Question 1

Is there a generic for Viloxazine hydrochloride?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Viloxazine hydrochloride. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Viloxazine hydrochloride?

Accepted Answer

QELBREE (NDA 211964, SUPERNUS PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Viloxazine hydrochloride?

Accepted Answer

The Orange Book lists 6 patents against Viloxazine hydrochloride products, with the earliest listed expiry in 2029. 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.

Question 4

Does Viloxazine hydrochloride have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 3 marketing-exclusivity periods for Viloxazine hydrochloride. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Viloxazine hydrochloride are approved?

Accepted Answer

Viloxazine hydrochloride is approved in the following dosage form: capsule, extended release.

Patent	Expires	In	Type
12121523	Sep 04, 2029	in 3 yr 3 mo	U-727
11458143	Sep 04, 2029	in 3 yr 3 mo	U-727
11324753	Sep 04, 2029	in 3 yr 3 mo	U-727
9603853	Feb 07, 2033	in 6 yr 9 mo	U-727
9358204	Feb 07, 2033	in 6 yr 9 mo	Product
9662338	Apr 02, 2035	in 8 yr 11 mo	Product

Viloxazine hydrochloride

Brand (NDA) products · capsule, extended release

Marketing exclusivity (3)

Listed patents (6)

Viloxazine hydrochloride — frequently asked questions

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