calcitonin salmon · Mylan Ireland Ltd · NDA 017808, 020313
Miacalcin
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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 017808 · 001 · RLD · discontinued | injectable, injection | 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 017808 · 002 · RLD | injectable, injection | 200 IU/ML | open |
| 020313 · 002 · RLD · discontinued | spray, metered, nasal | 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |