SINGULAIR Drug Patent Profile

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

Singulair is a drug marketed by Organon and is included in three NDAs.

The generic ingredient in SINGULAIR is montelukast sodium. There are thirty-five drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Singulair

A generic version of SINGULAIR was approved as montelukast sodium by AUROBINDO PHARMA LTD on August 3^rd, 2012.

Summary for SINGULAIR

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	102
Patent Applications:	3,916
Drug Prices:	Drug price information for SINGULAIR
What excipients (inactive ingredients) are in SINGULAIR?	SINGULAIR excipients list
DailyMed Link:	SINGULAIR at DailyMed

See drug prices for SINGULAIR

See drug sales revenues for SINGULAIR

Recent Clinical Trials for SINGULAIR

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

Sponsor	Phase
Texas A&M University	Phase 1
Michael E. DeBakey VA Medical Center	Phase 1
Baylor College of Medicine	Phase 1

See all SINGULAIR clinical trials

Pharmacology for SINGULAIR

Drug Class	Leukotriene Receptor Antagonist
Mechanism of Action	Leukotriene Receptor Antagonists

Paragraph IV (Patent) Challenges for SINGULAIR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SINGULAIR	Oral Granules	montelukast sodium	4 mg	021409	1	2008-10-17
SINGULAIR	Tablets	montelukast sodium	10 mg	020829	2	2007-02-20
SINGULAIR	Chewable Tablets	montelukast sodium	4 mg and 5 mg	020830	1	2006-12-26

US Patents and Regulatory Information for SINGULAIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	SINGULAIR	montelukast sodium	GRANULE;ORAL	021409-001	Jul 26, 2002	AB	RX	Yes	Yes
Organon	SINGULAIR	montelukast sodium	TABLET;ORAL	020829-002	Feb 20, 1998	AB	RX	Yes	Yes
Organon	SINGULAIR	montelukast sodium	TABLET, CHEWABLE;ORAL	020830-002	Mar 3, 2000	AB	RX	Yes	No
Organon	SINGULAIR	montelukast sodium	TABLET, CHEWABLE;ORAL	020830-001	Feb 20, 1998	AB	RX	Yes	Yes

Expired US Patents for SINGULAIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	SINGULAIR	montelukast sodium	GRANULE;ORAL	021409-001	Jul 26, 2002	5,565,473*PED
Organon	SINGULAIR	montelukast sodium	TABLET;ORAL	020829-002	Feb 20, 1998	5,565,473*PED
Organon	SINGULAIR	montelukast sodium	TABLET, CHEWABLE;ORAL	020830-001	Feb 20, 1998	5,565,473*PED
Organon	SINGULAIR	montelukast sodium	GRANULE;ORAL	021409-001	Jul 26, 2002	8,007,830
Organon	SINGULAIR	montelukast sodium	TABLET, CHEWABLE;ORAL	020830-002	Mar 3, 2000	5,565,473*PED

International Patents for SINGULAIR

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

Country	Patent Number	Title	Estimated Expiration
Finland	914796
Finland	20000250
Peru	20030638	FORMULACION GRANULAR DE MONTELUKAST SODICO
Finland	104897
Spain	2114882

Supplementary Protection Certificates for SINGULAIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0480717	98C0022	France		PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
0480717	C990009	Netherlands		PRODUCT NAME: MONTELUKASTUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER NATRII MONTELUKASTUM; NATL REGISTRATION NO/DATE: RVG 23164 AND RVG 23165 19981103; FIRST REGISTRATION: FI 12766 AND 12767 19970825
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0480717	19/1999	Austria		PRODUCT NAME: MONTELUKAST ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE MONTELUKASTNATRIUM; NAT. REGISTRATION NO/DATE: 1-22765 UND 1-22766 19981030; FIRST REGISTRATION: FI 12766 UND 12767 19970825
0480717	9890027-7	Sweden		PRODUCT NAME: MONTELUKAST, R-(E)-1-1-3-2-(7-KLOR-2KINOLINYL)-ETENYL)-FENYL)-3-(2-(1-HYDROXI-1-METYLETYL)-FENYL)-PROPYL)-TIO)METYL)-CYKLOPROPANAETTIKSYRA, ELLER ETT FARMACEUTISKT GODDTAGBART SALT DAERAV, FOERETRAEDESVIS NATRIUMSALTET; NAT REG./DATE: 13944 19880111; FIRST REG.: FI EG 12766 19970825

