DrugPatentWatch Database Preview
DIFICID Drug Profile
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Which patents cover Dificid, and when can generic versions of Dificid launch?
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. Two suppliers are 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: | 2 |
| Bulk Api Vendors: | 5 |
| Clinical Trials: | 9 |
| Patent Applications: | 23 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DIFICID |
| DailyMed Link: | DIFICID at DailyMed |
Pharmacology for DIFICID
| Ingredient-type | Macrolides |
| 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 | ➤ 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 | ||||
| Cubist Pharms Llc | DIFICID | fidaxomicin | TABLET;ORAL | 201699-001 | May 27, 2011 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Paragraph IV (Patent) Challenges for DIFICID
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 200 mg | ➤ Subscribe | 2015-05-27 |
Non-Orange Book US Patents for DIFICID
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,728,796 | Tiacumicin production | ➤ Sign Up |
| 7,507,564 | Tiacumicin production | ➤ Sign Up |
| 8,883,986 | Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof | ➤ Sign Up |
| 8,518,899 | Macrocyclic polymorphs, compositions comprising such polymorphs and methods of use and manufacture thereof | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for DIFICID
Supplementary Protection Certificates for DIFICID
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2015000026 | Germany | ➤ Sign Up | PRODUCT NAME: FIDAXOMICIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205 |
| 2015 00020 | Denmark | ➤ Sign Up | PRODUCT NAME: FIDAXOMICIN; REG. NO/DATE: EU/1/11/733/001-004 20111207 |
| 0150013 00220 | Estonia | ➤ Sign Up | PRODUCT NAME: FIDAKSOMITSIIN;REG NO/DATE: EU/1/11/733 07.12.2011 |
| /2015 | Austria | ➤ Sign Up | PRODUCT NAME: FIDAXOMICIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/733/001 - 004 (MITTEILUNG) 20111207 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
