X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
Canada
0
Australia
South Africa
0
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
0
Details:
SPN-830 (apomorphine) is a novel and less invasive therapy, which is acts as dopamine D2 receptor agonist, which is investigated for the treatment of motor fluctuations (OFF episodes) in Parkinson’s disease.
Lead Product(s): Apomorphine Hydrochloride
Therapeutic Area: Neurology Product Name: SPN-830
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2023
Details:
SPN-830 (apomorphine) is a novel and less invasive therapy, which is acts as dopamine D2 receptor agonist, which is investigated for the treatment of motor fluctuations (OFF episodes) in Parkinson’s disease.
Lead Product(s): Apomorphine Hydrochloride
Therapeutic Area: Neurology Product Name: SPN-830
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 09, 2023
Details:
Sage is the "first approved applicant" for Apomorphine Hydrochloride Injection, 30 mg/3 mL (10 mg/mL), Single-Patient-Use glass cartridge for use with a reusable pen injector (APOKYN® Pen).
Lead Product(s): Apomorphine Hydrochloride
Therapeutic Area: Neurology Product Name: Apomorphine Hydrochloride-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2022
Details:
U.S.FDA notice for company’s NDA, resubmission for SPN-830 for treatment of motor fluctuations in Parkinson’s disease is considered a standard review thereby assigning a timeline of 10 months for review by FDA and establishing a PDUFA target action date in early October 2022.
Lead Product(s): Apomorphine Hydrochloride
Therapeutic Area: Neurology Product Name: SPN-830
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2022
Details:
Company announced resubmission of NDA for SPN-830 (Apomorphine Hydrochloride) for the continuous treatment of motor fluctuations in Parkinson’s Disease.
Lead Product(s): Apomorphine Hydrochloride
Therapeutic Area: Neurology Product Name: SPN-830
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 08, 2021
Details:
The acquisition of AL-101 brings in a product with a substantially large market potential for existing and unmet medical needs into the Company. AL-101 has shown a safety and efficacy profile and is phase 3 ready with 6 clinical trials completed and over 200 patients treated.
Lead Product(s): Apomorphine Hydrochloride
Therapeutic Area: Neurology Product Name: AL-101
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Oncotelic Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition October 04, 2021
Details:
Under the terms of the agreement, BIAL will be responsible for regulatory approvals and submissions, including interactions with the European Medicines Agency (EMA) for APL-130277, which is currently in Phase 3 clinical development in Europe.
Lead Product(s): Apomorphine Hydrochloride
Therapeutic Area: Neurology Product Name: Kynmobi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bial
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement September 02, 2021
Details:
The acquisition of AL-101 (intranasal apomorphine), expands Oncotelic's product portfolio. AL-101 will also be developed as a new drug against Female Sexual Dysfunction ("FSD"), including Hypoactive Sexual Desire Disorder ("HSDD").
Lead Product(s): Apomorphine Hydrochloride
Therapeutic Area: Neurology Product Name: AL-101
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Oncotelic Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition September 01, 2021
Details:
Marathon will receive all royalties and other payments due under Aquestive’s license agreement with Sunovion Pharmaceuticals as a result of commercialization of KYNMOBI™ sublingual film for acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease.
Lead Product(s): Apomorphine Hydrochloride
Therapeutic Area: Neurology Product Name: Kynmobi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Marathon Asset Management
Deal Size: $125.0 million Upfront Cash: Undisclosed
Deal Type: Agreement November 03, 2020
Details:
Sunovion Pharmaceuticalsannounced today that Health Canada has approved KYNMOBI™ (apomorphine HCI) soluble film for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD).
Lead Product(s): Apomorphine Hydrochloride
Therapeutic Area: Neurology Product Name: Kynmobi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2020
Details:
This acquisition significantly expands Supernus' business in CNS and increases and diversifies its revenue and earnings streams, while continuing to maintain a strong balance sheet.
Lead Product(s): Apomorphine Hydrochloride
Therapeutic Area: Neurology Product Name: Apokyn
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Supernus Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition June 09, 2020
Details:
In a Phase 3 study, patients with Parkinson’s disease treated with KYNMOBI experienced significant improvements in motor symptoms at 30 minutes, compared to placebo.
Lead Product(s): Apomorphine Hydrochloride
Therapeutic Area: Neurology Product Name: Kynmobi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 21, 2020
Details:
Acquisition adds three products developed and sold in the U.S. market with a late-stage development candidate in the Supernus pipeline: APOKYN ®, MYOBLOC ® XADAGO ® and Apomorphine Infusion Pump.
Lead Product(s): Apomorphine Hydrochloride
Therapeutic Area: Neurology Product Name: Apokyn
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Supernus Pharmaceuticals
Deal Size: $530.0 million Upfront Cash: $300.0 million
Deal Type: Acquisition April 28, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
