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Details:
Treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds, and inhibition of platelet aggregation. It is indicated for the treatment for pulmonary arterial hypertension.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Remodulin-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 April 21, 2023
Details:
Treprostinil is a solution for infusion and act as platelet aggregation, which being evaluated for the treatment of patients with pulmonary arterial hypertension.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Treprostinil-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 12, 2022
Details:
Under the terms agreement, Sagard Healthcare will receive royalty payments on net sales of Tyvaso DPI (treprostinil) inhalation powder indicated for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Tyvaso DPI
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mannkind
Deal Size: $200.0 million Upfront Cash: Undisclosed
Deal Type: Agreement January 02, 2024
Details:
Tyvaso (treprostinil) inhalation solution is an approved prostacyclin mimetic indicated for the treatment of Pulmonary arterial hypertension. It is under phase 3 clinical development for progressive pulmonary fibrosis.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Tyvaso
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 31, 2023
Details:
Liquidia will be responsible for development, regulatory and commercial activities of L606, an inhaled, sustained-release formulation of treprostinil being evaluated for treating PAH and pulmonary hypertension associated with interstitial lung disease, in North America.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: L606
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Liquidia Corporation
Deal Size: $225.0 million Upfront Cash: $10.0 million
Deal Type: Collaboration June 28, 2023
Details:
Liquidia intends to use the proceeds to fund the potential launch of Yutrepia, an inhaled dry powder formulation of treprostinil, upon final regulatory approval by the U.S. FDA and to support the continued clinical development of Yutrepia.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Yutrepia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: HealthCare Royalty
Deal Size: $100.0 million Upfront Cash: Undisclosed
Deal Type: Financing January 09, 2023
Details:
Treprostinil Injection contains the same active ingredient, same strengths, same dosage form and same inactive ingredients as Remodulin® (treprostinil). Liquidia Technologies has developed YUTREPIA™ (treprostinil) inhalation powder for the treatment of PAH.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Treprostinil-Generic
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mainbridge Health Partners
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration December 05, 2022
Details:
Remodulin (treprostinil) is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) to diminish symptoms associated with exercise.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Remodulin
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 31, 2022
Details:
Data from the FREEDOM-EV open label extension study of Orenitram® details an association with improved survival and, separately, its effects as part of a combination therapy regimen in patients with pulmonary arterial hypertension.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Tyvaso
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2022
Details:
TYVASO (treprostinil) inhalation solution and TYVASO DPI (treprostinil) inhalation powder are prostacyclin mimetics indicated for the treatment of Pulmonary arterial hypertension.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Tyvaso
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 11, 2022
Details:
TYVASO (treprostinil) Inhalation Solution and TYVASO DPI (treprostinil) Inhalation Powder are prescription medicines used in adults to treat Pulmonary arterial hypertension.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Tyvaso DPI
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2022
Details:
YUTREPIA/Tyvaso (treprostinil) inhalation powder, is an investigational, inhaled dry powder formulation of treprostinil delivered through a proven, convenient, palm-sized device for the treatment of pulmonary arterial hypertension.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Tyvaso
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: United Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 19, 2022
Details:
Studies with TYVASO (Treprostinil) establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Tyvaso DPI
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 2022
Details:
In subjects with PAH, transition from Tyvaso Inhalation Solution to Tyvaso DPI (Treprostinil) demonstrated safety and tolerance during 3 week treatment phase with significant improvements in six minute walk distance, device preference and satisfaction, and outcomes.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Tyvaso DPI
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 2022
Details:
In subjects with PAH, transition from Tyvaso to Tyvaso DPI (treprostinil), demonstrated safety and tolerability with significant improvements in six-minute walk distance, device preference and satisfaction, and patient reported outcomes.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Tyvaso Dpi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2022
Details:
Under the agreement, Ferrer has been appointed as the exclusive, worldwide distributor to commercialise Tyvaso (treprostinil) for the treatment of PH-ILD, a rare, serious and progressive disease without an approved treatment in Europe and many other parts of the world.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Tyvaso
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Ferrer Internacional
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement February 28, 2022
Details:
YUTREPIA is indicated for the treatment of pulmonary arterial hypertension to improve exercise ability in adult patients. Tentative approval indicates that YUTREPIA has met all regulatory standards required for approval.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Yutrepia
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 08, 2021
Details:
Tyvaso DPI is drug-device combination product comprised of dry powder formulation of treprostinil Inhalation Powder. The FDA declined to approve NDA, noting only one deficiency related to open inspection issue at a third-party analytical testing center for treprostinil.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Tyvaso Dpi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 18, 2021
Details:
TYVASO DPI (treprostinil) Inhalation Powder are prescription medicines used in adults to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), to improve exercise capacity.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Tyvaso DPI
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 18, 2021
