| Rifaximin | SALIX Pharma | ||
| 550 mg; Tablet, Oral |
More Than $1000 mn
|
||
|
Less Than 5
|
More Than 5
|
||
|
More Than 5
|
More Than 5
|
||
|
Less Than 5
|
None | ||
| Indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. | |||
|
Yes
| |||
| Xifaxan | Patent 1 | Patent 2 | Patent 3 | Patent 4 | Patent 5 | Patent 6 | Patent 7 | Patent 8 | Patent 9 | Patent 10 | Patent 11 | Patent 12 | Patent 13 | Patent 14 | Patent 15 | Patent 16 | Patent 17 | Patent 18 | Patent 19 | Patent 20 | Patent 21 | Patent 22 | Patent 23 | Patent 24 | Patent 25 | Patent 26 | Patent 27 | Patent 28 | Patent 29 | Patent 30 | Patent 31 | Patent 32 | Patent 33 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ******* (****) | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | *** ********* | *** ********* | *** ********* | *** ********* (***** ******) | *** ********* (***** ******) |
| ****** | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | *** ********* | *** ********* | *** ********* | *** ********* (***** ******) | *** ********* (***** ******) |
| ******* (*******) | *** ********* | **** ** ***** **, **** | *** ********* | *** ********* | *** ** ** *** ** | *** ********* | *** ** ** *** ** | **** ** ***** **, **** | **** ** ***** **, **** | *** ********* | **** ** ***** **, **** | **** ** ***** **, **** | **** ** ***** **, **** | *** ** ** *** ** | **** ** ***** **, **** | **** ** ** *** ** | **** ** ***** **, **** | **** ** *** **, **** | **** ** ***** **, **** | **** ** ***** **, **** | **** ** *** **, **** | **** ** *** **, **** | **** ** ***** **, **** | **** ** ** *** ** | **** ** ***** **. **** | **** ** ***** **. **** | **** ** ** *** ** | **** ** ***** **. **** | **** ** *** **, **** | **** ** *** **, **** | *** ** ** *** ** | **** ** *** **, **** (***** ******) | **** ** *** **, **** (***** ******) |
| Company | FTF Status / 180 days exclusivity | 30-Months stay | Current Litigation Status | Current Approval Status | Likelihood of launch |
|---|---|---|---|---|---|
| ******* (****) | *** \ *** | *** *, **** | ******* | ******** | ** *** **, **** |
| ****** | ** \ ** | ***** **, **** | ******* | ********* ******** | ** *** **, **** |
| ******* (*******) | ** \ ** | *** **, **** | ********* **** ** ** / ******* | ********* ******** | *** ****** *** **, **** |
| Rifaximin | SALIX Pharma | ||
| 200 mg; Tablet, Oral |
More Than $1000 mn
|
||
|
Less Than 5
|
Less Than 5
|
||
|
More Than 5
|
Less Than 5
|
||
| None | None | ||
| Indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. | |||
|
Yes
| |||
| Xifaxan | Patent 1 | Patent 2 | Patent 3 | Patent 4 | Patent 5 | Patent 6 | Patent 7 | Patent 8 | Patent 9 | Patent 10 | Patent 11 | Patent 12 | Patent 13 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| *** ****** | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* |
| ******* (*******) | **** *** | **** *** | **** *** | **** *** | **** *** | **** *** | **** *** | **** *** | **** *** | **** *** | **** *** | **** *** | **** *** |
| ************ ***** ** *********, ********* *** ***** ********** *** *** ******* ** ********* ************ | *********** ***** α, β, *** γ ** ********* | *********** ***** α, β *** γ ** ********* | ************** ************ ********** *********** ***** α, β, *** γ ** ********* | ******* ** ******** ********* ******** *** ******* ************** | ************** ************ ********** *********** ***** α, β, *** γ ** ********* | ************** ************ ********** *********** ***** α, β, *** γ ** ********* | ************ ***** ** *********, ********* *** ***** ********** *** *** ******* ** *** ********* ************ | ************ ***** ** *********, ********* *** ***** ********** *** *** ******* ** *** ********* ************ | ************ ***** ** *********, ********* *** ***** ********** *** *** ******* ** *** ********* ************ | *********** ***** α, β *** γ ** ********* | ************** ************ ********** *********** ***** α, β, *** γ ** ********* | ************ ***** ** *********, ********* *** ***** ********** *** *** ******* ** *** ********* ************ |
| Company | FTF Status / 180 days exclusivity | 30-Months stay | Current Litigation Status | Current Approval Status | Likelihood of launch |
|---|---|---|---|---|---|
| *** ****** | *** \ ********* | *** **, **** | ******* | **** | ** *** **, **** |
| ******* (*******) | ** \ ** | -**- | **** *** | ********* ******** | ** *** **, **** |
| Rifaximin | None | ||
| 550MG |
Less Than $1000 mn
|
||
| None | None | ||
| None | None | ||
| None | None | ||
| XIFAXAN is a rifamycin antibacterial indicated for: • The treatment of patients (≥ 12 years of age) with travelers’ diarrhea caused by noninvasive strains of Escherichia coli. • Reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ≥ 18 years of age. | |||
|
Yes
| |||
| Xifaxan | Patent 1 | Patent 2 | Patent 3 | Patent 4 | Patent 5 | Patent 6 | Patent 7 | Patent 8 | Patent 9 | Patent 10 | Patent 11 | Patent 12 | Patent 13 | Patent 14 | Patent 15 | Patent 16 | Patent 17 | Patent 18 | Patent 19 | Patent 20 | Patent 21 | Patent 22 | Patent 23 | Patent 24 | Patent 25 | Patent 26 | Patent 27 | Patent 28 | Patent 29 | Patent 30 | Patent 31 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| *** ********* | |||||||||||||||||||||||||||||||
| ************ ***** ** *********, ********* *** ***** ********** *** *** ******* ** *** ********* ************ | ******* *** ******** ********-********** ********* ***** ******** | ************ ***** ** *********, ********* *** ***** ********** *** *** ******* ** *** ********* ************ | ******* ** ******** ******* ************** | ************ ***** ** *********, ********* *** ***** ********** *** *** ******* ** *** ********* ************ | ******* ** ******** ********'* ******** *** ******* ************** | ******* ** ******** ********'* ******** *** ******* ************** | ******* ** ******** ******* ************** | ************ ***** ** *********, ********* *** ***** ********** *** *** ******* ** *** ********* ************ | ******* ** ******** ******* ************** | ******* ** ******** ********'* ******** *** ******* ************** | ******* ** ******** ******* ************** | ******* ** ******** ******* ************** | ******* *** ******** ********* ***** ******** (***) | ************ ***** ** *********, ********* *** ***** ********** *** *** ******* ** *** ********* ************ | ******* ** ******** ******* ************** | ******* *** ******** ********* ***** ******** (***) |
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| Drug Name | Generic Name | Dosage | Route of Administration | Probable FTF | Known Para IV Filers | Other ANDA Developers |
|---|