dolutegravir sodium · Viiv Hlthcare · NDA 213983
Tivicay Pd
Earliest generic entry, as listed
8 Jun 2030
Blocked by patent: US 9242986 (pediatric extension).
Listed patents · 2 unexpired
4 Orange Book listing rows for 2 patents, including 2 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 9242986 | drug substance, drug product | 8 Jun 2030 |
| US 9242986 listing row | drug substance, drug product | 8 Dec 2029 |
| US 9242986 listing row | pediatric extension · sets the listed date | 8 Jun 2030 |
| US 8129385 | drug substance, drug product | 5 Apr 2028 |
| US 8129385 listing row | drug substance, drug product | 5 Oct 2027 |
| US 8129385 listing row | pediatric extension | 5 Apr 2028 |
Exclusivities · 2 unexpired
| PED | pediatric (6 months added) | 25 Feb 2030 |
| NPP | new patient population | 25 Aug 2029 |
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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213983 · 001 · RLD | tablet, for suspension, oral | EQ 5MG BASE | 8 Jun 2030 |