.

BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries

► See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

Dow
Medtronic
Johnson and Johnson
UBS
Argus Health
Cerilliant
McKesson
Deloitte
Baxter
Cipla

Generated: September 23, 2017

DrugPatentWatch Database Preview

DIFICID Drug Profile

« Back to Dashboard

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 ninety-three 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 Tradename: DIFICID

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list2
Clinical Trials: see list9
Patent Applications: see list22
Drug Prices:see details
DailyMed Link:DIFICID at DailyMed

Pharmacology for Tradename: DIFICID

Ingredient-typeMacrolides
Drug ClassMacrolide 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;ORAL201699-001May 27, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Cubist Pharms Llc
DIFICID
fidaxomicin
TABLET;ORAL201699-001May 27, 2011RXYesYes► Subscribe► Subscribe ► Subscribe
Cubist Pharms Llc
DIFICID
fidaxomicin
TABLET;ORAL201699-001May 27, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Cubist Pharms Llc
DIFICID
fidaxomicin
TABLET;ORAL201699-001May 27, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Cubist Pharms Llc
DIFICID
fidaxomicin
TABLET;ORAL201699-001May 27, 2011RXYesYes► Subscribe► Subscribe ► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Paragraph IV (Patent) Challenges 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
8,518,899Macrocyclic polymorphs, compositions comprising such polymorphs and methods of use and manufacture thereof► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: DIFICID

Country Document Number Estimated Expiration
HungaryE031581► Subscribe
South Korea20050053598► Subscribe
Hong Kong1126410► Subscribe
Slovenia1539977► Subscribe
Taiwan200840562► Subscribe
New Zealand601347► Subscribe
Canada2676061► Subscribe
Taiwan201350114► Subscribe
Australia2003251902► Subscribe
South Korea101399621► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

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
0727Netherlands► SubscribePRODUCT NAME: FIDAXOMICINE; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207
2015 00020Denmark► SubscribePRODUCT NAME: FIDAXOMICIN; REG. NO/DATE: EU/1/11/733/001-004 20111207
2015000026Germany► SubscribePRODUCT NAME: FIDAXOMICIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
00727Netherlands► SubscribePRODUCT NAME: FIDAXOMICINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
1539977/01Switzerland► SubscribePRODUCT NAME: FIDAXOMICIN; REGISTRATION NO/DATE: SWISSMEDIC 62957 01.05.2014
/2015Austria► SubscribePRODUCT NAME: FIDAXOMICIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/733/001 - 004 (MITTEILUNG) 20111207
C0028France► SubscribePRODUCT NAME: FIDAXOMICINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207
15/019Ireland► SubscribePRODUCT NAME: FIDAXOMICIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
684Luxembourg► SubscribePRODUCT NAME: FIDAXOMICINE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20111207
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Novartis
US Department of Justice
Cantor Fitzgerald
AstraZeneca
Cipla
Fish and Richardson
Julphar
Medtronic
US Army
Moodys

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot