Fidaxomicin Patent Expiration
Fidaxomicin is Used for treating Clostridioides difficile-associated diarrhea in patients 6 months of age and older. It was first introduced by Cubist Pharmaceuticals Llc
Fidaxomicin Patents
Given below is the list of patents protecting Fidaxomicin, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Dificid |
US9808530 (Pediatric) | Composition of tiacumicin compounds | Nov 28, 2034 | Cubist Pharms Llc |
| Dificid | US9808530 | Composition of tiacumicin compounds | May 28, 2034 | Cubist Pharms Llc |
| Dificid |
US7378508 (Pediatric) | Polymorphic crystalline forms of tiacumicin B | Jan 31, 2028 | Cubist Pharms Llc |
| Dificid |
US7863249 (Pediatric) | Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof | Jan 31, 2028 | Cubist Pharms Llc |
| Dificid |
US8859510 (Pediatric) | Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof | Jan 31, 2028 | Cubist Pharms Llc |
| Dificid |
US7906489 (Pediatric) | 18-membered macrocycles and analogs thereof | Sep 04, 2027 | Cubist Pharms Llc |
| Dificid | US7378508 | Polymorphic crystalline forms of tiacumicin B | Jul 31, 2027 | Cubist Pharms Llc |
| Dificid | US7863249 | Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof | Jul 31, 2027 | Cubist Pharms Llc |
| Dificid | US7863249 | Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof | Jul 31, 2027 | Cubist Pharms Llc |
| Dificid | US8859510 | Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof | Jul 31, 2027 | Cubist Pharms Llc |
| Dificid | US7906489 | 18-membered macrocycles and analogs thereof | Mar 04, 2027 | Cubist Pharms Llc |
| Dificid |
US8586551 (Pediatric) | 18-membered macrocycles and analogs thereof |
Jan 15, 2024
(Expired) | Cubist Pharms Llc |
| Dificid | US8586551 | 18-membered macrocycles and analogs thereof |
Jul 23, 2023
(Expired) | Cubist Pharms Llc |
| Dificid | US8586551 | 18-membered macrocycles and analogs thereof |
Jul 15, 2023
(Expired) | Cubist Pharms Llc |
Fidaxomicin's Family Patents
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Clinical Trials
Recent Clinical Trials on Fidaxomicin:
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 |
|---|---|---|---|---|
 | ||||
| Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients | Hospices Civils de Lyon | NA |
RECRUITING
(Sep 1, 2026)
| PHASE1, PHASE2 |
| Vancomycin Taper to Prevent Recurrent Clostridioides Difficile | McGill University Health Centre/Research Institute of the McGill University Health Centre | NA |
RECRUITING
(Sep 1, 2026)
| PHASE3 |
| Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and First Recurrence | Benoit Guery | NA |
RECRUITING
(Jul 1, 2026)
| PHASE3 |
| Secondary Prevention of Clostridioides Difficile Using Vancomycin | McGill University Health Centre/Research Institute of the McGill University Health Centre | NA |
RECRUITING
(Jun 1, 2026)
| PHASE2, PHASE3 |