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DIFICID Drug Profile

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Dificid is a drug marketed by Cubist Pharms Llc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-two patent family members in twenty-two 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 Tradename: DIFICID

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: DIFICID

Ingredient-typeMacrolides
Drug ClassMacrolide Antibacterial
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cubist Pharms Llc
DIFICID
fidaxomicin
TABLET;ORAL201699-001May 27, 2011RXYes8,859,510► subscribe ► subscribe
Cubist Pharms Llc
DIFICID
fidaxomicin
TABLET;ORAL201699-001May 27, 2011RXYes7,863,249► subscribeYY ► subscribe
Cubist Pharms Llc
DIFICID
fidaxomicin
TABLET;ORAL201699-001May 27, 2011RXYes7,906,489► subscribe ► subscribe
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Paragraph IV activity for: DIFICID

Drugname Dosage Strength RLD Submissiondate
fidaxomicinTablets200 mgDificid5/27/2015

Non-Orange Book Patents for Tradename: 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
7,507,564Tiacumicin production► subscribe
8,883,986Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof► subscribe
8,728,796Tiacumicin production► 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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International Patent Family for Tradename: DIFICID

Country Document Number Estimated Expiration
Australia2003251902► subscribe
European Patent Office1848273► subscribe
European Patent Office2468761► 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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Supplementary Protection Certificates for Tradename: DIFICID

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015 00020Denmark► subscribePRODUCT NAME: FIDAXOMICIN ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/11/733/001-004 20111205
C0028France► subscribePRODUCT NAME: FIDAXOMICINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207
684Luxembourg► subscribePRODUCT 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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