abrocitinib · Pfizer · NDA 213871
Cibinqo
Earliest generic entry, as listed · earliest of 3 marketed strengths
14 Jan 2036
Blocked by patent: US 9035074.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9035074 | drug substance, drug product · sets the listed date | 14 Jan 2036 |
| US 9545405 | drug substance, drug product | 19 Feb 2034 |
| US 9549929 | use U-3195 | 19 Feb 2034 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 14 Jan 2027 |
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
- Exclusivity expires within 90 days NCE · 213871-003Exclusivity expires 14 Jan 2027Detected 24 Oct 2026
- Exclusivity expires within 90 days NCE · 213871-002Exclusivity expires 14 Jan 2027Detected 24 Oct 2026
- Exclusivity expires within 90 days NCE · 213871-001Exclusivity expires 14 Jan 2027Detected 24 Oct 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213871 · 001 · RLD | tablet, oral | 50MG | 14 Jan 2036 |
| 213871 · 002 · RLD | tablet, oral | 100MG | 14 Jan 2036 |
| 213871 · 003 · RLD | tablet, oral | 200MG | 14 Jan 2036 |
Expired or delisted (1)
- NPP · 9 Feb 2026