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FDA Office of Orphan Products Development — Portfolio Competitive Intelligence Brief

FDA Office of Orphan Products Development pipeline: 0 marketed, 0 filed, 2 Phase 3, 1 Phase 2. Recent regulatory actions, upcoming PDUFA, patent timeline, top competitor overlap.

0 marketed 0 filed 2 Phase 3 1 Phase 2 2 Phase 1 Live · 30-min refresh

Portfolio leaders (marketed + Phase 3 / filed)

DrugGenericPhaseClassTargetAreaFirst approval
chondrocyte-alginate gel suspension chondrocyte-alginate gel suspension phase 3 Cell therapy Orthopedics
monoclonal antibody cA2 monoclonal antibody cA2 phase 3 Monoclonal antibody CD19 Oncology

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. Alexion Pharmaceuticals, Inc. · 1 shared drug class
  2. Amgen · 1 shared drug class
  3. Arbeitsgemeinschaft medikamentoese Tumortherapie · 1 shared drug class
  4. Assistance Publique - Hôpitaux de Paris · 1 shared drug class
  5. Avicenna Research Institute · 1 shared drug class
  6. Azienda Ospedaliera Universitaria Integrata Verona · 1 shared drug class
  7. Baxalta now part of Shire · 1 shared drug class
  8. AgeneBio · 1 shared drug class

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Cite this brief

Drug Landscape (2026). FDA Office of Orphan Products Development — Portfolio Competitive Intelligence Brief. https://druglandscape.com/ci/company/fda-office-of-orphan-products-development. Accessed 2026-05-17.

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