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DIFICID Drug Profile
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» See Plans and PricingWhen 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 forty-nine patent family members in thirty-four 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.
US ANDA Litigation and Generic Entry Outlook for Dificid
Dificid was eligible for patent challenges on May 27, 2015.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 31, 2028. This may change due to patent challenges or generic licensing.
There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for DIFICID
| International Patents: | 149 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 13 |
| Clinical Trials: | 10 |
| Patent Applications: | 24 |
| Drug Prices: | Drug price information for DIFICID |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DIFICID |
| DailyMed Link: | DIFICID at DailyMed |
Generic Entry Opportunity Date for DIFICID
Generic Entry Dates for DIFICID*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
Generic Entry Dates for DIFICID*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
FOR SUSPENSION;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for DIFICID
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Alberta | Phase 2 |
| McMaster University | Phase 3 |
| Astellas Pharma Europe B.V. | Phase 3 |
Recent Litigation for DIFICID
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| MERCK SHARP & DOHME CORP. v. ACTAVIS LABORATORIES FL, INC. | 2020-01-16 |
| MERCK SHARP & DOHME CORP. v. ACTAVIS LABORATORIES FL, INC. | 2015-08-31 |
| MERCK SHARP & DOHME CORP. v. ACTAVIS LABORATORIES FL, INC. |
Pharmacology for DIFICID
| Drug Class | Macrolide Antibacterial |
Synonyms for DIFICID
| (2R,3S,4S,5S,6R)-6-{[(3E,5E,8S,9E,11S,12R,13E,15E,18S)-12-{[(2R,3S,4R,5S)-3,4-dihydroxy-6,6-dimethyl-5-[(2-methylpropanoyl)oxy]oxan-2-yl]oxy}-11-ethyl-8-hydroxy-18-[(1R)-1-hydroxyethyl]-9,13,15-trimethyl-2-oxo-1-oxacycloocta |
| 873857-62-6 |
| BRN 5228707 |
| CHEMBL1255800 |
| Clostomicin B1 |
| Clostomycin B1 |
| DB08874 |
| Dificlir |
| Difimicin |
| FI8 |
| Fidaxomicin |
| Fidaxomicin [USAN:INN] |
| Fidaxomicin, >=98% (HPLC) |
| fidaxomicin/Dificid |
| Lipiarmicin |
| Lipiarmycin |
| Lipiarmycin A 3 |
| Lipiarmycin A3 |
| Lipiarrmycin |
| OPT-80 |
| OPT-80;PAR-101;Clostomicin B1;Tiacumicin B |
| PAR 01 |
| PAR-101 |
| Q5446672 |
| R-Tiacumicin B |
| S-7827 |
| SCHEMBL10000818 |
| Tiacumicin B |
| UNII-Z5N076G8YQ |
| Z5N076G8YQ |
Paragraph IV (Patent) Challenges for DIFICID
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| DIFICID | TABLET;ORAL | fidaxomicin | 201699 | 2015-05-27 |
US Patents and Regulatory Information for DIFICID
| 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 | Start Trial | Start Trial | Y | Start Trial | |||
| Cubist Pharms Llc | DIFICID | fidaxomicin | FOR SUSPENSION;ORAL | 213138-001 | Jan 24, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Cubist Pharms Llc | DIFICID | fidaxomicin | FOR SUSPENSION;ORAL | 213138-001 | Jan 24, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for DIFICID
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1120358 | Start Trial |
| European Patent Office | 2305245 | Start Trial |
| Taiwan | 200626585 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for DIFICID
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1539977 | C 2015 015 | Romania | Start Trial | PRODUCT NAME: FIDAXOMICIN; NATIONAL AUTHORISATION NUMBER: EU/1/11/733/001, EU/1/11/733/002, EU/1/11/733/003, EU/1/11/733/004; DATE OF NATIONAL AUTHORISATION: 20111205; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/733/001, EU/1/11/733/002, EU/1/11/733/003, EU/1/11/733/004; DATE OF FIRST AUTHORISATION IN EEA: 20111205 |
| 1539977 | 300727 | Netherlands | Start Trial | PRODUCT NAME: FIDAXOMICINE; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207 |
| 1539977 | 92684 | Luxembourg | Start Trial | PRODUCT NAME: FIDAXOMICINE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20111207 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
