Biaxin Xl is a drug owned by Abbvie Inc. 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 Jul 15, 2017. Details of Biaxin Xl'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). | |||
| US6551616 | Extended release formulations of erythromycin derivatives |
Jul, 2017
(9 years ago) |
Expired
|
| US6010718 | Extended release formulations of erythromycin derivatives |
Apr, 2017
(9 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but
Biaxin Xl 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 Biaxin Xl's family patents as well as insights into
ongoing legal events
on those patents.
Biaxin Xl's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Biaxin Xl:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Biaxin Xl's generic launch date based on the expiry of its last outstanding patent is estimated to be Jul 15, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Biaxin Xl Generic API suppliers:
Clarithromycin is the generic name for the brand Biaxin Xl. 20 different companies have already filed for the generic of Biaxin Xl, with Sun Pharm Inds Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Biaxin Xl's generic
How can I launch a generic of Biaxin Xl before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Biaxin Xl's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Biaxin Xl'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 Biaxin Xl -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 05 Feb, 2009 | None |
Alternative Brands for Biaxin Xl
Biaxin Xl which is used for treating mild to moderate infections caused by susceptible strains., has several other brand drugs using the same active ingredient (Clarithromycin). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Phathom |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Clarithromycin, Biaxin Xl's active ingredient. Check the complete list of approved generic manufacturers for Biaxin Xl
About Biaxin Xl
Biaxin Xl is a drug owned by Abbvie Inc. It is used for treating mild to moderate infections caused by susceptible strains. Biaxin Xl uses Clarithromycin as an active ingredient. Biaxin Xl was launched by Abbvie in 2000.
Approval Date:
Biaxin Xl was approved by FDA for market use on 03 March, 2000.
Active Ingredient:
Biaxin Xl uses Clarithromycin as the active ingredient. Check out other Drugs and Companies using Clarithromycin ingredient
Treatment:
Biaxin Xl is used for treating mild to moderate infections caused by susceptible strains.
Dosage:
Biaxin Xl is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |