ivermectin · Merck Sharp Dohme · NDA 050742
Stromectol
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 216808, E5 Pharma · 050742-001Approved 9 Mar 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 218509, Ajanta Pharma Ltd · 050742-001Approved 7 Apr 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 216863, Zydus Lifesciences · 050742-001Approved 26 Feb 2026Detected 25 Oct 2026Historical import
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 050742 · 001 · RLD · discontinued | tablet, oral | 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 050742 · 002 · RLD | tablet, oral | 3MG | open |