nicotine polacrilex · Haleon Us Holdings · NDA 018612, 020066, 021330, 022360
Nicorette
Earliest generic entry, as listed · earliest of 8 marketed strengths
30 Apr 2028
Other strengths are listed to 14 Jun 2029; 4 of 8 marketed strengths have no unexpired patent or exclusivity listed.
Blocked by patent: US 8323683.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8501164 | drug product | 14 Jun 2029 |
| US 8940772 | drug product | 30 Apr 2029 |
| US 8323683 | drug product · sets the listed date | 30 Apr 2028 |
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 · 8
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 018612 · 002 · RLD | gum, chewing, buccal | EQ 2MG BASE | 30 Apr 2028 |
| 018612 · 004 · RLD | gum, chewing, buccal | EQ 2MG BASE | open |
| 020066 · 002 · RLD | gum, chewing, buccal | EQ 4MG BASE | 30 Apr 2028 |
| 020066 · 004 · RLD | gum, chewing, buccal | EQ 4MG BASE | open |
| 021330 · 001 · RLD | troche/lozenge, oral | EQ 2MG BASE | open |
| 021330 · 002 · RLD | troche/lozenge, oral | EQ 4MG BASE | open |
| 022360 · 001 · RLD | troche/lozenge, oral | EQ 2MG BASE | 14 Jun 2029 |
| 022360 · 002 · RLD | troche/lozenge, oral | EQ 4MG BASE | 14 Jun 2029 |