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STIOLTO RESPIMAT Drug Patent Profile

When do Stiolto Respimat patents expire, and when can generic versions of Stiolto Respimat launch?

Stiolto Respimat is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety-four patent family members in forty countries.

The generic ingredient in STIOLTO RESPIMAT is olodaterol hydrochloride; tiotropium bromide. One supplier is listed for this compound. Additional details are available on the olodaterol hydrochloride; tiotropium bromide profile page.

DrugPatentWatch^® Generic Entry Outlook for Stiolto Respimat

Stiolto Respimat was eligible for patent challenges on July 31, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 19, 2027. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for STIOLTO RESPIMAT

International Patents:	194
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Drug Prices:	Drug price information for STIOLTO RESPIMAT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STIOLTO RESPIMAT
What excipients (inactive ingredients) are in STIOLTO RESPIMAT?	STIOLTO RESPIMAT excipients list
DailyMed Link:	STIOLTO RESPIMAT at DailyMed

See drug prices for STIOLTO RESPIMAT

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for STIOLTO RESPIMAT

Constraining patent/regulatory exclusivity:

7,727,984

NDA:

206756

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 STIOLTO RESPIMAT

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

Sponsor	Phase
HealthCore-NERI	Phase 4
Healthcore	Phase 4
Boehringer Ingelheim	Phase 4

See all STIOLTO RESPIMAT clinical trials

Pharmacology for STIOLTO RESPIMAT

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

Paragraph IV (Patent) Challenges for STIOLTO RESPIMAT

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 STIOLTO RESPIMAT

STIOLTO RESPIMAT is protected by nine US patents.

This potential generic entry date is based on patent 7,727,984.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	7,220,742		Y	Y
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	7,837,235*PED				Y
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	7,727,984			Y
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	7,396,341*PED				Y
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	8,034,809
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	8,733,341		Y
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	9,027,967		Y

Expired US Patents for STIOLTO RESPIMAT

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
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	8,044,046
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	5,964,416
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	7,246,615
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	7,104,470
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	7,988,001
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	7,491,719

International Patents for STIOLTO RESPIMAT

See the table below for patents covering STIOLTO RESPIMAT around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005000476
Estonia	200000085
Czech Republic	9004523
Portugal	1156769
Canada	2238760	COMPTEUR MECANIQUE POUR DOSEUR (MECHANICAL COUNTER FOR A METERING APPARATUS)
Ukraine	85865	ПРИСТРІЙ ДЛЯ КРІПЛЕННЯ СТРУМИННОЇ ДЕТАЛІ;устройство для крепления струйной детали (Device for fastening of fluidic component)
European Patent Office	1493492	Buse à microstructure pour haute pression avec fonction de filtrage (Microstructured high-pressure nozzle with integrated filter function)

Supplementary Protection Certificates for STIOLTO RESPIMAT

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	513	Finland
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	C01562603/01	Switzerland		PRODUCT NAME: OLODATEROL; REGISTRATION NO/DATE: SWISSMEDIC 62880 12.05.2014
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	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	132014902316088	Italy		PRODUCT NAME: OLODATEROLO, SUOI SINGOLI ISOMERI OTTICI, MISCELE DEI SINGOLI ENANTIOMERI O DI RACEMATI, SUOI SALI DI ADDIZIONE CON ACIDI FARMACOLOGICAMENTE ACCETTABILI NONCHE' SUOI SOLVATI E/O IDRATI, IN PARTICOLARE OLODATEROLO E OLODATEROLO CLORIDRATO(STRIVERDI RESPIMAT); AUTHORISATION NUMBER(S) AND DATE(S): MA211/00401, 20130918;042432017-029-031-043, 20140618

STIOLTO RESPIMAT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Stiolto Respimat

Introduction

Stiolto Respimat, a combination of tiotropium and olodaterol, is a maintenance bronchodilator treatment for chronic obstructive pulmonary disease (COPD) developed by Boehringer Ingelheim. The drug's market dynamics and financial trajectory are influenced by several factors, including regulatory approvals, competitive landscape, pricing strategies, and value-based contracts.

Regulatory Approval and Clinical Efficacy

Stiolto Respimat received FDA approval in May 2015 for the long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema[2][4].

The drug has demonstrated clinically meaningful improvements in lung function and health-related quality of life. Studies such as the OTEMTO 1&2 trials showed that Stiolto Respimat provided significant improvements in FEV1 and reduced the St. George's Respiratory Questionnaire (SGRQ) scores by more than four points compared to placebo, indicating a clinically meaningful improvement in health-related quality of life[4].

Competitive Landscape

The respiratory market, particularly for COPD treatments, is highly competitive. Stiolto Respimat faces competition from established products like GlaxoSmithKline's Advair and AstraZeneca's Symbicort. The exclusion of Advair from Express Scripts' national preferred formulary in 2014 and subsequent aggressive discounting by GlaxoSmithKline to regain formulary inclusion highlight the intense competition and pricing pressures in this market[1].

