Question 1

Is there a generic for Ensartinib hydrochloride?

Accepted Answer

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

Question 2

What is the reference-listed drug for Ensartinib hydrochloride?

Accepted Answer

ENSACOVE (NDA 218171, XCOVERY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Ensartinib hydrochloride?

Accepted Answer

The Orange Book lists 4 patents against Ensartinib 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 Ensartinib hydrochloride have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Ensartinib hydrochloride is approved in the following dosage form: capsule.

Patent	Expires	In	Type
8551995	Feb 09, 2029	in 2 yr 8 mo	Substance
9296724	Jun 18, 2029	in 3 yr 1 mo	SubstanceU-4099
9126947	Nov 29, 2031	in 5 yr 6 mo	Substance
10899744	Jun 01, 2037	in 11 yr 1 mo	SubstanceU-4099

Ensartinib hydrochloride

Brand (NDA) products · capsule

Marketing exclusivity (2)

Listed patents (4)

Ensartinib hydrochloride — frequently asked questions

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