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Details for New Drug Application (NDA): 212477
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NDA 212477 describes HARVONI, which is a drug marketed by Gilead Sciences Inc and is included in two NDAs. It is available from two suppliers. There are seventeen patents protecting this drug. Additional details are available on the HARVONI profile page.
The generic ingredient in HARVONI is ledipasvir; sofosbuvir. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the ledipasvir; sofosbuvir profile page.
The generic ingredient in HARVONI is ledipasvir; sofosbuvir. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the ledipasvir; sofosbuvir profile page.
Summary for 212477
| Tradename: | HARVONI |
| Applicant: | Gilead Sciences Inc |
| Ingredient: | ledipasvir; sofosbuvir |
| Patents: | 16 |
Generic Entry Opportunity Date for 212477
Generic Entry Date for 212477*:
Constraining patent/regulatory exclusivity:
Dosage:
PELLETS;ORAL |
*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: 212477
Suppliers and Packaging for NDA: 212477
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HARVONI | ledipasvir; sofosbuvir | PELLETS;ORAL | 212477 | NDA | Gilead Sciences, Inc | 61958-1804 | 61958-1804-1 | 120 PELLET in 1 PACKET (61958-1804-1) |
| HARVONI | ledipasvir; sofosbuvir | PELLETS;ORAL | 212477 | NDA | Gilead Sciences, Inc | 61958-1805 | 61958-1805-1 | 90 PELLET in 1 PACKET (61958-1805-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | PELLETS;ORAL | Strength | 33.75MG;150MG/PACKET | ||||
| Approval Date: | Aug 28, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 15, 2022 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO THE DOSIG SECTION IN REGARD TO THE TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION IN PATIENTS WITH SEVERE RENAL IMPAIRMENT INCLUDING PATIENTS WITH END STAGE RENAL DISEASE ON DIALYSIS | ||||||||
| Regulatory Exclusivity Expiration: | Aug 28, 2026 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH CHRONIC HCV GENOTYPE 1 INFECTION WITH DECOMPENSATED CIRRHOSIS, FOR USE IN COMBINATION WITH RIBAVIRIN | ||||||||
| Regulatory Exclusivity Expiration: | Aug 28, 2026 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH CHRONIC HCV GENOTYPE 1 OR 4 INFECTION WHO ARE LIVER TRANSPLANT RECIPIENTS WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS, FOR USE IN COMBINATION WITH RIBAVIRIN | ||||||||
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