Details for New Drug Application (NDA): 206843
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NDA 206843 describes DAKLINZA, which is a drug marketed by Bristol-myers Squibb and is included in one NDA. There are five patents protecting this drug. Additional details are available on the DAKLINZA profile page.
The generic ingredient in DAKLINZA is daclatasvir dihydrochloride. There are five drug master file entries for this compound. Additional details are available on the daclatasvir dihydrochloride profile page.
The generic ingredient in DAKLINZA is daclatasvir dihydrochloride. There are five drug master file entries for this compound. Additional details are available on the daclatasvir dihydrochloride profile page.
Summary for 206843
| Tradename: | DAKLINZA |
| Applicant: | Bristol-myers Squibb |
| Ingredient: | daclatasvir dihydrochloride |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 206843
*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.
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 30MG BASE | ||||
| Approval Date: | Jul 24, 2015 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 24, 2029 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jun 13, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | METHOD OF INHIBITING HEPATITIS C VIRUS | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 11, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | METHOD OF INHIBITING HEPATITIS C VIRUS | ||||||||
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