calcitriol · Esjay Pharma · NDA 018044, 021068
Rocaltrol
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
- Generic approved · ANDA 219796, Humanwell Puracap · 018044-001Approved 27 Feb 2026Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 018044 · 001 · RLD | capsule, oral | 0.25MCG | open |
| 018044 · 002 · RLD | capsule, oral | 0.5MCG | open |
| 021068 · 001 · RLD | solution, oral | 1MCG/ML | open |