Assyro AI

Orange Book product · Brand (NDA)

NURTEC ODT

RIMEGEPANT SULFATE

Brand (NDA)NDA 212728RX PFIZER

At a glance

Feb 27, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

5

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 27, 2020

    6 yr 5 mo ago

  2. Today

  3. Patent 8759372 expires

    Listed drug substance patent expiration.

    Feb 25, 2033

    in 6 yr 9 mo

  4. Patent 8314117 expires

    Listed drug substance patent expiration.

    Feb 27, 2034

    in 7 yr 10 mo

  5. Patent 8314117 expires

    Listed drug substance patent expiration.

    Feb 27, 2034

    in 7 yr 10 mo

  6. Patent 11083724 expires

    Listed drug product patent expiration.

    Mar 25, 2039

    in 12 yr 11 mo

  7. Patent 11083724 expires

    Listed drug product patent expiration.

    Mar 25, 2039

    in 12 yr 11 mo

Pharmaceutical detail

Active ingredient

RIMEGEPANT SULFATE

Strength

EQ 75MG BASE

Dosage form

TABLET, ORALLY DISINTEGRATING

Route

ORAL

TE code

Not listed

Application

NDA 212728

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
8759372Feb 25, 2033in 6 yr 9 mo
SubstanceProduct
8314117Feb 27, 2034in 7 yr 10 mo
SubstanceProductU-2718
8314117Feb 27, 2034in 7 yr 10 mo
SubstanceProductU-3142
11083724Mar 25, 2039in 12 yr 11 mo
ProductU-2718
11083724Mar 25, 2039in 12 yr 11 mo
ProductU-3142
Agent CTA Background

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