Applicant, as named in the Orange Book

Glaxo Grp Ltd

GSK plc · NYSE: GSK

Company and ticker: cliffwatch mapping, checked against SEC EDGAR · SEC filings

Next listed expiry: Breo Ellipta on 11 Apr 2031. 1 products with live protection, 8 without.

Products with listed protection

DrugEarliest generic entry
Breo Ellipta
NDA 204275 · 3 strengths
fluticasone furoate; vilanterol trifenatate
11 Apr 2031
patent

Recent events

  • Flovent Hfa · First generic approved · ANDA 219602, Glenmark SpecltApproved 3 Mar 2026Detected 25 Oct 2026
  • Flovent Hfa · Generic approved · ANDA 219602, Glenmark SpecltApproved 3 Mar 2026Detected 25 Oct 2026
  • Breo Ellipta · Exclusivity expires within 90 days PEDExclusivity expires 13 Nov 2026Detected 24 Oct 2026
  • Breo Ellipta · Exclusivity expires within 90 days PEDExclusivity expires 13 Nov 2026Detected 24 Oct 2026
Products without listed protection (8)
DrugEarliest generic entry
Advair Diskus 100/50
NDA 021077
fluticasone propionate; salmeterol xinafoate
open now
no listed protection
Advair Diskus 250/50
NDA 021077
fluticasone propionate; salmeterol xinafoate
open now
no listed protection
Advair Diskus 500/50
NDA 021077
fluticasone propionate; salmeterol xinafoate
open now
no listed protection
Advair Hfa
NDA 021254 · 3 strengths
fluticasone propionate; salmeterol xinafoate
open now
no listed protection
Flovent Diskus 100
NDA 020833
fluticasone propionate
open now
no listed protection
Flovent Diskus 250
NDA 020833
fluticasone propionate
open now
no listed protection
Flovent Diskus 50
NDA 020833
fluticasone propionate
open now
no listed protection
Flovent Hfa
NDA 021433 · 3 strengths
fluticasone propionate
open now
no listed protection