Market Dynamics and Financial Trajectory for SINGULAIR (Montelukast)

Last updated: December 17, 2025

Executive Summary

Singulair (montelukast), developed by Merck & Co., is a leukotriene receptor antagonist widely used to manage asthma and allergic rhinitis. Since its US approval in 1998, Singulair has secured a dominant market position, peaking with approximately $5 billion in global annual sales. However, recent patent expirations, evolving regulatory landscapes, and competitive pressures are reshaping its market trajectory. This report assesses the current market dynamics, forecasts future financial prospects, and evaluates key factors influencing Singulair's commercial lifecycle.

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What Are the Core Market Dynamics Affecting Singulair?

1. Patent Expiry and Generic Competition

Timeline and Impact:

• Merck's patent for Singulair expired in the United States in August 2012, with subsequent expirations in several other jurisdictions.
• Generic versions launched shortly thereafter, leading to substantial revenue decline.

Market Share Shift:	Year	Brand Sales (Global, USD)	Generics Introduced	Market Share (% Singulair)
2012	~$5.2 billion	Yes	~80%
2018	~$1.5 billion	Yes	<20%
2022	~$500 million	Yes	<10%

Lessons:

• Patents are critical to maintaining market exclusivity.
• Once expired, generics rapidly erode brand revenues.

2. Regulatory and Legal Actions

• Merck faced significant legal challenges related to off-label marketing and safety concerns, impacting brand perception (notably the 2010 FDA warning for neuropsychiatric events).
• Despite safety advisories, safety issues have not significantly curtailed usage, but have influenced prescriber behavior and regulatory scrutiny.

3. Therapeutic Landscape and Competition

• New Treatment Options:
  • Biologicals such as omalizumab (Xolair), which target allergic pathways, offer alternatives for severe asthma.
  • Inhaled corticosteroids and long-acting beta-agonists (LABAs) remain mainstays.
• Alternative Leukotriene Receptor Antagonists:
  • Limited, as montelukast is the most prominent in its class.

Key Competitors	Drug Class	Indications	Market Position
Xolair	Monoclonal antibody	Severe allergic asthma	Competitive for severe cases
Zileuton	Leukotriene synthesis inhibitor	Asthma	Niche, less widely used
Generic montelukast	Leukotriene receptor antagonist	Mild to moderate asthma, allergic rhinitis	Dominant post-patent expiry

4. Geographic Market Trends

Region	Dominant Market Actor	Notes
North America	Generics, Biosimilars	Significant price erosion post-patent expiration
Europe	Generics predominant	Market declines, with occasional brand persistence
Emerging Markets	Lower generic penetration	Potential growth due to affordability and prescribing habits

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What Is the Financial Trajectory for Singulair?

1. Revenue Trends Post-Patent Expiration

Historical Revenue Pattern:

• 2010: Peak sales (~\$5 billion)
• 2012: Patent expiry initiated; price competition intensified
• 2018: Revenue dropped below \$2 billion globally
• 2022: Estimated \$500 million, with further decline likely

Revenue Forecast (2023–2027):

Year	Projected Revenue (USD, millions)	Assumptions
2023	\$350	Continued generic penetration, moderate reversal in select emerging markets
2024	\$250	Market saturation, further generic share
2025	\$150	Decline driven by generics, biosimilars entry in some regions
2026	\$100	Near market exhaustion, alternative therapies gaining ground
2027	\$75	Substitutes and off-label decline continue

2. Profitability and Margins

• Original margins (pre-patent expiry): >70%
• Current margins (generic era): Approximately 30–40%
• Impact from price erosion, legal, and safety-related expenses affects profitability outlook.

3. Market Valuation and Investment Outlook

Aspect	Status
Total Addressable Market (TAM)	~\$10 billion (global asthma & allergy market)
Share of Singulair	Declined progressively post-patent expiry
Investment Focus	Limited; focus shifts to pipeline drugs and biosimilars

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How Do Regulatory and Policy Frameworks Affect Singulair's Market?

Policy Element	Impact on Singulair
Patent Laws	Expiry halts exclusive rights, enabling generics
Price Controls	In some jurisdictions, limit revenue potential
Labeling & Safety Regulations	Heightened safety expectations reduce prescriber confidence for some indications
Reimbursement Policies	Favor generic substitution to reduce costs

How Do New Therapeutic Developments Influence Singulair’s Future?

