SEEBRI Drug Patent Profile

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

Seebri is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug.

This drug has ninety-nine patent family members in thirty-two countries.

The generic ingredient in SEEBRI is glycopyrrolate. There are seventeen drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Seebri

A generic version of SEEBRI was approved as glycopyrrolate by AM REGENT on July 23^rd, 1986.

Summary for SEEBRI

International Patents:	99
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	3
Patent Applications:	3,818
Drug Prices:	Drug price information for SEEBRI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SEEBRI
DailyMed Link:	SEEBRI at DailyMed

See drug prices for SEEBRI

Recent Clinical Trials for SEEBRI

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

Sponsor	Phase
University of Saskatchewan	Phase 4
Sunovion Respiratory Development Inc.	Phase 1

See all SEEBRI clinical trials

US Patents and Regulatory Information for SEEBRI

SEEBRI is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015		DISCN	Yes	No			Y
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015		DISCN	Yes	No			Y

Expired US Patents for SEEBRI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015
Novartis	SEEBRI	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015

International Patents for SEEBRI

See the table below for patents covering SEEBRI around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	336142
United Kingdom	0409133
Canada	2405767	FORMULATIONS PHARMACEUTIQUES POUR INHALATEUR A POUDRE SECHE (PHARMACEUTICAL FORMULATIONS FOR DRY POWDER INHALERS)
Japan	2004500424
Austria	535233

Supplementary Protection Certificates for SEEBRI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1267866	479	Finland
1267866	493	Finland
1267866	C300651	Netherlands		PRODUCT NAME: COMBINATIE VAN; REGISTRATION NO/DATE: EU/1/13/862/001-006 20130919
2435025	LUC00124	Luxembourg		PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
1267866	122014000025	Germany		PRODUCT NAME: GLYCOPYRRONIUM ODER EIN SALZ ODER DERIVAT HIERVON (KOMPONENTE 1) UND INDACATEROL ODER EIN DERIVAT HIERVON ODER EIN SALZ VON INDACATEROL ODER EINEM DERIVAT HIERVON (KOMPONENTE 2); REGISTRATION NO/DATE: EU/1/13/862 20130919

SEEBRI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SEEBRI

Introduction to SEEBRI

SEEBRI, also known as glycopyrrolate, is a medication used to treat chronic obstructive pulmonary disease (COPD) in adults. It is available in two main formulations: SEEBRI Neohaler and SEEBRI Breezhaler.

Market Segmentation and Positioning

Therapeutic Area

SEEBRI falls under the COPD therapeutics market, which is a significant segment within the respiratory disease treatment landscape. The COPD market is expected to grow, driven by increasing prevalence and the need for effective treatments[1].

Product Type

SEEBRI Neohaler and SEEBRI Breezhaler are part of the long-acting muscarinic antagonist (LAMA) class of drugs. These products compete with other LAMAs such as Spiriva (tiotropium bromide) and Incruse Ellipta (umeclidinium bromide)[1].

Market Dynamics

Drivers

• Increasing Prevalence: The rising incidence of COPD due to aging populations and environmental factors drives demand for effective treatments like SEEBRI.
• Advancements in Technology: Improvements in inhalation devices, such as the Neohaler and Breezhaler, enhance patient compliance and efficacy.
• Regulatory Approvals: Successful regulatory approvals and extensions of indications support market growth[4].

Barriers

• Competition: The COPD market is highly competitive, with several established brands and generic alternatives.
• Regulatory Challenges: The process of obtaining and maintaining regulatory approvals can be complex and time-consuming, as seen with the FDA's stringent standards for generic inhalation products[3].

Opportunities

• Global Expansion: There is significant potential for growth in regions outside the US, where Novartis continues to commercialize SEEBRI Breezhaler[4].
• Partnerships and Licensing: Collaborations with other companies, such as the out-licensing to Sunovion in the US, can expand market reach and revenue streams[4].

Financial Performance

Revenue and Sales

• SEEBRI, as part of Novartis's respiratory portfolio, contributes to the company's overall revenue. While specific financial figures for SEEBRI alone are not always disclosed, the product is part of a larger portfolio that has shown strong performance. For instance, the Vectura Group, which has developed and partnered on similar inhalation products, reported strong underlying financial performance with key products like Seebri Breezhaler contributing to gross margins[3].

Out-Licensing and Commercialization

• In 2023, Novartis out-licensed the US commercialization rights for SEEBRI Neohaler to Sunovion. This move is expected to optimize the product's market impact in the US by leveraging Sunovion's established presence in the COPD field. Novartis will continue to manufacture these medicines, ensuring a steady revenue stream from manufacturing and licensing agreements[4].

Geographical Performance

North America

• The out-licensing agreement with Sunovion is expected to enhance SEEBRI's market presence in the US. This strategic move aligns with Novartis's focus on areas where they have strong capabilities and leadership[4].

Europe and Asia Pacific

• Outside the US, Novartis continues to commercialize SEEBRI Breezhaler, capitalizing on growing demand in regions like Europe and the Asia Pacific. These markets offer significant growth opportunities due to their large patient populations and increasing healthcare spending[1][4].

Competitive Landscape

Key Competitors

• SEEBRI competes with other COPD treatments such as Advair (fluticasone/salmeterol), Spiriva (tiotropium bromide), and Incruse Ellipta (umeclidinium bromide). The competitive landscape is dynamic, with companies like AstraZeneca, Boehringer Ingelheim, and GlaxoSmithKline also playing significant roles[1].

Market Share and Profitability

• While specific market share figures for SEEBRI are not readily available, it is part of a highly competitive market where profitability is influenced by factors such as pricing, regulatory approvals, and patient compliance. Companies with strong portfolios and strategic partnerships tend to maintain a competitive edge[1].

Regulatory Overview

Approvals and Extensions

• Regulatory approvals and extensions are crucial for the continued success of SEEBRI. The FDA's approval process for inhalation products is rigorous, but successful navigation of this process can significantly boost market presence[3][4].

Key Takeaways

• Growing Demand: The COPD market is driven by increasing prevalence and the need for effective treatments.
• Strategic Partnerships: Out-licensing agreements, such as the one with Sunovion, can enhance market reach and revenue.
• Global Expansion: Opportunities exist in regions outside the US, where Novartis continues to commercialize SEEBRI Breezhaler.
• Regulatory Focus: Successful regulatory approvals and extensions are critical for market growth.

FAQs

Q: What is SEEBRI used for? A: SEEBRI is used to treat chronic obstructive pulmonary disease (COPD) in adults.

Q: Who manufactures SEEBRI? A: Novartis manufactures SEEBRI, although the US commercialization rights have been out-licensed to Sunovion.

Q: What are the different formulations of SEEBRI? A: SEEBRI is available as SEEBRI Neohaler and SEEBRI Breezhaler.

Q: How does SEEBRI compete in the market? A: SEEBRI competes with other COPD treatments like Spiriva and Incruse Ellipta, leveraging its position as a LAMA and through strategic partnerships.

Q: What are the key drivers for the growth of SEEBRI in the market? A: Key drivers include increasing prevalence of COPD, advancements in inhalation technology, and successful regulatory approvals.

Cited Sources

1. Asthma and COPD Therapeutics Market and Forecast 2024-2031 - iHealthcareAnalyst
2. Seer Reports Fourth Quarter and Full Year 2023 Financial Results - Seer Bio
3. Vectura Group plc Annual Report and Accounts 2017 - AnnualReports.com
4. Novartis out-licenses three COPD products in the US - Novartis