Assyro AI

Orange Book product · Brand (NDA)

BAQSIMI

GLUCAGON

Brand (NDA)NDA 210134RX AMPHASTAR PHARMS INC

At a glance

Jul 24, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

3

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 24, 2019

    7 yr ago

  2. Today

  3. Exclusivity ends · NPP

    New patient population exclusivity (3 years)

    Mar 17, 2028

    in 1 yr 9 mo

  4. Patent 10213487 expires

    Listed drug product patent expiration.

    Feb 16, 2036

    in 9 yr 10 mo

  5. Patent 12370241 expires

    Listed drug product patent expiration.

    Feb 16, 2036

    in 9 yr 10 mo

  6. Patent 10765602 expires

    Listed drug product patent expiration.

    Sep 23, 2039

    in 13 yr 5 mo

Pharmaceutical detail

Active ingredient

GLUCAGON

Strength

3MG

Dosage form

POWDER

Route

NASAL

TE code

Not listed

Application

NDA 210134

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.

Marketing exclusivity (1)

  • NPPNew patient population exclusivity (3 years)

    Mar 17, 2028

    in 1 yr 9 mo

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10213487Feb 16, 2036in 9 yr 10 mo
ProductU-2604
12370241Feb 16, 2036in 9 yr 10 mo
ProductU-2604
10765602Sep 23, 2039in 13 yr 5 mo
Product
Agent CTA Background

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