Question 1

Is there a generic for Sarecycline hydrochloride?

Accepted Answer

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

Question 2

What is the reference-listed drug for Sarecycline hydrochloride?

Accepted Answer

SEYSARA (NDA 209521, ALMIRALL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Sarecycline hydrochloride?

Accepted Answer

The Orange Book lists 4 patents against Sarecycline hydrochloride products, with the earliest listed expiry in 2028. 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

What dosage forms of Sarecycline hydrochloride are approved?

Accepted Answer

Sarecycline hydrochloride is approved in the following dosage form: tablet.

Patent	Expires	In	Type
9481639	Aug 10, 2028	in 2 yr 2 mo	U-2409
8513223	Dec 07, 2029	in 3 yr 6 mo	U-2406
8318706	Jan 03, 2032	in 5 yr 7 mo	SubstanceProductU-2405
9255068	Feb 09, 2033	in 6 yr 9 mo	SubstanceProductU-2407

Sarecycline hydrochloride

Brand (NDA) products · tablet

Listed patents (4)

Sarecycline hydrochloride — frequently asked questions

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