Lead Product(s) : Roflumilast
Therapeutic Area : Pulmonary/Respiratory Diseases
Study Phase : Approved FDF
Sponsor : Senores Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Acquisition
Senores Pharma Gains After Arm Inks Pact to Acquire Roflumilast Tablets
Details : Senores acquire the USFDA-approved abbreviated new drug application for Roflumilast, indicated as a treatment to reduce the risk of COPD exacerbations, from Breckenridge.
Product Name : Roflumilast-Generic
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
February 21, 2025
Lead Product(s) : Roflumilast
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Sponsor : Senores Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Acquisition
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 FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
December 18, 2024
Lead Product(s) : Methadone Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
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 FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
April 22, 2022
Lead Product(s) : Dabigatran Etexilate Mesylate
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Miglustat
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
April 21, 2022
Lead Product(s) : Miglustat
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Penicillamine
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Other Small Molecule
Upfront Cash : Inapplicable
April 20, 2022
Lead Product(s) : Penicillamine
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Inapplicable
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
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
January 08, 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) : Teriflunomide
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
ANDA Approval for Teriflunomide Tablets
Details : Aubagio-Generic (teriflunomide) is a USFDA approved pyrimidine synthesis inhibitor which is indicated for the treatment of patients with relapsing forms of multiple sclerosis.
Product Name : Aubagio-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 29, 2021
Lead Product(s) : Teriflunomide
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Norepinephrine Bitartrate,Dextrose
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Levophed-Generic (norepinephrine bitartrate) is an adrenergic receptor agonist, small molecule drug candidate. Along with Dextrose it is indicated for the treatment of severe, acute hypotension
Product Name : Levophed-Generic
Product Type : Hormone
Upfront Cash : Inapplicable
August 20, 2021
Lead Product(s) : Norepinephrine Bitartrate,Dextrose
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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