ACCOLATE Drug Patent Profile
✉ Email this page to a colleague
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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for ACCOLATE?
- What are the global sales for ACCOLATE?
- What is Average Wholesale Price for ACCOLATE?
Summary for ACCOLATE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 113 |
| Clinical Trials: | 3 |
| Patent Applications: | 5,283 |
| Drug Prices: | Drug price information for ACCOLATE |
| What excipients (inactive ingredients) are in ACCOLATE? | ACCOLATE excipients list |
| DailyMed Link: | ACCOLATE at DailyMed |
Recent Clinical Trials for ACCOLATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Dana-Farber Cancer Institute | Phase 2 |
| National Institutes of Health (NIH) | Phase 2 |
| University of California, San Francisco | Phase 2 |
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 | ACCOLATE | zafirlukast | TABLET;ORAL | 020547-003 | Sep 17, 1999 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Strides Pharma | ACCOLATE | zafirlukast | TABLET;ORAL | 020547-001 | Sep 26, 1996 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Strides Pharma | ACCOLATE | zafirlukast | TABLET;ORAL | 020547-001 | Sep 26, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Strides Pharma | ACCOLATE | zafirlukast | TABLET;ORAL | 020547-003 | Sep 17, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Strides Pharma | ACCOLATE | zafirlukast | TABLET;ORAL | 020547-003 | Sep 17, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Strides Pharma | ACCOLATE | zafirlukast | TABLET;ORAL | 020547-003 | Sep 17, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Israel | 100090 | Crystalline form of n-[4[5-(cyclopentyloxycarbonyl) amino-1-methyl-indol 3-ylmethyl]-3-methoxybenzoyl)-2-methoxybenzoyl]-2-methylbenzene sulphonamide process for its preparation and pharmaceutical compositions containing it | ⤷ Sign Up |
| Czech Republic | 283181 | Farmaceutická činidla (PHARMACEUTICAL PREPARATION, PROCESS OF ITS PREPARATION, PROCESS FOR PREPARING ACTIVE COMPONENT THEREOF AND INTERMEDIATE FOR SUCH PROCESS) | ⤷ Sign Up |
| Hong Kong | 81597 | Physical forms of benzene-sulphonamides | ⤷ Sign Up |
| Israel | 100091 | Pharmaceutical compositions containing a physical form of n-[4-[5-(cyclopentyloxycarbonyl)amino-1-methyl indol-3-yl-methyl]-2-methylbenzenesulpho-namide and process for their preparation | ⤷ Sign Up |
| Philippines | 30928 | Pharmaceutical agents. | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ACCOLATE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0199543 | 97C0031 | Belgium | ⤷ Sign Up | PRODUCT NAME: ZAFIRLUKAST; NAT. REGISTRATION NO/DATE: 624 S 295 F 3 19961216; FIRST REGISTRATION: IE PA 51/67/1 19960103 |
| 0199543 | SPC/GB98/033 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ZAFIRLUKAST AND OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT.; REGISTERED: IE PA 51/67/1 19960103; UK 12619/0108 19980605 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
