Dificid Patent Expiration

Dificid is a drug owned by Cubist Pharmaceuticals Llc. It is protected by 12 US drug patents filed from 2013 to 2020. Out of these, 10 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 28, 2034. Details of Dificid's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8586551 18-membered macrocycles and analogs thereof
Jul, 2023

(11 months ago)

Expired
US7378508 Polymorphic crystalline forms of tiacumicin B
Jul, 2027

(3 years from now)

Active
US7863249 Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Jul, 2027

(3 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8586551

(Pediatric)

18-membered macrocycles and analogs thereof
Jan, 2024

(6 months ago)

Expired
US7906489 18-membered macrocycles and analogs thereof
Mar, 2027

(2 years from now)

Active
US8859510 Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Jul, 2027

(3 years from now)

Active
US7863249 Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Jul, 2027

(3 years from now)

Active
US7906489

(Pediatric)

18-membered macrocycles and analogs thereof
Sep, 2027

(3 years from now)

Active
US8859510

(Pediatric)

Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Jan, 2028

(3 years from now)

Active
US7378508

(Pediatric)

Polymorphic crystalline forms of tiacumicin B
Jan, 2028

(3 years from now)

Active
US7863249

(Pediatric)

Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Jan, 2028

(3 years from now)

Active
US9808530 Composition of tiacumicin compounds
May, 2034

(9 years from now)

Active
US9808530

(Pediatric)

Composition of tiacumicin compounds
Nov, 2034

(10 years from now)

Active


FDA has granted several exclusivities to Dificid. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Dificid, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Dificid.

Exclusivity Information

Dificid holds 4 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Dificid's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) May 27, 2016
New Patient Population(NPP) Jan 24, 2023
Pediatric Exclusivity(PED) Jul 24, 2023
Orphan Drug Exclusivity(ODE-367) Jan 24, 2027

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US patents provide insights into the exclusivity only within the United States, but Dificid is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Dificid's family patents as well as insights into ongoing legal events on those patents.

Dificid's family patents

Dificid has patent protection in a total of 35 countries. It's US patent count contributes only to 21.4% of its total global patent coverage. 3 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Dificid.

Family Patents

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Generic Launch

Generic Release Date:

Dificid's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 28, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Dificid Generics:

Fidaxomicin is the generic name for the brand Dificid. 1 company has already filed for the generic of Dificid. Check out the entire list of companies who have already received approval for Dificid's generic

How can I launch a generic of Dificid before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Dificid's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Dificid's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Dificid -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
200 mg 27 May, 2015 1 31 Jul, 2027




About Dificid

Dificid is a drug owned by Cubist Pharmaceuticals Llc. It is used for treating Clostridioides difficile-associated diarrhea in patients 6 months of age and older. Dificid uses Fidaxomicin as an active ingredient. Dificid was launched by Cubist Pharms Llc in 2011.

Market Authorisation Date:

Dificid was approved by FDA for market use on 27 May, 2011.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Dificid is 27 May, 2011, its NCE-1 date is estimated to be 24 July, 2022

Active Ingredient:

Dificid uses Fidaxomicin as the active ingredient. Check out other Drugs and Companies using Fidaxomicin ingredient

Treatment:

Dificid is used for treating Clostridioides difficile-associated diarrhea in patients 6 months of age and older.

Dosage:

Dificid is available in the following dosage forms - tablet form for oral use, for suspension form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
200MG TABLET Prescription ORAL
40MG/ML FOR SUSPENSION Prescription ORAL