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 in its drug Dificid on May 27, 2011. 2 different companies have introduced drugs containing Fidaxomicin.


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 US7378508 Polymorphic crystalline forms of tiacumicin B Jul 31, 2027 Cubist Pharms Llc
Dificid US7378508

(Pediatric)

Polymorphic crystalline forms of tiacumicin B Jan 31, 2028 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 US7863249

(Pediatric)

Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof Jan 31, 2028 Cubist Pharms Llc
Dificid US7906489 18-membered macrocycles and analogs thereof Mar 04, 2027 Cubist Pharms Llc
Dificid US7906489

(Pediatric)

18-membered macrocycles and analogs thereof Sep 04, 2027 Cubist Pharms Llc
Dificid US8586551 18-membered macrocycles and analogs thereof Jul 15, 2023

(Expired)

Cubist Pharms Llc
Dificid US8586551 18-membered macrocycles and analogs thereof Jul 23, 2023

(Expired)

Cubist Pharms Llc
Dificid US8586551

(Pediatric)

18-membered macrocycles and analogs thereof Jan 15, 2024

(Expired)

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 US8859510

(Pediatric)

Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof Jan 31, 2028 Cubist Pharms Llc
Dificid US9808530 Composition of tiacumicin compounds May 28, 2034 Cubist Pharms Llc
Dificid US9808530

(Pediatric)

Composition of tiacumicin compounds Nov 28, 2034 Cubist Pharms Llc


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Fidaxomicin Generics

Only one generic application has been filed for Fidaxomicin.

Given below is the list of companies who have filed for Fidaxomicin generic.


1. ACTAVIS LABS FL

Actavis Laboratories Fl Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 1 generic for Fidaxomicin. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG tablet Prescription ORAL AB Jan 16, 2024