cliffwatch

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 12589075, US 12599598.

Listed patents · 13 unexpired

30 Orange Book listing rows for 13 patents, including 10 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 11311488drug product, use U-1995, U-305510 Jun 2041
US 11311488 listing rowdrug product, use U-1995 · sets the listed date10 Jun 2041
US 11311488 listing rowdrug product, use U-3055 · sets the listed date10 Jun 2041
US 12589075use U-1995, U-305510 Jun 2041
US 12589075 listing rowuse U-1995 · sets the listed date10 Jun 2041
US 12589075 listing rowuse U-3055 · sets the listed date10 Jun 2041
US 12599598use U-1995, U-305510 Jun 2041
US 12599598 listing rowuse U-1995 · sets the listed date10 Jun 2041
US 12599598 listing rowuse U-3055 · sets the listed date10 Jun 2041
US 11179386drug product, use U-1995, U-305515 Sep 2038
US 11179386 listing rowdrug product, use U-199515 Mar 2038
US 11179386 listing rowdrug product, use U-305515 Mar 2038
US 11179386 listing rowpediatric extension15 Sep 2038
US 11813232drug product15 Sep 2038
US 11813232 listing rowdrug product15 Mar 2038
US 11813232 listing rowpediatric extension15 Sep 2038
US 10959996use U-30557 Sep 2036
US 10959996 listing rowuse U-30557 Mar 2036
US 10959996 listing rowpediatric extension7 Sep 2036
US 11357772use U-1995, U-30557 Sep 2036
US 11357772 listing rowuse U-19957 Mar 2036
US 11357772 listing rowuse U-30557 Mar 2036
US 11357772 listing rowpediatric extension7 Sep 2036
US 11446291use U-19957 Sep 2036
US 11446291 listing rowuse U-19957 Mar 2036
US 11446291 listing rowpediatric extension7 Sep 2036
US 11564917use U-19957 Sep 2036
US 11564917 listing rowuse U-19957 Mar 2036
US 11564917 listing rowpediatric extension7 Sep 2036
US 11648244use U-19957 Sep 2036
US 11648244 listing rowuse U-19957 Mar 2036
US 11648244 listing rowpediatric extension7 Sep 2036
US 12016858use U-1995, U-30557 Sep 2036
US 12016858 listing rowuse U-19957 Mar 2036
US 12016858 listing rowuse U-30557 Mar 2036
US 12016858 listing rowpediatric extension7 Sep 2036
US 9550780drug substance, drug product, use U-1995, U-305518 Mar 2034
US 9550780 listing rowdrug substance, drug product, use U-199518 Sep 2033
US 9550780 listing rowdrug substance, drug product, use U-305518 Sep 2033
US 9550780 listing rowpediatric extension18 Mar 2034
US 8524733drug substance, drug product3 Oct 2031
US 8524733 listing rowdrug substance, drug product3 Apr 2031
US 8524733 listing rowpediatric extension3 Oct 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 · productFormStrengthListed expiry
216354 · 001 · RLDtablet, extended release, oral6MG10 Jun 2041
216354 · 002 · RLDtablet, extended release, oral12MG10 Jun 2041
216354 · 003 · RLDtablet, extended release, oral24MG10 Jun 2041
216354 · 004 · RLDtablet, extended release, oral30MG10 Jun 2041
216354 · 005 · RLDtablet, extended release, oral36MG10 Jun 2041
216354 · 006 · RLDtablet, extended release, oral42MG10 Jun 2041
216354 · 007 · RLDtablet, extended release, oral48MG10 Jun 2041
216354 · 008 · RLDtablet, extended release, oral18MG10 Jun 2041