Biologics and targeted therapies have shifted treatment paradigms, especially for severe cases, thereby reducing reliance on leukotriene antagonists.

New Treatments	Potential Effect on Singulair	Strengths	Limitations
Biologics (omalizumab, mepolizumab)	Reduce overall asthma medication needs	Effective for severe asthma	High cost, limited approval scope
Precision medicine	Shift toward targeted therapy	Personalized treatment	Market may fragment, impacting volume

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Comparison with Similar Market Dynamics: Other Post-Patent Drugs

Drug Name	Year of Patent Expiry	Peak Revenue	Post-Patent Market Share Decline	Key Factors
Singulair	2012	~$5 billion	Rapid decline post-2012	Generic competition, safety concerns
Lipitor	2011	~$10 billion	Sharp decline over 3 years	Pricing, generics, patent expirations
Crestor	2016	~$3 billion	Stabilized, slower decline	Stronger brand retention, narrow patent ecosystem

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Key Factors Influencing Future Market and Financial Trajectory

Factor	Impact
Patent and Data Exclusivity	Limited, as most expire; no significant extension prospects
Generic and Biosimilar Entry	Continuous erosion of revenue, aggressive pricing pressure
Regulatory Scrutiny	Ongoing safety concerns may affect usage patterns
Industry Innovation	Shift toward biologics decreases dependence on small molecule drugs
Geographic Expansion	Growth opportunities in emerging markets, constrained by affordability and patent laws
New Treatment Approvals	Could replace or complement existing therapies, challenging Singulair’s market share

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Conclusion: Future Outlook for Singulair

Timeline	Outlook
Short-term (1-2 years)	Revenue decline continues; strategic focus on cost management and market segmentation
Mid-term (3-5 years)	Significantly diminished market presence; potential off-label uses or niche indications maintain limited revenue streams
Long-term (beyond 5 years)	Likely phased out of mainstream treatment options or replaced entirely by newer classes of therapeutics

Summary:
Singulair's market is in decline, driven predominantly by patent expirations and increasing generic competition. While still generating revenue, its financial trajectory points toward continued erosion unless new formulations or indications emerge. The shifting therapeutic landscape, regulatory policies, and the advent of novel biologics suggest that Singulair's role is diminishing, requiring strategic adaptation by the manufacturer.

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Key Takeaways

• Patent expirations in 2012 led to a rapid decline in Singulair revenues, with generics now dominating global markets.
• Current revenues are estimated around \$350 million globally (2023), with further decline expected in subsequent years.
• Market dynamics are increasingly influenced by regulatory safety concerns, competition from biologics, and policy-driven price controls.
• Emerging markets offer limited growth potential due to affordability and patent statuses.
• Long-term viability relies on pipeline innovations, potential new indications, or repositioning within specialty niches.

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FAQs

1. What is the primary driver behind Singulair's revenue decline?
   Patent expiration in 2012 and subsequent entry of generic competitors have severely curtailed brand sales, accounting for the decline from peak revenues exceeding \$5 billion to below \$500 million today.

2. Are there any efforts toextend Singulair's market exclusivity?
   No, Merck & Co. has not pursued significant patent extensions or new formulations, rendering the drug largely reliant on its existing indications and market presence.

3. Can biosimilars or new formulations revive Singulair's market potential?
   Given that Singulair is a small-molecule drug, biosimilars are not applicable. Reformulations or new indications could provide incremental growth but are unlikely to fully restore former revenues.

4. What are the key competitors now impacting Singulair?
   The primary competition stems from generic montelukast products, other asthma medications like biologics (e.g., omalizumab), and alternative therapies targeting different inflammatory pathways.

5. What strategic moves should Merck consider to manage Singulair's decline?
   Merck might focus on licensing newer therapies, developing novel formulations, or shifting resources to pipeline products with higher growth prospects.

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References

[1] U.S. Food and Drug Administration. (2010). FDA Drug Safety Communication: FDA reviewing rare neuropsychiatric events associated with montelukast (Singulair).
[2] IMS Health (2022). Pharmaceutical Market Performance Reports.
[3] Merck & Co. Annual Reports (2010–2022).
[4] European Medicines Agency. (2018). Safety and efficacy reviews of leukotriene receptor antagonists.
[5] IQVIA (2023). Global prescription medicines market analysis.