TheraRadar
Data updated: Jun 28, 2026

KYNMOBI (apomorphine hydrochloride) · SUMITOMO PHARMA AM

CNS Approved 2020-05-21

KYNMOBI is FDA-approved to treat 1 condition (same as ONAPGO).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
6
Years on Market

Details

Status
Discontinued
First Approved
2020-05-21
Patent Cliff
2036

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Patent cliff and revenue data

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Routes
SUBLINGUAL
Dosage Forms
FILM

Companies

SUMITOMO PHARMA AM
Active Ingredient: APOMORPHINE HYDROCHLORIDE

KYNMOBI Approval History

2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
15 FDA actions from 2020 to 2022 · 1 indication expansions
Sep 2022 SUPPL
Efficacy
FDA Letter Label
May 2022 SUPPL
Label · Labeling
FDA Letter Label
May 2020 ORIGINAL
New Form · Type 3 - New Dosage Form
FDA Letter Label

What KYNMOBI Treats

1 indications

KYNMOBI is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as ONAPGO (same active ingredient).

Source: FDA Label

SUMITOMO PHARMA AM's other novel FDA approvals

Other CDER-designated drugs from the same sponsor (2016–2025).

GEMTESA
2020
VIBEGRON
ORGOVYX
2020
RELUGOLIX
1 designation
📋

Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT02006121 TOLEDO results posted CT-37527-13-0124 2013-000980-10 Ph 3 completed Clinical Trial of Apomorphine Subcutaneous Infusion in Patients With Advanced Parkinson's Disease
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

KYNMOBI FDA Label Details

Indications & Usage

FDA Label (PDF)

KYNMOBI is FDA-approved to treat 1 condition — same approved indications as ONAPGO.

View full patent landscape →
12 OB patents · 4 families · 185 international docs across 23 countries

KYNMOBI Patents & Exclusivity

Latest Patent: Apr 2036

Patents (12 active)

US10449146 Expires Apr 19, 2036
US10959943 Expires Apr 19, 2036
US11419769 Expires Dec 16, 2031
US8414922 Expires Dec 16, 2031
US8846074 Expires Dec 16, 2031
US9669021 Expires Jun 11, 2030
US9669019 Expires Jun 11, 2030
US9283219 Expires Jun 11, 2030
US10420763 Expires Jun 11, 2030
US9326981 Expires Jun 11, 2030
US9044475 Expires Jun 11, 2030
US10821074 Expires Aug 7, 2029
Source: FDA Orange Book

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Revenue Insights

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Patent Timeline

  • • Cliff: 2036
  • • 300 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA210875 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.