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Generated: September 23, 2017
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.| Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 2 |
| Bulk Api Vendors: see list | 2 |
| Clinical Trials: see list | 9 |
| Patent Applications: see list | 22 |
| Drug Prices: | see details |
| DailyMed Link: | DIFICID at DailyMed |
| Ingredient-type | Macrolides |
| Drug Class | Macrolide Antibacterial |
| 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 | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||
Cubist Pharms Llc | DIFICID | fidaxomicin | TABLET;ORAL | 201699-001 | May 27, 2011 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||
Cubist Pharms Llc | DIFICID | fidaxomicin | TABLET;ORAL | 201699-001 | May 27, 2011 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||
Cubist Pharms Llc | DIFICID | fidaxomicin | TABLET;ORAL | 201699-001 | May 27, 2011 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||
Cubist Pharms Llc | DIFICID | fidaxomicin | TABLET;ORAL | 201699-001 | May 27, 2011 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| fidaxomicin | Tablets | 200 mg | Dificid | 5/27/2015 |
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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,507,564 | Tiacumicin production | ► Subscribe | |||||||||||||
| 8,883,986 | Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof | ► Subscribe | |||||||||||||
| 8,728,796 | Tiacumicin production | ► Subscribe | |||||||||||||
| 8,518,899 | Macrocyclic polymorphs, compositions comprising such polymorphs and methods of use and manufacture thereof | ► Subscribe | |||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hungary | E031581 | ► Subscribe | |||||||||||||
| South Korea | 20050053598 | ► Subscribe | |||||||||||||
| Hong Kong | 1126410 | ► Subscribe | |||||||||||||
| Slovenia | 1539977 | ► Subscribe | |||||||||||||
| Taiwan | 200840562 | ► Subscribe | |||||||||||||
| New Zealand | 601347 | ► Subscribe | |||||||||||||
| Canada | 2676061 | ► Subscribe | |||||||||||||
| Taiwan | 201350114 | ► Subscribe | |||||||||||||
| Australia | 2003251902 | ► Subscribe | |||||||||||||
| South Korea | 101399621 | ► Subscribe | |||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Subscribe for complete access.
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2015 00020 | Denmark | ► Subscribe | PRODUCT NAME: FIDAXOMICIN ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/11/733/001-004 20111205 | ||||||||||||
| 0727 | Netherlands | ► Subscribe | PRODUCT NAME: FIDAXOMICINE; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207 | ||||||||||||
| 2015 00020 | Denmark | ► Subscribe | PRODUCT NAME: FIDAXOMICIN; REG. NO/DATE: EU/1/11/733/001-004 20111207 | ||||||||||||
| 2015000026 | Germany | ► Subscribe | PRODUCT NAME: FIDAXOMICIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205 | ||||||||||||
| 00727 | Netherlands | ► Subscribe | PRODUCT NAME: FIDAXOMICINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205 | ||||||||||||
| 1539977/01 | Switzerland | ► Subscribe | PRODUCT NAME: FIDAXOMICIN; REGISTRATION NO/DATE: SWISSMEDIC 62957 01.05.2014 | ||||||||||||
| /2015 | Austria | ► Subscribe | PRODUCT NAME: FIDAXOMICIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/733/001 - 004 (MITTEILUNG) 20111207 | ||||||||||||
| C0028 | France | ► Subscribe | PRODUCT NAME: FIDAXOMICINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207 | ||||||||||||
| 15/019 | Ireland | ► Subscribe | PRODUCT NAME: FIDAXOMICIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205 | ||||||||||||
| 684 | Luxembourg | ► Subscribe | PRODUCT NAME: FIDAXOMICINE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20111207 | ||||||||||||
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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