Question 1

Is there a generic for Vamorolone?

Accepted Answer

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

Question 2

What is the reference-listed drug for Vamorolone?

Accepted Answer

AGAMREE (NDA 215239, CATALYST 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 Vamorolone?

Accepted Answer

The Orange Book lists 7 patents against Vamorolone 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 Vamorolone have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Vamorolone. 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 Vamorolone are approved?

Accepted Answer

Vamorolone is approved in the following dosage form: suspension.

Patent	Expires	In	Type
10857161	May 28, 2029	in 3 yr	ProductU-3747
8334279	May 28, 2029	in 3 yr	U-3747
11833159	May 28, 2029	in 3 yr	Product
11690853	Mar 07, 2033	in 6 yr 10 mo	U-3747
12201639	Mar 17, 2040	in 13 yr 11 mo	SubstanceProductU-3747
11471471	Mar 17, 2040	in 13 yr 11 mo	U-3747
11382922	Jul 16, 2040	in 14 yr 3 mo	SubstanceProduct

Vamorolone

Brand (NDA) products · suspension

Marketing exclusivity (2)

Listed patents (7)

Vamorolone — frequently asked questions

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