Pylera is a drug owned by Laboratoires Juvise Pharmaceuticals. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 14, 2018. Details of Pylera'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). | |||
| US6350468 | Double capsule for the administration of active principles in multiple therapies |
Dec, 2018
(5 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Pylera 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 Pylera's family patents as well as insights into ongoing legal events on those patents.
Pylera's Family Patents
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Generic Launch
Generic Release Date:
Pylera's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 14, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Pylera Generic API suppliers:
Bismuth Subcitrate Potassium; Metronidazole; Tetracycline Hydrochloride is the generic name for the brand Pylera. 2 different companies have already filed for the generic of Pylera, with Endo Operations having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Pylera's generic
How can I launch a generic of Pylera before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Pylera's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Pylera'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 Pylera -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 140 mg/125 mg/ 125 mg | 12 Aug, 2014 | 1 | 14 Dec, 2018 | Extinguished |
About Pylera
Pylera is a drug owned by Laboratoires Juvise Pharmaceuticals. It is used for treating patients with H. pylori infection and duodenal ulcer disease. Pylera uses Bismuth Subcitrate Potassium; Metronidazole; Tetracycline Hydrochloride as an active ingredient. Pylera was launched by Labs Juvise in 2006.
Approval Date:
Pylera was approved by FDA for market use on 28 September, 2006.
Active Ingredient:
Pylera uses Bismuth Subcitrate Potassium; Metronidazole; Tetracycline Hydrochloride as the active ingredient. Check out other Drugs and Companies using Bismuth Subcitrate Potassium; Metronidazole; Tetracycline Hydrochloride ingredient
Treatment:
Pylera is used for treating patients with H. pylori infection and duodenal ulcer disease.
Dosage:
Pylera is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 140MG;125MG;125MG | CAPSULE | Prescription | ORAL |