doxercalciferol · Sanofi · NDA 020862, 021027
Hectorol
Earliest generic entry, as listed · earliest of 5 marketed strengths
11 Jun 2028
2 of 5 marketed strengths have no unexpired patent or exclusivity listed; no marketed reference-listed strength; date taken from all listed strengths.
Blocked by exclusivity: M-14.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 1 unexpired
| M-14 | miscellaneous (3 years) | 11 Jun 2028 |
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 · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 020862 · 001 · RLD · discontinued | capsule, oral | 2.5MCG | 11 Jun 2028 |
| 020862 · 002 · RLD · discontinued | capsule, oral | 0.5MCG | 11 Jun 2028 |
| 020862 · 003 · RLD · discontinued | capsule, oral | 1MCG | 11 Jun 2028 |
| 021027 · 001 · RLD · discontinued | injectable, injection | 4MCG/2ML (2MCG/ML) | open |
| 021027 · 002 · RLD · discontinued | injectable, injection | 2MCG/ML (2MCG/ML) | open |