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Details for New Drug Application (NDA): 212477
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The generic ingredient in HARVONI is ledipasvir; sofosbuvir. There is one drug master file entry for this compound. One supplier is 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: | Aug 28, 2026 | ||||||||
Regulatory Exclusivity Use: | |||||||||
Regulatory Exclusivity Expiration: | Nov 15, 2022 | ||||||||
Regulatory Exclusivity Use: | |||||||||
Patent: | Start Trial | Patent Expiration: | Sep 14, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? |
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