enoxaparin sodium · Sanofi Aventis Us · NDA 020164
Lovenox (Preservative Free)
Earliest generic entry, as listed · earliest of 7 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 218775, Hebei Changshan · 020164-001Approved 7 Jan 2026Detected 25 Oct 2026Historical import
Products covered · 8
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 020164 · 001 · RLD | injectable, subcutaneous | 30MG/0.3ML (100MG/ML) | open |
| 020164 · 002 · RLD | injectable, subcutaneous | 40MG/0.4ML (100MG/ML) | open |
| 020164 · 003 · RLD | injectable, subcutaneous | 60MG/0.6ML (100MG/ML) | open |
| 020164 · 004 · RLD | injectable, subcutaneous | 80MG/0.8ML (100MG/ML) | open |
| 020164 · 005 · RLD | injectable, subcutaneous | 100MG/ML (100MG/ML) | open |
| 020164 · 006 · RLD · discontinued | injectable, subcutaneous | 90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020164 · 007 · RLD | injectable, subcutaneous | 120MG/0.8ML (150MG/ML) | open |
| 020164 · 008 · RLD | injectable, subcutaneous | 150MG/ML (150MG/ML) | open |