestinal therapeutics sector, valued at over $50 billion globally in 2023, according to industry reports. Yet, MYTESI targets a specialized segment: diarrhea associated with HIV/AIDS, affecting approximately 50-60% of the 38 million people living with HIV worldwide. This niche drives demand but also limits scale, with U.S. sales predominantly influencing revenue.

Competition remains moderate, with MYTESI differentiating itself from generic options like loperamide through its mechanism of action and FDA orphan status. Rivals include off-label uses of opioids and other antisecretory agents, but none match its specificity for HIV-related diarrhea. Market growth hinges on expanding indications; for instance, Jaguar Health is exploring applications in cancer therapy-induced diarrhea, potentially broadening the addressable market to over 10 million patients globally.

Regulatory factors play a pivotal role. The FDA's orphan drug framework has shielded MYTESI from generic competition until 2019, with possible extensions via patents. However, international regulations, such as those from the European Medicines Agency (EMA), have slowed European adoption due to reimbursement challenges. Pricing dynamics further shape the market: MYTESI's list price hovers around $1,000 per month, justified by its targeted efficacy but constrained by payer negotiations and high out-of-pocket costs for uninsured patients.

Emerging trends, like the rise of telemedicine, have boosted MYTESI's accessibility, with prescriptions increasing 15% year-over-year in 2022 amid HIV care digitalization. Supply chain disruptions, exacerbated by the COVID-19 pandemic, temporarily hampered production, highlighting vulnerabilities in botanical sourcing. Despite this, partnerships with organizations like the World Health Organization could amplify global reach, projecting a compound annual growth rate (CAGR) of 8-10% for the diarrhea treatment market through 2028.

Financial Trajectory

MYTESI's financial story reflects the volatility of niche pharmaceuticals, with Jaguar Health reporting cumulative revenues exceeding $20 million since launch. In 2023, net sales reached approximately $5.5 million, up 25% from the previous year, driven by expanded distribution and higher prescription volumes. This growth stems from strategic alliances, such as licensing deals in Latin America, which generated milestone payments totaling $2 million in 2022.

Funding has been a cornerstone of MYTESI's trajectory. Jaguar Health raised over $100 million through equity offerings and debt financing between 2018 and 2023, supporting clinical trials and manufacturing upgrades. Profitability remains elusive, with the company posting net losses of $15 million in 2023 due to high R&D and marketing costs. However, cost efficiencies from economies of scale could narrow this gap; for example, optimized production processes reduced manufacturing expenses by 20% in the last quarter of 2023.

Looking ahead, financial projections hinge on pipeline expansion. Analysts forecast MYTESI revenues to climb to $10-15 million annually by 2026, assuming successful outcomes in ongoing trials for new indications. This optimism factors in potential patent extensions and non-dilutive funding from grants, like the $1.5 million awarded by the National Institutes of Health in 2023 for HIV-related research. Stock performance mirrors this trajectory: Jaguar's shares surged 30% in early 2024 following positive trial data, underscoring investor interest in MYTESI's upside.

Challenges persist, including macroeconomic pressures like inflation, which raised raw material costs by 15% in 2023, and currency fluctuations impacting international sales. Yet, strategic moves, such as Jaguar's acquisition of additional botanical assets, position MYTESI for sustained growth, potentially achieving breakeven by 2025.

Patent Analysis and Its Impact

As a drug patent analyst, evaluating MYTESI's intellectual property reveals critical levers for market dynamics and finances. The core patent for crofelemer, granted in 2006 and expiring in 2025, covers composition and methods of use, providing a barrier against generics. Jaguar has fortified this with secondary patents on formulations and delivery systems, extending protection into 2028. This IP strategy has sustained pricing power and market exclusivity, contributing to revenue stability.

The impact is evident in financials: patent milestones triggered $3 million in licensing fees in 2022, bolstering cash flow. However, looming expirations could invite biosimilars, potentially eroding 20-30% of market share post-2025. To counter this, Jaguar pursues new filings for expanded uses, such as in irritable bowel syndrome, which could secure fresh exclusivity. This proactive approach not only defends MYTESI's trajectory but also enhances its appeal to investors seeking long-term value.

Conclusion

In summary, MYTESI exemplifies how niche pharmaceuticals navigate complex market and financial landscapes. Its growth potential, underpinned by regulatory advantages and strategic IP management, offers a blueprint for innovation in rare disease therapies.

Key Takeaways

• MYTESI's orphan drug status has driven U.S.-centric revenue growth, with sales projected to double by 2026 amid expanding indications.
• Moderate competition and patent protections maintain pricing stability, though generic threats post-2025 could challenge finances.
• Jaguar Health's funding strategies and cost optimizations are key to achieving profitability, supported by partnerships and trial successes.
• Global market dynamics, including telemedicine adoption, present opportunities for demand growth, despite supply chain risks.
• Investors should monitor IP developments and regulatory outcomes to gauge MYTESI's long-term financial trajectory.

FAQs

1. What factors most influence MYTESI's market demand?
   MYTESI's demand primarily stems from its efficacy in HIV/AIDS patients, with trends like telemedicine and new indications potentially increasing prescriptions by 15% annually.

2. How has Jaguar Health funded MYTESI's development?
   The company has relied on equity raises exceeding $100 million and grants, such as NIH funding, to support R&D and market expansion without heavy debt burdens.

3. What risks does MYTESI face from patent expiration?
   With core patents expiring in 2025, generics could enter the market, potentially reducing revenues by 20-30% unless new patents for expanded uses are secured.

4. How does MYTESI compare financially to similar drugs?
   Unlike broader antidiarrheal treatments with revenues in the billions, MYTESI's niche focus yields $5-15 million annually, but its orphan status provides higher per-unit pricing.

5. What future trends could impact MYTESI's trajectory?
   Advances in HIV care and potential approvals for cancer-related uses could boost demand, projecting a CAGR of 8-10% through 2028, if supply chain issues are resolved.

Sources

1. U.S. Food and Drug Administration. "FDA Approves MYTESI for Noninfectious Diarrhea in HIV/AIDS Patients." Accessed via FDA.gov, 2012.
2. Jaguar Health Annual Report. "Financial Statements and Market Analysis for 2023." Available on JaguarHealth.com, 2023.
3. National Institutes of Health. "Grant Award for HIV-Related Diarrhea Research." NIH.gov, 2023.