Assyro AI

Orange Book product · Brand (NDA)

TRULANCE

PLECANATIDE

Brand (NDA)NDA 208745RX SALIX

At a glance

Jan 19, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

12

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 19, 2017

    9 yr 7 mo ago

  2. Today

  3. Patent 7041786 expires

    Listed drug substance patent expiration.

    Jan 30, 2028

    in 1 yr 8 mo

  4. Patent 9610321 expires

    Listed method-of-use patent (U-1999) expiration.

    Sep 15, 2031

    in 5 yr 4 mo

  5. Patent 9610321 expires

    Listed method-of-use patent (U-2230) expiration.

    Sep 15, 2031

    in 5 yr 4 mo

  6. Patent 9919024 expires

    Listed method-of-use patent (U-2230) expiration.

    Sep 15, 2031

    in 5 yr 4 mo

  7. Patent 9919024 expires

    Listed method-of-use patent (U-1999) expiration.

    Sep 15, 2031

    in 5 yr 4 mo

  8. Patent 9925231 expires

    Listed drug product patent expiration.

    Sep 15, 2031

    in 5 yr 4 mo

  9. Patent 11319346 expires

    Listed drug product patent expiration.

    Mar 01, 2032

    in 5 yr 9 mo

  10. Patent 9616097 expires

    Listed drug product patent expiration.

    Aug 20, 2032

    in 6 yr 3 mo

  11. Patent 10011637 expires

    Listed drug substance patent expiration.

    Jun 05, 2034

    in 8 yr 1 mo

  12. Patent 11142549 expires

    Listed drug product patent expiration.

    Jun 05, 2034

    in 8 yr 1 mo

  13. Patent 11834521 expires

    Listed drug product patent expiration.

    Jun 05, 2034

    in 8 yr 1 mo

  14. Patent 12146003 expires

    Listed drug product patent expiration.

    Jun 05, 2034

    in 8 yr 1 mo

Pharmaceutical detail

Active ingredient

PLECANATIDE

Strength

3MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 208745

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 (12)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7041786Jan 30, 2028in 1 yr 8 mo
Substance
9610321Sep 15, 2031in 5 yr 4 mo
U-1999
9610321Sep 15, 2031in 5 yr 4 mo
U-2230
9919024Sep 15, 2031in 5 yr 4 mo
U-2230
9919024Sep 15, 2031in 5 yr 4 mo
U-1999
9925231Sep 15, 2031in 5 yr 4 mo
Product
11319346Mar 01, 2032in 5 yr 9 mo
Product
9616097Aug 20, 2032in 6 yr 3 mo
Product
10011637Jun 05, 2034in 8 yr 1 mo
Substance
11142549Jun 05, 2034in 8 yr 1 mo
Product
11834521Jun 05, 2034in 8 yr 1 mo
Product
12146003Jun 05, 2034in 8 yr 1 mo
Product
Agent CTA Background

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