Question 1

Is there a generic for Sodium phenylbutyrate; taurursodiol?

Accepted Answer

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

Question 2

What is the reference-listed drug for Sodium phenylbutyrate; taurursodiol?

Accepted Answer

RELYVRIO (NDA 216660, AMYLYX) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Sodium phenylbutyrate; taurursodiol?

Accepted Answer

The Orange Book lists 5 patents against Sodium phenylbutyrate; taurursodiol products, with the earliest listed expiry in 2033. 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 Sodium phenylbutyrate; taurursodiol have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Sodium phenylbutyrate; taurursodiol. 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 Sodium phenylbutyrate; taurursodiol are approved?

Accepted Answer

Sodium phenylbutyrate; taurursodiol is approved in the following dosage form: for suspension.

Patent	Expires	In	Type
10857162	Dec 24, 2033	in 7 yr 8 mo	U-3460
10251896	Dec 24, 2033	in 7 yr 8 mo	U-3460
9872865	Dec 24, 2033	in 7 yr 8 mo	U-3460
11071742	Dec 24, 2033	in 7 yr 8 mo	Product
11583542	Jul 27, 2040	in 14 yr 4 mo	Product

Sodium phenylbutyrate; taurursodiol

Brand (NDA) products · for suspension

Marketing exclusivity (2)

Listed patents (5)

Sodium phenylbutyrate; taurursodiol — frequently asked questions

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