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Details:
Hikma will immediately resume launch activities of its generic product for Advair Diskus® (Fluticasone Propionate and Salmeterol Inhalation Powder, USP), 100mcg/50mcg and 250mcg/50mcg doses in the US.
Lead Product(s): Fluticasone Propionate,Salmeterol Xinafoate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Fluticasone Propionate/Salmeterol-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hikma Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 21, 2021
Details:
The new device is an evolution of Vectura’s lever-operated multi-dose (LOMI) device and builds on Vectura and Hikma’s shared experience with the generic Advair Diskus® programme, enabling accelerated development under this agreement.
Lead Product(s): Fluticasone Propionate,Salmeterol Xinafoate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Fluticasone Propionate/Salmeterol-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hikma Pharmaceuticals
Deal Size: $95.0 million Upfront Cash: $15.0 million
Deal Type: Agreement December 17, 2020
Details:
Fluticasone Propionate / Salmeterol or VR315 is a generic, inhaled combination therapy for asthma/COPD delivered using Vectura's proprietary dry powder inhaler and formulation technology.
Lead Product(s): Fluticasone Propionate,Salmeterol Xinafoate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: VR315
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hikma Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 22, 2020
Details:
AirDuo Digihaler contains salmeterol. Long-acting beta2-agonist (LABA) medicines such as salmeterol when used alone increase the risk of hospitalizations and death from asthma problems.
Lead Product(s): Salmeterol Xinafoate,Fluticasone Propionate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: AirDuo Digihaler
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 07, 2022
Details:
Hikma will immediately resume launch activities of its generic product for Advair Diskus® (Fluticasone Propionate and Salmeterol Inhalation Powder, USP), 100mcg/50mcg and 250mcg/50mcg doses in the US.
Lead Product(s): Fluticasone Propionate,Salmeterol Xinafoate
Therapeutic Area: Pulmonary/Respiratory 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 April 20, 2021
Details:
Respirent Pharmaceuticals has summited an Abbreviated New Drug Application for Fluticasone propionate and Salmeterol inhalation powder (100/50 mcg, 250/50 mcg and 500/50 mcg) to the U.S. FDA. The product is the generic equivalent of ADVAIR DISKUS of GlaxoSmithKline.
Lead Product(s): Fluticasone Propionate,Salmeterol Xinafoate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
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 April 01, 2021
Details:
Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces that it has temporarily paused the launch of its generic version of GlaxoSmithKline’s Advair Diskus®.
Lead Product(s): Fluticasone Propionate,Salmeterol Xinafoate
Therapeutic Area: Pulmonary/Respiratory 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 January 15, 2021
Details:
Hikma announces it has received FDA approval and launched its generic version of GlaxoSmithKline’s Advair Diskus® (Fluticasone Propionate and Salmeterol Inhalation Powder, USP), 100mcg/50mcg and 250mcg/50mcg doses in the US.
Lead Product(s): Fluticasone Propionate,Salmeterol Xinafoate
Therapeutic Area: Pulmonary/Respiratory 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 December 17, 2020
Details:
AirDuo® Digihaler® and ArmonAir® Digihaler® are part of Teva’s Digihaler® portfolio,including ProAir® Digihaler®, the first and only digital rescue inhaler indicated in patients 4 years or older for the treatment of bronchospasm who have reversible obstructive airway disease.
Lead Product(s): Fluticasone Propionate,Salmeterol Xinafoate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: AirDuo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2020
Details:
Achieves a significant milestone towards strengthening its regulated markets Respiratory franchise.
Lead Product(s): Fluticasone Propionate,Salmeterol Xinafoate
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 April 03, 2020