| Sofosbuvir | Gilead | ||
| 400 mg; Tablet, Oral |
Less Than $1000 mn
|
||
|
Less Than 5
|
Less Than 5
|
||
|
More Than 5
|
None | ||
| None | None | ||
| Chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis in adults with genotype 1 or 4, in combination with pegylated interferon and ribavirin, or in adults and children with genotype 2 or 3, in combination with ribavirin. | |||
|
Yes
| |||
| Sovaldi | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ***** | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* |
| **** | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* | ******* |
| ******** *********** ********** ********* | ********** *************** ******** | ********** *************** ******** | ******** *********** ********** ********* | ********** *************** ******** | ********** **************** | ********** **************** | ********** **************** | ********** **************** | ********** **************** | ************ *** ******* *** ******** ********* * ***** | ********** *************** ******** | ********** **************** | ********** **************** | ***** ***** ** ** ********* ******** | ************ *** ******* *** ******** ********* * ***** | ********** **************** |
| Company | FTF Status / 180 days exclusivity | 30-Months stay | Current Litigation Status | Current Approval Status | Likelihood of launch |
|---|---|---|---|---|---|
| ***** | *** \ ********* | **** **, **** | ******* | **** | ***** ***** **** (***** ******) |
| **** | *** \ ********* | **** **, **** | ******* | ******** ************ | ***** ***** **** (***** ******) |
| Sofosbuvir | None | ||
| 150MG, 200MG |
Less Than $1000 mn
|
||
| None | None | ||
| None | None | ||
| None | None | ||
| SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of: • Adult patients with genotype 1, 2, 3 or 4 chronic HCV infection without cirrhosis or with compensated cirrhosis as a component of a combination antiviral treatment regimen. • Pediatric patients 3 years of age and older with genotype 2 or 3 chronic HCV infection without cirrhosis or with compensated cirrhosis in combination with ribavirin. | |||
|
Yes
| |||
| Sovaldi | Patent 1 | Patent 2 | Patent 3 | Patent 4 | Patent 5 | Patent 6 | Patent 7 | Patent 8 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| *** ********* | ||||||||||||||||
| ********** *************** ******** | ********** *************** ******** | ********** *************** ******** | ********** *************** ******** | ********** *************** ******** | ********** *************** ******** | ********** **************** | ********** **************** | ********** **************** | ********** **************** | ************ *** ******* *** ******** ********* * ***** | ************ *** ******* *** ******** ********* * ***** | ********** *************** ******** | ********** *************** ******** | ********** **************** | ********** **************** |
Download ParaIV Report
| Drug Name | Generic Name | Dosage | Route of Administration | Probable FTF | Known Para IV Filers | Other ANDA Developers |
|---|