OLODATEROL HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for olodaterol hydrochloride and what is the scope of freedom to operate?

Olodaterol hydrochloride is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim and is included in two NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Olodaterol hydrochloride has one hundred and ninety-four patent family members in forty countries.

One supplier is listed for this compound.

Summary for OLODATEROL HYDROCHLORIDE

International Patents:	194
US Patents:	12
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	40
Patent Applications:	103
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OLODATEROL HYDROCHLORIDE
DailyMed Link:	OLODATEROL HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OLODATEROL HYDROCHLORIDE

Dosage:

SPRAY, METERED;INHALATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for OLODATEROL HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Boehringer Ingelheim	N/A
Yonsei University	N/A
Fraunhofer-Institute of Toxicology and Experimental Medicine	Phase 4

See all OLODATEROL HYDROCHLORIDE clinical trials

Pharmacology for OLODATEROL HYDROCHLORIDE

Drug Class	beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists

Anatomical Therapeutic Chemical (ATC) Classes for OLODATEROL HYDROCHLORIDE

R03AC	Selective beta-2-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for OLODATEROL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014		RX	Yes	Yes			Y
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes			Y
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014		RX	Yes	Yes			Y	Y
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes			Y
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014		RX	Yes	Yes			Y
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes

Expired US Patents for OLODATEROL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014

International Patents for OLODATEROL HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	008665	ЛЕКАРСТВЕННЫЕ СРЕДСТВА ДЛЯ ЛЕЧЕНИЯ ХРОНИЧЕСКОГО ОБСТРУКТИВНОГО ЗАБОЛЕВАНИЯ ЛЁГКИХ (NOVEL MEDICAMENTS FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASES)
Japan	5299723
Denmark	1579130
Denmark	1539368
Croatia	P20100698
European Patent Office	1641569	AJUTAGE HAUTE PRESSION MICROSTRUCTURE COMPORTANT UNE FONCTION DE FILTRAGE INTEGREE (MICROSTRUCTURED HIGH PRESSURE NOZZLE WITH AN IN-BUILT FILTER FUNCTION)

Supplementary Protection Certificates for OLODATEROL HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1562603	159 5009-2014	Slovakia		PRODUCT NAME: OLODATEROL HYDROCHLORID; NAT. REGISTRATION NO/DATE: 14/0394/13-S 20131029; FIRST REGISTRATION: MT MA211/00401 20130918
1562603	122014000018	Germany		PRODUCT NAME: OLODATEROL, OPTISCHE ISOMERE DAVON, MISCHUNGEN VON ISOMEREN DAVON, SAEUREADDITIONSSALZE DAVON MIT PHARMAKOLOGISCH UNBEDENKLICHEN SAEUREN, SOWIE SOLVATE UND/ODER HYDRATE DAVON, INSBESONDERE OLODATEROL UND OLODATEROLHYDROCHLORID; NAT. REGISTRATION NO/DATE: 87146.00.00 20131126; FIRST REGISTRATION: MALTA MA 211/00401 20130918
1562603	PA2014012	Lithuania		PRODUCT NAME: OLODATEROLUM; REGISTRATION NO/DATE: LT/1/13/3429/001 LT/1/13/3429/003 LT/1/13/3429/003 LT/1/13/3429/004 20131031
1562603	PA2014012,C1562603	Lithuania		PRODUCT NAME: OLODATEROLIS, JO OPTINIAI IZOMERAI, JO ATSKIRU ENANTIOMERU ARBA RACEMATU MISINIAI, JO RUGSTIES ADITYVINES DRUSKOS SU FRAMAKOLOGINIU POZIURIU PRIIMTINOMIS RUGSTIMIS, O TAIP PAT JO SOLVATAI IR/ARBA HIDRATAI, KONKRECIAI OLODATEROLIS IR OLODATEROLIO CHLORIDAS; NAT. REGISTRATION NO/DATE: LT/1/13/3429/001, LT/1/13/3429/002, LT/1/13/3429/003, LT/1/13/3429/004 20131031; FIRST REGISTRATION: MA211/00401 20130918
1562603	92433	Luxembourg		PRODUCT NAME: OLODATEROL,SES ISOMERES OPTIQUES INDIVIDUELS,MELANGES D ENANTIOMERES INDIVIDUELS OU DE RACEMATES,SES SELS D ADDITION D ACIDE AVEC DES ACIDES PHARMACEUTIQUEMENT ACCEPTABLES,AINSI QUE SES SOLVATES ET/OU SES HYDRATES,EN PARTICULIER L OLODATEROL ET LE CHLORHYDRATE D OLODATEROL
1562603	2014/016	Ireland		PRODUCT NAME: OLODATEROL, OPTICAL ISOMERS THEREOF, MIXTURES OF ISOMERS THEREOF, ACID ADDITION SALTS THEREOF WITH PHARMACOLOGICALLY ACCEPTABLE ACIDS, AS WELL AS SOLVATES AND/OR HYDRATES THEREOF, IN PARTICULAR OLODATEROL AND OLODATEROL HYDROCHLORIDE.; NAT REGISTRATION NO/DATE: PA0775/006/001 20131018; FIRST REGISTRATION NO/DATE: MA211/00401 20130918

OLODATEROL HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Olodaterol Hydrochloride

Introduction

Olodaterol hydrochloride, a long-acting beta2-adrenergic agonist (LABA), is a crucial component in the management of chronic obstructive pulmonary disease (COPD). This article delves into the market dynamics and financial trajectory of olodaterol hydrochloride, highlighting its clinical efficacy, market performance, and financial implications.

Clinical Efficacy of Olodaterol Hydrochloride

Olodaterol hydrochloride is used in the treatment of COPD, exerting its pharmacological effect by binding and activating beta2-adrenergic receptors in the lungs. This activation leads to smooth muscle relaxation and bronchodilation, improving airflow and reducing symptoms of COPD[3].

Real-World Effectiveness

Studies have shown that olodaterol, often combined with tiotropium (a long-acting muscarinic antagonist or LAMA), improves symptoms and lung function in patients with COPD. A post hoc analysis of a 52-week post-marketing surveillance study in Japanese patients demonstrated sustained improvements in symptoms and lung function, particularly in treatment-naive patients and those with higher baseline COPD Assessment Test (CAT) scores[1].

Market Demand and Growth

The demand for COPD treatments is driven by the increasing prevalence of the disease, particularly among older populations and those exposed to environmental and occupational hazards. The global COPD market is expected to grow due to the introduction of innovative treatments and the expanding patient population.

Competitive Landscape

Olodaterol hydrochloride competes in a market dominated by other LABAs and combination therapies. The combination of tiotropium and olodaterol is a significant player, offering a fixed-dose option that simplifies treatment regimens and enhances patient compliance. This combination has been shown to be effective in real-world settings, supporting its market position[1].

Financial Performance

Revenue and Market Share

The financial performance of olodaterol hydrochloride is closely tied to the overall performance of its parent company and the broader pharmaceutical market. For instance, the combination therapy of tiotropium and olodaterol contributes to the revenue of companies like Boehringer Ingelheim, which has seen significant growth in its respiratory portfolio.

Pricing and Cost Dynamics

The pricing of olodaterol hydrochloride is influenced by factors such as patent status, competition from generic alternatives, and regulatory environments. In the pharmaceutical market, price increases for branded products are common, but these are often offset by off-invoice discounts and rebates. For example, in 2014, price increases for protected brands contributed significantly to spending growth, but net price growth was lower due to these discounts[4].

Impact of Patent Expiries

The expiration of patents can significantly impact the financial trajectory of drugs like olodaterol hydrochloride. However, the transition to generic status can be mitigated by the development of combination therapies and the introduction of new formulations, which can help maintain market share and revenue.

Regulatory Environment

Approval and Licensing

Olodaterol hydrochloride has been approved for use in various regions, including the United States and Europe, for the maintenance treatment of COPD. Regulatory approvals and licensing agreements play a crucial role in the drug's market access and financial performance[5].

Compliance and Safety

Regulatory bodies closely monitor the safety and efficacy of drugs like olodaterol hydrochloride. Compliance with regulatory standards is essential for maintaining market approval and avoiding financial penalties.

Research and Development

Clinical Trials and Studies

The development of olodaterol hydrochloride involved extensive clinical trials to evaluate its pharmacokinetics, efficacy, and safety. These studies have been instrumental in establishing the drug's place in the treatment of COPD[5].

Future Directions

Continued research and development are critical for the long-term financial success of olodaterol hydrochloride. This includes exploring new indications, developing new formulations, and enhancing existing treatments to stay competitive in the market.

Financial Projections

Revenue Growth

Given the growing demand for COPD treatments and the established efficacy of olodaterol hydrochloride, revenue growth is expected to continue. However, this growth will be influenced by factors such as competition, pricing strategies, and regulatory changes.

Cost Optimization

Companies involved in the production and distribution of olodaterol hydrochloride are focusing on cost optimization strategies, such as streamlining operations and reducing SG&A expenses, to improve profitability. For example, Santen Pharmaceutical has implemented structural reforms to enhance profitability, a strategy that could be applied to other companies in the sector[2].

Key Takeaways

• Clinical Efficacy: Olodaterol hydrochloride is effective in improving symptoms and lung function in COPD patients, particularly when combined with tiotropium.
• Market Demand: The demand for COPD treatments is increasing, driven by the growing prevalence of the disease.
• Financial Performance: The financial trajectory of olodaterol hydrochloride is influenced by factors such as patent status, pricing dynamics, and regulatory environments.
• Regulatory Environment: Regulatory approvals and compliance are crucial for maintaining market access and avoiding financial penalties.
• Research and Development: Continued R&D is essential for the long-term financial success of the drug.

FAQs

1. What is the primary use of olodaterol hydrochloride? Olodaterol hydrochloride is primarily used as a once-daily maintenance bronchodilator treatment for patients with chronic obstructive pulmonary disease (COPD)[5].

2. How does olodaterol hydrochloride work? Olodaterol hydrochloride works by binding and activating beta2-adrenergic receptors in the lungs, leading to smooth muscle relaxation and bronchodilation[3].

3. What are the key benefits of the combination therapy of tiotropium and olodaterol? The combination therapy of tiotropium and olodaterol offers sustained improvements in symptoms and lung function, particularly in treatment-naive patients and those with higher baseline COPD Assessment Test (CAT) scores[1].

4. How do patent expiries impact the financial performance of olodaterol hydrochloride? Patent expiries can lead to a reduction in revenue due to the introduction of generic alternatives. However, companies can mitigate this by developing combination therapies and new formulations[4].

5. What are the regulatory considerations for olodaterol hydrochloride? Regulatory approvals and compliance with safety and efficacy standards are essential for maintaining market access and avoiding financial penalties[5].

Sources

1. Effectiveness of Tiotropium/Olodaterol in the Real World: A Post Hoc Analysis - PMC.
2. FY2023 Financial Results - Santen Pharmaceutical - Santen.
3. Olodaterol: Uses, Interactions, Mechanism of Action - DrugBank Online.
4. Medicines Use and Spending Shifts in the US in 2014 - IQVIA.
5. 203108Orig1s000 - accessdata.fda.gov - FDA.