Accolate is a drug owned by Strides Pharma Global Pte Ltd. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 18, 2014. Details of Accolate's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5612367 | Method of enhancing bioavailability of pharmaceutical agents |
Mar, 2014
(10 years ago) |
Expired
|
| US5482963 | Pharmaceutical agents useful as leukotriene antagonists |
Jan, 2013
(11 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Accolate is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Accolate's family patents as well as insights into ongoing legal events on those patents.
Accolate's Family Patents
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Generic Launch
Generic Release Date:
Accolate's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 18, 2014 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Accolate Generic API suppliers:
Zafirlukast is the generic name for the brand Accolate. 4 different companies have already filed for the generic of Accolate, with Annora Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Accolate's generic
How can I launch a generic of Accolate before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Accolate's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Accolate's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Accolate -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg and 20 mg | 29 Feb, 2008 | 1 | 18 Nov, 2010 | 18 Mar, 2014 | Eligible |
About Accolate
Accolate is a drug owned by Strides Pharma Global Pte Ltd. It is used for increasing the absorption of the drug substance in the body. Accolate uses Zafirlukast as an active ingredient. Accolate was launched by Strides Pharma in 1999.
Approval Date:
Accolate was approved by FDA for market use on 17 September, 1999.
Active Ingredient:
Accolate uses Zafirlukast as the active ingredient. Check out other Drugs and Companies using Zafirlukast ingredient
Treatment:
Accolate is used for increasing the absorption of the drug substance in the body.
Dosage:
Accolate is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MG | TABLET | Prescription | ORAL |
| 10MG | TABLET | Prescription | ORAL |