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Data updated: Jul 17, 2026

Fresenius Kabi

Generics
OncologyInfectious DiseaseMetabolic Execution: Good

Fresenius Kabi is a generic drug manufacturer focused on Oncology, Infectious Disease, Metabolic. Key products include SMOFLIPID 20%.

1948
Since
304
Drugs
-
Trials
15
New Drugs (2yr)
Modality:
14 Small Molecules

FDA Novel Drug Designations

(2018)
1 Novel 1 Orphan 1 Priority Review 1 Fast Track
See 1 novel approval →
2018 OMEGAVEN (FISH OIL TRIGLYCERIDES) Orphan · Priority Review · Fast Track

Fresenius Kabi at a Glance

  • Fast trial execution (14 months median completion)

Fresenius Kabi's Key Drugs

Fresenius Kabi's core commercial portfolio centers on BOMYNTRA, POTASSIUM CHLORIDE 20MEQ, POTASSIUM CHLORIDE 10MEQ, spanning Oncology and Infectious Disease — its most strategically important drugs approved in the last 15 years.

BOMYNTRA
Oncology

Multiple Myeloma

RANKL Approved 2025
POTASSIUM CHLORIDE 20MEQ
Other

Hypokalemia

Approved 2020
POTASSIUM CHLORIDE 10MEQ
Other

Hypokalemia

Approved 2020
POTASSIUM CHLORIDE 40MEQ
Other

Hypokalemia

Approved 2020
SODIUM PHOSPHATES
Other

Hypophosphatemia

Approved 2022

Fresenius Kabi's Recent FDA Approvals

Fresenius Kabi secured 15 new FDA approvals for novel drugs (NDA/BLA) in the last two years.

SODIUM BICARBONATE NDA
2026-07-09
sodium bicarbonate
Metabolic Acidosis
EPINEPHRINE NDA
2026-03-30
epinephrine
1 INDICATIONS AND USAGE Epinephrine is a non-selective alpha and beta adrenergic agonist indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. ( 1.1 ) 1.1 Hypotension associated with Septic Shock Epinephrine Injection USP, 1 mg/10 mL (0.1 mg/mL) is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
CONEXXENCE BLA
2025-10-29
denosumab-bnht
Osteoporosis
ROCURONIUM BROMIDE NDA
2025-10-24
rocuronium bromide
Routine tracheal intubation
FAMOTIDINE NDA
2025-07-16
famotidine
1 INDICATIONS AND USAGE Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: • active duodenal ulcer (DU). • active gastric ulcer (GU). • symptomatic nonerosive gastroesophageal reflux disease (GERD). • erosive esophagitis due to GERD, diagnosed by biopsy. Famotidine tablets are indicated in adults for the: • treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). • reduction of the risk of duodenal ulcer recurrence. Famotidine tablets are a histamine-2 (H 2 ) receptor antagonist indicated ( 1 ): In adult and pediatric patients 40 kg and greater for the treatment of: • active duodenal ulcer (DU). • active gastric ulcer. • symptomatic nonerosive gastroesophageal reflux disease (GERD). • erosive esophagitis due to GERD, diagnosed by biopsy. In adults for the: • treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). • reduction of the risk of DU recurrence.
BENDAMUSTINE HYDROCHLORIDE NDA
2025-07-03
bendamustine hydrochloride
ROCURONIUM BROMIDE NDA
2025-06-09
rocuronium bromide
Routine tracheal intubation
OTULFI BLA
2025-04-30
ustekinumab-aauz
Plaque Psoriasis
CONEXXENCE BLA
2025-03-25
denosumab-bnht
Osteoporosis
TYENNE BLA
2025-03-14
tocilizumab-aazg
Rheumatoid Arthritis

Fresenius Kabi's Therapeutic Areas

Fresenius Kabi's approved drugs and pipeline span 5 therapeutic areas, led by Oncology and Infectious Disease, across 0 biologic and 14 small-molecule drugs. Weighted by commercial stage — approved drugs count most, then late-stage trials.

Oncology 26%
18 drugs Phase 1: 1
Infectious Disease 24%
17 drugs
Metabolic 19%
13 drugs Phase 1: 1
Cardiovascular 16%
11 drugs Phase 1: 2
Neurology 16%
11 drugs

Fresenius Kabi Pipeline Snapshot

Fresenius Kabi has 4 active clinical programs from ClinicalTrials.gov — 0 Phase 3, 0 Phase 2 and 4 Phase 1.

0
Phase 3
0
Phase 2
4
Phase 1

Pro Intelligence Preview

Deep insights for investors and analysts

Revenue Insights

  • • BOMYNTRA leads revenue
  • • 5 key drugs tracked

Trial Catalysts

  • • Oncology pipeline focus
  • • Phase 3 readout tracking

Patent Risk

  • • Patent expiration timeline
  • • Revenue at risk analysis

Compare Companies

  • • Side-by-side pipeline analysis
  • • Revenue & market share comparison

Execution Intelligence

  • • Phase 3: 4/5 completed
  • • Speed: 14 months avg
Unlock Full Intelligence

Revenue forecasts • Trial milestones • Patent risk modeling

How We Calculate These Metrics

Execution Quality Score

Measures trial completion rates weighted by phase importance. Phase 3 trials count 4x more than Phase 1 because late-stage completion is harder and more valuable.

What counts as "completed": A trial that reached its planned endpoint and reported results. Trials that were terminated early, withdrawn, or suspended are not counted as completed—these often indicate safety issues, lack of efficacy, or strategic pivots.

  • Excellent (80%+): Top-tier execution, most trials reach planned endpoints
  • Good (60-79%): Strong execution with occasional early terminations
  • Fair (40-59%): Average execution, notable rate of terminated/withdrawn trials
  • Needs Improvement (under 40%): High termination rates, execution challenges