deutetrabenazine · Teva · NDA 216354
Austedo Xr
Earliest generic entry, as listed · earliest of 8 marketed strengths
10 Jun 2041
Blocked by patent: US 11311488, US 11311488, US 12589075, US 12589075, US 12599598, US 12599598.
Listed patents · 30 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11311488 | product, use U-1995 | 10 Jun 2041 |
| US 11311488 | product, use U-3055 | 10 Jun 2041 |
| US 12589075 | use U-3055 | 10 Jun 2041 |
| US 12589075 | use U-1995 | 10 Jun 2041 |
| US 12599598 | use U-1995 | 10 Jun 2041 |
| US 12599598 | use U-3055 | 10 Jun 2041 |
| US 11179386 | — | 15 Sep 2038 |
| US 11813232 | — | 15 Sep 2038 |
| US 11179386 | product, use U-1995 | 15 Mar 2038 |
| US 11179386 | product, use U-3055 | 15 Mar 2038 |
| US 11813232 | product | 15 Mar 2038 |
| US 10959996 | — | 7 Sep 2036 |
| US 11357772 | — | 7 Sep 2036 |
| US 11446291 | — | 7 Sep 2036 |
| US 11564917 | — | 7 Sep 2036 |
| US 11648244 | — | 7 Sep 2036 |
| US 12016858 | — | 7 Sep 2036 |
| US 10959996 | use U-3055 | 7 Mar 2036 |
| US 11357772 | use U-1995 | 7 Mar 2036 |
| US 11357772 | use U-3055 | 7 Mar 2036 |
| US 11446291 | use U-1995 | 7 Mar 2036 |
| US 11564917 | use U-1995 | 7 Mar 2036 |
| US 11648244 | use U-1995 | 7 Mar 2036 |
| US 12016858 | use U-3055 | 7 Mar 2036 |
| US 12016858 | use U-1995 | 7 Mar 2036 |
| US 9550780 | — | 18 Mar 2034 |
| US 9550780 | substance, product, use U-3055 | 18 Sep 2033 |
| US 9550780 | substance, product, use U-1995 | 18 Sep 2033 |
| US 8524733 | — | 3 Oct 2031 |
| US 8524733 | substance, product | 3 Apr 2031 |
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 |
|---|---|---|---|
| 216354 · 001 · RLD | tablet, extended release, oral | 6MG | 10 Jun 2041 |
| 216354 · 002 · RLD | tablet, extended release, oral | 12MG | 10 Jun 2041 |
| 216354 · 003 · RLD | tablet, extended release, oral | 24MG | 10 Jun 2041 |
| 216354 · 004 · RLD | tablet, extended release, oral | 30MG | 10 Jun 2041 |
| 216354 · 005 · RLD | tablet, extended release, oral | 36MG | 10 Jun 2041 |
| 216354 · 006 · RLD | tablet, extended release, oral | 42MG | 10 Jun 2041 |
| 216354 · 007 · RLD | tablet, extended release, oral | 48MG | 10 Jun 2041 |
| 216354 · 008 · RLD | tablet, extended release, oral | 18MG | 10 Jun 2041 |