DIFICID Drug Patent Profile
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When do Dificid patents expire, and what generic alternatives are available?
Dificid is a drug marketed by Cubist Pharms Llc and is included in two NDAs. There are six patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and fifty-eight patent family members in thirty-six countries.
The generic ingredient in DIFICID is fidaxomicin. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fidaxomicin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dificid
A generic version of DIFICID was approved as fidaxomicin by ACTAVIS LABS FL on January 16th, 2024.
Summary for DIFICID
International Patents: | 158 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 29 |
Clinical Trials: | 10 |
Patent Applications: | 738 |
Drug Prices: | Drug price information for DIFICID |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DIFICID |
What excipients (inactive ingredients) are in DIFICID? | DIFICID excipients list |
DailyMed Link: | DIFICID at DailyMed |
Recent Clinical Trials for DIFICID
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Alberta | Phase 2 |
McMaster University | Phase 3 |
Vancouver Island Health Authority | Phase 3 |
Pharmacology for DIFICID
Drug Class | Macrolide Antibacterial |
Anatomical Therapeutic Chemical (ATC) Classes for DIFICID
Paragraph IV (Patent) Challenges for DIFICID
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
DIFICID | Tablets | fidaxomicin | 200 mg | 201699 | 1 | 2015-05-27 |
US Patents and Regulatory Information for DIFICID
DIFICID is protected by six US patents and one FDA Regulatory Exclusivity.
Patents protecting DIFICID
Polymorphic crystalline forms of tiacumicin B
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
18-membered macrocycles and analogs thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
18-membered macrocycles and analogs thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Composition of tiacumicin compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting DIFICID
PEDIATRIC PATIENTS AGED 6 MONTHS AND OLDER FOR THE TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA (CDAD)
Exclusivity Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cubist Pharms Llc | DIFICID | fidaxomicin | FOR SUSPENSION;ORAL | 213138-001 | Jan 24, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Cubist Pharms Llc | DIFICID | fidaxomicin | FOR SUSPENSION;ORAL | 213138-001 | Jan 24, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Cubist Pharms Llc | DIFICID | fidaxomicin | FOR SUSPENSION;ORAL | 213138-001 | Jan 24, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for DIFICID
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Tillotts Pharma GmbH | Dificlir | fidaxomicin | EMEA/H/C/002087 Dificlir film-coated tablets is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adult and paediatric patients with a body weight of at least 12.5 kg.Consideration should be given to official guidelines on the appropriate use of antibacterial agents.Dificlir granules for oral suspension is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adults and paediatric patients from birth to < 18 years of age.Consideration should be given to official guidelines on the appropriate use of antibacterial agents. |
Authorised | no | no | no | 2011-12-05 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for DIFICID
When does loss-of-exclusivity occur for DIFICID?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Austria
Patent: 16024
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering DIFICID around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 2305244 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2008091554 | ⤷ Try a Trial | |
Poland | 2945613 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DIFICID
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1539977 | 1590020-2 | Sweden | ⤷ Try a Trial | PRODUCT NAME: FIDAXOMICIN; TOTAL VALIDITY PERIOD: 16 JULY 2023 THROUGH 6 JUNE 2027 |
1539977 | C201530022 | Spain | ⤷ Try a Trial | PRODUCT NAME: FIDAXOMICINA; NATIONAL AUTHORISATION NUMBER: EU/1/11/733/001-004; DATE OF AUTHORISATION: 20111207; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/733/001-004; DATE OF FIRST AUTHORISATION IN EEA: 20111207 |
1539977 | 366 50006-2015 | Slovakia | ⤷ Try a Trial | OWNER(S): MERCK SHARP & DOHME LLC, RAHWAY, NJ, US; PREDCHADZAJUCI MAJITEL: MERCK SHARP & DOHME CORP., RAHWAY, NJ, US; DATUM ZAPISU DO REGISTRA: 7.10.2022 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |