Details for New Drug Application (NDA): 205834
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NDA 205834 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 205834
| Tradename: | HARVONI |
| Applicant: | Gilead Sciences Inc |
| Ingredient: | ledipasvir; sofosbuvir |
| Patents: | 17 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205834
*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: 205834
Suppliers and Packaging for NDA: 205834
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HARVONI | ledipasvir; sofosbuvir | TABLET;ORAL | 205834 | NDA | Gilead Sciences, Inc | 61958-1801 | 61958-1801-1 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1801-1) |
| HARVONI | ledipasvir; sofosbuvir | TABLET;ORAL | 205834 | NDA | Gilead Sciences, Inc | 61958-1803 | 61958-1803-1 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1803-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 90MG;400MG | ||||
| Approval Date: | Oct 10, 2014 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 28, 2026 | ||||||||
| Regulatory Exclusivity Use: | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) | ||||||||
| Regulatory Exclusivity Expiration: | Oct 7, 2024 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Apr 7, 2024 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER OR WEIGHING AT LEAST 35 KG WITH CHRONIC HEPATITIS C VIRUS GENOTYPE 1, 4, 5, OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS | ||||||||
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