varenicline tartrate · Oyster Point Pharma · NDA 213978
Tyrvaya
Earliest generic entry, as listed
19 Oct 2035
Blocked by patent: US 10456396, US 11224598, US 11903941, US 11903942, US 11903943, US 11911380, US 12576080, US 12653824, US 9504644, US 9504645, US 9532944, US 9597284.
Listed patents · 12 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10456396 | product, use U-1900 | 19 Oct 2035 |
| US 11224598 | use U-1900 | 19 Oct 2035 |
| US 11903941 | use U-1900 | 19 Oct 2035 |
| US 11903942 | product | 19 Oct 2035 |
| US 11903943 | use U-1900 | 19 Oct 2035 |
| US 11911380 | use U-1900 | 19 Oct 2035 |
| US 12576080 | use U-1900 | 19 Oct 2035 |
| US 12653824 | product | 19 Oct 2035 |
| US 9504644 | use U-1900 | 19 Oct 2035 |
| US 9504645 | product | 19 Oct 2035 |
| US 9532944 | use U-1900 | 19 Oct 2035 |
| US 9597284 | use U-1900 | 19 Oct 2035 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213978 · 001 · RLD | spray, nasal | EQ 0.03MG BASE/SPRAY | 19 Oct 2035 |