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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

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
Ecuador	SP13012650	MÉTODOS Y COMPOSICIONES PARA TRATAR DIARREA ASOCIADA CON VIH
Colombia	6771411	Metodos y composiciones para tratar diarrea asociada al vih
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 Africa	201303136	METHODS AND COMPOSITION FOR TREATING HIV-ASSOCIATED DIARRHEA
Japan	4195728
Hungary	E035393
Mexico	2013004873	METODOS Y COMPOSICIONES PARA TRATAR DIARREA ASOCIADA CON VIH. (METHODS AND COMPOSITIONS FOR TREATING HIV-ASSOCIATED DIARRHEA.)

MYTESI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mytesi (Crofelemer)

Introduction

Mytesi, also known as crofelemer, is a groundbreaking drug developed by Jaguar Health, Inc., and its subsidiary Napo Pharmaceuticals. It is the first oral drug approved under the FDA's botanical guidance, specifically designed to treat diarrhea in patients with HIV/AIDS. Here, we delve into the market dynamics and financial trajectory of Mytesi.

Approval and Initial Market Impact

Mytesi was approved by the FDA in 2012 for the treatment of non-infectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. This approval marked a significant milestone, as it addressed a critical unmet need in the HIV/AIDS patient population[1].

Sales Growth and Prescription Volume

In the initial years following its approval, Mytesi showed promising growth. For instance, in 2018, the total Mytesi prescription volume grew by 20% in the fourth quarter compared to the prior quarter and increased by 94% over the fourth quarter of 2017. This growth was attributed to consistent direct representative efforts and educational platforms aimed at healthcare professionals and prescribers[1].

Financial Performance

Recent Financial Results

As of 2023, the combined net revenue for Mytesi and another Jaguar Health product, Canalevia-CA1, was approximately $9.7 million, representing an 18% decrease from the $11.9 million in 2022. The fourth quarter of 2023 saw a net revenue of $2.3 million, a decrease of 18% from the third quarter of 2023 and 30% from the fourth quarter of 2022[2].

Quarterly Variations

In the third quarter of 2024, Mytesi's net revenue showed a positive trend, increasing by approximately 14% from the second quarter of 2024 and by 8% from the third quarter of 2023, totaling around $3.0 million[5].

Pipeline and Future Indications

Jaguar Health has a robust pipeline with multiple potential follow-on indications for Mytesi. One of the lead targets is the preventative treatment of diarrhea related to cancer therapy. The company has proof-of-concept clinical data for most of these planned indications, which includes supportive care solutions for large patient populations across various disease indications[1].

Licensing and Commercialization Agreements

Napo Pharmaceuticals has entered into revenue-sharing and commercialization agreements for Mytesi, such as the one with Quadri Pharmaceuticals Store LLC, granting exclusive promotional, commercialization, and distribution rights for rare disease indications like microvillus inclusion disease (MVID) and short bowel syndrome (SBS) in several Middle East countries[3].

Pricing Dynamics

Mytesi has been at the center of pricing controversies. In 2021, the drug saw a substantial price increase, prompting investigations by the House Oversight and Reform committee and New York’s Department of Financial Services. This increase was part of a broader trend where US drug prices rose by 4.24% in January 2021, reversing a multi-year trend of declining price increases[4].

Market Challenges and Regulatory Scrutiny

The pharmaceutical industry, including Jaguar Health, faces significant challenges related to drug pricing. The substantial price hike of Mytesi in 2020 led to public scrutiny and regulatory investigations. Such events highlight the complexities and risks associated with drug pricing strategies in a highly regulated and publicly scrutinized market[4].

Competitive Landscape

Mytesi operates in a competitive landscape where patient needs and regulatory environments are constantly evolving. The drug's unique approval under FDA botanical guidance sets it apart, but it also faces competition from other anti-diarrheal agents and treatments. Jaguar Health's efforts to expand Mytesi's indications and secure non-dilutive funding through business development deals are crucial in maintaining its market position[1].

Investor and Market Expectations

Investors are keenly watching the top-line results from Jaguar Health's phase 3 trial of crofelemer for the preventative treatment of cancer therapy-related diarrhea. Positive outcomes from this trial could significantly boost the financial trajectory of Mytesi and enhance its market value[2].

Key Takeaways

• Growth in Prescription Volume: Mytesi has shown significant growth in prescription volume, particularly in the early years following its approval.
• Financial Performance: Despite recent declines, Mytesi's revenue has shown resilience, with positive quarterly variations in 2024.
• Pipeline and Future Indications: The drug has a robust pipeline with multiple potential follow-on indications, including cancer therapy-related diarrhea.
• Pricing Controversies: Mytesi has faced regulatory scrutiny due to substantial price increases, highlighting the challenges in drug pricing.
• Licensing Agreements: Jaguar Health has secured important licensing agreements to expand Mytesi's reach into rare disease indications.

FAQs

What is Mytesi (crofelemer), and what is it used for?

Mytesi, or crofelemer, is an FDA-approved oral drug used to treat non-infectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy.

How has the prescription volume of Mytesi evolved over time?

The prescription volume of Mytesi has shown significant growth, particularly in the early years following its approval, with a 94% increase in the fourth quarter of 2018 compared to the same period in 2017[1].

What are the future indications being explored for Mytesi?

Jaguar Health is exploring several future indications for Mytesi, including the preventative treatment of diarrhea related to cancer therapy, microvillus inclusion disease (MVID), and short bowel syndrome (SBS)[1][3].

Why has Mytesi been under regulatory scrutiny?

Mytesi faced regulatory scrutiny due to a substantial price increase in 2020, which prompted investigations by the House Oversight and Reform committee and New York’s Department of Financial Services[4].

How does Mytesi's pricing impact its market dynamics?

The pricing of Mytesi has been a subject of controversy, contributing to broader discussions on drug pricing regulations and public scrutiny. This has impacted the drug's market dynamics and investor expectations[4].

What licensing agreements has Jaguar Health secured for Mytesi?

Jaguar Health has secured a revenue-sharing and commercialization agreement with Quadri Pharmaceuticals Store LLC for the exclusive promotional, commercialization, and distribution rights of Mytesi for rare disease indications in several Middle East countries[3].

Sources

1. Annual Reports: Jaguar Health, Inc. - Annual Report 2018.
2. Jaguar Health: Jaguar Health Reports 2023 Financial Results.
3. Larvol Delta: Mytesi (crofelemer) / Jaguar Health, Knight Therap.
4. Pharmaceutical Technology: US drug prices rise over 4% in 2021 reversing multi-year trend.
5. BioSpace: Jaguar Health Reports Third Quarter 2024 Financial Results.