Details:
In subjects with PAH, transition from Tyvaso® to Tyvaso DPI™ demonstrated safety and tolerance with significant improvements in six-minute walk distance, device preference and satisfaction, and patient reported outcomes.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Tyvaso DPI
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 07, 2021
Details:
A next-generation formulation of treprostinil, Tyvaso DPI incorporates the dry powder formulation technology and Dreamboat® inhalation device technology used in MannKind’s Afrezza® (insulin human) Inhalation Powder.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Tyvaso DPI
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mannkind
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 16, 2021
Details:
TYVASO DPI (treprostinil) Inhalation Powder are prescription medicines used in adults to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), to improve exercise capacity.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Tyvaso DPI
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 16, 2021
Details:
Treprostinil Injection is the first-to-file, fully substitutable generic treprostinil for parenteral administration. it's used to treat PAH patients in US.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Remodulin-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: United Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 2021
Details:
LIQ861 (treprostinil) Inhalation Powder and act as platelet aggregation, which being evaluated for the treatment of patients with pulmonary arterial hypertension.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: LIQ861
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 10, 2021
Details:
The submission includes the results of the recently-completed BREEZE clinical study evaluating the use of Tyvaso DPI in PAH patients transitioning from Tyvaso (treprostinil) Inhalation Solution, along with additional pharmacokinetic data from a study in healthy volunteers.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Tyvaso DPI
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2021
Details:
Remodulin (treprostinil) is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) to diminish symptoms associated with exercise.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Remodulin
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: DEKA Research & Development
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2021
Details:
Treprostinil palmitil inhalation powder is a dry powder formulation of treprostinil palmitil, a treprostinil prodrug consisting of treprostinil linked by an ester bond to a 16-carbon chain.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
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 February 16, 2021
Details:
Alembic Global Holding SA has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) Treprostinil Injection, 20 mg/20 ml (1 mg/ml), 50 mg/20 ml (2.5 mg/ml), 100 mg/20 ml (5 mg/ml), and 200 mg/20 ml (10 mg/ml), Multiple-Dose Vials.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 12, 2021
Details:
Remodulin (treprostinil) is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) to diminish symptoms associated with exercise.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Remodulin
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 10, 2021
Details:
Through the acquisition, United Therapeutics gains a Rare Pediatric Disease PRV, which it intends to apply for Tyvaso DPI, an investigational drug-device combination comprised of a dry powder formulation of treprostinil and a small, portable, dry powder inhaler.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Tyvaso DPI
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: United Therapeutics
Deal Size: $105.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition December 28, 2020
Details:
United Therapeutics intends to initiate a phase 3 study, called TETON, to evaluate the use of Tyvaso® (treprostinil) Inhalation Solution in patients with IPF.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Tyvaso
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 December 09, 2020
Details:
This is the fourth development milestone brining it to $50M, under Mankind's licensing deal with United Therapeutics for the development and commercialization of a dry powder formulation of treprostinil. MannKind will get low double-digit royalties on net sales of TreT.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: TreT
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: United Therapeutics
Deal Size: $95.0 million Upfront Cash: $45.0 million
Deal Type: Licensing Agreement November 19, 2020
Details:
The presentation featured safety data from the phase 3 INCREASE study of Tyvaso, which showed that patients with PH-ILD receiving Tyvaso, vs those receiving placebo, experienced fewer exacerbations of underlying lung disease and an improvement in forced vital capacity.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Tyvaso
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2020
Details:
The presentation will include data from the phase 3 INCREASE study of Tyvaso in patients with PH-ILD, which included an evaluation of the impact of Tyvaso on parameters on lung function measured by patients' forced vital capacity.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Tyvaso
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 15, 2020
Details:
The patent is expected to cover methods of treating patients with pulmonary hypertension through the inhalation of dry powder treprostinil.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: LIQ861
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 28, 2020
Details:
FDA accepted for review the supplemental New Drug Application (sNDA) for Tyvaso® (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Tyvaso
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 17, 2020
Details:
New data from INSPIRE LIQ861 safety and tolerability study in pulmonary arterial hypertension (PAH) patients demonstrate positive trends in exploratory endpoints, including quality of life (QoL)
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: LIQ861
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 05, 2020
Details:
Through the acquisition, RareGen attains the right to to commercialize Liquidia’s lead product candidate in Pulmonary Arterial Hypertension (PAH), LIQ861, an inhalation dry powder formulation of treprostinil that is produced using Liquidia's PRINT® Technology.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Cardiology/Vascular Diseases Product Name: LIQ861
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Liquidia Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition June 29, 2020
Details:
First pivotal clinical trial to demonstrate a benefit in PH-ILD. NDA supplement to be filed by mid-year.
Lead Product(s): Treprostinil Sodium
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2020
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