STRIVERDI RESPIMAT Drug Patent Profile

Which patents cover Striverdi Respimat, and when can generic versions of Striverdi Respimat launch?

Striverdi Respimat is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are eight patents protecting this drug.

This drug has one hundred and eighty-six patent family members in forty countries.

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

DrugPatentWatch^® Generic Entry Outlook for Striverdi Respimat

Striverdi 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 STRIVERDI RESPIMAT

International Patents:	186
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	2
Patent Applications:	39
Drug Prices:	Drug price information for STRIVERDI RESPIMAT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STRIVERDI RESPIMAT
What excipients (inactive ingredients) are in STRIVERDI RESPIMAT?	STRIVERDI RESPIMAT excipients list
DailyMed Link:	STRIVERDI RESPIMAT at DailyMed

See drug prices for STRIVERDI RESPIMAT

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

Constraining patent/regulatory exclusivity:

7,727,984

NDA:

203108

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 STRIVERDI RESPIMAT

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

Sponsor	Phase
Università degli Studi di Ferrara	Phase 4
Boehringer Ingelheim

See all STRIVERDI RESPIMAT clinical trials

Pharmacology for STRIVERDI RESPIMAT

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

US Patents and Regulatory Information for STRIVERDI RESPIMAT

STRIVERDI RESPIMAT is protected by eight 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	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014		RX	Yes	Yes	8,034,809
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014		RX	Yes	Yes	8,733,341		Y
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014		RX	Yes	Yes	9,027,967		Y
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014		RX	Yes	Yes	7,896,264		Y
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014		RX	Yes	Yes	7,220,742		Y	Y

Expired US Patents for STRIVERDI RESPIMAT

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	7,988,001
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014	7,284,474
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014	5,964,416
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014	7,104,470
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014	7,491,719

International Patents for STRIVERDI RESPIMAT

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

Country	Patent Number	Title	Estimated Expiration
Argentina	041969	MEDICAMENTO PARA EL TRATAMIENTO DE LA ENFERMEDAD PULMONAR OBSTRUCTIVA CRONICA
Japan	4317664
Peru	11572000
Poland	373917	Urządzenie blokujące mechanizmu zamkowego o działaniu sprężynowym (BLOCKING DEVICE FOR A SPRUNG LOCK WITH A SPRING OPERATION)
Spain	2201204

Supplementary Protection Certificates for STRIVERDI RESPIMAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1562603	1490016-1	Sweden		PRODUCT NAME: OLODATEROL, INDIVIDUELLA OPTISKA ISOMERER DAERAV, BLANDNINGAR AV DE SEPARATA ENANTIOMERERNA ELLER RACEMATEN DAERAV, SYRA ADDITIONSSALTER DAERAV MED FARMAKOLOGISKT GODTAGBARA SYROR SAVAEL SOM SOLVATER OCH/ELLER HYDRATER DAERAV, SAERSKILT OLODATEROL OCH OLODATEROLHYDROKLORID; NAT. REG. NO/DATE: MT-NR 48116 20131114; FIRST REG.: MT MA 211/00401 20130918
1562603	14C0049	France		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	513	Finland
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	SPC/GB14/023	United Kingdom		PRODUCT NAME: OLODATEROL OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTERED: MT MA 211/00401 20130918; UK PL 14598/0093 20131010

Market Dynamics and Financial Trajectory for Striverdi Respimat

Introduction to Striverdi Respimat

Striverdi Respimat, developed by Boehringer Ingelheim, is a significant addition to the treatment options for chronic obstructive pulmonary disease (COPD). This medication, indicated for the treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema, has been making waves in the respiratory therapeutics market.

Market Need and Demand

COPD is a prevalent condition, affecting approximately 15 million Americans who have been diagnosed by healthcare providers[4]. The financial burden of managing COPD is substantial, with patients often relying on multiple medications such as bronchodilators and steroids[3].

Regulatory Approval and Launch

Striverdi Respimat received approval from the US Food and Drug Administration (FDA) in July, based on data from eight Phase III clinical trials involving 4,450 patients with COPD. This approval marked a significant milestone, as it introduced a new long-acting beta agonist (LABA) delivered through the Respimat inhaler[4].

Market Positioning

Boehringer Ingelheim has a strong heritage in respiratory diseases, and the introduction of Striverdi Respimat further solidifies its position in the market. The company's senior vice-president, Kathleen Dowd, emphasized the importance of this new treatment option, highlighting the need for innovative therapies in the COPD treatment landscape[4].

Competitive Landscape

The COPD therapeutics market is highly competitive, with several established and new entrants. Boehringer Ingelheim's Spiriva, for instance, has been a major player in the COPD market, although its sales have seen a decline in recent years[1].

Financial Performance and Projections

While specific financial data for Striverdi Respimat alone is not readily available, the overall performance of Boehringer Ingelheim's respiratory portfolio provides insight into the potential trajectory.

• Boehringer Ingelheim's Respiratory Segment: The company's respiratory products, including Spiriva, have been key contributors to its revenue. Despite a decline in Spiriva's sales, new products like Striverdi Respimat are expected to pick up market share during the forecast period[1][5].

• Revenue Growth: Boehringer Ingelheim's net sales have shown steady growth, with a 3% increase from 2019 to 2020, reaching €19.566 billion. The Human Pharma segment, which includes respiratory products, accounted for 74% of the total net sales[5].

• Research and Development: The company's significant investment in research and development, with expenses increasing by 7% from 2019 to 2020, indicates a strong commitment to innovation and the development of new therapies like Striverdi Respimat[5].

Regional Impact

The global market for COPD therapeutics is diverse, with significant sales in the Americas, Europe, and the Asia/Australia/Africa region. Boehringer Ingelheim's sales in these regions have been consistent, with the Asia/Australia/Africa region showing strategic growth potential[2][5].

Patient and Provider Acceptance

The introduction of Striverdi Respimat has been well-received by both providers and patients. The medication offers a new maintenance treatment option, which is crucial given the chronic nature of COPD. Patient acceptance is likely to be high due to the convenience and efficacy of the Respimat inhaler[4].

Challenges and Opportunities

• Patent Expiry and Competition: The COPD market is subject to patent expiries and the introduction of new market entrants. While this presents a challenge, it also drives innovation and competition, which can benefit patients and providers alike[1].

• Reimbursement and Access: The financial burden of COPD treatment is a significant concern. Ensuring adequate reimbursement and access to new treatments like Striverdi Respimat will be crucial for its long-term success[3].

Future Outlook

Given the growing demand for effective COPD treatments and Boehringer Ingelheim's strong track record in respiratory therapeutics, Striverdi Respimat is poised for positive growth.

• Market Growth Projections: The global asthma and COPD therapeutics market is expected to reach $44.1 billion by 2031, growing at a CAGR of 7.3%. New products like Striverdi Respimat are likely to contribute significantly to this growth[1].

• Innovation and Expansion: Boehringer Ingelheim's continued investment in research and development suggests that the company will continue to innovate and expand its respiratory portfolio, further solidifying its market position[5].

Key Takeaways

• Striverdi Respimat is a new COPD treatment option approved by the FDA, offering a long-acting beta agonist delivered through the Respimat inhaler.
• Market Need: The medication addresses a significant need in the COPD treatment landscape, particularly given the financial burden and prevalence of the disease.
• Competitive Landscape: The COPD market is competitive, but Boehringer Ingelheim's strong heritage and new product introductions position it well for market share growth.
• Financial Performance: While specific data for Striverdi Respimat is not available, Boehringer Ingelheim's overall financial performance and investment in R&D indicate a positive trajectory.
• Regional Impact: The medication is expected to have a global impact, particularly in regions with growing healthcare needs.

FAQs

1. What is Striverdi Respimat used for? Striverdi Respimat is used to treat airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema[4].

2. How was Striverdi Respimat approved? Striverdi Respimat was approved by the US FDA based on data from eight Phase III clinical trials involving 4,450 patients with COPD[4].

3. What is the competitive landscape for COPD therapeutics? The COPD therapeutics market is highly competitive with established products like Boehringer Ingelheim's Spiriva and new entrants like Striverdi Respimat and GSK’s Incruse Ellipta[1].

4. How does Striverdi Respimat fit into Boehringer Ingelheim's respiratory portfolio? Striverdi Respimat is part of Boehringer Ingelheim's extensive respiratory portfolio, which includes other successful products like Spiriva. It is expected to contribute to the company's revenue growth in the respiratory segment[4][5].

5. What are the future growth prospects for Striverdi Respimat? Given the growing demand for COPD treatments and Boehringer Ingelheim's strong position in the market, Striverdi Respimat is expected to experience positive growth and contribute to the overall market growth projected to reach $44.1 billion by 2031[1].

Sources

1. Global Asthma and COPD Therapeutics Market $44.1 Billion by 2031 - iHealthcareAnalyst
2. Boehringer Ingelheim Annual Report 2019 - Annual Reports
3. Therapeutic Focus: Respiratory - Media.MMM-Online
4. Boehringer brings Striverdi Respimat to market for COPD treatment - World Pharma Today
5. Boehringer Ingelheim Annual Report 2020 - Annual Reports