Assyro AI

Orange Book product · Brand (NDA)

GILOTRIF

AFATINIB DIMALEATE

Brand (NDA)NDA 201292RX BOEHRINGER INGELHEIM

At a glance

Jul 12, 2013

Approved

Brand (NDA)

Application

Not listed

TE code

10

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 12, 2013

    13 yr 2 mo ago

  2. Patent RE43431 expires

    Listed drug substance patent expiration.

    Jan 13, 2026

    5 mo ago

  3. Today

  4. Patent RE43431*PED expires

    Listed listed patent expiration.

    Jul 13, 2026

    in 24 d

  5. Patent 9539258 expires

    Listed method-of-use patent (U-1950) expiration.

    Nov 09, 2026

    in 5 mo

  6. Patent 9539258*PED expires

    Listed listed patent expiration.

    May 09, 2027

    in 11 mo

  7. Patent 8426586 expires

    Listed drug substance patent expiration.

    Oct 10, 2029

    in 3 yr 4 mo

  8. Patent 8545884 expires

    Listed drug product patent expiration.

    Dec 19, 2029

    in 3 yr 7 mo

  9. Patent 8426586*PED expires

    Listed listed patent expiration.

    Apr 10, 2030

    in 3 yr 10 mo

  10. Patent 8545884*PED expires

    Listed listed patent expiration.

    Jun 19, 2030

    in 4 yr 1 mo

  11. Patent 10004743 expires

    Listed drug product patent expiration.

    Jul 05, 2030

    in 4 yr 1 mo

  12. Patent 10004743*PED expires

    Listed listed patent expiration.

    Jan 05, 2031

    in 4 yr 7 mo

Pharmaceutical detail

Active ingredient

AFATINIB DIMALEATE

Strength

EQ 20MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 201292

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 (10)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
RE43431Jan 13, 20265 mo ago
Substance
RE43431*PEDJul 13, 2026in 24 d
9539258Nov 09, 2026in 5 mo
U-1950
9539258*PEDMay 09, 2027in 11 mo
8426586Oct 10, 2029in 3 yr 4 mo
Substance
8545884Dec 19, 2029in 3 yr 7 mo
Product
8426586*PEDApr 10, 2030in 3 yr 10 mo
8545884*PEDJun 19, 2030in 4 yr 1 mo
10004743Jul 05, 2030in 4 yr 1 mo
Product
10004743*PEDJan 05, 2031in 4 yr 7 mo
Agent CTA Background

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