teriflunomide · Sanofi Aventis Us · NDA 202992
Aubagio
Earliest generic entry, as listed · earliest of 2 marketed strengths
4 Aug 2034
Blocked by patent: US 9186346 (pediatric extension).
Listed patents · 3 unexpired
5 Orange Book listing rows for 3 patents, including 3 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 9186346 | use U-1786 | 4 Aug 2034 |
| US 9186346 listing row | use U-1786 | 4 Feb 2034 |
| US 9186346 listing row | pediatric extension · sets the listed date | 4 Aug 2034 |
| US 8802735 | drug product | 14 Mar 2031 |
| US 8802735 listing row | drug product | 14 Sep 2030 |
| US 8802735 listing row | pediatric extension | 14 Mar 2031 |
| US 6794410 | pediatric extension | 12 Mar 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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 202992 · 001 · RLD | tablet, oral | 7MG | 4 Aug 2034 |
| 202992 · 002 · RLD | tablet, oral | 14MG | 4 Aug 2034 |
Expired or delisted (1)
- US 6794410 · use U-1285 · 12 Sep 2026