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Details:
Through the acquisition, Eton gains access to an abbreviated new drug application for Nitisinone Capsules via Oakrum. Nitisinone is FDA approved or the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
Lead Product(s): Nitisinone
Therapeutic Area: Genetic Disease Product Name: Nitisinone-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: Oakrum Pharma, LLC
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition October 04, 2023
Details:
FDA issued a Complete Response Letter (CRL) in response to its New Drug Application (NDA) for dehydrated alcohol injection for the treatment of methanol poisoning.
Lead Product(s): Ethanol
Therapeutic Area: Pharmacology/Toxicology Product Name: Undsclosed
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 28, 2023
Details:
Betaine anhydrous for oral solution is indicated in children and adults for the treatment of homocystinuria to decrease high homocysteine blood levels. The program will provide prescription fulfillment, insurance benefits investigation, educational support.
Lead Product(s): Betaine
Therapeutic Area: Genetic Disease Product Name: Cystadane-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 May 10, 2023
Details:
Through the acquisition, Eton will expand its portfolio with ET-600 which is an innovative product candidate under development for the treatment of an endocrinology condition.
Lead Product(s): ET-600
Therapeutic Area: Endocrinology Product Name: ET-600
Highest Development Status: UndisclosedProduct Type: Undisclosed
Recipient: Tulex Pharmaceutical
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition March 15, 2023
Details:
USFDA has accepted for review the company’s NDA response for dehydrated alcohol injection (a nerve blocking agent) for the proposed indication of methanol poisoning.
Lead Product(s): Ethanol
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
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 January 11, 2023
Details:
Betaine shares the same prescriber base as the carglumic acid tablets, so it is an attractive opportunity to leverage the existing commercial infrastructure.
Lead Product(s): Betaine
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition September 13, 2022
Details:
Zonisade is the first and only zonisamide formulation for oral liquid administration to be approved by the US Food and Drug Administration as an adjunctive therapy for the treatment of partial seizures in adults and paediatric patients aged 16 years and older with epilepsy.
Lead Product(s): Zonisamide
Therapeutic Area: Neurology Product Name: Zonisade
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Azurity Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 18, 2022
Details:
Under terms of the agreement, Dr Reddy’s purchased the Biorphen® (phenylephrine hydrochloride), Rezipres®, and Cysteine Hydrochloride products. Dr Reddy’s will immediately take ownership of Eton’s rights and interests in the products.
Lead Product(s): Phenylephrine Hydrochloride
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Biorphen
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Dr. Reddy\'s Laboratories
Deal Size: $50.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition June 24, 2022
Details:
U.S.FDA granted company,180 days of generic exclusivity as a result of being the first ANDA submitted for cysteine hydrochloride injection, a bioequivalent generic of Exela Pharma Sciences’ Elcys, against the reference product.
Lead Product(s): L-Cysteine Hydrochloride
Therapeutic Area: Nutrition and Weight Loss Product Name: Cysteine 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 April 11, 2022
Details:
Under terms of the agreement, Tolmar’s sales force will promote ALKINDI SPRINKLE® to their pediatric endocrinology targets alongside FENSOLVI®. ALKINDI SPRINKLE® (hydrocortisone) oral granules is FDA-approved as replacement therapy for Adrenocortical Insufficiency (AI).
Lead Product(s): Hydrocortisone
Therapeutic Area: Endocrinology Product Name: Alkindi Sprinkle
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: Tolmar
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement November 15, 2021
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