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Data updated: Jun 28, 2026

AMNEAL

Generics
OncologyCardiovascularInfectious Disease Execution: Excellent

AMNEAL is a generic drug manufacturer focused on Oncology, Cardiovascular, Infectious Disease. Key products include BREKIYA (AUTOINJECTOR).

1992
Since
183
Drugs
-
Trials
6
New Drugs (2yr)
Modality:
5 Small Molecules

FDA Novel Drug Designations

(2020)
1 Novel
See 1 novel approval →
2020 ONGENTYS (OPICAPONE)

AMNEAL at a Glance

  • Strong track record with 85% execution quality across 11 trials
  • Fast trial execution (8 months median completion)

AMNEAL's Key Drugs

AMNEAL's core commercial portfolio centers on CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE, BRIMONIDINE TARTRATE AND TIMOLOL MALEATE, BREKIYA (AUTOINJECTOR), spanning Oncology and Cardiovascular — its most strategically important drugs approved in the last 15 years.

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
Gastrointestinal

Gastrointestinal Disorder

Approved 2020
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
Ophthalmology

Glaucoma

alpha-2 adrenergic receptor Approved 2022
BREKIYA (AUTOINJECTOR)
CNS

Migraine

Approved 2025
CIPROFLOXACIN AND DEXAMETHASONE
Infectious Disease

Acute Otitis Media

Approved 2020
ONGENTYS
CNS

Parkinson's Disease

COMT Approved 2020

AMNEAL's Recent FDA Approvals

AMNEAL secured 6 new FDA approvals for novel drugs (NDA/BLA) in the last two years.

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.
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.
BREKIYA (AUTOINJECTOR) NDA
2025-05-14
dihydroergotamine mesylate
Migraine
EPINEPHRINE NDA
2025-03-13
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.
PYRIDOSTIGMINE BROMIDE NDA
2024-10-04
pyridostigmine bromide
INDICATIONS AND USAGE Pyridostigmine Bromide Tablets USP are useful in the treatment of myasthenia gravis.
POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE NDA
2024-07-26
potassium phosphate, dibasic
Hypophosphatemia

AMNEAL's Therapeutic Areas

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

Oncology 29%
18 drugs Phase 2: 1
Cardiovascular 26%
16 drugs Phase 3: 1 Phase 1: 1
Infectious Disease 18%
10 drugs Phase 3: 2
Immunology 15%
9 drugs Phase 3: 1
Neurology 12%
8 drugs

AMNEAL Pipeline Snapshot

AMNEAL has 6 active clinical programs from ClinicalTrials.gov — 4 Phase 3, 1 Phase 2 and 1 Phase 1.

4
Phase 3
1
Phase 2
1
Phase 1

Pro Intelligence Preview

Deep insights for investors and analysts

Revenue Insights

  • • CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 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: 6/7 completed
  • • Speed: 8 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