| FIDAXOMICIN | CUBIST (Merck) | ||
| 200 mg; Tablet, Oral |
Less Than $1000 mn
|
||
|
Less Than 5
|
Less Than 5
|
||
|
More Than 5
|
None | ||
|
Less Than 5
|
Less Than 5
|
||
| DIFICID is a macrolide antibacterial drug indicated in adults ( ≥ 18 years of age) for treatment of Clostridium difficile-associated diarrhea (CDAD). | |||
|
Yes
| |||
| DIFICID | Patent 1 | Patent 2 | Patent 3 | Patent 4 | Patent 5 |
|---|---|---|---|---|---|
| ******* | ******* | ******* | ******* / ********* ***** *** | ******* | ******* / ********* ***** *** |
| *** ****** | ******* | ******* | ******* | ******* **** **** | ******* |
| ******* | ******* *** ********* | ******* *** ********* | ******* *** ********* | ******* **** *** | ******* *** ********* |
| Company | FTF Status / 180 days exclusivity | 30-Months stay | Current Litigation Status | Current Approval Status | Likelihood of launch |
|---|---|---|---|---|---|
| ******* | *** \ ** | ***** *, **** | ******* | ******** | ******** ** *** **, **** |
| *** ****** | ** \ ** | *** **, **** | ******* | **** | ******* *** **** *** *** **** |
| ******* | ** \ ** | -**- | ******* *** ********* | ******** | ******** ** *** **, **** |
| FIDAXOMICIN | None | ||
| 40MG/1ML |
Less Than $1000 mn
|
||
| None | None | ||
| None | None | ||
| None | None | ||
| DIFICID is a macrolide antibacterial indicated in adult and pediatric patients 6 months of age and older for the treatment of C. difficile-associated diarrhea. | |||
|
Yes
| |||
| DIFICID | Patent 1 | Patent 2 | Patent 3 | Patent 4 | Patent 5 | Patent 6 | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| *** ********* | ||||||||||
| *********** *********** ***** ** ********** * | *********** *********** ***** ** ********** * | ********* **********, ************ ********** **** **********, *** ******* ** *** *** *********** ******* | ********* **********, ************ ********** **** **********, *** ******* ** *** *** *********** ******* | **-******** *********** *** ******* ******* | **-******** *********** *** ******* ******* | ******-*********** ****** | *********** **********, ************ ********** **** **********, *** ******* ** *** *** *********** ******* | *********** ** ********** ********* | *********** ** ********** ********* |
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| Drug Name | Generic Name | Dosage | Route of Administration | Probable FTF | Known Para IV Filers | Other ANDA Developers |
|---|