Minakem Generic APIs Minakem Generic APIs

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Announces Submission of New Drug Application (NDA) of Wakix\u00ae (pitolisant) for narcolepsy with and without cataplexy in China","therapeuticArea":"Sleep","highestDevelopmentStatus":"Approved","country":"CHINA","productType":"Small molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"RareStone Group"},{"orgOrder":0,"company":"Idorsia Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Idorsia Announces its Insomnia Medication, QUVIVIQ (daridorexant), is Now Covered by CVS","therapeuticArea":"Sleep","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Idorsia Pharmaceuticals"},{"orgOrder":0,"company":"Sosei Heptares","sponsor":"Idorsia Pharmaceuticals","pharmaFlowCategory":"D","amount":"$440.0 million","upfrontCash":"Undisclosed","newsHeadline":"Sosei Heptares Announces Submission of New Drug Application in Japan for Daridorexant (ACT-541468), a Dual Orexin Receptor Antagonist for the Treatment of Insomnia","therapeuticArea":"Sleep","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Sosei Heptares"},{"orgOrder":0,"company":"Idorsia Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Europe\u2019s first Dual Orexin Receptor Antagonist \u2013 QUVIVIQ (daridorexant) \u2013 Granted Approval to Improve Both Nighttime Symptoms and Daytime Functioning in Adults with Chronic Insomnia Disorder","therapeuticArea":"Sleep","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Idorsia Pharmaceuticals"},{"orgOrder":0,"company":"Idorsia Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Idorsia\u2019s new Treatment QUVIVIQ (daridorexant) is now Available in the us for Adults Living with Insomnia","therapeuticArea":"Sleep","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Idorsia Pharmaceuticals"},{"orgOrder":0,"company":"Breckenridge Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Breckenridge Pharmaceutical, Inc. 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"}]

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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

            Arab Pharma Expo 2024

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            Details:

            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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            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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            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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            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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            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 May 01, 2023

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            Details:

            Wakix (pitolisant) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse.

            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 March 15, 2023

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