tiotropium bromide dry powder inhaler / Generic mfg. - LARVOL DELTA

EXACERBATION RATES IN COPD PATIENTS: A RETROSPECTIVE ANALYSIS OF THE NEBULIZED ONCE DAILY LONG-ACTING MUSCARINIC ANTAGONIST REVEFENACIN IN A 52-WEEK SAFETY STUDY (CHEST 2025) - " This retrospective data analysis evaluated exacerbation rates in a 52-week, randomized, open-label Phase 3 safety trial comparing revefenacin (175 and 88 mcg) with tiotropium HandiHaler® in patients with moderate-to-severe COPD. In this retrospective analysis, exacerbations over 52 weeks are reported for COPD patients treated with revefenacin or tiotropium. These findings suggest that once-daily revefenacin provides a viable long-term exacerbation control, offering an alternative nebulized LAMA option for COPD patients. CLINICAL IMPLICATIONS: Once-daily revefenacin provides a long term exacerbation profile at least as effective as tiotropium based upon this retrospective analysis over 52 weeks."

Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

ANTES B+ Clinical Trial (clinicaltrials.gov) - P4 | N=48 | Terminated | Sponsor: Fundacio Privada Mon Clinic Barcelona | N=1028 ➔ 48 | Trial completion date: Sep 2025 ➔ Jan 2025 | Recruiting ➔ Terminated | Trial primary completion date: Sep 2025 ➔ Jan 2025; Delays in the opening and activation of participating sites, and a low recruitment rate, with only 48 participants enrolled over the course of one year

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Lupin inks pact with China's Sino Universal for Tiotropium inhaler supply (Business Standard) - "Pharma major Lupin Ltd on Monday said it has signed a license and supply agreement with China's Sino Universal Pharmaceuticals for the commercialisation of Tiotropium dry powder inhaler in the Chinese market. The agreement pertains to the commercialisation of the Tiotropium dry powder inhaler of strength 18 mcg/capsule, which is used in the treatment of Chronic Obstructive Pulmonary Disease (COPD), Lupin said in a regulatory filing. Under the agreement, Sino Universal Pharmaceuticals (SUP) will obtain regulatory approvals for selling Tiotropium DPI in China, while Lupin will be the marketing authorisation holder and responsible for manufacturing of the product, it added."

Commercial • Chronic Obstructive Pulmonary Disease

Effect of Tiotropium on eye findings in the treatment of chronic obstructive pulmonary disease. (PubMed, BMC Pulm Med) - P | "This study is the first research that investigate the effects of Tiotropium on anterior chamber parameters, pupil diameters, and intraocular pressure in COPD treatment. In conclusion, patients with COPD receiving Tiotropium therapy for three months showed narrowing in angle parameters, an increase in intraocular pressure, and photopic-mesopic pupil diameter; however, no patients developed drug-induced acute angle closure glaucoma."

Journal • Observational data • Chronic Obstructive Pulmonary Disease • Glaucoma • Immunology • Inflammation • Ocular Inflammation • Ophthalmology • Pulmonary Disease • Respiratory Diseases

Comparison table: Inhaled drugs for treatment of COPD. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Drugs for COPD. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tobacco Cessation

A Trial to Assess the Bioequivalence of Tiotropium Bromide Inhalation Powder in Healthy Adult Participants Under Fasting Conditions (clinicaltrials.gov) - P1 | N=186 | Active, not recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P1 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Trial to Assess the Bioequivalence of Generic Tiotropium Bromide Inhalation Powder and Reference Product in Healthy Adult Participants Under Fasting Conditions (Pilot) (clinicaltrials.gov) - P1 | N=39 | Active, not recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P1 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Tiotropium Reduces Deterioration in Mild-to-Moderate COPD: Tie-COPD Study Analysis (Respiratory Medicine, Physician’s Weekly) - P4 | N=841 | Tie-COPD (NCT01455129) | "In the post hoc analysis of the 24-month Tie-COPD study comparing 18 μg tiotropium with placebo in patients with mild-to-moderate COPD, CID was defined as a decrease of ≥100 mL in trough forced expiratory volume in 1 s, an increase of ≥2 units in COPD Assessment Test (CAT) score, or a moderate-to-severe exacerbation....Out of 841 randomized patients, 771 were included in the full analysis set, with 643 patients (83.4%) experiencing at least one CID event. Tiotropium significantly reduced CID risk and delayed the time to first CID compared with placebo (adjusted hazard ratio = 0.58, 95% CI = 0.49–0.68, P < 0.001)."

Retrospective data • Chronic Obstructive Pulmonary Disease

Tiotropium Reduces Deterioration in Mild-to-Moderate COPD: Tie-COPD Study Analysis (Respiratory Medicine, Physician’s Weekly) - P4 | N=841 | Tie-COPD (NCT01455129) | "In the post hoc analysis of the 24-month Tie-COPD study comparing 18 μg tiotropium with placebo in patients with mild-to-moderate COPD, CID was defined as a decrease of ≥100 mL in trough forced expiratory volume in 1 s, an increase of ≥2 units in COPD Assessment Test (CAT) score, or a moderate-to-severe exacerbation....Out of 841 randomized patients, 771 were included in the full analysis set, with 643 patients (83.4%) experiencing at least one CID event. Tiotropium significantly reduced CID risk and delayed the time to first CID compared with placebo (adjusted hazard ratio = 0.58, 95% CI = 0.49–0.68, P < 0.001)."

Retrospective data • Chronic Obstructive Pulmonary Disease

ANTES B+ Clinical Trial (clinicaltrials.gov) - P4 | N=1028 | Recruiting | Sponsor: Fundacio Privada Mon Clinic Barcelona | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

ANTES B+ Clinical Trial (clinicaltrials.gov) - P4 | N=1028 | Not yet recruiting | Sponsor: Fundacio Privada Mon Clinic Barcelona

New P4 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

ARBORUS: Bioequivalence Study of Tiotropium 18 μg Inhalation Powder, Hard Capsule With Spiriva®Handihaler® 18 μg Inhalation Powder, Hard Capsule in Patients With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P3 | N=335 | Completed | Sponsor: Xiromed LLC | Active, not recruiting ➔ Completed

Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

PIFR-2: Phase 4 COPD and Suboptimal Inspiratory Flow Rate (clinicaltrials.gov) - P4 | N=404 | Completed | Sponsor: Theravance Biopharma | Recruiting ➔ Completed | Trial completion date: Sep 2022 ➔ Nov 2023 | Trial primary completion date: Sep 2022 ➔ Nov 2023

Trial completion • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma (clinicaltrials.gov) - P=N/A | N=60 | Recruiting | Sponsor: Gelb, Arthur F., M.D. | Trial completion date: Jun 2022 ➔ Jun 2027 | Trial primary completion date: Jun 2022 ➔ Jun 2027

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

Lupin Collaborates with Mark Cuban Cost Plus Drug Company and COPD (Lupin Pharmaceuticals Press Release) - "Global pharma major Lupin Limited (Lupin) today forged a unique collaboration with Mark Cuban Cost Plus Drug Company (Cost Plus Drugs), a pioneer in affordable medicines, and the COPD Foundation, dedicated to enhancing the lives of COPD patients. This collaboration aims to bolster access to healthcare by expanding the availability of Tiotropium Bromide Inhalation Powder, 18 mcg/capsule, to COPD patients in the US."

Licensing / partnership • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Lupin Collaborates with Mark Cuban Cost Plus Drug Company and COPD Foundation to Expand Access to Medication for COPD Patients (PRNewswire) - "Global pharma major Lupin Limited (Lupin) today forged a unique collaboration with Mark Cuban Cost Plus Drug Company (Cost Plus Drugs), a pioneer in affordable medicines, and the COPD Foundation, dedicated to enhancing the lives of COPD patients. This collaboration aims to bolster access to healthcare by expanding the availability of Tiotropium Bromide Inhalation Powder, 18 mcg/capsule, to COPD patients in the US."

Licensing / partnership • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Lupin Launches Tiotropium Dry Powder for Inhaler for the Treatment of COPD in the United States (Lupin Pharmaceuticals Press Release) - "Global pharma major Lupin Limited (Lupin) today announced the launch of Tiotropium Bromide Inhalation Powder, 18 mcg/capsule, for the treatment of chronic obstructive pulmonary disease (COPD) in the US. Tiotropium Bromide Inhalation Powder, 18 mcg/capsule is a generic equivalent of Spiriva® HandiHaler® (Tiotropium Bromide Inhalation Powder), 18 mcg/capsule of Boehringer Ingelheim Pharmaceuticals, Inc."

Launch US • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

ARBORUS: Bioequivalence Study of Tiotropium 18 μg Inhalation Powder, Hard Capsule With Spiriva®Handihaler® 18 μg Inhalation Powder, Hard Capsule in Patients With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P3 | N=335 | Active, not recruiting | Sponsor: Xiromed LLC

New P3 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Lupin receives approval from TGA Australia for Tiotropium dry powder (ExpressPharma) - "Lupin has announced that its wholly owned subsidiary in Australia, Generic Health Pty Ltd, has received approval for Tiotropium 18 micrograms powder for inhalation in capsules for use with LupinHaler, its bioequivalent version of SPIRIVA tiotropium (as bromide monohydrate) powder for inhalation from Therapeutic Goods Administration (TGA).....This will provide a high-quality and low-cost treatment option to healthcare professionals in Australia for the treatment of COPD."

Non-US regulatory • Asthma • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Lupin Announces Health Canada Approval of Tiotropium Bromide Inhalation Powder for Treatment of COPD (Canada Newswire) - "Global pharma major Lupin Limited (Lupin) announced on May 26, 2023, that its Canada subsidiary, Lupin Pharma Canada Ltd., has received approval from Health Canada to market a generic version of Spiriva® (tiotropium bromide inhalation powder) for the treatment of chronic obstructive pulmonary disease (COPD), in Canada. Lupin wishes to clarify that Tiotropium Bromide Inhalation Powder is indicated in Canada for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema....Tiotropium Bromide Inhalation Powder (RLD Spiriva®) had estimated annual sales of USD 42 million in Canada (IQVIA MAT Q4 of 2022)."

Canadian regulatory • Sales • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Bioequivalence of Two Tiotropium Dry Powder Inhalers and the Utility of Realistic Impactor Testing. (PubMed, J Aerosol Med Pulm Drug Deliv) - " The test tiotropium DPI and Spiriva HandiHaler were bioequivalent when equitable biobatch comparisons, based on realistic NGI testing, were performed. The observations from this program support the utility of realistic test methods for inhaled product development."

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

"Lupin wins USFDA nod for Tiotropium Dry Powder Inhaler @LupinIndia,@LupinGlobal,@US_FDA,@Boehringer #lupin #lupinnews #tiotropiumbromideinhalationpowder #spirivahandihaler #boehringeringelheimpharma #usfda https://t.co/p6xvCxZnCW" (@medicaldialogs)

Lupin Receives Approval from U.S. FDA for Tiotropium Dry Powder Inhaler (Lupin Pharmaceuticals Press Release) - "Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Tiotropium Bromide Inhalation Powder, 18 mcg/capsule, a generic equivalent of Spiriva® HandiHaler®(Tiotropium Bromide Inhalation Powder), 18 mcg/capsule of Boehringer Ingelheim Pharmaceuticals, Inc. This product will be manufactured at Lupin’s Pithampur facility in India."

ANDA • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Tiotropium Handihaler vs. Tiotropium Respimat in COPD (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Duke University | N=25 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases