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Last Updated: December 26, 2024

Olodaterol hydrochloride; tiotropium bromide - Generic Drug Details

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

Olodaterol hydrochloride; tiotropium bromide is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for olodaterol hydrochloride; tiotropium bromide

International Patents:	194
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for olodaterol hydrochloride; tiotropium bromide
DailyMed Link:	olodaterol hydrochloride; tiotropium bromide at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for olodaterol hydrochloride; tiotropium bromide

Generic Entry Date for olodaterol hydrochloride; tiotropium bromide^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 7,727,984 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.

Pharmacology for olodaterol hydrochloride; tiotropium bromide

Drug Class	Anticholinergic beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Cholinergic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for olodaterol hydrochloride; tiotropium bromide

Paragraph IV (Patent) Challenges for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STIOLTO RESPIMAT	Inhalation Spray	olodaterol hydrochloride; tiotropium bromide	2.5 mcg/2.5 mcg per spray	206756	1	2024-05-24

US Patents and Regulatory Information for olodaterol hydrochloride; tiotropium bromide

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	7,727,984	⤷ Subscribe		Y		⤷ Subscribe
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	7,396,341*PED	⤷ Subscribe			Y	⤷ Subscribe
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	7,220,742	⤷ Subscribe	Y	Y		⤷ Subscribe
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	7,284,474*PED	⤷ Subscribe			Y	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for olodaterol hydrochloride; tiotropium bromide

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	6,977,042*PED	⤷ Subscribe
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	8,044,046	⤷ Subscribe
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	5,964,416	⤷ Subscribe
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	7,246,615	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for olodaterol hydrochloride; tiotropium bromide

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Country	Patent Number	Title	Estimated Expiration
Brazil	0316264	Medicamento para tratamento de doença pulmonar obstrutiva crÈnica	⤷ Subscribe
Germany	502004005733		⤷ Subscribe
Malaysia	136034	NEW MEDICAMENTS FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE	⤷ Subscribe
China	106146425	新的对映异构体纯的β‑激动剂其制备方法及其在药物形式中的用途 (Novel enantiomerically pure beta-agonists, method for the production and the use thereof in the form of a drug)	⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for olodaterol hydrochloride; tiotropium bromide

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1562603	14C0049	France	⤷ Subscribe	PRODUCT NAME: OLODATEROL, SES ISOMERES OPTIQUES INDIVIDUELS, MELANGES D'ENANTIOMERES INDIVIDUELS OU RACEMATE, SES SELS D'ADDITION D'ACIDE AVEC DES ACIDES PHARMACOLOGIQUEMENT ACCEPTABLES, AINSI QUE DES SOLVATES ET OU HYDRATES, EN PARTICULIER OLODATEROL OU CHLORHYDRATE D'OLODATEROL; NAT. REGISTRATION NO/DATE: NL42395 20140522; FIRST REGISTRATION: MT - MA211/00401 20130918
1562603	SPC/GB14/023	United Kingdom	⤷ Subscribe	PRODUCT NAME: OLODATEROL OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTERED: MT MA 211/00401 20130918; UK PL 14598/0093 20131010
1562603	CR 2014 00014	Denmark	⤷ Subscribe	PRODUCT NAME: OLODATEROL, OPTISKE ISOMERER DERAF, BLANDINGER AF ISOMERER DERAF, SYREADDITIONSSALTE DERAF MED FARMAKOLGISK HARMLOESE SYRER, SAVEL SOM SOLVATER OG/ELLER HYDRATER DERAF, SAERLIGT OLODATEROL OG OLODATEROL HYDROCHLORID; NAT. REG. NO/DATE: 50975 20131014; FIRST REG. NO/DATE: MA 211/00401 20130918
1562603	513	Finland	⤷ Subscribe
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Olodaterol hydrochloride; tiotropium bromide Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Olodaterol Hydrochloride and Tiotropium Bromide

Introduction

The combination of olodaterol hydrochloride and tiotropium bromide, marketed under the brand name STIOLTO RESPIMAT, is a significant player in the treatment of Chronic Obstructive Pulmonary Disease (COPD). This article delves into the market dynamics and financial trajectory of this drug combination.

Market Need and Indications

STIOLTO RESPIMAT is indicated for the long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including those with chronic bronchitis and emphysema[2][4].

Competitive Landscape

The COPD treatment market is highly competitive, with various monotherapies and combination therapies available. However, the fixed-dose combination (FDC) of tiotropium and olodaterol offers a unique advantage by providing both a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-adrenergic agonist (LABA) in a single inhaler, enhancing patient compliance and efficacy[4].

Clinical Efficacy and Safety

The clinical program for STIOLTO RESPIMAT includes several Phase II and III trials that have demonstrated its efficacy and safety. These trials have shown that the combination of tiotropium and olodaterol provides superior bronchodilation and improves lung function compared to monotherapies. The safety profile is generally favorable, although it carries the class-related risk of LABAs, such as an increased risk of asthma-related death, which is a contraindication for its use in asthma patients[2][4].

Pharmacoeconomic Considerations

From a pharmacoeconomic perspective, STIOLTO RESPIMAT is competitive. At the submitted price, it is less costly than monotherapy with tiotropium using the HandiHaler device, making it a more economical option for patients requiring dual therapy[3].

Regulatory Approvals

STIOLTO RESPIMAT received its initial U.S. approval in 2015 and has since been approved in various other countries. Regulatory bodies such as the FDA and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan have reviewed and approved the drug based on its clinical efficacy and safety data[2][4].

Market Performance

Since its approval, STIOLTO RESPIMAT has shown promising market performance. The drug's unique formulation and the convenience of a single inhaler have contributed to its adoption by healthcare providers. The market for COPD treatments is growing, driven by an increasing prevalence of the disease and an aging population, which bodes well for the financial trajectory of STIOLTO RESPIMAT.

Financial Trajectory

The financial performance of STIOLTO RESPIMAT is influenced by several factors, including market demand, pricing strategies, and competition. Given its clinical benefits and pharmacoeconomic advantages, the drug has the potential to capture a significant share of the COPD treatment market. Here are some key financial considerations:

Revenue Growth

The revenue from STIOLTO RESPIMAT has been increasing steadily since its launch. This growth is attributed to its acceptance by healthcare providers and patients, as well as the expanding COPD patient population.

Pricing Strategies

The pricing of STIOLTO RESPIMAT is competitive with other combination therapies in the market. The cost-effectiveness of the drug, particularly when compared to monotherapies, is a significant factor in its financial success[3].

Market Share

STIOLTO RESPIMAT has been gaining market share in the COPD treatment segment. Its unique combination and the convenience of a single inhaler device contribute to its popularity among both prescribers and patients.

Adverse Reactions and Safety Concerns

While STIOLTO RESPIMAT has a generally favorable safety profile, it is associated with certain adverse reactions, including immediate hypersensitivity reactions, paradoxical bronchospasm, and worsening of narrow-angle glaucoma. These safety concerns are closely monitored and managed through appropriate warnings and precautions[2].

Patient Compliance and Adherence

Patient compliance is a critical factor in the financial trajectory of any drug. The once-daily dosing regimen of STIOLTO RESPIMAT enhances patient adherence, which in turn can lead to better health outcomes and reduced healthcare costs in the long term.

Future Outlook

The future outlook for STIOLTO RESPIMAT is positive, driven by the growing need for effective COPD treatments and the drug's established clinical and economic benefits. As the global population ages and the prevalence of COPD increases, the demand for this combination therapy is expected to rise.

Key Takeaways

Market Need: STIOLTO RESPIMAT addresses the significant need for effective COPD treatments.
Clinical Efficacy: The combination of tiotropium and olodaterol has demonstrated superior bronchodilation and improved lung function.
Pharmacoeconomic Benefits: It is less costly than some monotherapies, making it a more economical option.
Regulatory Approvals: Approved in several countries, including the U.S. and Japan.
Financial Trajectory: Steady revenue growth and increasing market share.
Safety Profile: Generally favorable but with specific safety concerns that are managed through warnings and precautions.

FAQs

Q: What is the primary indication for STIOLTO RESPIMAT?

A: STIOLTO RESPIMAT is indicated for the long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including those with chronic bronchitis and emphysema.

Q: What are the active ingredients in STIOLTO RESPIMAT?

A: The active ingredients are tiotropium bromide and olodaterol hydrochloride.

Q: What is the dosing regimen for STIOLTO RESPIMAT?

A: The usual adult dosage is 2 inhalations once daily, delivering 5 μg of tiotropium and 5 μg of olodaterol.

Q: Is STIOLTO RESPIMAT approved for the treatment of asthma?

A: No, STIOLTO RESPIMAT is not indicated for the treatment of asthma due to the increased risk of asthma-related death associated with LABAs like olodaterol.

Q: What are the common adverse reactions associated with STIOLTO RESPIMAT?

A: Common adverse reactions include nasopharyngitis, cough, back pain, and immediate hypersensitivity reactions. Serious adverse reactions can include COPD exacerbation and pneumonia.

Sources

Report on the Deliberation Results: Tiotropium Bromide Hydrate/Olodaterol Hydrochloride (JAN*), PMDA.
STIOLTO RESPIMAT: Label, FDA.
Pharmacoeconomic Review Report: Tiotropium bromide and Olodaterol, NCBI.
Public Assessment Report: Scientific discussion Spiolto Respimat, CBG-MEB.
Product Pipeline Review: FDA Winter 2015, AJMC.

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