fluticasone propionate inhalation powder / Generic mfg. - LARVOL DELTA

An In Vitro Dissolution Method for Inhaled Drugs Depositing in the Tracheobronchial Lung Region. (PubMed, Pharm Res) - "The dissolution method discriminated between the two inhalers and is a promising new tool for use in the dissolution testing of orally inhaled drug products."

Journal • Preclinical

ANASSA-PD: A Clinical Trial for Examining the Therapeutic Equivalence Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100mcg/Blister Oral Inhalation Powder/GSK in Patients With Asthma (clinicaltrials.gov) - P3 | N=451 | Completed | Sponsor: Respirent Pharmaceuticals Co Ltd. | Recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Bioequivalence Study Between Fluticasone Propionate 250 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 250 mcg/Blister Oral Inhalation Powder /GSK in Healthy Volunteers Under Fasting Conditions (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Respirent Pharmaceuticals Co Ltd.

New P1 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Using Filters to Estimate Regional Lung Deposition with Dry Powder Inhalers. (PubMed, Pharm Res) - "Because of its design, the TB filter apparatus makes it possible to estimate regional deposition with inhalers directly using variable inhalation profiles without any additional equipment or changes to the experimental configuration. This method may be useful to expedite development of both innovative and generic drug products as it provides regional respiratory tract deposition estimates using fewer resources than exisiting methods."

Journal

A Bioequivalence Study Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100 mcg/Blister Oral Inhalation Powder /GSK in Healthy Volunteers Under Fasting Conditions (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Respirent Pharmaceuticals Co Ltd.

Clinical • New P1 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

LANNETT expands respiratory pipeline, signs exclusive commercialization agreement for generic SPIRIVA handihaler (PRNewswire) - “Lannett Company, Inc…announced that it has entered into an exclusive U.S. commercialization agreement for a therapeutically equivalent generic of Spiriva^® Handihaler^® (Tiotropium Bromide inhalation powder) with Respirent Pharmaceuticals Co. Ltd….’The generic Spiriva Handihaler product is currently in development and tracking to Abbreviated New Drug Application (ANDA) submission in 2023’….For generic Flovent® Diskus® (Fluticasone Propionate Powder Inhaler), the company said development is underway and an ANDA submission is expected in 2022.”

ANDA • Licensing / partnership • Asthma • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

ANASSA-PD: A Clinical Trial for Examining the Therapeutic Equivalence Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100mcg/Blister Oral Inhalation Powder/GSK in Patients With Asthma (clinicaltrials.gov) - P3; N=451; Recruiting; Sponsor: Respirent Pharmaceuticals Co Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Asthma • Immunology • Respiratory Diseases

ANASSA-PD: A Clinical Trial for Examining the Therapeutic Equivalence Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100mcg/Blister Oral Inhalation Powder/GSK in Patients With Asthma (clinicaltrials.gov) - P3; N=451; Not yet recruiting; Sponsor: Respirent Pharmaceuticals Co Ltd.

Clinical • New P3 trial • Asthma • Immunology • Respiratory Diseases

This study will evaluate and confirm that a new formulation of Fluticasone propionate 100 mcg/blister oral inhalation powder/RespirentPharmaceuticals is therapeutically equivalent to the marketed formulation Flovent DISKUS® 100 mcg/blister oral inhalation powder/GSK in patients with asthma Αυτή η μελέτη θα αξιολογήσει και τεκμηριώσει ότι ένα νέο σκεύασμα Προπιονικής Φλουτικαζόνης 100mcg/ανά... (clinicaltrialsregister.eu) - P3; N=451; Ongoing; Sponsor: RESPIRENT Pharmaceuticals

Clinical • New P3 trial • Asthma • Immunology • Inflammation • Respiratory Diseases

Lannett Signs Agreement To Be Exclusive Distributor Of Generic Flovent Diskus (Lannett Press Release) - "Lannett Company... today announced that it has entered into an exclusive U.S. distribution agreement for the therapeutically equivalent generic of Flovent® Diskus® (Fluticasone Propionate Powder Inhaler) of Respirent Pharmaceuticals Co. Ltd. According to the Orange Book, all patents covering Flovent Diskus have expired. U.S. sales of Flovent Diskus, which have been increasing in recent years, were $94 million for the 12 months ending June, 2020 according to IQVIA...We remain on track to submit late this calendar year an Abbreviated New Drug Application (ANDA) for this product."

ANDA • Licensing / partnership • Asthma • Respiratory Diseases