Is there a generic for Deutetrabenazine?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Deutetrabenazine, referencing the brand AUSTEDO XR. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Deutetrabenazine?

AUSTEDO XR (NDA 216354, TEVA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Deutetrabenazine?

The Orange Book lists 31 patents against Deutetrabenazine products, with the earliest listed expiry in 2031. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Deutetrabenazine are approved?

Deutetrabenazine is approved in the following dosage forms: tablet, tablet, extended release.

FDA Orange Book · active-ingredient family

Deutetrabenazine

Deutetrabenazine is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:AUSTEDO XR · NDA 216354

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet, tablet, extended release

Product	Applicant	Application	TE	Approved
AUSTEDO XRRLD×8	TEVA	NDA 216354	—	Feb 17, 2023
AUSTEDORLD×3	TEVA BRANDED PHARM	NDA 208082	—	Apr 03, 2017

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
DEUTETRABENAZINE×3	AUROBINDO PHARMA LTD	ANDA 215971	—	Dec 26, 2024

Listed patents (31)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8524733	Apr 03, 2031	in 4 yr 10 mo	SubstanceProduct
8524733*PED	Oct 03, 2031	in 5 yr 4 mo
9550780	Sep 18, 2033	in 7 yr 4 mo	SubstanceProductU-1995
9233959	Sep 18, 2033	in 7 yr 4 mo	Product
9296739	Sep 18, 2033	in 7 yr 4 mo	Product
11666566	Sep 18, 2033	in 7 yr 4 mo	Product
9814708	Sep 18, 2033	in 7 yr 4 mo	Product
9550780*PED	Mar 18, 2034	in 7 yr 10 mo
9233959*PED	Mar 18, 2034	in 7 yr 10 mo
9296739*PED	Mar 18, 2034	in 7 yr 10 mo
9814708*PED	Mar 18, 2034	in 7 yr 10 mo
11666566*PED	Mar 18, 2034	in 7 yr 10 mo
12016858	Mar 07, 2036	in 9 yr 10 mo	U-1995
10959996	Mar 07, 2036	in 9 yr 10 mo	U-3055
11564917	Mar 07, 2036	in 9 yr 10 mo	U-1995
11446291	Mar 07, 2036	in 9 yr 10 mo	U-1995
11357772	Mar 07, 2036	in 9 yr 10 mo	U-1995
11648244	Mar 07, 2036	in 9 yr 10 mo	U-1995
11648244*PED	Sep 07, 2036	in 10 yr 4 mo
12016858*PED	Sep 07, 2036	in 10 yr 4 mo
10959996*PED	Sep 07, 2036	in 10 yr 4 mo
11564917*PED	Sep 07, 2036	in 10 yr 4 mo
11446291*PED	Sep 07, 2036	in 10 yr 4 mo
11357772*PED	Sep 07, 2036	in 10 yr 4 mo
11179386	Mar 15, 2038	in 11 yr 11 mo	ProductU-1995
11813232	Mar 15, 2038	in 11 yr 11 mo	Product
11813232*PED	Sep 15, 2038	in 12 yr 5 mo
11179386*PED	Sep 15, 2038	in 12 yr 5 mo
11311488	Jun 10, 2041	in 15 yr 2 mo	ProductU-1995
12599598	Jun 10, 2041	in 15 yr 2 mo	U-3055
12589075	Jun 10, 2041	in 15 yr 2 mo	U-3055

Deutetrabenazine — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo