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Announces Launch of Zolpidem Tartrate Extended-Release Tablets, USP (generic for Ambien\u00ae CR)","therapeuticArea":"Sleep","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Breckenridge Pharmaceutical"},{"orgOrder":0,"company":"Harmony Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HARMONY BIOSCIENCES Receives FDA Approval for WAKIX\u00ae in Pediatric Narcolepsy","therapeuticArea":"Sleep","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Harmony Biosciences"}]

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            Details:

            Ambien-Generic (zolpidem tartrate) is a small molecule, GABA A receptor alpha-1/beta-1/gamma-2 positive allosteric modulator. It is indicated for the treatment of insomnia.

            Lead Product(s): Zolpidem Tartrate

            Therapeutic Area: Sleep Product Name: Ambien-Generic

            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 July 08, 2021

            Breckenridge Pharmaceutical

            IPS 2024

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            Details:

            Wakix (pitolisant) is an oral H3 receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of narcolepsy in pediatric patients 6 years of age and older.

            Lead Product(s): Pitolisant Hydrochloride

            Therapeutic Area: Sleep Product Name: Wakix

            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 24, 2024

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            Sosei Heptares gained Japan and Asia-Pacific (ex-China) rights to ACT-541468 (daridorexant), a dual orexin receptor antagonist being developed for the treatment of adult patients with insomnia, from Idorsia.

            Lead Product(s): Daridorexant HCl

            Therapeutic Area: Sleep Product Name: Quviviq

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Idorsia Pharmaceuticals

            Deal Size: $440.0 million Upfront Cash: Undisclosed

            Deal Type: Acquisition October 31, 2023

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            Quviviq (daridorexant) is a dual orexin receptor antagonist (DORA) acting on both orexin 1 and orexin 2 receptors equipotently, approved for the management of adult patients with insomnia.

            Lead Product(s): Daridorexant

            Therapeutic Area: Sleep Product Name: Quviviq

            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 July 10, 2023

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            Wakix (pitolisant) is a selective histamine 3 (H3) receptor antagonist/inverse agonist, which was granted orphan drug designation for the treatment of narcolepsy by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

            Lead Product(s): Pitolisant Hydrochloride

            Therapeutic Area: Sleep Product Name: Wakix

            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 July 04, 2023

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            sodium oxybate oral solution indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy.

            Lead Product(s): Sodium Oxybate

            Therapeutic Area: Sleep Product Name: Xyrem-Generic

            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 July 03, 2023

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            Details:

            Quviviq (daridorexant) is a dual orexin receptor antagonist (DORA) acting on both orexin 1 and orexin 2 receptors equipotently, it is being developed for the management of adult patients with insomnia.

            Lead Product(s): Daridorexant

            Therapeutic Area: Sleep Product Name: Quviviq

            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 12, 2023

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            Details:

            Lumryz (sodium oxybate) is a once-nightly formulation of the USFDA approved central nervous system depressant sodium oxybate in development for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.

            Lead Product(s): Sodium Oxybate

            Therapeutic Area: Sleep Product Name: Lumryz

            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 05, 2023

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            Details:

            Quviviq™ (daridorexant) is a dual orexin receptor antagonist (DORA) acting on both orexin 1 and orexin 2 receptors equipotently, it is being developed for the management of adult patients with insomnia.

            Lead Product(s): Daridorexant

            Therapeutic Area: Sleep Product Name: Quviviq

            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, 2023

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