daclatasvir dihydrochloride · Bristol-Myers Squibb · NDA 206843
Daklinza
Earliest generic entry, as listed · earliest of 3 marketed strengths
8 Aug 2027
Other strengths are listed to 13 Jun 2031; no marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8900566, US 9421192.
Listed patents · 5 unexpired
8 Orange Book listing rows for 5 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8629171 | drug substance, drug product, use U-1724 | 13 Jun 2031 |
| US 8329159 | drug substance | 24 Jul 2029 |
| US 8642025 | drug substance, drug product, use U-1724, U-1725 | 11 Aug 2027 |
| US 8642025 listing row | drug substance, drug product, use U-1724 | 11 Aug 2027 |
| US 8642025 listing row | drug substance, drug product, use U-1725 | 11 Aug 2027 |
| US 8900566 | use U-1724, U-1725 | 8 Aug 2027 |
| US 8900566 listing row | use U-1724 · sets the listed date | 8 Aug 2027 |
| US 8900566 listing row | use U-1725 · sets the listed date | 8 Aug 2027 |
| US 9421192 | drug substance, use U-1724, U-1725 | 8 Aug 2027 |
| US 9421192 listing row | drug substance, use U-1724 · sets the listed date | 8 Aug 2027 |
| US 9421192 listing row | drug substance, use U-1725 · sets the listed date | 8 Aug 2027 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- Enters 12-month window basis: patent · 206843-003Listed date 8 Aug 2027Detected 24 Oct 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 206843 · 001 · RLD · discontinued | tablet, oral | EQ 30MG BASE | 13 Jun 2031 |
| 206843 · 002 · RLD · discontinued | tablet, oral | EQ 60MG BASE | 13 Jun 2031 |
| 206843 · 003 · RLD · discontinued | tablet, oral | EQ 90MG BASE | 8 Aug 2027 |