Generic Mytesi Availability
Last updated on May 7, 2025.
Mytesi is a brand name of crofelemer, approved by the FDA in the following formulation(s):
MYTESI (crofelemer - tablet, delayed release;oral)
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Manufacturer: NAPO PHARMS INC
Approval date: December 31, 2012
Strength(s): 125MG [RLD]
Is there a generic version of Mytesi available?
No. There is currently no therapeutically equivalent version of Mytesi available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Mytesi. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Methods and compositions for treating HIV-associated diarrhea
Patent 8,962,680
Issued: February 24, 2015
Inventor(s): Forbes; William et al.
Assignee(s): Salix Pharmaceuticals, Ltd. (Raleigh, NC); Napo Pharmaceuticals, Inc. (San Francisco, CA)Presented herein are methods for treating diarrhea by administering to a patient in need thereof, an inhibitor of chloride-ion transport in an amount sufficient to treat diarrhea. Treatment of diarrhea includes the treatment of the diarrhea as well as the pain, abdominal discomfort and other symptoms associated with diarrhea. In one embodiment, the inhibitor of chloride-ion transport is crofelemer.
Patent expiration dates:
- October 31, 2031✓
- October 31, 2031
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Methods and compositions for treating HIV-associated diarrhea
Patent 9,585,868
Issued: March 7, 2017
Inventor(s): Forbes William & Bortey Enoch & King Steven & Chaturvedi Pravin
Assignee(s): NAPO PHARMACEUTICALS, INC.Presented herein are methods for treating diarrhea by administering to a patient in need thereof, an inhibitor of chloride-ion transport in an amount sufficient to treat diarrhea. Treatment of diarrhea includes the treatment of the diarrhea as well as the pain, abdominal discomfort and other symptoms associated with diarrhea. In one embodiment, the inhibitor of chloride-ion transport is crofelemer.
Patent expiration dates:
- October 31, 2031✓
- October 31, 2031
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- Drug class: antidiarrheals
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.