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Last Updated: December 22, 2024

ACCOLATE Drug Patent Profile


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

Accolate is a drug marketed by Strides Pharma 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 18th, 2010.

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Summary for ACCOLATE
Drug patent expirations by year for ACCOLATE
Drug Prices for ACCOLATE

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Recent Clinical Trials for ACCOLATE

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

SponsorPhase
National Institutes of Health (NIH)Phase 2
Dana-Farber Cancer InstitutePhase 2
University of California, San FranciscoPhase 2

See all ACCOLATE clinical trials

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

Expired US Patents for ACCOLATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Strides Pharma ACCOLATE zafirlukast TABLET;ORAL 020547-001 Sep 26, 1996 5,319,097 ⤷  Subscribe
Strides Pharma ACCOLATE zafirlukast TABLET;ORAL 020547-001 Sep 26, 1996 6,143,775 ⤷  Subscribe
Strides Pharma ACCOLATE zafirlukast TABLET;ORAL 020547-003 Sep 17, 1999 5,583,152 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ACCOLATE

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

Country Patent Number Title Estimated Expiration
Hungary 913863 ⤷  Subscribe
United Kingdom 2280606 Physical forms of benzenesulphonamides ⤷  Subscribe
German Democratic Republic 251348 VERFAHREN ZUR HERSTELLUNG VON HETEROZYKLISCHEN AMIDDERIVATEN ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ACCOLATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0199543 SPC/GB98/033 United Kingdom ⤷  Subscribe 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 ⤷  Subscribe PRODUCT NAME: ZAFIRLUKAST; NAT. REGISTRATION NO/DATE: 624 S 295 F 3 19961216; FIRST REGISTRATION: IE PA 51/67/1 19960103
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

ACCOLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: ACCOLATE

Introduction

ACCOLATE, also known as zafirlukast, is a leukotriene receptor antagonist (LTRA) used primarily for the chronic treatment of asthma in adult and pediatric patients 5 years and older. To understand the market dynamics and financial trajectory of ACCOLATE, it is essential to delve into its clinical efficacy, market positioning, and financial performance.

Clinical Efficacy and Market Positioning

Asthma Treatment

ACCOLATE has been shown to improve various asthma symptoms, including daytime asthma symptoms, nighttime awakenings, mornings with asthma symptoms, and the use of rescue beta2-agonists. Clinical trials have demonstrated its efficacy in improving FEV1 (Forced Expiratory Volume in one second) and peak expiratory flow rates[1].

Off-Label Uses

While primarily used for asthma, there have been exploratory studies suggesting potential off-label uses, such as in the treatment of tuberculosis. An in silico drug repurposing approach identified zafirlukast as a potential inhibitor against the FadD32 protein, which is a target in TB therapy[2].

Market Competition

Leukotriene Receptor Antagonists

ACCOLATE competes within the LTRA market, which includes other drugs like montelukast. The competition in this segment is driven by the efficacy, safety profile, and patient compliance of each drug.

Asthma Treatment Market

The asthma treatment market is diverse, with various therapeutic options including inhaled corticosteroids, bronchodilators, and biologics. ACCOLATE's position is as an add-on therapy for patients who are not adequately controlled by other treatments.

Financial Trajectory

Revenue and Growth

The financial performance of ACCOLATE is tied to its sales and market share within the asthma treatment market. However, specific financial data for ACCOLATE alone is not readily available, as it is often reported as part of the broader portfolio of its manufacturer.

Pharmaceutical Industry Trends

The pharmaceutical industry, particularly the respiratory segment, has seen significant growth driven by increasing prevalence of respiratory diseases and advancements in treatment options. Companies involved in respiratory care often report strong revenue growth and expanding market share.

Drug Interactions and Safety Profile

Impact on Financials

The safety profile and potential drug interactions of ACCOLATE can influence its market dynamics. For instance, the need for close monitoring of patients on warfarin or other drugs metabolized by the CYP2C9 isoenzyme can affect prescribing habits and patient compliance, potentially impacting sales[1][4].

Hepatotoxicity

Cases of liver injury associated with ACCOLATE have been reported, which can lead to regulatory scrutiny and affect market confidence. The necessity for periodic liver function testing and the risk of severe hepatic adverse events may influence prescribing decisions and patient adherence[1].

Regulatory Environment

FDA Approval and Monitoring

ACCOLATE is FDA-approved for the chronic treatment of asthma. Regulatory bodies closely monitor its safety profile, and any significant adverse events can lead to changes in labeling or prescribing guidelines, which can impact its market trajectory.

Patient and Physician Preferences

Compliance and Adherence

Patient compliance and physician preference play crucial roles in the market dynamics of ACCOLATE. The drug's efficacy, safety profile, and ease of administration influence these factors. For example, the need for regular dosing and potential interactions with other medications can affect patient adherence.

Future Prospects

Repurposing and New Indications

The potential repurposing of ACCOLATE for other indications, such as TB therapy, could expand its market reach and financial potential. However, this would require additional clinical trials and regulatory approvals[2].

Market Expansion

Expanding into new markets, particularly in regions with high prevalence of asthma and other respiratory diseases, could also drive growth. This would involve strategic marketing, distribution agreements, and possibly partnerships with local healthcare providers.

Key Takeaways

  • Clinical Efficacy: ACCOLATE has demonstrated efficacy in improving asthma symptoms and is used as an add-on therapy.
  • Market Competition: It competes within the LTRA market and broader asthma treatment segment.
  • Financial Trajectory: While specific financial data is limited, the drug's performance is influenced by its market share, safety profile, and regulatory environment.
  • Drug Interactions and Safety: Close monitoring is required due to potential drug interactions and hepatotoxicity risks.
  • Regulatory Environment: FDA approval and ongoing monitoring are critical for its market presence.
  • Future Prospects: Potential repurposing and market expansion could drive future growth.

FAQs

What is ACCOLATE used for?

ACCOLATE (zafirlukast) is used for the chronic treatment of asthma in adult and pediatric patients 5 years and older.

What are the potential side effects of ACCOLATE?

ACCOLATE can cause liver injury, and patients should be monitored for symptoms of hepatic dysfunction. It also interacts with various drugs, including warfarin and opioids, which can lead to increased risk of adverse effects.

Can ACCOLATE be used for acute asthma attacks?

No, ACCOLATE is not a bronchodilator and should not be used to treat acute episodes of asthma.

What are the implications of ACCOLATE's potential repurposing for TB therapy?

If approved for TB therapy, ACCOLATE could expand its market reach and financial potential by addressing a new therapeutic area.

How does ACCOLATE's safety profile impact its market dynamics?

The need for close monitoring due to potential drug interactions and hepatotoxicity risks can affect prescribing habits and patient compliance, potentially impacting sales and market share.

Sources

  1. Accolate (zafirlukast) - accessdata.fda.gov
  2. In Silico Drug Repurposing Approach - NCBI
  3. Accolade Inc. - Public now
  4. Accolate - Drug Summary - PDR.Net

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