gemcitabine hydrochloride · Sun Pharm · NDA 208313
Infugem
Earliest generic entry, as listed · earliest of 10 marketed strengths
1 Jul 2033
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 9241948.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9241948 | product | 1 Jul 2033 |
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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 10
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208313 · 001 · RLD · discontinued | solution, intravenous | EQ 1200MG BASE/120ML (EQ 10MG BASE/ML) | 1 Jul 2033 |
| 208313 · 002 · RLD · discontinued | solution, intravenous | EQ 1300MG BASE/130ML (EQ 10MG BASE/ML) | 1 Jul 2033 |
| 208313 · 003 · RLD · discontinued | solution, intravenous | EQ 1400MG BASE/140ML (EQ 10MG BASE/ML) | 1 Jul 2033 |
| 208313 · 004 · RLD · discontinued | solution, intravenous | EQ 1500MG BASE/150ML (EQ 10MG BASE/ML) | 1 Jul 2033 |
| 208313 · 005 · RLD · discontinued | solution, intravenous | EQ 1600MG BASE/160ML (EQ 10MG BASE/ML) | 1 Jul 2033 |
| 208313 · 006 · RLD · discontinued | solution, intravenous | EQ 1700MG BASE/170ML (EQ 10MG BASE/ML) | 1 Jul 2033 |
| 208313 · 007 · RLD · discontinued | solution, intravenous | EQ 1800MG BASE/180ML (EQ 10MG BASE/ML) | 1 Jul 2033 |
| 208313 · 008 · RLD · discontinued | solution, intravenous | EQ 1900MG BASE/190ML (EQ 10MG BASE/ML) | 1 Jul 2033 |
| 208313 · 009 · RLD · discontinued | solution, intravenous | EQ 2000MG BASE/200ML (EQ 10MG BASE/ML) | 1 Jul 2033 |
| 208313 · 010 · RLD · discontinued | solution, intravenous | EQ 2200MG BASE/220ML (EQ 10MG BASE/ML) | 1 Jul 2033 |