Crofelemer - Generic Drug Details

What are the generic drug sources for crofelemer and what is the scope of freedom to operate?

Crofelemer is the generic ingredient in one branded drug marketed by Napo Pharms Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Crofelemer has twenty-seven patent family members in twenty-one countries.

One supplier is listed for this compound.

Summary for crofelemer

International Patents:	27
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	14
Clinical Trials:	13
What excipients (inactive ingredients) are in crofelemer?	crofelemer excipients list
DailyMed Link:	crofelemer at DailyMed

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

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 crofelemer

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

Sponsor	Phase
Napo Pharmaceuticals, Inc.	Phase 3
Beth Israel Deaconess Medical Center	Phase 4
Napo Pharmaceuticals, Inc.	Phase 4

See all crofelemer clinical trials

Pharmacology for crofelemer

Drug Class

Antidiarrheal

Anatomical Therapeutic Chemical (ATC) Classes for crofelemer

A07XA	Other antidiarrheals
A07X	OTHER ANTIDIARRHEALS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for crofelemer

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 crofelemer

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 crofelemer

Country	Patent Number	Title	Estimated Expiration
China	103370101	Methods and compositions for treating HIV-associated diarrhea
Hong Kong	1249036	用於治療HIV相關性腹瀉的方法和組合物 (METHODS AND COMPOSITIONS FOR TREATING HIV-ASSOCIATED DIARRHEA)
Japan	6063385

Crofelemer Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Crofelemer

Introduction to Crofelemer

Crofelemer, marketed under the trade name Mytesi®, is an FDA-approved, plant-based prescription drug developed by Jaguar Health. It is extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon rainforest. The drug is primarily indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART)[3].

Current Market Position

Crofelemer has established itself in the market for HIV-related diarrhea, with a growing revenue stream for Jaguar Health. The company has reported continuous growth in Mytesi revenue, highlighting the drug's acceptance and demand in its primary indication[4].

Expansion into New Markets

Jaguar Health has entered into an exclusive license and commercialization agreement with GEN, a Turkish specialty pharmaceutical company, to commercialize crofelemer in Turkey and eight neighboring countries. This agreement includes a $2 million investment by GEN in Jaguar stock at a 75% premium to the market price and double-digit royalties to Jaguar on all crofelemer products sold in the licensed territory. This strategic move is expected to expand crofelemer's market reach and increase Jaguar's revenue streams[1][3].

Financial Implications of the GEN Agreement

The agreement with GEN is financially significant for Jaguar Health. The upfront $2 million investment at a 75% premium to the market price reflects a strong vote of confidence in Jaguar's valuation and future prospects. GEN's 6.7% ownership stake in Jaguar further indicates a long-term commitment to the company's success. The double-digit royalties on crofelemer sales in the licensed territories are expected to provide a steady income stream, potentially bolstering Jaguar's financial health[1][3].

Revenue Growth and Financial Performance

Jaguar Health has seen a notable increase in revenue, with a 14% increase in the third quarter of 2024 compared to the previous quarter. The company reported a net revenue of approximately $3.1 million, which is a significant improvement from previous quarters. Despite increased sales and marketing expenses, Jaguar reduced its loss from operations by $1.5 million compared to the previous year[2].

Clinical Trials and Future Indications

Jaguar Health is actively pursuing new indications for crofelemer, particularly in the area of cancer therapy-related diarrhea (CTD). The Phase 3 OnTarget trial, although not meeting its primary endpoint across all tumor types, showed clinically relevant signals for crofelemer in patients with breast and respiratory cancers, including lung cancer. These findings are promising and could lead to expanded use of crofelemer in cancer supportive care[5].

Market Potential in New Indications

The potential market for crofelemer in cancer therapy-related diarrhea is substantial. Diarrhea affects 50-80% of chemotherapy patients, leading to dehydration, potential infections, and non-adherence to treatment. Patients with CTD are 40% more likely to discontinue their chemotherapy or targeted therapy, and the cost of care for CTD patients is estimated to be 2.9 times higher than for patients without CTD. Successfully commercializing crofelemer for CTD could significantly expand its market and patient reach[4].

Regulatory and Market Challenges

The successful commercialization of crofelemer in new markets and indications will depend on several factors, including GEN's ability to navigate the regulatory landscape in the licensed territories and effectively market the drug to both physicians and patients. Regulatory hurdles and market penetration challenges are risks that investors should be aware of[1][3].

Manufacturing and Supply Chain

The agreement with GEN allows for the local manufacturing of crofelemer finished products, which could reduce logistical costs and optimize supply chain management for Jaguar. This could increase the profitability of crofelemer in these regions by streamlining the supply chain and reducing costs associated with international shipping[1][3].

Sustainability and Ecological Integrity

Jaguar Health has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity. This approach aligns with the company's focus on sustainable practices and support for Indigenous communities, which could enhance its brand reputation and appeal to environmentally conscious consumers[3].

Key Takeaways

• Market Expansion: Crofelemer is set to expand its market reach through an exclusive license and commercialization agreement with GEN in Turkey and eight neighboring countries.
• Financial Growth: The agreement includes a $2 million investment and double-digit royalties, which could significantly boost Jaguar Health's revenue.
• Clinical Trials: Positive signals from the Phase 3 OnTarget trial for cancer therapy-related diarrhea indicate potential new indications for crofelemer.
• Regulatory Challenges: Successful commercialization will depend on navigating regulatory hurdles and effective marketing strategies.
• Sustainability: Jaguar Health's commitment to sustainable practices and ecological integrity is a key aspect of its brand and market strategy.

FAQs

Q: What is the primary indication for crofelemer? A: Crofelemer is primarily indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART)[3].

Q: Which company has Jaguar Health partnered with for the commercialization of crofelemer in new territories? A: Jaguar Health has partnered with GEN, a Turkish specialty pharmaceutical company, for the commercialization of crofelemer in Turkey and eight neighboring countries[1][3].

Q: What are the financial terms of the agreement with GEN? A: The agreement includes a $2 million investment by GEN in Jaguar stock at a 75% premium to the market price and double-digit royalties to Jaguar on all crofelemer products sold in the licensed territory[1][3].

Q: What are the results of the Phase 3 OnTarget trial for crofelemer in cancer therapy-related diarrhea? A: The trial did not meet its primary endpoint across all tumor types but showed clinically relevant signals for crofelemer in patients with breast and respiratory cancers, including lung cancer[5].

Q: How does Jaguar Health ensure the sustainability of crofelemer production? A: Jaguar Health has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity[3].

Sources:

1. Stock Titan: GEN to Commercialize Jaguar Health's Crofelemer in Turkey and Eight Neighboring Countries[1].
2. Business Insider: Jaguar Health Sees Revenue Growth with New Product Launches[2].
3. Jaguar Health: GEN to Commercialize Jaguar Health's Crofelemer in Turkey and Eight Neighboring Countries[3].
4. Jaguar Health: Jaguar Health Provides Company Updates and Reports 2022 Third Quarter Financial Results[4].
5. Stock Titan: Jaguar Health Reports Phase 3 OnTarget Trial Results for its Cancer Supportive Care Drug Crofelemer[5].