Crofelemer Patent Expiration

Crofelemer is Used for providing symptomatic relief for non-infectious diarrhea. It was first introduced by Napo Pharmaceuticals Inc in its drug Mytesi on Dec 31, 2012.


Crofelemer Patents

Given below is the list of patents protecting Crofelemer, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Mytesi US8962680 Methods and compositions for treating HIV-associated diarrhea Oct 31, 2031 Napo Pharms Inc
Mytesi US9585868 Methods and compositions for treating HIV-associated diarrhea Oct 31, 2031 Napo Pharms Inc
Mytesi US7341744 Method of treating secretory diarrhea with enteric formulations of proanthocyanidin polymer Jun 16, 2018

(Expired)

Napo Pharms Inc
Mytesi US7323195 Enteric formulations of proanthocyanidin polymer antidiarrheal compositions Jun 07, 2018

(Expired)

Napo Pharms Inc
Mytesi US8574634 Compositions and methods of treatment with proanthocyanidin polymer antidiarrheal compositions Jan 11, 2018

(Expired)

Napo Pharms Inc



About Veterinary Crofelemer

Crofelemer is used in a drug marketed by 1 company: Jaguar Animal Health.

Other drugs containing Crofelemer are: Canalevia ca1 .

Crofelemer's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Crofelemer:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Ascending Doses of Crofelemer Powder for Oral Solution in Pediatric Microvillus Inclusion Disease (MVID) Napo Pharmaceuticals, Inc. NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2, PHASE3
Safety and Efficacy of Crofelemer in Adult Patients With Short Bowel Syndrome and Intestinal Failure (SBS-IF) Without Colon-in-continuity (CIC) Napo Therapeutics, S.p.A. NA RECRUITING
(May 1, 2026)
PHASE2


Crofelemer Generic API Manufacturers

Given below is the list of companies who have filed for Crofelemer generic, along with the locations of their manufacturing plants worldwide.