Assyro AI

Orange Book product · Brand (NDA)

BREO ELLIPTA

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

Brand (NDA)NDA 204275RX GLAXO GRP LTD

At a glance

May 10, 2013

Approved

Brand (NDA)

Application

Not listed

TE code

12

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 10, 2013

    13 yr 4 mo ago

  2. Exclusivity ends · NPP

    New patient population 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 expires

    Listed drug product patent expiration.

    Jun 14, 2027

    in 1 yr

  7. Patent 8511304 expires

    Listed drug product patent expiration.

    Jun 14, 2027

    in 1 yr

  8. Patent 8511304*PED expires

    Listed listed patent expiration.

    Dec 14, 2027

    in 1 yr 6 mo

  9. Patent 11116721 expires

    Listed drug product patent expiration.

    Feb 26, 2029

    in 2 yr 9 mo

  10. Patent 11116721 expires

    Listed drug product patent expiration.

    Feb 26, 2029

    in 2 yr 9 mo

  11. Patent 11116721 expires

    Listed drug product patent expiration.

    Feb 26, 2029

    in 2 yr 9 mo

  12. Patent 11116721*PED expires

    Listed listed patent expiration.

    Aug 26, 2029

    in 3 yr 3 mo

  13. Patent 8534281 expires

    Listed drug product patent expiration.

    Mar 08, 2030

    in 3 yr 9 mo

  14. Patent 8534281*PED expires

    Listed listed patent expiration.

    Sep 08, 2030

    in 4 yr 3 mo

  15. Patent 8746242 expires

    Listed drug product patent expiration.

    Oct 11, 2030

    in 4 yr 5 mo

  16. 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

0.1MG/INH;EQ 0.025MG BASE/INH

Dosage form

POWDER

Route

INHALATION

TE code

Not listed

Application

NDA 204275

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 (2)

  • NPPNew patient population exclusivity (3 years)

    May 13, 2026

    1 mo ago

  • PEDPediatric exclusivity (adds 6 months)

    Nov 13, 2026

    in 5 mo

Listed patents (12)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8511304Jun 14, 2027in 1 yr
ProductU-1691
8511304Jun 14, 2027in 1 yr
ProductU-1424
8511304Jun 14, 2027in 1 yr
ProductU-3623
8511304*PEDDec 14, 2027in 1 yr 6 mo
11116721Feb 26, 2029in 2 yr 9 mo
ProductU-1401
11116721Feb 26, 2029in 2 yr 9 mo
ProductU-3623
11116721Feb 26, 2029in 2 yr 9 mo
ProductU-1691
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

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