Locoid Lipocream is a drug owned by Precision Dermatology Inc. 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 Jun 03, 2014. Details of Locoid Lipocream'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5635497 | Topical application compositions |
Jun, 2014
(10 years ago) |
Expired
|
FDA has granted several exclusivities to Locoid Lipocream. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Locoid Lipocream, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Locoid Lipocream.
Exclusivity Information
Locoid Lipocream holds 1 exclusivities. All of its exclusivities have expired in 2012. Details of Locoid Lipocream's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-613) | Oct 19, 2012 |
US patents provide insights into the exclusivity only within the United States, but Locoid Lipocream 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 Locoid Lipocream's family patents as well as insights into ongoing legal events on those patents.
Locoid Lipocream's family patents
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Generic Launch
Generic Release Date:
Locoid Lipocream's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 03, 2014 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Locoid Lipocream Generics:
Hydrocortisone Butyrate is the generic name for the brand Locoid Lipocream. 6 different companies have already filed for the generic of Locoid Lipocream, with Taro Pharm Inds having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Locoid Lipocream's generic
How can I launch a generic of Locoid Lipocream before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Locoid Lipocream's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Locoid Lipocream'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 Locoid Lipocream -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.001 | 28 Jun, 2010 | 1 | 27 Sep, 2013 | 03 Jun, 2014 | Eligible |
About Locoid Lipocream
Locoid Lipocream is a drug owned by Precision Dermatology Inc. Locoid Lipocream uses Hydrocortisone Butyrate as an active ingredient. Locoid Lipocream was launched by Precision Dermat in 1997.
Market Authorisation Date:
Locoid Lipocream was approved by FDA for market use on 08 September, 1997.
Active Ingredient:
Locoid Lipocream uses Hydrocortisone Butyrate as the active ingredient. Check out other Drugs and Companies using Hydrocortisone Butyrate ingredient
Dosage:
Locoid Lipocream is available in cream form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.1% | CREAM | Prescription | TOPICAL |