Alli is a drug owned by Haleon Us Holdings Llc. 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 Jan 06, 2018. Details of Alli'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). | |||
| US6004996 | Tetrahydrolipstatin containing compositions |
Jan, 2018
(6 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Alli 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 Alli's family patents as well as insights into ongoing legal events on those patents.
Alli's Family Patents
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Generic Launch
Generic Release Date:
Alli's generic launch date based on the expiry of its last outstanding patent is estimated to be Jan 06, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Alli Generics:
There are no approved generic versions for Alli as of now.
How can I launch a generic of Alli before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Alli's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Alli'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 Alli -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 60 mg | 08 Sep, 2010 | 1 | 06 Jan, 2018 | Extinguished |
Alternative Brands for Alli
There are several other brand drugs using the same active ingredient (Orlistat) as Alli. 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 | |
|---|---|---|
| Cheplapharm |
|
About Alli
Alli is a drug owned by Haleon Us Holdings Llc. Alli uses Orlistat as an active ingredient. Alli was launched by Haleon Us Holdings in 2007.
Approval Date:
Alli was approved by FDA for market use on 07 February, 2007.
Active Ingredient:
Alli uses Orlistat as the active ingredient. Check out other Drugs and Companies using Orlistat ingredient
Dosage:
Alli is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 60MG | CAPSULE | Over the counter | ORAL |