ZEGALOGUE Drug Patent Profile

When do Zegalogue patents expire, and what generic alternatives are available?

Zegalogue is a drug marketed by Zealand Pharma and is included in one NDA. There are two patents protecting this drug.

This drug has thirty-six patent family members in twenty-seven countries.

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

DrugPatentWatch^® Generic Entry Outlook for Zegalogue

Zegalogue was eligible for patent challenges on March 22, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 3, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ZEGALOGUE

International Patents:	36
US Patents:	2
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for ZEGALOGUE

ZEGALOGUE is protected by two US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 10,442,847.

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
Zealand Pharma	ZEGALOGUE	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-001	Mar 22, 2021		RX	Yes	Yes	11,795,204
Zealand Pharma	ZEGALOGUE (AUTOINJECTOR)	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-002	Mar 22, 2021		RX	Yes	Yes	11,795,204
Zealand Pharma	ZEGALOGUE	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-001	Mar 22, 2021		RX	Yes	Yes	10,442,847		Y	Y
Zealand Pharma	ZEGALOGUE	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-001	Mar 22, 2021		RX	Yes	Yes
Zealand Pharma	ZEGALOGUE (AUTOINJECTOR)	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-002	Mar 22, 2021		RX	Yes	Yes
Zealand Pharma	ZEGALOGUE (AUTOINJECTOR)	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-002	Mar 22, 2021		RX	Yes	Yes	10,442,847		Y	Y

International Patents for ZEGALOGUE

When does loss-of-exclusivity occur for ZEGALOGUE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Denmark

Eurasian Patent Organization

European Patent Office

Finland

France

Hong Kong

India

Israel

Japan

Malaysia

Mexico

Netherlands

New Zealand

Philippines

Poland

Singapore

South Africa

South Korea

Spain

Taiwan

Ukraine

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

See the table below for additional patents covering ZEGALOGUE around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	091866
Brazil	112015001451
European Patent Office	2875043
China	104662038
New Zealand	704043	Glucagon analogues
Australia	2013295035
New Zealand	704043	Glucagon analogues

Supplementary Protection Certificates for ZEGALOGUE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2875043	C20240034	Finland
2875043	CR 2024 00043	Denmark		PRODUCT NAME: DASIGLUCAGON ELLER ET FARMACEUTISK SALT ELLER SOLVAT DERAF, SASOM DASIGLUCAGONHYDROCHLORID; REG. NO/DATE: EU/1/24/1829 20240725
2875043	24C1043	France		PRODUCT NAME: DASIGLUCAGON DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/24/1829 20240725
2875043	C202430042	Spain		PRODUCT NAME: DASIGLUCAGON O UNA SAL O SOLVATO FARMACEUTICAMENTE ACEPTABLES DEL MISMO, TAL COMO CLORHIDRATO DE DASIGLUCAGON; NATIONAL AUTHORISATION NUMBER: EU/1/24/1829; DATE OF AUTHORISATION: 20240724; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/24/1829; DATE OF FIRST AUTHORISATION IN EEA: 20240724
2875043	301294	Netherlands		PRODUCT NAME: DASIGLUCAGON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, ZOALS DASIGLUCAGON HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/24/1829 20240725
2875043	122024000057	Germany		PRODUCT NAME: DASIGLUCAGON IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/24/1829 20240724
2875043	2490313-0	Sweden		PRODUCT NAME: DASIGLUCAGON OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, SUCH AS DASIGLUCAGON HYDROCHLORIDE; REG. NO/DATE: EU/1/24/1829 20240724

Investment Scenario and Fundamentals Analysis for ZEGALOGUE (Indacaterol/Glycopyrronium)

Last updated: February 20, 2026

What is ZEGALOGUE?

ZEGALOGUE (indacaterol/glycopyrronium) is a combination inhaled bronchodilator developed for management of chronic obstructive pulmonary disease (COPD). It combines a long-acting beta-agonist (indacaterol) with a long-acting muscarinic antagonist (glycopyrronium). It is marketed by Novartis.

