cliffwatch

deutetrabenazine · Teva Branded Pharm · NDA 208082

Austedo

Earliest generic entry, as listed · earliest of 3 marketed strengths
15 Sep 2038

Blocked by patent: US 11179386, US 11813232.

Listed patents · 32 unexpired

PatentClaimsExpires
US 11179386—15 Sep 2038
US 11813232—15 Sep 2038
US 11179386product, use U-199515 Mar 2038
US 11179386product, use U-305515 Mar 2038
US 11813232product15 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 10959996use U-30557 Mar 2036
US 11357772use U-30557 Mar 2036
US 11357772use U-19957 Mar 2036
US 11446291use U-19957 Mar 2036
US 11564917use U-19957 Mar 2036
US 11648244use U-19957 Mar 2036
US 12016858use U-30557 Mar 2036
US 12016858use U-19957 Mar 2036
US 11666566—18 Mar 2034
US 9233959—18 Mar 2034
US 9296739—18 Mar 2034
US 9550780—18 Mar 2034
US 9814708—18 Mar 2034
US 11666566product18 Sep 2033
US 9233959product18 Sep 2033
US 9296739product18 Sep 2033
US 9550780substance, product, use U-305518 Sep 2033
US 9550780substance, product, use U-199518 Sep 2033
US 9814708product18 Sep 2033
US 8524733—3 Oct 2031
US 8524733substance, product3 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 · 3

NDA · productFormStrengthListed expiry
208082 · 001 · RLDtablet, oral6MG15 Sep 2038
208082 · 002 · RLDtablet, oral9MG15 Sep 2038
208082 · 003 · RLDtablet, oral12MG15 Sep 2038