Assyro AI

Orange Book product · Brand (NDA)

BREO ELLIPTA

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

Brand (NDA)NDA 204275RX GLAXO GRP LTD

At a glance

May 12, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

8

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 12, 2023

    3 yr 2 mo ago

  2. Exclusivity ends · NS

    New strength exclusivity (3 years)

    May 13, 2026

    1 mo ago

  3. Today

  4. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Nov 13, 2026

    in 5 mo

  5. Patent 8511304 expires

    Listed drug product patent expiration.

    Jun 14, 2027

    in 1 yr

  6. Patent 8511304*PED expires

    Listed listed patent expiration.

    Dec 14, 2027

    in 1 yr 6 mo

  7. Patent 11116721 expires

    Listed drug product patent expiration.

    Feb 26, 2029

    in 2 yr 9 mo

  8. Patent 11116721*PED expires

    Listed listed patent expiration.

    Aug 26, 2029

    in 3 yr 3 mo

  9. Patent 8534281 expires

    Listed drug product patent expiration.

    Mar 08, 2030

    in 3 yr 9 mo

  10. Patent 8534281*PED expires

    Listed listed patent expiration.

    Sep 08, 2030

    in 4 yr 3 mo

  11. Patent 8746242 expires

    Listed drug product patent expiration.

    Oct 11, 2030

    in 4 yr 5 mo

  12. Patent 8746242*PED expires

    Listed listed patent expiration.

    Apr 11, 2031

    in 4 yr 11 mo

Pharmaceutical detail

Active ingredient

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

Strength

0.05MG/INH;EQ 0.025MG BASE/INH

Dosage form

POWDER

Route

INHALATION

TE code

Not listed

Application

NDA 204275

Product number

003

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 (2)

  • NSNew strength exclusivity (3 years)

    May 13, 2026

    1 mo ago

  • PEDPediatric exclusivity (adds 6 months)

    Nov 13, 2026

    in 5 mo

Listed patents (8)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8511304Jun 14, 2027in 1 yr
ProductU-3623
8511304*PEDDec 14, 2027in 1 yr 6 mo
11116721Feb 26, 2029in 2 yr 9 mo
ProductU-3623
11116721*PEDAug 26, 2029in 3 yr 3 mo
8534281Mar 08, 2030in 3 yr 9 mo
Product
8534281*PEDSep 08, 2030in 4 yr 3 mo
8746242Oct 11, 2030in 4 yr 5 mo
Product
8746242*PEDApr 11, 2031in 4 yr 11 mo
Agent CTA Background

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