Assyro AI

Orange Book product · Brand (NDA)

CLENPIQ

CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

Brand (NDA)NDA 209589RX FERRING PHARMS INC

At a glance

Nov 28, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

5

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 28, 2017

    8 yr 8 mo ago

  2. Today

  3. Patent 10624879 expires

    Listed drug product patent expiration.

    Jun 23, 2034

    in 8 yr 2 mo

  4. Patent 11191753 expires

    Listed method-of-use patent (U-3261) expiration.

    Jun 23, 2034

    in 8 yr 2 mo

  5. Patent 12576072 expires

    Listed drug product patent expiration.

    Jun 23, 2034

    in 8 yr 2 mo

  6. Patent 9827231 expires

    Listed drug product patent expiration.

    Jun 26, 2034

    in 8 yr 2 mo

  7. Patent 12458634 expires

    Listed drug product patent expiration.

    Jan 27, 2038

    in 11 yr 9 mo

Pharmaceutical detail

Active ingredient

CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

Strength

12GM/BOT;3.5GM/BOT;10MG/BOT

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 209589

Product number

001

Marketing status

RX

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 (5)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10624879Jun 23, 2034in 8 yr 2 mo
Product
11191753Jun 23, 2034in 8 yr 2 mo
U-3261
12576072Jun 23, 2034in 8 yr 2 mo
ProductU-3261
9827231Jun 26, 2034in 8 yr 2 mo
ProductU-2162
12458634Jan 27, 2038in 11 yr 9 mo
Product
Agent CTA Background

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