DULERA Drug Patent Profile

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

Dulera is a drug marketed by Organon Llc and is included in one NDA.

The generic ingredient in DULERA is formoterol fumarate; mometasone furoate. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the formoterol fumarate; mometasone furoate profile page.

Summary for DULERA

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for DULERA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-003	Aug 12, 2019		RX	Yes	Yes
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-001	Jun 22, 2010		RX	Yes	Yes
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010		RX	Yes	Yes

International Patents for DULERA

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

Country	Patent Number	Title	Estimated Expiration
Austria	216243
Austria	518520
Austria	519489
Austria	525075
Austria	531364
Australia	1727195
Australia	691880

Supplementary Protection Certificates for DULERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0613371	2002C/022	Belgium		PRODUCT NAME: BUDESONID. MICRONIS. AND FORMOTEROL. FUMARAS DIHYDR., NATL REGISTRATION NO/DATE: 624 IS 234 F 0 20010129; FIRST REGISTRATION: SE 16047 20000825
2435025	19C1040	France		PRODUCT NAME: COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET DE FORMOTEROL (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); NAT. REGISTRATION NO/DATE: EU/1/18/1339 20181220; FIRST REGISTRATION: - EU/1/18/1339 20181220
2435024	LUC00208	Luxembourg		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210
2435025	CA 2019 00032	Denmark		PRODUCT NAME: KOMBINATION AF GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF, OG FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF; REG. NO/DATE: EU/1/18/1339 20181220
2435024	CA 2021 00014	Denmark		PRODUCT NAME: KOMBINATION AF FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, OG BUDESONID, HERUNDER...; REG. NO/DATE: EU/1/20/1498 20201210
2435025	PA2019014,C2435025	Lithuania		PRODUCT NAME: GLIKOPIRONIO BROMIDAS/FORMOTEROLIS; REGISTRATION NO/DATE: EU/1/18/1339 20181218
2435024	122021000026	Germany		PRODUCT NAME: GLYCOPYRROLAT MIT FORMOTEROL MIT BUDESONID, ODER SALZE, ESTER, SOLVATE, ENANTIOMERE UND MISCHUNGEN VON ENANTIOMEREN DERSELBEN; AUTHORISATION NO/DATE: EU/1/20/1498 20201209

Last updated: February 10, 2026

What Are the Key Investment Fundamentals of DULERA?

DULERA is an inhaled medication developed by AstraZeneca for the management of asthma and chronic obstructive pulmonary disease (COPD). It combines formoterol fumarate dihydrate (a long-acting beta-agonist) and mometasone furoate (an inhaled corticosteroid). Since its approval in 2012, DULERA has maintained a steady market position, but several factors influence its investment outlook.

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How Does DULERA Fit Within the Market Landscape?

DULERA operates in a competitive segment, primarily comprising combination inhalers for asthma and COPD management. Key competitors include:

• Symbicort (budesonide/formoterol) by AstraZeneca
• Advair (fluticasone/salmeterol) by GlaxoSmithKline
• Brethine (terbutaline) — less common, older therapy

Market share data suggests DULERA holds approximately 10-15% within the fixed-dose combination segment in the U.S. (IMS Health, 2022). The global respiratory drug market is projected to grow at a CAGR of 4-6% through 2027, driven by rising COPD prevalence, especially in aging populations.

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What Are Commercial Benefits and Risks?

Revenue Performance and Market Penetration

• AstraZeneca's respiratory franchise reported $8.3 billion in sales in 2022, with DULERA contributing a fraction.
• DULERA's prescription volume has remained stable but faces erosion from expanded generic options for certain components, notably mometasone.

Patent and Patent Expiry

• DULERA's patent protection began in 2012; the key patents are expected to expire between 2024 and 2026.
• Patent expiration risks allow generic competitors entry, potentially reducing revenue by 30-50% over two years post-expiry.

Pricing and Reimbursement Dynamics

• DULERA is priced higher than monotherapy alternatives due to combination benefits.
• Reimbursement policies favor generic versions, pressuring prices until exclusivity lapses.

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How Do Regulatory and Developmental Factors Impact Investment?

Regulatory Approvals and Extensions

• US FDA approved DULERA in 2012; no current plans for label expansion.
• Market exclusivity is tied to patent life, not to regulatory extensions. No new indications or key label updates are expected in the near term.

Pipeline and Lifecycle Management

• AstraZeneca has invested in developing new inhaler devices and formulations to extend product lifecycle.
• The company is also exploring triple-combination inhalers, which could substitute DULERA in clinical use.

Patent Litigation and Patent Challenges

• Patent challenges in Europe have delayed generic launches until at least 2024.
• Litigation outcomes could extend exclusivity or lead to early generic entry.

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What Are the Key Market and R&D Risks?

• Generic Entrants: The imminent patent expiry could flood the market with lower-cost options.
• Market Share Erosion: Competitors launching similar inhalers with better efficacy or fewer side effects.
• Regulatory Delays: New formulations or indications could face delays, impacting revenue.
• Pricing Pressure: Payer policies increasingly favor generics to reduce outpatient drug costs.

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Investment Scenario Analysis

Scenario	Description	Impact on DULERA Revenue	Investment Implication
Base Case	Patents held until 2026, stable market share	Revenue stable, slight decline	Moderate investment risk; limited upside
Optimistic	Patent extended, new indications approved	Revenue growth, market expansion	High upside if patent litigation favors AstraZeneca
Pessimistic	Patent invalidated, early generic entry	Revenue declines >50%	High risk; potential sale or divestment

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What Are the Strategic Considerations?

• Patent Strategy: Monitoring patent litigation outcomes and potential extensions.
• Pipeline Investing: Supporting development of next-generation inhalers, combinations, and delivery systems.
• Market Penetration: Increasing prescriber adoption through clinical trials and direct-to-consumer efforts.
• Pricing Power: Maintaining a competitive edge to sustain margins until patent expiry.

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Conclusion

DULERA remains a mid-sized asset within AstraZeneca’s respiratory portfolio. Its investment case hinges on patent protection stability, market share retention, and pipeline enhancements. The imminent patent expiry in the U.S. suggests a potential decline in revenue unless mitigated by new product filings or extended exclusivity.

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Key Takeaways

• DULERA’s market share is stabilizing but faces medium-term revenue decline due to patent expiration.
• Patent protection lapses are expected between 2024 and 2026, risking significant price erosion.
• Market dynamics favor generics, pressuring pricing and margins.
• Pipeline developments in combination inhalers could offset some revenue declines.
• Risk factors include patent challenges, competitive product launches, and regulatory delays.

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FAQs

1. When will DULERA lose patent exclusivity?
Patent protection is expected to expire between 2024 and 2026, after which generics are likely to enter the market.

2. What factors could extend DULERA’s revenue life?
Successful patent litigation, new regulatory approvals for expanded indications, or formulation improvements.

3. How does DULERA compare financially to competitors?
DULERA’s sales are lower than Symbicort and Advair, which hold larger market shares, but it benefits from AstraZeneca’s dedicated sales force.

4. What is the outlook for inhaled corticosteroids and long-acting beta-agonists?
The segment is mature; growth depends on new formulations and improved delivery systems rather than new molecule approvals.

5. Should investors consider DULERA amid patent expiry?
Risks increase as patent expiry approaches; investors should weigh potential generic erosion against pipeline projects and lifecycle management efforts.

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References

1. IMS Health, 2022. Market research report on respiratory medications.
2. AstraZeneca Annual Report, 2022.
3. FDA approval documents for DULERA, 2012.
4. Patent expiry estimates based on patent databases, 2023.