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[{"orgOrder":0,"company":"Osmotica Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Osmotica Pharmaceuticals US LLC Submits Amended NDA for Arbaclofen Extended Release Tablets to U.S. Food and Drug Administration","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Osmotica Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Osmotica Pharmaceuticals plc Receives FDA Approval for Upneeq for Acquired Blepharoptosis (Droopy Eyelid) in Adults","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Approved"},{"orgOrder":0,"company":"Osmotica Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Osmotica Pharmaceutical US LLC Announces FDA User Fee Goal Date of December 29, 2020 for Arbaclofen Extended Release Tablets","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Osmotica Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"JAMA Ophthalmology Publishes Pooled Analysis of Data from two Phase 3 Clinical Trials of Osmotica's Upneeq\u2122 for Acquired Ptosis","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Approved"},{"orgOrder":0,"company":"Osmotica Pharmaceuticals","sponsor":"Adamas Pharmaceuticals","pharmaFlowCategory":"D","amount":"$7.5 million","upfrontCash":"Undisclosed","newsHeadline":"Osmotica Pharmaceuticals plc Announces Agreement to Settle Patent Litigation with Adamas","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Osmotica Pharmaceuticals","sponsor":"Adamas Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Adamas Completes Acquisition of OSMOLEX ER\u00ae","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Osmotica Pharmaceuticals","sponsor":"Alora Pharmaceuticals","pharmaFlowCategory":"D","amount":"$170.0 million","upfrontCash":"$110.0 million","newsHeadline":"Osmotica Announces Conclusion of Strategic Process with Agreement for the Sale of Legacy Business to Alora Pharmaceuticals, LLC","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Approved"},{"orgOrder":0,"company":"Osmotica Pharmaceuticals","sponsor":"Athyrium Capital Management","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Osmotica Pharmaceuticals plc Announces Debt Financing from Athyrium Capital Management of up to $100 Million","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Approved"},{"orgOrder":0,"company":"Osmotica Pharmaceuticals","sponsor":"Osmotica Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Brand Institute Partners on Brand Name Development for FDA Approved Treatment for Attention Deficit Hyperactivity Disorder (ADHD)","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"}]

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            Details:

            RELEXXII® (methylphenidate hydrochloride extended-release tablets) is an oral medication indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults up to the age of 65 and pediatric patients 6 years of age and older.

            Lead Product(s): Methylphenidate Hydrochloride

            Therapeutic Area: Psychiatry/Psychology Product Name: Relexxii

            Highest Development Status: Approved Product Type: Small molecule

            Recipient: Brand Institute

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 11, 2022

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            The financing provides the Company with additional cash to support the commercialization of Upneeq. As a first-in-class treatment for acquired ptosis, Upneeq offers patients and clinicians a convenient non-surgical therapeutic option.

            Lead Product(s): Oxymetazoline Hydrochloride

            Therapeutic Area: Ophthalmology Product Name: Upneeq

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Athyrium Capital Management

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Financing October 07, 2021

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            Osmotica will retain the RVL Pharmaceuticals business focused on ophthalmology and aesthetics, led by its flagship product, UPNEEQ (Oxymetazoline Hydrochloride).

            Lead Product(s): Oxymetazoline Hydrochloride

            Therapeutic Area: Ophthalmology Product Name: Upneeq

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Alora Pharmaceuticals

            Deal Size: $170.0 million Upfront Cash: $110.0 million

            Deal Type: Divestment June 25, 2021

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            Through this acquisition, OSMOLEX ER joins the Adamas portfolio which includes GOCOVRI® extended-release capsules for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy with or without concomitant dopaminergic medications.

            Lead Product(s): Amantadine Hydrochloride

            Therapeutic Area: Neurology Product Name: Osmolex ER

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Adamas Pharmaceuticals

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition January 05, 2021

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            Under the terms of the agreement, both parties will drop their respective claims relating to the patent litigation, and Adamas will acquire the global rights to OSMOLEX ER for $7.5 million.

            Lead Product(s): Amantadine Hydrochloride

            Therapeutic Area: Neurology Product Name: Osmolex ER

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Adamas Pharmaceuticals

            Deal Size: $7.5 million Upfront Cash: Undisclosed

            Deal Type: Agreement December 02, 2020

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            Details:

            Phase 3 trials showed UPNEEQ was associated with positive outcomes after instillation on days 1 and 14 and was well-tolerated, demonstrating its potential promise for the treatment of acquired ptosis.

            Lead Product(s): Oxymetazoline Hydrochloride

            Therapeutic Area: Ophthalmology Product Name: Upneeq

            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 October 01, 2020

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            Osmotica Pharmaceuticals plc is developing arbaclofen ER tablets for the treatment of spasticity in patients with MS. This program aims to demonstrate the clinical efficacy and safety of arbaclofen ER tablets in patients with spasticity due to MS.

            Lead Product(s): Baclofen

            Therapeutic Area: Neurology Product Name: AERT

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 20, 2020

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            Details:

            U.S FDA has approved Upneeq (oxymetazoline hydrochloride ophthalmic solution), 0.1%, formerly known as RVL-1201, its novel treatment for acquired blepharoptosis, or ptosis, a condition characterized by the abnormal drooping of the upper eyelid that can limit field of vision.

            Lead Product(s): Oxymetazoline Hydrochloride

            Therapeutic Area: Ophthalmology Product Name: Upneeq

            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 09, 2020

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            Submission based on world’s largest database of patients treated for spasticity associated with Multiple Sclerosis.

            Lead Product(s): Baclofen

            Therapeutic Area: Neurology Product Name: AERT

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 30, 2020

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