Assyro AI

Orange Book product · Brand (NDA)

BEVESPI AEROSPHERE

FORMOTEROL FUMARATE; GLYCOPYRROLATE

Brand (NDA)NDA 208294RX ASTRAZENECA

At a glance

Apr 25, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

7

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 25, 2016

    10 yr 4 mo ago

  2. Today

  3. Patent 10716753 expires

    Listed drug product patent expiration.

    May 28, 2030

    in 4 yr

  4. Patent 8324266 expires

    Listed method-of-use patent (U-2889) expiration.

    May 28, 2030

    in 4 yr

  5. Patent 8703806 expires

    Listed method-of-use patent (U-2889) expiration.

    May 28, 2030

    in 4 yr

  6. Patent 8808713 expires

    Listed drug product patent expiration.

    May 28, 2030

    in 4 yr

  7. Patent 9415009 expires

    Listed method-of-use patent (U-2889) expiration.

    May 28, 2030

    in 4 yr

  8. Patent 9463161 expires

    Listed drug product patent expiration.

    May 28, 2030

    in 4 yr

  9. Patent 8815258 expires

    Listed method-of-use patent (U-2889) expiration.

    Mar 17, 2031

    in 4 yr 10 mo

Pharmaceutical detail

Active ingredient

FORMOTEROL FUMARATE; GLYCOPYRROLATE

Strength

0.0048MG/INH;0.0090MG/INH

Dosage form

AEROSOL, METERED

Route

INHALATION

TE code

Not listed

Application

NDA 208294

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 (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10716753May 28, 2030in 4 yr
ProductU-2889
8324266May 28, 2030in 4 yr
U-2889
8703806May 28, 2030in 4 yr
U-2889
8808713May 28, 2030in 4 yr
ProductU-2889
9415009May 28, 2030in 4 yr
U-2889
9463161May 28, 2030in 4 yr
ProductU-2889
8815258Mar 17, 2031in 4 yr 10 mo
U-2889
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