Assyro AI

Orange Book product · Brand (NDA)

SEYSARA

SARECYCLINE HYDROCHLORIDE

Brand (NDA)NDA 209521RX ALMIRALL

At a glance

Oct 01, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

5

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 01, 2018

    7 yr 10 mo ago

  2. Today

  3. Patent 9481639 expires

    Listed method-of-use patent (U-2409) expiration.

    Aug 10, 2028

    in 2 yr 2 mo

  4. Patent 8513223 expires

    Listed method-of-use patent (U-2406) expiration.

    Dec 07, 2029

    in 3 yr 6 mo

  5. Patent 8318706 expires

    Listed drug substance patent expiration.

    Jan 03, 2032

    in 5 yr 7 mo

  6. Patent 9255068 expires

    Listed drug substance patent expiration.

    Feb 09, 2033

    in 6 yr 9 mo

  7. Patent 9255068 expires

    Listed drug substance patent expiration.

    Feb 09, 2033

    in 6 yr 9 mo

Pharmaceutical detail

Active ingredient

SARECYCLINE HYDROCHLORIDE

Strength

EQ 60MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 209521

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 (5)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9481639Aug 10, 2028in 2 yr 2 mo
U-2409
8513223Dec 07, 2029in 3 yr 6 mo
U-2406
8318706Jan 03, 2032in 5 yr 7 mo
SubstanceProductU-2405
9255068Feb 09, 2033in 6 yr 9 mo
SubstanceProductU-2407
9255068Feb 09, 2033in 6 yr 9 mo
SubstanceProductU-2408
Agent CTA Background

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