DIFICID Drug Patent Profile
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When do Dificid patents expire, and what generic alternatives are available?
Dificid is a drug marketed by Cubist Pharms Llc and is included in two NDAs. There are six patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and fifty-eight patent family members in thirty-six 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.
DrugPatentWatch® Generic Entry Outlook for Dificid
Dificid was eligible for patent challenges on May 27, 2015.
There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for DIFICID?
- What are the global sales for DIFICID?
- What is Average Wholesale Price for DIFICID?
Summary for DIFICID
| International Patents: | 158 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 29 |
| Clinical Trials: | 10 |
| Patent Applications: | 551 |
| Drug Prices: | Drug price information for DIFICID |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DIFICID |
| What excipients (inactive ingredients) are in DIFICID? | DIFICID excipients list |
| DailyMed Link: | DIFICID at DailyMed |
Recent Clinical Trials for DIFICID
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Alberta | Phase 2 |
| McMaster University | Phase 3 |
| Vancouver Island Health Authority | Phase 3 |
Pharmacology for DIFICID
| Drug Class | Macrolide Antibacterial |
Paragraph IV (Patent) Challenges for DIFICID
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| DIFICID | Tablets | fidaxomicin | 200 mg | 201699 | 1 | 2015-05-27 |
US Patents and Regulatory Information for DIFICID
DIFICID is protected by six US patents and one FDA Regulatory Exclusivity.
Patents protecting DIFICID
Polymorphic crystalline forms of tiacumicin B
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
18-membered macrocycles and analogs thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
18-membered macrocycles and analogs thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Composition of tiacumicin compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting DIFICID
PEDIATRIC PATIENTS AGED 6 MONTHS AND OLDER FOR THE TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA (CDAD)
Exclusivity Expiration: ⤷ Sign Up
| 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 | FOR SUSPENSION;ORAL | 213138-001 | Jan 24, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Cubist Pharms Llc | DIFICID | fidaxomicin | FOR SUSPENSION;ORAL | 213138-001 | Jan 24, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Cubist Pharms Llc | DIFICID | fidaxomicin | FOR SUSPENSION;ORAL | 213138-001 | Jan 24, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Cubist Pharms Llc | DIFICID | fidaxomicin | TABLET;ORAL | 201699-001 | May 27, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | 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 |
EU/EMA Drug Approvals for DIFICID
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Tillotts Pharma GmbH | Dificlir | fidaxomicin | EMEA/H/C/002087 Dificlir film-coated tablets is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adult and paediatric patients with a body weight of at least 12.5 kg.Consideration should be given to official guidelines on the appropriate use of antibacterial agents.Dificlir granules for oral suspension is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adults and paediatric patients from birth to < 18 years of age.Consideration should be given to official guidelines on the appropriate use of antibacterial agents. |
Authorised | no | no | no | 2011-12-05 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for DIFICID
See the table below for patents covering DIFICID around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hungary | E031581 | ⤷ Sign Up | |
| Australia | 2014207083 | Composition of tiacumicin compounds | ⤷ Sign Up |
| China | 102503994 | Method of treating clostridium difficile-associated diarrhea | ⤷ Sign Up |
| Spain | 2608046 | ⤷ Sign Up | |
| Luxembourg | 92684 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DIFICID
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1539977 | C20150013 00220 | Estonia | ⤷ Sign Up | PRODUCT NAME: FIDAKSOMITSIIN;REG NO/DATE: EU/1/11/733 07.12.2011 |
| 1539977 | 1590020-2 | Sweden | ⤷ Sign Up | PRODUCT NAME: FIDAXOMICIN; TOTAL VALIDITY PERIOD: 16 JULY 2023 THROUGH 6 JUNE 2027 |
| 1539977 | C01539977/01 | Switzerland | ⤷ Sign Up | FUSION; FORMER OWNER: MERCK SHARP AND DOHME CORP., US |
| 1539977 | 2015/019 | Ireland | ⤷ Sign Up | PRODUCT NAME: FIDAXOMICIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205; FIRST REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205 |
| 1539977 | C300727 | Netherlands | ⤷ Sign Up | PRODUCT NAME: FIDAXOMICINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 verification 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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