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Details:
The received FDA approval will allow Breckenridge, to launch generic Teriflunomide in the US market from the beginning of 2023 onwards. Teriflunomide, a small molecule is a generic of Aubagio® available in 7mg & 14mg Tablets.
Lead Product(s): Teriflunomide
Therapeutic Area: Immunology Product Name: Teriflunomide-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Breckenridge Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 06, 2021
RDD 2024
Not Confirmed
Contact SupplierDetails:
The approval confirms Aubagio as the first oral multiple sclerosis (MS) therapy for first-line treatment of children and adolescents with MS in the European Union.
Lead Product(s): Teriflunomide
Therapeutic Area: Immunology Product Name: Aubagio
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 18, 2021
RDD 2024
Not Confirmed
Contact SupplierDetails:
Aubagio (teriflunomide) is an immunomodulatory agent with anti-inflammatory properties, inhibits dihydroorotate dehydrogenase. It is being developed for the treatment of children and adolescents 10 to 17 years of age with relapsing forms of multiple sclerosis.
Lead Product(s): Teriflunomide
Therapeutic Area: Neurology Product Name: Aubagio
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 June 15, 2021
RDD 2024
Not Confirmed
Contact SupplierDetails:
Aubagio-Generic (teriflunomide) is a USFDA approved pyrimidine synthesis inhibitor which is indicated for the treatment of patients with relapsing forms of multiple sclerosis.
Lead Product(s): Teriflunomide
Therapeutic Area: Neurology Product Name: Aubagio-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 September 29, 2021
Details:
Teriflunomide is a pyrimidine synthesis inhibitor with anti-inflammatory and immunomodulatory properties used to treat patients with the relapsing-remitting form of multiple sclerosis.
Lead Product(s): Teriflunomide
Therapeutic Area: Immunology Product Name: Teriflunomide-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 June 01, 2022
RDD 2024
Not Confirmed
Contact SupplierDetails:
Teriflunomide is a novel disease-modifying agent,primarily an inhibitor of dihydroorotate-dehydrogenase (DHODH), a key mitochondrial enzyme involved in the de novo synthesis of pyrimidines in rapidly proliferating cells.
Lead Product(s): Teriflunomide
Therapeutic Area: Immunology Product Name: Teriflunomide-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 February 23, 2021
RDD 2024
Not Confirmed
Contact SupplierDetails:
Teriflunomide, an immunomodulatory agent with anti-inflammatory properties, inhibits dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo pyrimidine synthesis. It is indicated for the treatment of relapsing forms of multiple sclerosis.
Lead Product(s): Teriflunomide
Therapeutic Area: Neurology Product Name: Aubagio-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 13, 2023
Details:
Aubagio-Generic (teriflunomide) is an immunomodulatory agent with anti-inflammatory properties, inhibits dihydroorotate dehydrogenase. It is indicated for the treatment of patients with relapsing remitting multiple sclerosis.
Lead Product(s): Teriflunomide
Therapeutic Area: Neurology Product Name: pms-Teriflunomide
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 27, 2022
Details:
When ublituximab binds to the B-cell it triggers a series of immunological reactions, including antibody-dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC), leading to destruction of the cell.
Lead Product(s): Ublituximab,Teriflunomide
Therapeutic Area: Neurology Product Name: TG-1101
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 25, 2022
Details:
The submission was based on the results of the ULTIMATE I & II trials, two identical Phase 3, randomized, global, multi-center, double-blinded, active-controlled trials evaluating ublituximab compared to teriflunomide in patients with RMS.
Lead Product(s): Ublituximab,Teriflunomide
Therapeutic Area: Neurology Product Name: TG-1101
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2021
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