doxorubicin hydrochloride · Baxter Hlthcare Corp · NDA 050718
Doxil (Liposomal)
Earliest generic entry, as listed · earliest of 2 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
- Generic approved · ANDA 219881, Qilu Pharm Hainan · 050718-001Approved 3 Feb 2026Detected 25 Oct 2026Historical import
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 050718 · 001 · RLD | injectable, liposomal, injection | 20MG/10ML (2MG/ML) | open |
| 050718 · 002 · RLD | injectable, liposomal, injection | 50MG/25ML (2MG/ML) | open |