Details for New Drug Application (NDA): 213138
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NDA 213138 describes DIFICID, which is a drug marketed by Cubist Pharms Llc and is included in two NDAs. It is available from one supplier. There are six 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 213138
| Tradename: | DIFICID |
| Applicant: | Cubist Pharms Llc |
| Ingredient: | fidaxomicin |
| Patents: | 6 |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 213138
*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: 213138
Suppliers and Packaging for NDA: 213138
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIFICID | fidaxomicin | FOR SUSPENSION;ORAL | 213138 | NDA | Merck Sharp & Dohme LLC | 52015-700 | 52015-700-22 | 1 POUCH in 1 CARTON (52015-700-22) / 1 BOTTLE, GLASS in 1 POUCH (52015-700-23) / 150 mL in 1 BOTTLE, GLASS (52015-700-21) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 40MG/ML | ||||
| Approval Date: | Jan 24, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 24, 2023 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Regulatory Exclusivity Expiration: | Jul 24, 2023 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Jan 24, 2027 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC PATIENTS AGED 6 MONTHS AND OLDER FOR THE TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA (CDAD) | ||||||||
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