fexofenadine hydrochloride · Chattem Sanofi · NDA 020872, 021909, 201373
Children's Allegra Hives
Earliest generic entry, as listed · earliest of 3 marketed strengths
2 Aug 2030
2 of 3 marketed strengths have no unexpired patent or exclusivity listed; no marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8933097.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8933097 | product | 2 Aug 2030 |
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 |
|---|---|---|---|
| 020872 · 006 · RLD · discontinued | tablet, oral | 30MG | open |
| 021909 · 003 · RLD · discontinued | tablet, orally disintegrating, oral | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 201373 · 002 · RLD · discontinued | suspension, oral | 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2 Aug 2030 |