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Details:
Formoterol Fumarate is a long-acting bronchodilator used as a long-term treatment to prevent or decrease wheezing and trouble breathing caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema).
Lead Product(s): Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Formoterol Fumarate-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 December 01, 2022
Details:
The acquisition of “Combihale” is expected to strengthen Mankind’s presence in the inhalation respiratory market segment. Daffy is a soap-free moisturising bar for infant babies.
Lead Product(s): Formoterol Fumarate,Fluticasone Propionate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Combihale
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mankind Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition February 16, 2022
Details:
Under the agreement, Mankind Pharma will distribute AstraZeneca's anti-asthma inhaled corticosteroid drug Symbicort, (budesonide/formoterol) approved to treat asthma and COPD, in India.
Lead Product(s): Budesonide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Symbicort
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mankind Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 13, 2024
Details:
Breyna™ (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol is the first generic version of AstraZeneca's Symbicort drug-device combination product and is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD).
Lead Product(s): Budesonide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Breyna
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 31, 2023
Details:
Duaklir (aclidinium bromide) and Duaklir (aclidinium bromide/formoterol) are inhaled respiratory medicines used for the maintenance treatment of COPD. Eklira is a LAMA and Duaklir is a combination therapy that contains both a LAMA and a long-acting beta2-agonist (LABA).
Lead Product(s): Aclidinium Bromide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Duaklir
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 25, 2022
Details:
Luforbec (formoterol) oral inhalation is used to control wheezing, shortness of breath, and chest tightness caused by chronic obstructive pulmonary disease.
Lead Product(s): Formoterol Fumarate,Beclomethasone Dipropionate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Luforbec
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 25, 2022
Details:
Breyna (Budesonide and Formoterol Fumarate Dihydrate), first approved generic version of AstraZeneca's Symbicort, a drug-device combination product, is indicated for certain patients with asthma or COPD and will be available in 160 /4.5 and 80/4.5 mcg dosage strengths.
Lead Product(s): Budesonide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Breyna
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kindeva Drug Delivery
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2022
Details:
U.S.FDA approved generic budesonide and formoterol fumarate dihydrate aerosol for treatment of two pulmonary health conditions: asthma in patients six years of age and older; and maintenance treatment of airflow obstruction and reducing exacerbations for patients with COPD.
Lead Product(s): Budesonide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Budesonide/Formoterol Fumarate Dihydrate-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 15, 2022
Details:
A recently completed Phase I clinical trial of the propellant HFO-1234ze in a pMDI containing budesonide, glycopyrronium, formoterol fumarate in healthy adults was positive, demonstrating similar safety and tolerability profile.
Lead Product(s): Budesonide,Glycopyrronium Bromide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Breztri Aerosphere
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership February 22, 2022
Details:
Formoterol fumarate inhalation solution is a long-acting beta2-adrenergic agonist indicated for long-term, twice daily administration in the maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema.
Lead Product(s): Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Perforomist
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 23, 2021
Details:
Iconovo is working on a generic Symbicort in ICOres with Amneal. The extended agreement covers 90 percent of the global Symbicort market, doubling the expected annual royalty revenue from Amneal.
Lead Product(s): Budesonide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: ICOres
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Iconovo
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 17, 2021
Details:
European Commission has granted the marketing authorization for Trimbow inhalation powder delivered through NEXThaler (beclometasone dipropionate, formoterol fumarate dihydrate and glycopyrronium) for treatment of moderate to severe COPD.
Lead Product(s): Beclomethasone Dipropionate,Formoterol Fumarate,Glycopyrronium Bromide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Trimbow
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, 2021
Details:
The U.S. Food and Drug Administration (FDA) granted tentative approval of budesonide/formoterol fumarate dihydrate products, the first generic version of Symbicort based on an Abbreviated New Drug Application (ANDA).
Lead Product(s): Budesonide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kindeva Drug Delivery
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 09, 2021
Details:
Trimbow is the first extrafine formulation fixed triple combination therapy in a single inhaler to be approved for use in appropriate asthma patients. This follows the 2017 approval of this therapeutic option for the treatment of appropriate moderate to severe COPD patients.
Lead Product(s): Beclomethasone Dipropionate,Formoterol Fumarate,Glycopyrronium Bromide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Trimbow
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 01, 2021
Details:
With this approval, Symbicort Turbuhaler becomes the first dual-combination therapy approved in China for mild, moderate and severe asthma.
Lead Product(s): Budesonide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Symbicort Turbuhaler
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 26, 2021
Details:
The approval by the European Commission was based on positive results from the ETHOS Phase III trial in which Trixeo Aerosphere, showed a statistically significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies 52 weeks.
Lead Product(s): Formoterol Fumarate,Glycopyrronium Bromide,Budesonide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Trixeo Aerosphere
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 14, 2020
Details:
Trixeo Aerosphere, a triple-combination therapy, is approved under the brand name Breztri Aerosphere in Japan, China and the US for patients with COPD. Recommendation of triple-combination therapy based on positive results from ETHOS and KRONOS Phase III trials.
Lead Product(s): Budensonide,Glycopyrronium Bromide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Trixeo Aerosphere
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 19, 2020
Details:
The administration of the two drugs Formoterol fumarate (LABA) + Glycopyrrolate (LAMA) in a single inhalation will improve outcomes due to the desired synergistic effect of the two drugs and a better adherence to the treatment.
Lead Product(s): Formoterol Fumarate,Glycopyrronium Bromide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Forglyn
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 08, 2020
Details:
The collaboration will support Bilim Pharmaceutical’s launch into the Turkish market of Ventofor Combi Fix, a formulation of Budesonide Formoterol for Asthma and COPD management, delivered by the PowdAir Plus Dry Powder Inhaler (DPI).
Lead Product(s): Budesonide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ventofor
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bilim Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 01, 2020
Details:
The UK pharma giant has received approval for its Breztri Aerosphere, formerly dubbed PT010, culminating the drug’s bumpy regulatory journey in a win. Now, AstraZeneca can challenge the leader in the area — GlaxoSmithKline’s Trelegy — without obstacle.
Lead Product(s): Budensonide,Glycopyrronium Bromide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Breztri Aerosphere
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 24, 2020
Details:
Results from the positive Phase III ETHOS trial showed AstraZeneca’s triple-combination therapy Breztri Aerosphere demonstrated a statistically significant reduction in moderate or severe exacerbations compared with 2 dual-combination therapies in moderate to very severe COPD.
Lead Product(s): Budensonide,Glycopyrronium Bromide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Breztri Aerosphere
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 24, 2020
Details:
Approval by the NMPA was based on positive results from the Phase III PINNACLE 4 trial1 in which Bevespi Aerosphere demonstrated a statistically significant improvement in lung function as compared to its monotherapy components and placebo.
Lead Product(s): Formoterol Fumarate,Glycopyrronium Bromide
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 May 18, 2020
Details:
AIRZ-FF is India's first Glycopyrronium + Formoterol + Fluticasone combination, exclusively studied in the Indian population.
Lead Product(s): Formoterol Fumarate,Glycopyrronium Bromide,Fluticasone Propionate
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 May 11, 2020
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