ACCOLATE Drug Patent Profile
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Which patents cover Accolate, and when can generic versions of Accolate launch?
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 |
---|---|
National Institutes of Health (NIH) | Phase 2 |
Dana-Farber Cancer Institute | 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 | 020547-001 | 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 |
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 |
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 |
>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 |
---|---|---|---|
Cyprus | 1705 | Heterocyclic amide derivatives | ⤷ Try a Trial |
Spain | 557643 | ⤷ Try a Trial | |
United Kingdom | 9115107 | ⤷ Try a Trial | |
Russian Federation | 2106140 | ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СПОСОБ ЕЕ ПОЛУЧЕНИЯ, ФИЗИЧЕСКАЯ ФОРМА N-[4-[5-(ЦИКЛОПЕНТИЛОКСИКАРБОНИЛ)АМИНО-1-МЕТИЛИНДОЛ-3-ИЛ-МЕТИЛ]-3-МЕТОКСИБЕНЗОИЛ]-2-МЕТИЛБЕНЗОЛСУЛЬФОНАМИДА, СПОСОБЫ ЕЕ ПОЛУЧЕНИЯ (PHARMACEUTICAL COMPOSITION, METHOD FOR ITS OBTAINING, PHYSICAL FORM OF N-;4-;5-(CYCLOPENTYLOXYCARBONYL)AMINO-1-METHILINDOL-3-IL-METHYL-3- -METHOXYBENZOIL) | ⤷ Try a Trial |
Denmark | 169964 | ⤷ Try a Trial | |
China | 1043405 | ⤷ Try a Trial | |
Philippines | 26763 | Heterocyclic amide derivatives and pharmaceutical use | ⤷ 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 | 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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |