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. | |||
| US7378508 | Polymorphic crystalline forms of tiacumicin B |
Jul, 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 |
| US8586551 | 18-membered macrocycles and analogs thereof |
Jul, 2023
(1 year, 9 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
(9 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
(2 years from now) | Active |
|
US7863249 (Pediatric) | Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof |
Jan, 2028
(2 years from now) | Active |
|
US8859510 (Pediatric) | Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof |
Jan, 2028
(2 years from now) | Active |
|
US7906489 (Pediatric) | 18-membered macrocycles and analogs thereof |
Sep, 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 |
| US7863249 | Macrolide 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
(1 year, 9 months from now) | Active |
|
US8586551 (Pediatric) | 18-membered macrocycles and analogs thereof |
Jan, 2024
(1 year, 3 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.
Latest 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 |
|---|---|---|
 | ||
| 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) Critical | 04 Aug, 2021 | US9808530 |
| Email Notification Critical | 04 Aug, 2021 | US9808530 |
| Correspondence Address Change Critical | 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 |
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
Explore Our Curated Drug Screens
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 - for suspension form for oral use, tablet 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 |