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  • TABLET;ORAL - 0.0125MG;0.0031MG
  • TABLET;ORAL - 0.025MG;0.0063MG
  • TABLET;ORAL - 0.05MG;0.0125MG
  • TABLET;ORAL - 0.15MG;0.0375MG
  • TABLET;ORAL - 0.1MG;0.025MG
  • POWDER;INTRAVENOUS - 100MCG/VIAL
  • POWDER;INTRAVENOUS - 200MCG/VIAL
  • POWDER;INTRAVENOUS - 500MCG/VIAL
  • TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • TABLET;ORAL - 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
  • CAPSULE;ORAL - 0.013MG
  • CAPSULE;ORAL - 0.025MG
  • CAPSULE;ORAL - 0.0375MG
  • CAPSULE;ORAL - 0.044MG
  • CAPSULE;ORAL - 0.05MG
  • CAPSULE;ORAL - 0.0625MG
  • CAPSULE;ORAL - 0.075MG
  • CAPSULE;ORAL - 0.088MG
  • CAPSULE;ORAL - 0.112MG
  • CAPSULE;ORAL - 0.125MG
  • CAPSULE;ORAL - 0.137MG
  • CAPSULE;ORAL - 0.15MG
  • CAPSULE;ORAL - 0.175MG
  • CAPSULE;ORAL - 0.1MG
  • CAPSULE;ORAL - 0.2MG

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 IIProduct 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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Details:

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: ApprovedProduct 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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Details:

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: ApprovedProduct 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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Details:

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 IProduct 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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Details:

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 IProduct 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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Details:

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: ApprovedProduct 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: ApprovedProduct 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: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Cediprof

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement July 16, 2020

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