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[{"orgOrder":0,"company":"Lannett Company, Inc.","sponsor":"Cediprof","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Lannett and Cediprof Announce Exclusive Distribution Agreement for An Approved Levothyroxine","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Mannkind","sponsor":"Vertice Pharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"MannKind and Vertice to Co-Promote Thyquidity\u2122 (levothyroxine sodium) Oral Solution","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"IBSA Institut Biochimique","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Study Confirms the Stability and Potency of a Novel Formulation of Liquid Levothyroxine","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Xeris Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Xeris Pharmaceuticals Completes Enrollment of Its Phase 1 Study of Levothyroxine (XP-8121)","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase I"},{"orgOrder":0,"company":"IBSA Institut Biochimique","sponsor":"Mark Cuban Cost Plus Drug Company","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"IBSA Pharma and Mark Cuban Cost Plus Drug Company Team Up to Make Tirosint More Affordable","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Xeris Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Xeris Biopharma Announces Plans for a Phase II Dose-Finding Study for Its Investigational Subcutaneous (SC) Levothyroxine (XP-8121) as Replacement Therapy for Hypothyroidism","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase I"},{"orgOrder":0,"company":"Zydus Lifesciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zydus Receives Final Approval from the USFDA for Levothyroxine Sodium for Injection","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Approved"},{"orgOrder":0,"company":"Xeris Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Xeris Biopharma Announces First Participant Dosed in a Phase 2 Clinical Study of Its Investigational Subcutaneous (SC) Levothyroxine (XP-8121) in Patients with Hypothyroidism","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase II"}]

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            Details:

            XP-8121 (levothyroxine) is a Investigational Subcutaneous injection thus indicated for acquired thyroid disease (primary hypothyroidism), in cases of decreased secretion of TSH from the anterior pituitary gland (secondary hypothyroidism),

            Lead Product(s): Levothyroxine Sodium

            Therapeutic Area: Endocrinology Product Name: XP-8121

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 21, 2023

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            Levothyroxine sodium is a medicine used to treat an underactive thyroid gland (hypothyroidism). The thyroid gland makes thyroid hormones which help to control energy levels and growth. Levothyroxine is taken to replace the missing thyroid hormone thyroxine.

            Lead Product(s): Levothyroxine Sodium

            Therapeutic Area: Rare Diseases and Disorders Product Name: Levothyroxine Sodium-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 March 28, 2023

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            Tirosint capsules is the leading branded gel capsule formulation of levothyroxine sodium in the US. It is formulated without excipients that can cause tolerability and drug absorption problems commonly observed with traditional levothyroxine tablet therapies.

            Lead Product(s): Levothyroxine Sodium

            Therapeutic Area: Endocrinology Product Name: Tirosint

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Mark Cuban Cost Plus Drug Company

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement March 07, 2023

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            XP-8121 (levothyroxine sodium) is administered when the body is deficient in the endogenous hormone and indicated for acquired thyroid disease (primary hypothyroidism), in cases of decreased secretion of TSH from the anterior pituitary gland (secondary hypothyroidism).

            Lead Product(s): Levothyroxine Sodium

            Therapeutic Area: Endocrinology Product Name: XP-8121

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 15, 2022

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            XP-8121 is a novel formulation that could potentially mitigate challenges linked to oral formulations, such as identification of an ideal dose due to absorption variation and medication adherence for patients who have difficulty maintaining a stable, therapeutic serum level.

            Lead Product(s): Levothyroxine Sodium

            Therapeutic Area: Endocrinology Product Name: XP-8121

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 01, 2021

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            The study examined the potency and consistency of Tirosint-SOL marketed by IBSA Pharma Inc, using the same methodology as the previous study to determine the degree to which the product maintains its labeled potency over a five-week period.

            Lead Product(s): Levothyroxine Sodium

            Therapeutic Area: Endocrinology Product Name: Tirosint-SOL

            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 April 30, 2021

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            Details:

            Vertice will make a specified quarterly payment to MannKind to defray the costs of the additional promotional activity and will pay MannKind royalties on gross profit resulting from all sales of Thyquidity.

            Lead Product(s): Levothyroxine Sodium

            Therapeutic Area: Endocrinology Product Name: Thyquidity

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Vertice Pharma

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement December 17, 2020

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            Details:

            The companies have entered into an interim exclusive supply and distribution agreement for Cediprof's FDA approved Levothyroxine Sodium Tablets USP. Lannett to Commence Marketing on August 3, 2020.

            Lead Product(s): Levothyroxine Sodium

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Cediprof

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement July 16, 2020

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