| Sofosbuvir, LEDIPASVIR | None | ||
| 90MG;400MG, 45MG;200MG |
Less Than $1000 mn
|
||
| None | None | ||
| None | None | ||
| None | None | ||
| HARVONI is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, and is indicated for the treatment of chronic hepatitis C virus (HCV) in adults and pediatric patients 3 years of age and older: • Genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis • Genotype 1 infection with decompensated cirrhosis, in combination with ribavirin • Genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with ribavirin. | |||
|
Yes
| |||
| Harvoni | 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 | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| *** ********* | |||||||||||||||||||||||||||||||||
| ********** *************** ******** | ********** *************** ******** | ********* ********* | ********* ********* | ********* ********* | ********* ********* | ********** *************** ******** | ********** *************** ******** | ********** *************** ******** | ********** *************** ******** | ********** **************** | ********** **************** | ********** **************** | ********** **************** | ********** *************** ******** | ********** *************** ******** | ********* ********* | ********* ********* | ********* ********* | ********* ********* | ************ *** ******* *** ******** ********* * ***** | ************ *** ******* *** ******** ********* * ***** | ********** *************** ******** | ********** *************** ******** | ********** **************** | ********** **************** | ******* *** ******** *** | ******* *** ******** *** | ********* ********* | ********* ********* | *********** *********** ** *** ********* ********* | *********** *********** ** *** ********* ********* | ******* *** ******** *** |
| Sofosbuvir, LEDIPASVIR | None | ||
| 33.75MG;150MG, 45MG;200MG |
Less Than $1000 mn
|
||
| None | None | ||
| None | None | ||
| None | None | ||
| HARVONI is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, and is indicated for the treatment of chronic hepatitis C virus (HCV) in adults and pediatric patients 3 years of age and older: • Genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis • Genotype 1 infection with decompensated cirrhosis, in combination with ribavirin • Genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with ribavirin. | |||
|
Yes
| |||
| Harvoni | 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 | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| *** ********* | |||||||||||||||||||||||||||||||
| ********** *************** ******** | ********** *************** ******** | ********* ********* | ********* ********* | ********* ********* | ********* ********* | ********** *************** ******** | ********** *************** ******** | ********** *************** ******** | ********** *************** ******** | ********** **************** | ********** **************** | ********** **************** | ********** **************** | ********** *************** ******** | ********** *************** ******** | ********* ********* | ********* ********* | ********* ********* | ********* ********* | ************ *** ******* *** ******** ********* * ***** | ************ *** ******* *** ******** ********* * ***** | ********** *************** ******** | ********** *************** ******** | ********** **************** | ********** **************** | ******* *** ******** *** | ******* *** ******** *** | ********* ********* | ********* ********* | ******* *** ******** *** |
Download ParaIV Report
| Drug Name | Generic Name | Dosage | Route of Administration | Probable FTF | Known Para IV Filers | Other ANDA Developers |
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