Assyro AI

Orange Book product · Brand (NDA)

SEGLENTIS

CELECOXIB; TRAMADOL HYDROCHLORIDE

Brand (NDA)NDA 213426DISCN KOWA PHARMS

At a glance

Oct 15, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

7

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 15, 2021

    4 yr 9 mo ago

  2. Today

  3. Patent 10238668 expires

    Listed drug substance patent expiration.

    Apr 19, 2030

    in 3 yr 11 mo

  4. Patent 10245276 expires

    Listed drug substance patent expiration.

    Apr 19, 2030

    in 3 yr 11 mo

  5. Patent 10548909 expires

    Listed method-of-use patent (U-3244) expiration.

    Apr 19, 2030

    in 3 yr 11 mo

  6. Patent 11478488 expires

    Listed method-of-use patent (U-3244) expiration.

    Apr 19, 2030

    in 3 yr 11 mo

  7. Patent 8598152 expires

    Listed drug substance patent expiration.

    Apr 19, 2030

    in 3 yr 11 mo

  8. Patent 9012440 expires

    Listed drug substance patent expiration.

    Apr 19, 2030

    in 3 yr 11 mo

  9. Patent 8846744 expires

    Listed drug product patent expiration.

    Jun 03, 2031

    in 5 yr

Pharmaceutical detail

Active ingredient

CELECOXIB; TRAMADOL HYDROCHLORIDE

Strength

56MG;44MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 213426

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
10238668Apr 19, 2030in 3 yr 11 mo
SubstanceProductU-3244
10245276Apr 19, 2030in 3 yr 11 mo
SubstanceProduct
10548909Apr 19, 2030in 3 yr 11 mo
U-3244
11478488Apr 19, 2030in 3 yr 11 mo
U-3244
8598152Apr 19, 2030in 3 yr 11 mo
SubstanceProduct
9012440Apr 19, 2030in 3 yr 11 mo
SubstanceProduct
8846744Jun 03, 2031in 5 yr
Product
Agent CTA Background

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