levocetirizine dihydrochloride · Chattem Sanofi · NDA 209089, 209090
Xyzal Allergy 24hr
Earliest generic entry, as listed · earliest of 2 marketed strengths
16 Oct 2027
1 of 2 marketed strengths has no unexpired patent or exclusivity listed.
Blocked by patent: US 8633194.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8633194 | product | 16 Oct 2027 |
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
- 24 Oct 2026Enters 12-month window basis: patent · 209090-00116 Oct 2027
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 209089 · 001 · RLD | tablet, oral | 5MG | open |
| 209090 · 001 · RLD | solution, oral | 2.5MG/5ML | 16 Oct 2027 |