formoterol fumarate; mometasone furoate · Organon Llc · NDA 022518
Dulera
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
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 |
|---|---|---|---|
| 022518 · 001 · RLD | aerosol, metered, inhalation | 0.005MG/INH;0.1MG/INH | open |
| 022518 · 002 · RLD | aerosol, metered, inhalation | 0.005MG/INH;0.2MG/INH | open |
| 022518 · 003 · RLD | aerosol, metered, inhalation | 0.005MG/INH;0.05MG/INH | open |