Details:
Diazepam Injection is a ready-to-administer prefilled syringes which is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.
Lead Product(s): Diazepam
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 31, 2023
Details:
Brixadi™ (buprenorphine) injection for SC, will be indicated for the treatment of severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.
Lead Product(s): Buprenorphine
Therapeutic Area: Psychiatry/Psychology Product Name: Brixadi
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2023
Details:
The approval includes new higher Buvidal monthly 160 mg dose direct initiation onto Buvidal weekly, changing the contraindications in pregnancy and lactation to precautions.
Lead Product(s): Buprenorphine
Therapeutic Area: Psychiatry/Psychology Product Name: Buvidal
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 03, 2021
Details:
The new patent, US Patent further strengthens the company's intellectual property for ZUBSOLV® in the US. Orexo will now have six patents listed in the Orange Book for ZUBSOLV®.
Lead Product(s): Buprenorphine Hydrochloride,Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Zubsolv
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 30, 2020
Details:
Under the terms of the agreement, Orexo will be responsible for product supply and Accord will take responsibility for the commercialisation of ZUBSOLV®. Orexo will receive double-digit royalties on future net sales.
Lead Product(s): Buprenorphine Hydrochloride,Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Zubsolv
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Accord healthcare
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement December 07, 2020
Details:
The pivotal Phase 3 efficacy and safety trial demonstrated that Brixadi met the primary endpoint of non-inferiority for responder rate vs current standard of care and superiority for the secondary endpoint for the percentage of negative opioid assessments.
Lead Product(s): Buprenorphine
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2020