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Orange Book product · Brand (NDA)

COMETRIQ

CABOZANTINIB S-MALATE

Brand (NDA)NDA 203756RX EXELIXIS

At a glance

Nov 29, 2012

Approved

Brand (NDA)

Application

Not listed

TE code

8

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 29, 2012

    13 yr 9 mo ago

  2. Today

  3. Patent 7579473 expires

    Listed drug substance patent expiration.

    Aug 14, 2026

    in 2 mo

  4. Patent 11091439 expires

    Listed drug substance patent expiration.

    Jan 15, 2030

    in 3 yr 8 mo

  5. Patent 11091440 expires

    Listed drug product patent expiration.

    Jan 15, 2030

    in 3 yr 8 mo

  6. Patent 11098015 expires

    Listed method-of-use patent (U-1617) expiration.

    Jan 15, 2030

    in 3 yr 8 mo

  7. Patent 8877776 expires

    Listed drug substance patent expiration.

    Oct 08, 2030

    in 4 yr 4 mo

  8. Patent 11298349 expires

    Listed drug product patent expiration.

    Feb 10, 2032

    in 5 yr 9 mo

  9. Patent 12128039 expires

    Listed drug product patent expiration.

    Feb 10, 2032

    in 5 yr 9 mo

  10. Patent 9717720 expires

    Listed drug product patent expiration.

    Feb 10, 2032

    in 5 yr 9 mo

Pharmaceutical detail

Active ingredient

CABOZANTINIB S-MALATE

Strength

EQ 20MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 203756

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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.

Listed patents (8)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7579473Aug 14, 2026in 2 mo
SubstanceProduct
11091439Jan 15, 2030in 3 yr 8 mo
Substance
11091440Jan 15, 2030in 3 yr 8 mo
Product
11098015Jan 15, 2030in 3 yr 8 mo
U-1617
8877776Oct 08, 2030in 4 yr 4 mo
SubstanceProductU-1617
11298349Feb 10, 2032in 5 yr 9 mo
Product
12128039Feb 10, 2032in 5 yr 9 mo
ProductU-1617
9717720Feb 10, 2032in 5 yr 9 mo
Product
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