Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Everolimus
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Breckenridge Gains FDA Nod for Everolimus, Afinitor Disperz Generic
Details : Afinitor Disperz (everolimus) is an mTOR inhibitor small molecule drug candidate, which is currently being evaluated for the treatment of tuberous sclerosis complex.
Product Name : Afinitor Disperz-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 29, 2025
Lead Product(s) : Everolimus
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Methadone Hydrochloride
Therapeutic Area : Neurology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Breckenridge Announces final FDA Approval for Methadone Hydrochloride Multi-Dose Injection
Details : Methadone HCl Multi-Dose Vial is a Mu opioid receptor agonist indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic.
Product Name : Undisclosed
Product Type : Small molecule
Upfront Cash : Not Applicable
December 18, 2024
Lead Product(s) : Methadone Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Cabazitaxel
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Natco Pharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Cabazitaxel Intravenous Powder (generic for Jevtana Kit®), is a Microtubule inhibitor, available in the 60mg/1.5mL (40mg/mL) strength used fo the treatment of Prostate cancer.
Product Name : Cabazitaxel-Generic
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
August 01, 2022
Lead Product(s) : Cabazitaxel
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Natco Pharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Cabazitaxel
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Natco Pharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Natco Pharma's Partner Breckenridge Gets FDA Nod for Prostate Cancer Drug
Details : Cabazitaxel intravenous powder of strength 60mg/1.5ml (40mg/ml), is an antineoplastic agent and a microtubule inhibitor used in the treatment of prostate cancer.
Product Name : Cabazitaxel-Generic
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
July 25, 2022
Lead Product(s) : Cabazitaxel
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Natco Pharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dabigatran Etexilate Mesylate
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Dabigatran Etexilate Capsules (generic for Pradaxa®), is good at preventing blood clots that can cause a stroke or heart attack, but it can be very expensive and must be used carefully in patients with kidney problems.
Product Name : Dabigatran Etexilate-Generic
Product Type : Small molecule
Upfront Cash : Not Applicable
April 22, 2022
Lead Product(s) : Dabigatran Etexilate Mesylate
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Miglustat
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Breckenridge Announces Approval of its ANDA for Miglustat Capsules (generic for Zavesca®)
Details : Miglustat Capsules (generic for Zavesca), 100mg strength, is an inhibitor of the enzyme glucosylceramide synthase, which is a glucosyl transferase enzyme responsible for first step in synthesis of most glycosphingolipids.
Product Name : Miglustat-Generic
Product Type : Small molecule
Upfront Cash : Not Applicable
April 21, 2022
Lead Product(s) : Miglustat
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Penicillamine
Therapeutic Area : Genetic Disease
Study Phase : Approved
Recipient : Aggrega Pharma
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Penicillamine Capsules, USP (generic for Cuprimine®), a chelating agent recommended for the removal of excess copper in patients with Wilson's disease also in cystinuria, and in patients with severe, active rheumatoid arthritis.
Product Name : Pencillamine-Generic
Product Type : Small molecule
Upfront Cash : Not Applicable
April 20, 2022
Lead Product(s) : Penicillamine
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Recipient : Aggrega Pharma
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Penicillamine
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Cuprimine-Generic (penicillamine) is a copper chelating agent, small molecule drug candidate, which is being evauated for the treatment of Wilson's disease.
Product Name : Cuprimine-Generic
Product Type : Small molecule
Upfront Cash : Not Applicable
April 20, 2022
Lead Product(s) : Penicillamine
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Lacosamide
Therapeutic Area : Neurology
Study Phase : Approved
Recipient : MSN Laboratories
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Lacosamide Tablets, USP (generic version of Vimpat), indicated for the prevention and control of seizures, enhances the slow inactivation of voltage-gated sodium channels without affecting the fast inactivation of voltage-gated sodium channels.
Product Name : Lacosamide-Generic
Product Type : Small molecule
Upfront Cash : Not Applicable
April 19, 2022
Lead Product(s) : Lacosamide
Therapeutic Area : Neurology
Highest Development Status : Approved
Recipient : MSN Laboratories
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Teriflunomide
Therapeutic Area : Immunology
Study Phase : Approved
Recipient : Axplora
Deal Size : Not Applicable
Deal Type : Not Applicable
Teriflunomide – API and Licensing Agreements for Tablets Available
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.
Product Name : Teriflunomide-Generic
Product Type : Small molecule
Upfront Cash : Not Applicable
October 06, 2021
Lead Product(s) : Teriflunomide
Therapeutic Area : Immunology
Highest Development Status : Approved
Recipient : Axplora
Deal Size : Not Applicable
Deal Type : Not Applicable