alendronate sodium · Organon · NDA 020560, 021575
Fosamax
Earliest generic entry, as listed
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 214523, Precision Dose Inc · 021575-001Approved 2 Sep 2026Detected 25 Oct 2026Historical import
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 020560 · 001 · RLD · discontinued | tablet, oral | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020560 · 002 · RLD · discontinued | tablet, oral | EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020560 · 003 · RLD · discontinued | tablet, oral | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020560 · 004 · RLD · discontinued | tablet, oral | EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020560 · 005 · RLD | tablet, oral | EQ 70MG BASE | open |
| 021575 · 001 · RLD · discontinued | solution, oral | EQ 70MG BASE/75ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |