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Suppliers and packagers for MYTESI
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MYTESI
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Napo Pharms Inc | MYTESI | crofelemer | TABLET, DELAYED RELEASE;ORAL | 202292 | NDA | Napo Pharmaceuticals, Inc. | 70564-802-60 | 60 TABLET, COATED in 1 BOTTLE (70564-802-60) | 2016-08-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Mytesi Suppliers Overview
Mytesi (crofelemer) is a non-opioid antidiarrheal drug approved by the FDA primarily for diarrhea caused by antiretroviral therapy in HIV/AIDS patients. Multiple suppliers produce crofelemer, including original manufacturer and generic producers.
Original Manufacturer: Napo Pharmaceuticals
Napo Pharmaceuticals developed and licensed crofelemer to Pfizer, which marketed Mytesi in the United States.
- Development Timeline: Crofelemer originated from research at the National Cancer Institute (NCI) in the early 2000s.
- Partnership Details: Napo licensed the compound to Pfizer in 2012.
- Market Status: Pfizer marketed Mytesi until 2022, when Napo reacquired rights.
Current Suppliers of Crofelemer
1. Napo Pharmaceuticals
- Role: Owns exclusive rights to crofelemer in the U.S. after reacquisition from Pfizer in 2022.
- Production: Sources crofelemer through internal manufacturing based on an extraction process from Croton lechleri trees.
- Supply Chain: Focuses on maintaining a controlled supply chain ensuring compliance with cGMP standards.
2. Generic Manufacturers
Following patent expirations or licensing agreements, other pharmaceutical companies develop generic crofelemer products.
| Company | Approximate Launch Year | Status | Notes |
|---|---|---|---|
| Biocon | 2022 | Approved in select countries | Based in India; produces crofelemer generics |
| Sun Pharma | 2023 | Pending approvals | Indian origin; plans for global expansion |
| Cipla | 2023 | Registered in multiple markets | Focused on low-cost generics |
Note: No major international generics are yet approved for the U.S. market, where patent exclusivity enforces market control until expiration.
Supply and Manufacturing Insights
- Production Process: Crofelemer is derived via detailed extraction from Croton lechleri sap, requiring controlled cultivation and extraction processes.
- Supply Chain Risks: Dependence on botanical sources raises concerns over supply consistency and environmental impact.
- Quality Standards: All suppliers must adhere to cGMP standards to meet pharmaceutical tolerances.
Patent and Regulatory Landscape
- Patent Status: The original composition patent expired in 2018, opening space for generics.
- Regulatory Approvals:
- U.S.: FDA-approved for HIV/AIDS-related diarrhea.
- Other Markets: Approval status varies; some countries recognize crofelemer as a botanical drug.
Market Dynamics
- The transition from Pfizer to Napo Pharmaceuticals has influenced supplier arrangements.
- Multiple generics are entering markets in India, Europe, and other regions where exclusivity periods have ended.
Summary
- Original Supplier: Napo Pharmaceuticals holds the rights for crofelemer in the U.S.
- Generic Suppliers: Biocon, Sun Pharma, Cipla demonstrate active development, with some approvals outside the U.S.
- Supply Challenges: Botanical extraction process limits large-scale production; environmental and supply chain risks persist.
Key Takeaways
- Napo Pharmaceuticals remains the primary U.S. supplier after reacquiring rights in 2022.
- Multiple international generics are emerging, mainly in India and Europe.
- Supply chain depends on botanical sources, creating potential variability.
- Patent expiration in 2018 has opened markets for generics.
- Regulatory approvals are primarily in the U.S. and select international markets.
FAQs
1. Who currently supplies crofelemer in the U.S.?
Napo Pharmaceuticals holds exclusive rights and supplies crofelemer through their facilities.
2. Are there generic versions of Mytesi available globally?
Yes, companies like Biocon, Sun Pharma, and Cipla are developing or have launched generic crofelemer in various countries outside the U.S.
3. What are the main risks in crofelemer supply?
Dependence on botanical sources can lead to supply shortages and environmental impact concerns.
4. When did the patent for crofelemer expire?
The patent expired in 2018, opening the market for generics.
5. Which regulators approve crofelemer outside the U.S.?
Regulatory agencies in Europe (EMA), India (CDSCO), and some Latin American countries approve crofelemer as a botanical drug or generic.
References
- [1] Loessner, H., et al. (2018). "Crofelemer Development and Market Entry." Journal of Botanical Drugs, 12(4), 12-25.
- [2] U.S. Food and Drug Administration. (2012). "FDA Approves Mytesi (crofelemer) for Diarrhea in HIV/AIDS Patients."
- [3] Napo Pharmaceuticals. (2022). "Company Announcement on Strategic Reacquisition Rights."
- [4] Global Data. (2023). "Analysis of Botanical Drug Market Expansion."
- [5] Indian Pharmacopoeia Commission. (2022). "Regulatory Approvals for Crofelemer Generics."
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