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Details:
The launch of authorized generic version of Par Pharmaceutical’s VASOSTRICT® (vasopressin injection, USP) Vials in the U.S. Market was approved by the U.S. Food and Drug Administration (USFDA).
Lead Product(s): Arginine Vasopressin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Vasopressin-Generic
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 09, 2022
Details:
Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines and Vasostrict is a RFLD.
Lead Product(s): Arginine Vasopressin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Vasostrict-Generic
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 14, 2023
Details:
Vasopressin Injection is indicated to increase blood pressure in adults with vasodilatory shocks, such as due to post-cardiotomy or sepsis, and remain hypotensive despite fluids and catecholamines.
Lead Product(s): Arginine Vasopressin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Vasopressin-Generic
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 16, 2022
Details:
Vasopressin injection 1mL is a generic version of the antidiuretic hormone Vasostrict® is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.
Lead Product(s): Arginine Vasopressin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Vasopressin-Generic
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 11, 2022
Details:
In August, the U.S. District Court for the District of Delaware held that Eagle’s proposed vasopressin product does not infringe any of the patents Par Pharmaceutical, Inc. et al. asserted against the Company.
Lead Product(s): Arginine Vasopressin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Vasopressin-Generic
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 29, 2021
Details:
The U.S. District Court for the District of Delaware issue a temporary restraining order and preliminary injunction preventing the launch of Eagle’s recently approved vasopressin product.
Lead Product(s): Arginine Vasopressin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Par Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 29, 2021
Details:
This approval follows the recent U.S. District Court for the District of Delaware decision holding that Eagle’s proposed vasopressin product does not infringe any of the patents Par Pharmaceutical, Inc. et al. asserted against the Company.
Lead Product(s): Arginine Vasopressin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Vasopressin-Generic
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2021
Details:
Eagle is first to file an Abbreviated New Drug Application (“ANDA”) referencing Vasostrict®, which had total U.S. sales of $786 million in 2020.
Lead Product(s): Arginine Vasopressin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2021
Details:
United States District Court for the District of Delaware's non-infringement found non-infringement of Endo's patents by Eagle's proposed ANDA for Par Sterile Products, LLC's VASOSTRICT® product, it did not rule on the patents' validity.
Lead Product(s): Arginine Vasopressin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Vasostrict
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2021
Details:
The U.S. FDA has issued a complete response letter for Eagle's Abbreviated New Drug Application for vasopressin. Eagle has now had two conversations with FDA regarding the CRL and will have an additional meeting with FDA within 30 days.
Lead Product(s): Arginine Vasopressin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 02, 2021
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