Question 1

Is there a generic for Alectinib hydrochloride?

Accepted Answer

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

Question 2

What is the reference-listed drug for Alectinib hydrochloride?

Accepted Answer

ALECENSA (NDA 208434, HOFFMANN-LA ROCHE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Alectinib hydrochloride?

Accepted Answer

The Orange Book lists 5 patents against Alectinib hydrochloride products, with the earliest listed expiry in 2030. 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 Alectinib hydrochloride have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

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

Patent	Expires	In	Type
9440922	Jun 09, 2030	in 4 yr	Product
9126931	May 29, 2031	in 5 yr	Substance
9365514	Mar 04, 2032	in 5 yr 10 mo	Product
10350214	Apr 24, 2035	in 9 yr	Product
11433076	Apr 24, 2035	in 9 yr	Product

Alectinib hydrochloride

Brand (NDA) products · capsule

Marketing exclusivity (2)

Listed patents (5)

Alectinib hydrochloride — frequently asked questions

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