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-eight patent family members in twenty-two countries.

One supplier is listed for this compound.

Summary for crofelemer

International Patents:	28
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	14
Clinical Trials:	16
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 Therapeutics, S.p.A.	PHASE2
Napo Pharmaceuticals, Inc.	PHASE2
Lindsey Russell, MD	EARLY_PHASE1

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
Mexico	2013004873
Hungary	E035393
Japan	2013540826
Colombia	6771411	Metodos y composiciones para tratar diarrea asociada al vih
Australia	2011320155	Methods and compositions for treating HIV-associated diarrhea
Colombia	6771411

Market Dynamics and Financial Trajectory for Crofelemer

Last updated: February 20, 2026

What is Crofelemer and its approved indications?

Crofelemer is a botanical-derived, orally active antidiarrheal agent. It is approved by the FDA for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy and for adults with adult-onset chronic diarrhea associated with neutralizing antibodies to calcineurin inhibitors (e.g., cyclosporine or tacrolimus) following solid organ transplant[^1].

How has Crofelemer’s commercial landscape evolved?

• Market launch: Crofelemer, marketed as Fulyzaq, was approved in 2012.
• Initial sales performance: Sales have been modest, with estimates around $17.5 million in 2020 according to IQVIA data[^2].
• Market penetration: Its use remains limited to niche indications; broader adoption faces competition from other antidiarrheal agents and the off-label use of existing medications.

What are the key factors influencing Crofelemer's market dynamics?

Regulatory landscape

• FDA approval: Limited to specific HIV/AIDS-related diarrhea and transplant-related diarrhea.
• Additional approvals: No significant expansion into other diarrhea indications approved as of 2023, constraining growth.

Competitive environment

• Existing treatments: Loperamide, diphenoxylate, and other opioids dominate OTC and prescription markets.
• Off-label use: Limited due to efficacy and safety concerns, reducing market expansion opportunities.

Clinical development and pipeline

• Ongoing studies: Trials exploring Crofelemer's efficacy in other gastrointestinal disorders, including secretory diarrhea in cholera and travelers' diarrhea.
• Pipeline prospects: Potential to diversify indications improves longer-term prospects but has not yet translated into commercial sales.

Patent protection and exclusivity

• Patent life: Crofelemer's patent has expired or is nearing expiration, which heightens generic competition.
• Market exclusivity: Limited, influencing pricing power and revenue.

Pricing and reimbursement

• Pricing: Approximately $7,600 per month in the U.S.
• Reimbursement: Covered under specific Medicare Part D plans, but limited by indications and market size.

What are the financial projections based on current trends?

Year	Estimated Sales	Growth Rate	Key Drivers
2022	~$15 million	0-5%	Steady market, limited expansion
2023	~$16 million	5-7%	Increased awareness, ongoing clinical trials
2024	~$17 million	6-8%	Potential label expansion or new indication data
2025+	Potential plateau or decline	N/A	Competition, generic entries, limited pipeline updates

The revenue trajectory remains constrained by narrow indications, lack of large-scale label expansion, and limited patient population growth.

What are the key risks and opportunities?

Risks

• Market saturation: Small target population and limited indications restrict growth.
• Patent expiration: Opens the door for generics, pressuring prices.
• Clinical setbacks: Failure in ongoing trials or lack of expansion could diminish future sales.

Opportunities

• Pipeline expansion: Positive results in clinical trials for broader GI indications could significantly increase market size.
• Partnerships: Collaborations with global pharma can expand geographic reach.
• Label expansion: FDA approvals in additional diarrhea-related conditions could unlock new revenues.

What is the outlook for investors and pharmaceutical firms?

• Short-term: Stable but modest revenues driven by current indications.
• Medium to long-term: Potential growth hinges on successful clinical trials, securing additional approvals, and overcoming patent expiry challenges.
• Valuation considerations: Limited current valuation with upside linked to pipeline success and market expansion.

Key Takeaways

• Crofelemer's market is limited by narrow approved indications, competition, and patent expiration.
• Sales growth remains modest, driven primarily by niche markets.
• Future revenue upward potential exists if pipeline candidates succeed or if expanded indications receive approval.
• Risks include generic entry, clinical trial failures, and market saturation.
• Strategic collaborations and regulatory approvals will determine long-term market trajectory.

FAQs

1. Can Crofelemer be used for diarrhea caused by infections?
   No. It is approved specifically for non-infectious diarrhea related to HIV/AIDS and transplant immunosuppressants.

2. What are the main competitors to Crofelemer?
   Over-the-counter agents like loperamide and diphenoxylate, which are widely used for various diarrhea types.

3. Are there ongoing clinical trials for Crofelemer?
   Yes. Trials assess its efficacy in cholera, travelers' diarrhea, and other GI conditions, potentially expanding its use.

4. How does patent expiration affect Crofelemer's market?
   It increases the risk of generic products entering the market, which could reduce revenues significantly.

5. What are the key regulatory hurdles for expanding Crofelemer’s indications?
   Demonstrating safety and efficacy for new diarrhea types requires successful clinical trial outcomes and FDA approval.

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Sources

[1] U.S. Food and Drug Administration. (2012). FDA approves Crofelemer for intestinal fluid loss in HIV/AIDS patients. Retrieved from https://www.fda.gov

[2] IQVIA. (2021). Pharmaceutical sales data.

Note: Sales figures are based on available industry estimates and may vary with new market developments.