DrugPatentWatch Database Preview
DIFICID Drug Profile
Which patents cover Dificid, and when can generic versions of Dificid launch?
Dificid is a drug marketed by Cubist Pharms Llc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and sixteen patent family members in twenty-eight 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.
Summary for DIFICID
| International Patents: | 116 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 12 |
| 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 Date for DIFICID*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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. | 2015-08-31 |
| MERCK SHARP & DOHME CORP. v. ACTAVIS LABORATORIES FL, INC. |
Pharmacology for DIFICID
| Drug Class | Macrolide Antibacterial |
Synonyms for DIFICID
| 55352-58-4 |
| 56645-60-4 |
| 750595-89-2 |
| 873857-62-6 |
| AK402701 |
| BRN 5228707 |
| CHEMBL1255800 |
| Clostomicin B1 |
| Clostomycin B1 |
| Dificlir |
| Difimicin |
| FI8 |
| Fidaxomicin |
| Fidaxomicin (Dificid) |
| Fidaxomicin [USAN:INN] |
| Fidaxomicin, >=98% (HPLC) |
| fidaxomicin/Dificid |
| Lipiarmycin |
| Lipiarmycin A 3 |
| Lipiarmycin A3 |
| OPT-80 |
| PAR 01 |
| PAR-101 |
| R-Tiacumicin B |
| S-7827 |
| SCHEMBL10000818 |
| Tiacumicin B |
| UNII-Z5N076G8YQ |
| Z5N076G8YQ |
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 | TABLET;ORAL | 201699-001 | May 27, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Cubist Pharms Llc | DIFICID | fidaxomicin | TABLET;ORAL | 201699-001 | May 27, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Cubist Pharms Llc | DIFICID | fidaxomicin | TABLET;ORAL | 201699-001 | May 27, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Cubist Pharms Llc | DIFICID | fidaxomicin | TABLET;ORAL | 201699-001 | May 27, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Cubist Pharms Llc | DIFICID | fidaxomicin | TABLET;ORAL | 201699-001 | May 27, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 |
Paragraph IV (Patent) Challenges for DIFICID
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 200 mg | ➤ Subscribe | Start Trial |
International Patents for DIFICID
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20080064177 | Start Trial |
| Japan | 2012197309 | Start Trial |
| Spain | 2395404 | Start Trial |
| Denmark | 2305245 | Start Trial |
| Denmark | 2125850 | Start Trial |
| Japan | 5468388 | 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 | 92684 | Luxembourg | Start Trial | PRODUCT NAME: FIDAXOMICINE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20111207 |
| 1539977 | CA 2015 00020 | Denmark | Start Trial | PRODUCT NAME: FIDAXOMICIN ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/11/733/001-004 20111205 |
| 1539977 | 16/2015 | Austria | Start Trial | PRODUCT NAME: FIDAXOMICIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/733/001 - 004 (MITTEILUNG) 20111207 |
| 1539977 | CR 2015 00020 | Denmark | Start Trial | PRODUCT NAME: FIDAXOMICIN; REG. NO/DATE: EU/1/11/733/001-004 20111207 |
| 1539977 | 122015000026 | Germany | Start Trial | PRODUCT NAME: FIDAXOMICIN; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
