daprodustat · Glaxosmithkline · NDA 216951
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Earliest generic entry, as listed · earliest of 5 marketed strengths
13 Mar 2038
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 11117871, US 11649217.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11117871 | drug substance, drug product, use U-3535 · sets the listed date | 13 Mar 2038 |
| US 11649217 | drug product, use U-3535 · sets the listed date | 13 Mar 2038 |
| US 8324208 | drug substance, drug product | 11 Dec 2028 |
| US 11643397 | drug substance, use U-3535 | 22 Jun 2027 |
| US 8557834 | use U-1238 | 22 Jun 2027 |
| US 8815884 | drug product, use U-1238 | 22 Jun 2027 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 1 Feb 2028 |
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 · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216951 · 001 · RLD · discontinued | tablet, oral | 1MG | 13 Mar 2038 |
| 216951 · 002 · RLD · discontinued | tablet, oral | 2MG | 13 Mar 2038 |
| 216951 · 003 · RLD · discontinued | tablet, oral | 4MG | 13 Mar 2038 |
| 216951 · 004 · RLD · discontinued | tablet, oral | 6MG | 13 Mar 2038 |
| 216951 · 005 · RLD · discontinued | tablet, oral | 8MG | 13 Mar 2038 |