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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US7863249 Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Jul, 2027

(2 years from now)

Active
US7378508 Polymorphic crystalline forms of tiacumicin B
Jul, 2027

(2 years from now)

Active
US8586551 18-membered macrocycles and analogs thereof
Jul, 2023

(1 year, 3 months ago)

Expired
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9808530

(Pediatric)

Composition of tiacumicin compounds
Nov, 2034

(10 years from now)

Active
US9808530 Composition of tiacumicin compounds
May, 2034

(9 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
US8859510

(Pediatric)

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

(3 years from now)

Active
US7906489

(Pediatric)

18-membered macrocycles and analogs thereof
Sep, 2027

(2 years from now)

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

(2 years from now)

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

(2 years from now)

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

(2 years from now)

Active
US8586551

(Pediatric)

18-membered macrocycles and analogs thereof
Jan, 2024

(9 months ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Dificid's patents.

Given below is the list of recent legal activities going on the following patents of Dificid.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 10 Aug, 2022 US7906489 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 08 Jun, 2022 US7863249 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 09 Mar, 2022 US8859510 (Litigated)
Change in Power of Attorney (May Include Associate POA) 04 Aug, 2021 US9808530
Email Notification 04 Aug, 2021 US9808530
Correspondence Address Change 02 Aug, 2021 US9808530
Payment of Maintenance Fee, 4th Year, Large Entity 07 May, 2021 US9808530
Payment of Maintenance Fee, 8th Year, Large Entity 15 Apr, 2021 US8586551 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 22 Oct, 2019 US7378508 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 21 Aug, 2018 US7906489 (Litigated)


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 5 exclusivities out of which 4 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 Product(NP) Jan 24, 2023
New Patient Population(NPP) Jan 24, 2023
Pediatric Exclusivity(PED) Jul 24, 2023
Orphan Drug Exclusivity(ODE-367) Jan 24, 2027

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

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 Generic API suppliers:

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 2020.

Approval Date:

Dificid was approved by FDA for market use on 24 January, 2020.

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
40MG/ML FOR SUSPENSION Prescription ORAL
200MG TABLET Prescription ORAL