Assyro AI

Orange Book product · Brand (NDA)

MEKTOVI

BINIMETINIB

Brand (NDA)NDA 210498RX ARRAY BIOPHARMA INC

At a glance

Jun 27, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

9

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 27, 2018

    8 yr 1 mo ago

  2. Today

  3. Exclusivity ends · I-928

    New indication exclusivity (3 years)

    Oct 11, 2026

    in 4 mo

  4. Patent 7777050 expires

    Listed drug substance patent expiration.

    Mar 13, 2027

    in 9 mo

  5. Patent 10005761 expires

    Listed method-of-use patent (U-2331) expiration.

    Aug 27, 2030

    in 4 yr 3 mo

  6. Patent 10005761 expires

    Listed method-of-use patent (U-3737) expiration.

    Aug 27, 2030

    in 4 yr 3 mo

  7. Patent 9850229 expires

    Listed method-of-use patent (U-2333) expiration.

    Aug 27, 2030

    in 4 yr 3 mo

  8. Patent 9314464 expires

    Listed method-of-use patent (U-2332) expiration.

    Jul 04, 2031

    in 5 yr 1 mo

  9. Patent 9314464 expires

    Listed method-of-use patent (U-3737) expiration.

    Jul 04, 2031

    in 5 yr 1 mo

  10. Patent 9562016 expires

    Listed drug substance patent expiration.

    Oct 18, 2033

    in 7 yr 5 mo

  11. Patent 9598376 expires

    Listed method-of-use patent (U-2330) expiration.

    Oct 18, 2033

    in 7 yr 5 mo

  12. Patent 9980944 expires

    Listed method-of-use patent (U-2334) expiration.

    Oct 18, 2033

    in 7 yr 5 mo

Pharmaceutical detail

Active ingredient

BINIMETINIB

Strength

15MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 210498

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (1)

  • I-928New indication exclusivity (3 years)

    Oct 11, 2026

    in 4 mo

Listed patents (9)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7777050Mar 13, 2027in 9 mo
SubstanceProduct
10005761Aug 27, 2030in 4 yr 3 mo
U-2331
10005761Aug 27, 2030in 4 yr 3 mo
U-3737
9850229Aug 27, 2030in 4 yr 3 mo
U-2333
9314464Jul 04, 2031in 5 yr 1 mo
U-2332
9314464Jul 04, 2031in 5 yr 1 mo
U-3737
9562016Oct 18, 2033in 7 yr 5 mo
SubstanceProduct
9598376Oct 18, 2033in 7 yr 5 mo
U-2330
9980944Oct 18, 2033in 7 yr 5 mo
U-2334
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.