gemcitabine hydrochloride · Hospira Inc · NDA 200795, 209604
Gemcitabine Hydrochloride
Earliest generic entry, as listed · earliest of 3 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
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 · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 200795 · 001 · RLD | injectable, injection | 200MG/5.26ML (38MG/ML) | open |
| 200795 · 002 · RLD | injectable, injection | 1GM/26.3ML (38MG/ML) | open |
| 200795 · 003 · RLD | injectable, injection | 2GM/52.6ML (38MG/ML) | open |
| 209604 · 001 · RLD · discontinued | solution, intravenous | 200MG/2ML (100MG/ML) | open |
| 209604 · 002 · RLD · discontinued | solution, intravenous | 1GM/10ML (100MG/ML) | open |
| 209604 · 003 · RLD · discontinued | solution, intravenous | 1.5GM/15ML (100MG/ML) | open |
| 209604 · 004 · RLD · discontinued | solution, intravenous | 2GM/20ML (100MG/ML) | open |