Last reviewed · How we verify

Shire — Portfolio Competitive Intelligence Brief

Shire pipeline: 10 marketed, 0 filed, 29 Phase 3, 11 Phase 2. Recent regulatory actions, upcoming PDUFA, patent timeline, top competitor overlap.

10 marketed 0 filed 29 Phase 3 11 Phase 2 24 Phase 1 Live · 30-min refresh

Portfolio leaders (marketed + Phase 3 / filed)

DrugGenericPhaseClassTargetAreaFirst approval
TED TED marketed Central nervous system stimulant Neurology / Psychiatry
Dynepo Dynepo marketed Other
MMX Mesalamine MMX Mesalamine marketed 5-aminosalicylic acid (5-ASA) agent Prostaglandin and leukotriene pathways (topical anti-inflammatory) Gastroenterology / Immunology
rhPTH (1-84) rhPTH (1-84) marketed PTH1 receptor agonist PTH1 receptor Endocrinology
MMX mesalamine/ mesalazine MMX mesalamine/ mesalazine marketed 5-aminosalicylic acid (5-ASA) agent Prostaglandin and leukotriene synthesis; non-selective anti-inflammatory mechanism Gastroenterology / Immunology
Elaprase Elaprase marketed Other
C1 Esterase Inhibitor (Human) C1 Esterase Inhibitor (Human) marketed Serine protease inhibitor; complement regulator C1 esterase inhibitor (C1-INH); Factor XIIa; plasma kallikrein Immunology; Rare Genetic Disorders
SPD489 SPD489 marketed Other
C1 inhibitor (human) [C1 INH] C1 inhibitor (human) [C1 INH] marketed Complement inhibitor / Serine protease inhibitor C1s protease / Classical complement pathway Immunology / Rare disease
Replagal (agalsidase alfa) Replagal (agalsidase alfa) marketed Enzyme replacement therapy α-galactosidase A (GLA) Rare genetic disease / Lysosomal storage disorder
SPD476 (4.8 g) SPD476 (4.8 g) phase 3 SGLT2 inhibitor SGLT2 Diabetes
SPD503 (4 mg) SPD503 (4 mg) phase 3 Phosphodiesterase 4 (PDE4) inhibitor PDE4 Respiratory / Immunology

Therapeutic area mix

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this portfolio.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this portfolio.

Patent timeline (forward window)

No upcoming patent expiries for this portfolio.

Competitive overlap (companies sharing drug classes)

  1. Sanofi · 3 shared drug classes
  2. Bayer · 3 shared drug classes
  3. Novartis · 3 shared drug classes
  4. Pfizer · 3 shared drug classes
  5. GlaxoSmithKline · 3 shared drug classes
  6. AstraZeneca · 2 shared drug classes
  7. Beijing Tiantan Hospital · 2 shared drug classes
  8. Ahn-Gook Pharmaceuticals Co.,Ltd · 2 shared drug classes

Subscribe to ongoing alerts

Every new pipeline event for Shire:

Cite this brief

Drug Landscape (2026). Shire — Portfolio Competitive Intelligence Brief. https://druglandscape.com/ci/company/shire. Accessed 2026-05-14.

Related