Assyro AI

Orange Book product · Brand (NDA)

LASTACAFT

ALCAFTADINE

Brand (NDA)NDA 022134OTC ABBVIE

At a glance

Jul 28, 2010

Approved

Brand (NDA)

Application

Not listed

TE code

2

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 28, 2010

    16 yr 2 mo ago

  2. Today

  3. Patent 10617695 expires

    Listed drug product patent expiration.

    Mar 19, 2027

    in 9 mo

  4. Patent 8664215 expires

    Listed method-of-use patent (U-3267) expiration.

    Dec 23, 2027

    in 1 yr 6 mo

Pharmaceutical detail

Active ingredient

ALCAFTADINE

Strength

0.25%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 022134

Product number

001

Marketing status

OTC

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.

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10617695Mar 19, 2027in 9 mo
ProductU-3267
8664215Dec 23, 2027in 1 yr 6 mo
U-3267
Agent CTA Background

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