Additionally, Novartis's Ultibro Breezhaler, already available in Europe, was awaiting FDA approval in 2015, further complicating the competitive landscape for Stiolto Respimat[1].

Pricing and Payer Dynamics

Pricing has been a significant challenge for Stiolto Respimat. U.S. payers have increasingly used price as a lever to negotiate formulary positions. For instance, the exclusion of Advair from Express Scripts' formulary led to a 25% drop in U.S. sales for Advair in 2014. Despite GlaxoSmithKline's efforts to regain formulary inclusion through discounts, the impact on sales was substantial[1].

Boehringer Ingelheim's Allan Hillgrove acknowledged the pricing challenges, stating that U.S. payers have become more aggressive in using price as a negotiating tool. This environment poses a significant hurdle for Stiolto Respimat's market penetration and revenue growth[1].

Value-Based Contracts

To address the pricing and access challenges, Boehringer Ingelheim has entered into value-based contracts. In 2019, Highmark and Boehringer Ingelheim announced a value-based contract for Stiolto Respimat, which links reimbursement to patient outcomes. This contract evaluates whether Stiolto Respimat reduces the total cost of COPD care for members compared to other treatments, using GOLD guideline-based care as a benchmark[5].

Such contracts aim to improve patient care and lower overall healthcare costs by focusing on outcomes rather than the quantity of care. This approach is part of Boehringer Ingelheim's strategy to seek more outcomes-focused solutions to help manage healthcare costs[5].

Financial Performance

The financial performance of Stiolto Respimat has been impacted by the competitive and pricing pressures. Despite its clinical efficacy, the drug's sales have faced challenges similar to those of other respiratory treatments. For example, Boehringer Ingelheim's respiratory sales, including those of Spiriva Respimat, have declined due to competitive pressures and payer negotiations[1].

In 2014, Spiriva's sales fell by 8.1% to €3.3 billion, reflecting the broader market challenges. The approval and launch of Stiolto Respimat were expected to help mitigate some of these losses, but the drug's financial trajectory remains closely tied to its ability to secure favorable formulary positions and negotiate effective pricing with payers[1].

Market Trends and Projections

The prescription drug market, including respiratory treatments, is characterized by rising costs and increasing scrutiny over pricing. From 2018 to 2019, manufacturer net revenues from pharmaceutical sales grew by an estimated 5.2%, and prices for brand-name drugs increased by an average of 6.8% during the first half of 2020[3].

Given these trends, the financial trajectory of Stiolto Respimat will likely be influenced by ongoing efforts to manage healthcare costs and the success of value-based contracts in demonstrating the drug's value to payers.

Key Takeaways

• Regulatory Approval: Stiolto Respimat received FDA approval in May 2015 for COPD treatment.
• Clinical Efficacy: The drug has shown significant improvements in lung function and health-related quality of life.
• Competitive Landscape: The market is highly competitive, with established products and new entrants posing challenges.
• Pricing and Payer Dynamics: Pricing pressures and payer negotiations significantly impact the drug's market penetration.
• Value-Based Contracts: Boehringer Ingelheim has adopted value-based contracts to link reimbursement to patient outcomes.
• Financial Performance: Sales have been affected by competitive and pricing pressures, but value-based contracts offer a promising approach.

FAQs

Q: What is Stiolto Respimat used for? A: Stiolto Respimat is used for the long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Q: When was Stiolto Respimat approved by the FDA? A: Stiolto Respimat was approved by the FDA in May 2015.

Q: How does Stiolto Respimat compare to other COPD treatments in terms of efficacy? A: Stiolto Respimat has demonstrated significant improvements in lung function and health-related quality of life compared to single ingredient products and placebo in clinical trials.

Q: What are the main challenges facing Stiolto Respimat in the market? A: The main challenges include intense competition, pricing pressures, and payer negotiations.

Q: How is Boehringer Ingelheim addressing the pricing and access challenges for Stiolto Respimat? A: Boehringer Ingelheim has entered into value-based contracts that link reimbursement to patient outcomes, aiming to improve care and lower healthcare costs.

Cited Sources

1. FiercePharma: "Boehringer faces uphill battle for Stiolto, thanks to payer arm-twisting"
2. FDA: "206756Orig1s000 - accessdata.fda.gov"
3. HCPF: "Reducing Prescription Drug Costs in Colorado, 2nd Edition"
4. PR Newswire: "New Published Data Show STIOLTO™ RESPIMAT® Provides Clinically Meaningful Improvements in COPD Health-Related Quality of Life Measure"
5. PR Web: "Highmark, Boehringer Ingelheim Announce Value-Based Contract for COPD Medication Stiolto Respimat"