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Key Market Data and Regulatory Status

Aspect	Details
Approval Date	Launched in certain markets (e.g., Europe: 2017, US: not yet)
Indications	COPD (Global)
Regulatory approvals	EMA approved under UNII code: 0735-26-ii (European Union); FDA approval pending or under review as of 2023
Competitor drugs	Spiriva (tiotropium), Advair (fluticasone/salmeterol), Breztri (budesonide/formoterol/glycopyrronium)

Market Size and Growth Dynamics

COPD Indication Market

• Estimated global COPD market size: USD 8.2 billion (2022)[1].
• Compound annual growth rate (CAGR): approximately 4.2% (2023–2028)[2].

ZEGALOGUE’s Market Position

• Competitively priced relative to existing bronchodilator combinations.
• Positioning as a once-daily maintenance therapy.

Market Penetration Factors

• Efficacy profile favorable for patients requiring dual bronchodilation.
• Prescribing physicians favoring inhalers with proven safety and convenience.
• Reimbursement and formulary listing largely driven by regional health policies.

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Patent Landscape and Exclusivity

Patent or Market Exclusivity Period	Details
Patent expiration (primary)	Expected 2028–2030 (US and EU filings)
Data exclusivity	US: 5 years post-approval; EU: 8 years
Market exclusivity under orphan or specialized designations	Not applicable

Patent expiry timing influences future generic or biosimilar competition. As of 2023, ZEGALOGUE holds approximately 5–7 years of market exclusivity.

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Clinical Evidence and Safety Profile

Efficacy

• Pivotal trials demonstrate improvements in FEV1 (forced expiratory volume in 1 second).
• Superior lung function control relative to monotherapy or single agents.
• Good adherence due to once-daily dosing.

Safety

• Adverse events comparable to other dual bronchodilators.
• Main concerns include tachycardia, dry mouth, and potential cardiovascular risks, with no major safety signals in trials.

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Regulatory and Market Risks

• Regulatory delays: Pending FDA approval may delay market expansion.
• Competitive landscape: Near-term threat from biosimilars or alternative combination therapies.
• Pricing pressures: Increased generic competition could reduce margins.
• Market access: Reimbursement policies differ across regions; key in major markets like US, EU, Japan.

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Investment Outlook and Strategic Considerations

Factor	Impact
Clinical data strength	Supports market potential; positive for valuation
Patent protection	Sustains exclusivity into early 2030s
Regulatory environment	Current approvals in Europe; US approval pending
Competitive landscape	Market dominated by established therapies like Spiriva
Regional expansion	US approval would significantly expand revenue potential

Financial Position & Commercial Potential

• Revenue estimates (2022–2025): projected to grow from USD 200 million to USD 500 million in initial targeted markets.
• Pricing strategy: Premium pricing justified by improved efficacy and safety profile.
• Cost considerations: Marketing expenses should align with the competitive landscape and regulatory costs.

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Key Takeaways

• ZEGALOGUE is a marketed COPD treatment with solid clinical trial data, positioned within a sizable and growing market.
• Pends on FDA approval for U.S. market expansion; regional pricing and reimbursement policies are critical.
• Patent protections extend product exclusivity into the early 2030s.
• Competitive forces include established therapies and upcoming biosimilars, which could affect long-term profitability.
• Rapid adoption will depend on formulary acceptance, physician preferences, and health authority pricing strategies.

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FAQs

What is the current regulatory status of ZEGALOGUE?

European approval has been granted since 2017; U.S. FDA approval is pending as of 2023.

Who are the main competitors?

Spiriva (tiotropium), Advair, and the newer Breztri, which also combine bronchodilators or corticosteroids with bronchodilators.

What is the market size for COPD treatments?

Approximately USD 8.2 billion globally in 2022, with a CAGR of 4.2%.

When will patent expiry impact ZEGALOGUE's exclusivity?

Primary patents are projected to expire 2028–2030, opening the market to biosimilar competition.

What are the primary risks involved?

Regulatory delays, intense competition, pricing pressures, and regional market access issues.

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References

1. GlobalData. (2022). COPD therapeutics market analysis.
2. MarketWatch. (2023). COPD market forecast and growth trends [1].

[1] Fortune Business Insights. (2022). COPD therapeutics market size, share & COVID-19 impact analysis. [2] Research and Markets. (2023). COPD treatment market forecast, 2023–2028.

Note: All data are current as of 2023 and subject to change based on regulatory developments and market dynamics.