ACCOLATE Drug Patent Profile

Which patents cover Accolate, and what generic alternatives are available?

Accolate is a drug marketed by Strides Pharma Intl and is included in one NDA.

The generic ingredient in ACCOLATE is zafirlukast. There are four drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the zafirlukast profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Accolate

A generic version of ACCOLATE was approved as zafirlukast by DR REDDYS LABS LTD on November 18^th, 2010.

Summary for ACCOLATE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	3
Patent Applications:	4,256
Drug Prices:	Drug price information for ACCOLATE
What excipients (inactive ingredients) are in ACCOLATE?	ACCOLATE excipients list
DailyMed Link:	ACCOLATE at DailyMed

See drug prices for ACCOLATE

Recent Clinical Trials for ACCOLATE

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

Sponsor	Phase
National Institutes of Health (NIH)	Phase 2
Dana-Farber Cancer Institute	Phase 2
University of California, San Francisco	Phase 2

See all ACCOLATE clinical trials

Pharmacology for ACCOLATE

Drug Class	Leukotriene Receptor Antagonist
Mechanism of Action	Cytochrome P450 2C9 Inhibitors Leukotriene Receptor Antagonists

Paragraph IV (Patent) Challenges for ACCOLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ACCOLATE	Tablets	zafirlukast	10 mg and 20 mg	020547	1	2008-02-29

US Patents and Regulatory Information for ACCOLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999	AB	RX	Yes	No
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	AB	RX	Yes	Yes

Expired US Patents for ACCOLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996

International Patents for ACCOLATE

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

Country	Patent Number	Title	Estimated Expiration
China	1062291
Hungary	197724	PROCESS FOR PRODUCTION OF DERIVATIVES OF OF INDOLIL AND INDASOLIL CARBOXAMID AND MEDICAL COMPOSITIONS CONTAINING THEM
Hungary	T61281
Austria	145199

Supplementary Protection Certificates for ACCOLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0199543	SPC/GB98/033	United Kingdom		PRODUCT NAME: ZAFIRLUKAST AND OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT.; REGISTERED: IE PA 51/67/1 19960103; UK 12619/0108 19980605
0199543	97C0031	Belgium		PRODUCT NAME: ZAFIRLUKAST; NAT. REGISTRATION NO/DATE: 624 S 295 F 3 19961216; FIRST REGISTRATION: IE PA 51/67/1 19960103

Market Dynamics and Financial Trajectory for ACCOLATE (Zafirlukast)

Last updated: February 19, 2026

What is ACCOLATE and its approved indications?

ACCOLATE (zafirlukast) is a leukotriene receptor antagonist approved for the maintenance treatment of asthma in adults and pediatric patients aged 5 years and older. It reduces airway inflammation by blocking leukotriene receptors, thereby decreasing bronchoconstriction and airway edema.

How has the market for ACCOLATE evolved?

Since its approval in 1996 by the U.S. Food and Drug Administration (FDA), ACCOLATE has experienced fluctuating market share driven by competing asthma therapies, generics, and evolving treatment guidelines.

Market share and sales performance

• Peak sales: Approximately $544 million in 2000.
• Recent sales: Declined to approximately $100 million in 2022, with multiple factors affecting revenue.
• Geographic distribution: Primarily U.S., with limited international sales; the drug is marketed in select countries under different regulatory statuses.

Market challenges

• Generic competition: Zafirlukast lost patent exclusivity in 2014, leading to increased generic availability.
• Alternative therapies: Long-acting beta-agonists (LABAs), inhaled corticosteroids (ICS), and leukotriene receptor antagonists like montelukast (Singulair) have gained prominence.
• Regulatory changes: Updated guidelines favor inhaled corticosteroids, impacting prescriptions of leukotriene modifiers.
• Safety profile: Concerns over hepatic toxicity and hepatotoxicity—reported in post-marketing surveillance—have reduced prescribing.

Key competitors

• Montelukast (Singulair): Dominates the leukotriene receptor antagonist segment, with global sales exceeding $3 billion annually.
• Other asthma controllers: Inhaled corticosteroids and biologic therapies (e.g., omalizumab) increasingly replace leukotriene antagonists in moderate to severe cases.

What are the financial trends and projections?

Historical revenue data

Year	Approximate Global Sales
2000	$544 million
2010	$400 million
2015	$150 million
2022	$100 million

Revenue drivers

• Patent expiration in 2014 prompted generic erosion.
• Declining prescriptions due to safety concerns and competition.
• Limited market expansion as newer therapies dominate.

Future outlook

• Market contraction expected: Continued decline in branded ACCOLATE sales.
• Pipeline prospects: No significant new indications or formulations announced; unlikely to recover market share.
• Regulatory and safety considerations: Potential restrictions may further dampen usage.

How do regulatory policies influence ACCOLATE's market trajectory?

• FDA safety alerts: Post-marketing reports of hepatic adverse events led to dosing restrictions and warnings, reducing prescribing.
• International regulation: Approval statuses vary; some markets have withdrawn approval or restrictions.
• Patent status: Generic availability since 2014 significantly impacts pricing and profitability.

Conclusions

ACCOLATE's market has contracted substantially over the past decade due to patent loss, safety concerns, and competitive therapies. The drug's revenue trajectory continues downward, with limited prospects for recovery absent new indications or improved safety profiles. The competitive landscape favors inhaled therapies and biologics for asthma management.

Key Takeaways

• ACCOLATE peaked at over $500 million annually but has seen a steep decline since patent expiry.
• Market share eroded by generics, safety concerns, and superior alternatives such as montelukast.
• Regulatory restrictions and safety reports have further limited prescribing.
• No recent developments suggest a reversal trend; the drug remains a legacy therapy.
• The segment structure favors inhaled corticosteroids and biologics, leaving leukotriene receptor antagonists like ACCOLATE marginal.

Frequently Asked Questions

1. Why did ACCOLATE's market decline after 2014?
Patent expiration facilitated generic entry, reducing revenue. Safety concerns and competition from other asthma therapies contributed further to market decline.

2. Are there any new formulations of ACCOLATE under development?
No, there are no announced new formulations or indications, and the drug is considered a legacy therapy with limited future growth.

3. How does ACCOLATE compare to montelukast?
Montelukast dominates the leukotriene receptor antagonist market due to better safety profile, once-daily dosing, and broader international approval.

4. What impact do safety incidents have on ACCOLATE's market?
Safety concerns, particularly hepatic toxicity reports, have led to regulatory warnings and reduced clinician preference, accelerating market contraction.

5. Is there potential for ACCOLATE to regain market share?
Unlikely unless new safety data, formulations, or indications emerge that demonstrate clear clinical benefits and address prior safety issues.

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Sources

[1] U.S. Food and Drug Administration. (2016). FDA Drug Safety Communication: FDA requires label changes for leukotriene receptor antagonists to include warning about rare neuropsychiatric events.
[2] IMS Health. (2021). Global Pharmaceutical Market Data.
[3] EvaluatePharma. (2022). World Preview 2022 Outlook to 2027.
[4] European Medicines Agency. (2014). Zafirlukast summary of product characteristics.