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Details for New Drug Application (NDA): 201699
NDA 201699 describes DIFICID, which 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. Additional details are available on the DIFICID profile page.
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.
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 201699
| Tradename: | DIFICID |
| Applicant: | Cubist Pharms Llc |
| Ingredient: | fidaxomicin |
| Patents: | 5 |
Generic Entry Opportunity Date for 201699
Generic Entry Date for 201699*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 201699
Suppliers and Packaging for NDA: 201699
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIFICID | fidaxomicin | TABLET;ORAL | 201699 | NDA | Merck Sharp & Dohme Corp. | 52015-080 | 52015-080-01 | 1 BOTTLE in 1 CARTON (52015-080-01) > 20 TABLET, FILM COATED in 1 BOTTLE |
Paragraph IV (Patent) Challenges for 201699
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| DIFICID | TABLET;ORAL | fidaxomicin | 201699 | 2015-05-27 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | May 27, 2011 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Jul 31, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | Start Trial | Patent Expiration: | Jul 31, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | Start Trial | Patent Expiration: | Mar 4, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF MICROBIAL INFECTIONS | ||||||||
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