Question 1

Is there a generic for Binimetinib?

Accepted Answer

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

Question 2

What is the reference-listed drug for Binimetinib?

Accepted Answer

MEKTOVI (NDA 210498, ARRAY BIOPHARMA INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Binimetinib?

Accepted Answer

The Orange Book lists 7 patents against Binimetinib products, with the earliest listed expiry in 2027. 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 Binimetinib have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Binimetinib. 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 Binimetinib are approved?

Accepted Answer

Binimetinib is approved in the following dosage form: tablet.

Patent	Expires	In	Type
7777050	Mar 13, 2027	in 9 mo	SubstanceProduct
10005761	Aug 27, 2030	in 4 yr 3 mo	U-2331
9850229	Aug 27, 2030	in 4 yr 3 mo	U-2333
9314464	Jul 04, 2031	in 5 yr 1 mo	U-2332
9980944	Oct 18, 2033	in 7 yr 5 mo	U-2334
9598376	Oct 18, 2033	in 7 yr 5 mo	U-2330
9562016	Oct 18, 2033	in 7 yr 5 mo	SubstanceProduct

Binimetinib

Brand (NDA) products · tablet

Marketing exclusivity (1)

Listed patents (7)

Binimetinib — frequently asked questions

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