ACCOLATE Drug Patent Profile
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When do Accolate patents expire, 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. Eight 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.
Summary for ACCOLATE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 113 |
| Clinical Trials: | 3 |
| Patent Applications: | 4,990 |
| Formulation / Manufacturing: | see details |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for ACCOLATE
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Strides Pharma | ACCOLATE | zafirlukast | TABLET;ORAL | 020547-001 | Sep 26, 1996 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >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 | 020547-003 | Sep 17, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| Strides Pharma | ACCOLATE | zafirlukast | TABLET;ORAL | 020547-003 | Sep 17, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| Strides Pharma | ACCOLATE | zafirlukast | TABLET;ORAL | 020547-003 | Sep 17, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| Strides Pharma | ACCOLATE | zafirlukast | TABLET;ORAL | 020547-003 | Sep 17, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| Strides Pharma | ACCOLATE | zafirlukast | TABLET;ORAL | 020547-001 | Sep 26, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Strides Pharma | ACCOLATE | zafirlukast | TABLET;ORAL | 020547-001 | Sep 26, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Strides Pharma | ACCOLATE | zafirlukast | TABLET;ORAL | 020547-003 | Sep 17, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| Spain | 557643 | ⤷ Try a Trial | |
| Norway | 170482 | ⤷ Try a Trial | |
| Hong Kong | 81397 | Pharmaceutical compositions containing benzene-sulphonamides | ⤷ Try a Trial |
| Hong Kong | 81497 | Heterocyclic sulphonamide leukotriene antagonist | ⤷ Try a Trial |
| South Africa | 9109771 | ⤷ Try a Trial | |
| Canada | 2319308 | AGENTS PHARMACEUTIQUES (PHARMACEUTICAL AGENTS) | ⤷ Try a Trial |
| Israel | 78569 | SUBSTITUTED CARBOXAMIDO-BENZ-HETEROCYCLYL-METHYL-BENZOIC ACIDS,PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEM | ⤷ Try a Trial |
| >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 | ⤷ Try a Trial | 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 | ⤷ Try a Trial | 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
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