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 one patent family members in twenty-five 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: | 101 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 9 |
| 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
*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.
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-oxacyclooctad |
| 55352-58-4 |
| 56645-60-4 |
| 750595-89-2 |
| 873857-62-6 |
| BRN 5228707 |
| CHEMBL1255800 |
| Clostomicin B1 |
| Clostomycin B1 |
| D06LNW |
| Dificid (TN) |
| Dificlir |
| Difimicin |
| Fidaxomicin |
| Fidaxomicin (Dificid) |
| Fidaxomicin [USAN:INN] |
| Fidaxomicin, >=98% (HPLC) |
| fidaxomicin/Dificid |
| Lipiarmicin |
| Lipiarmycin |
| Lipiarmycin A 3 |
| Lipiarmycin A3 |
| OPT-80 |
| PAR 01 |
| PAR-101 |
| R-Tiacumicin B |
| RTECS OQ7378000 |
| 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 | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Cubist Pharms Llc | DIFICID | fidaxomicin | TABLET;ORAL | 201699-001 | May 27, 2011 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Cubist Pharms Llc | DIFICID | fidaxomicin | TABLET;ORAL | 201699-001 | May 27, 2011 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Cubist Pharms Llc | DIFICID | fidaxomicin | TABLET;ORAL | 201699-001 | May 27, 2011 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Cubist Pharms Llc | DIFICID | fidaxomicin | TABLET;ORAL | 201699-001 | May 27, 2011 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| 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 | ➤ Sign Up |
International Patents for DIFICID
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Mexico | 348083 | ➤ Sign Up |
| European Patent Office | 2860241 | ➤ Sign Up |
| Mexico | 340742 | ➤ Sign Up |
| European Patent Office | 1539977 | ➤ Sign Up |
| European Patent Office | 1765312 | ➤ Sign Up |
| Netherlands | 300727 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for DIFICID
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0028 | France | ➤ Sign Up | PRODUCT NAME: FIDAXOMICINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207 |
| 684 | Luxembourg | ➤ Sign Up | PRODUCT NAME: FIDAXOMICINE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20111207 |
| 2015 00020 | Denmark | ➤ Sign Up | PRODUCT NAME: FIDAXOMICIN; REG. NO/DATE: EU/1/11/733/001-004 20111207 |
| /2015 | Austria | ➤ Sign Up | PRODUCT NAME: FIDAXOMICIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/733/001 - 004 (MITTEILUNG) 20111207 |
| 2015 00020 | Denmark | ➤ Sign Up | PRODUCT NAME: FIDAXOMICIN ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/11/733/001-004 20111205 |
| 0727 | Netherlands | ➤ Sign Up | PRODUCT NAME: FIDAXOMICINE; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
