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Orange Book product · Brand (NDA)

DEXILANT SOLUTAB

DEXLANSOPRAZOLE

Brand (NDA)NDA 208056DISCN TAKEDA PHARMS USA

At a glance

Jan 26, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

7

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 26, 2016

    10 yr 7 mo ago

  2. Patent 8461187 expires

    Listed drug product patent expiration.

    Jan 17, 2026

    5 mo ago

  3. Patent 9238029 expires

    Listed drug product patent expiration.

    Jan 17, 2026

    5 mo ago

  4. Patent 9011926 expires

    Listed drug product patent expiration.

    Feb 24, 2026

    4 mo ago

  5. Today

  6. Patent 8461187*PED expires

    Listed listed patent expiration.

    Jul 17, 2026

    in 28 d

  7. Patent 8871273 expires

    Listed drug product patent expiration.

    Jan 11, 2028

    in 1 yr 7 mo

  8. Patent 8871273*PED expires

    Listed listed patent expiration.

    Jul 11, 2028

    in 2 yr 1 mo

  9. Patent 9241910 expires

    Listed drug product patent expiration.

    Mar 10, 2029

    in 2 yr 9 mo

Pharmaceutical detail

Active ingredient

DEXLANSOPRAZOLE

Strength

30MG

Dosage form

TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 208056

Product number

001

Marketing status

DISCN

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 (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8461187Jan 17, 20265 mo ago
Product
9238029Jan 17, 20265 mo ago
Product
9011926Feb 24, 20264 mo ago
Product
8461187*PEDJul 17, 2026in 28 d
8871273Jan 11, 2028in 1 yr 7 mo
Product
8871273*PEDJul 11, 2028in 2 yr 1 mo
9241910Mar 10, 2029in 2 yr 9 mo
Product
Agent CTA Background

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